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Category: In the News

Jul6Calyxo Raises $32.7 Million in Series C Financing to Support Novel Approach to Treating Kidney Stones »


PLEASANTON, Calif.--()--Calyxo, Inc., a medical device company focused on improving care for patients with kidney stones by delivering next generation treatment solutions, has announced the closing of a $32.7 million Series C financing round led by Questa Capital and CRG.

 

Calyxo has developed the innovative CVAC Aspiration System that utilizes irrigation and aspiration to remove kidney stones with the goal of a surgically stone-free outcome, a challenge that has always been difficult to achieve consistently.

“We are excited to be moving into the next step of our evolution,” said…

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Jun15Avinger Announces Presentations by Key Opinion Leaders and Live Case Transmission at LINC »


REDWOOD CITY, CA / ACCESSWIRE / June 15, 2022 / Avinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of Peripheral Artery Disease (PAD), today announced two podium presentations and a live case transmission featuring the company's Lumivascular technology at the Leipzig Interventional Course (LINC) 2022, which took place June 6 through June 9. LINC is a leading global forum for new methods and technology in the field of vascular medicine held each year in Leipzig, Germany.

 

Key opinion leaders in the fields of interventional cardiology and endovascular…

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Jan26Truveris Launches the First Member-Centric Patient Engagement Solution, oneRx™ »


NEW YORK, JANUARY 26, 2022 – Today, Truveris announced the launch of oneRxTM, its innovative patient engagement solution. oneRx is the only drug price transparency solution that helps members navigate the entirety of their pharmacy benefits, integrating directly with a patient’s pharmacy insurance plan, which enables real-time, optimized drug price comparisons.

 

oneRx is a powerful addition to Truveris’ existing suite of industry-leading pharmacy procurement and oversight solutions. oneRx is designed to engage members with the unique pharmacy benefits plans that are procured through the Truveris MarketplaceTM and that are continuously monitored with truGuardTM analytics. Together, the Truveris solutions suite delivers valuable plan data and cost-savings…

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Jan14Avinger Announces Closing of $7.6 Million Registered Direct Offering »


REDWOOD CITY, CA / ACCESSWIRE / January 14, 2022 / Avinger, Inc. (NASDAQ:AVGR) (the "Company"), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of Peripheral Artery Disease (PAD), today announced the closing of its previously announced registered direct offering of an aggregate of 7,600 shares of Series D convertible preferred stock (the "Preferred Stock") and warrants to purchase up to an aggregate of 16,150,000 shares of common stock to certain institutional investors for gross proceeds of $7.6 million. The shares of Preferred Stock have a stated value of $1,000 per share…

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Jan12State to use Truveris’ proprietary truBid® technology for PBM procurement and ongoing oversight of all pharmacy claims. »


NEW YORK, JANUARY 12, 2022 – Truveris, the leader in pharmacy cost containment and program performance, announced today that the State of Minnesota selects Truveris as its exclusive PBM procurement and oversight partner. Truveris will work in partnership with the State of Minnesota to conduct a full reverse-auction process to secure the best contract pricing and terms for the state’s pharmacy benefit needs. 

 

Truveris’ patented, reverse-auction technology, truBid®, creates a transparent and dynamic competitive PBM marketplace that drives significant savings on pharmacy pricing and improved contract terms. By conducting a rigorous reverse-auction process that has been tested and proven over several hundred procurements,…

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Jan11Avinger Announces 510(k) Clearance for Lightbox 3 Next-Generation Imaging Console »


REDWOOD CITY, CA / ACCESSWIRE / January 11, 2022 / Avinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of Peripheral Artery Disease (PAD), today announced that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its new Lightbox 3 imaging console.

 

"We are excited to receive U.S. pre-marketing clearance for the Lightbox 3 imaging console. Our new Lightbox 3 delivers important advancements in imaging, portability and capability," commented Jeff Soinski, Avinger's President and CEO. "The Lightbox 3 is designed to accelerate new…

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Oct26Bionova Scientific unveils new commercial-ready GMP biologics manufacturing facility at grand opening event »


Fremont, CA October 26, 2021 – Bionova Scientific, a biologics CDMO with extensive protein production, cell line development, process development and analytical expertise, today announced the grand opening of its commercial-ready fully single-use GMP biologics manufacturing center at its Fremont, California headquarters. The first clinical supply run at the state-of-the-art facility will be completed before year-end 2021.

 

After announcing the project in July 2021 amid the disruption of the COVID-19 pandemic, Bionova was able to overcome logistical and supply-chain challenges to complete construction on-time and on-budget in less than 12 months. The facility was designed by DGA Architecture and built…

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Sep30VGK Announce Credit One Bank & P3 Health Partners as Helmet Sponsors »


The Vegas Golden Knights announced today, Sept. 30, a season-long helmet entitlement partnership with Credit One Bank and P3 Health Partners.

 

Credit One Bank will officially receive branding on team helmets worn during all home games at T-Mobile Arena during the 2021-22 season. P3 Health Partners will receive branding on team helmets worn during all away games through the 2021-22 season.

 

For more information on Credit One Bank, click here. For more information on P3 Health Partners, click here.

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Aug16'MyCare Medical Group' Enters into Strategic Partnership with 'Medical Group of South Florida' and 'Radiant Medical Group' »


TAMPA, Fla., Aug. 16, 2021 /PRNewswire/ -- MyCare Medical Group officially announced it had entered into a partnership and full merger with both Medical Group of South Florida (MGSFL) and Radiant Medical Group. Marking another key milestone of continued growth, the merger allows MyCare to expand into Palm Beach County where MGSFL and Radiant are based. MyCare will also now offer cardiology, chiropractic, endocrinology, gastroenterology, orthopedics, physical therapy, podiatry, along with imaging and radiology oncology services through MGSFL's multidisciplinary approach. Specializing in older adult care, MyCare serves over 100,000 patients in Florida, with approximately 30,000 Medicare Advantage patients and 10,000 traditional Medicare patients.

 

"It was wonderful to find…

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Aug9Avinger Announces 510(k) Filing for New Lightbox 3 Imaging Console »


Smaller Footprint, Improved User Experience and Lower Cost to Drive Adoption

 

REDWOOD CITY, CA / ACCESSWIRE / August 9, 2021 / Avinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of Peripheral Artery Disease (PAD), today announced the submission of a 510(k) application to the U.S. Food & Drug Administration (FDA) for its new Lightbox 3 imaging console.

 

"Avinger's Lightbox 3 represents an important leap forward in imaging, portability and capability," commented Jeff Soinski, Avinger's President and CEO. "The Lightbox 3's compact size, next generation laser system…

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Aug4RV Health, A Red Ventures Business, Acquires Healthgrades.com from Mercury Healthcare »


CHARLOTTE, NC  and DENVER, CO –  RV Health, a Red Ventures business, has acquired Healthgrades.com from Mercury Healthcare, the new brand for the separate enterprise-wide technology and data platform for health systems formerly known as Healthgrades. Healthgrades.com is the leading online marketplace to find and connect with the right doctor, the right hospital and the right care. Half of all Americans who visit a doctor this year will visit Healthgrades.com as part of their healthcare journey. 

 

RV Health’s portfolio also includes Healthline Media, the #1 digital health property with 92MM unique monthly visitors according to the latest Comscore rankings,…

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Jul20CleanSlate, Nationwide Opioid Addiction Care Provider Serving Ten States, Reaches Historic Milestone: Treats Over 100,000 Patients »


BRENTWOOD, Tenn., July 20, 2021 /PRNewswire/ -- Today, CleanSlate Centers, a nationwide, community-based outpatient addiction medicine provider serving ten states, has announced it has reached a historic milestone, having now treated over 100,000 patients who suffer from opioid and alcohol addiction, as well as polysubstance use disorders, along with related medical and behavioral comorbidities. 

 

Founded in 2009 in Massachusetts in response to the growing opioid epidemic facing the United States, CleanSlate is one of the largest national medical groups that provide physician-led, office-based treatment for individuals suffering from substance use disorders.

 

"We're proud of this achievement in helping thousands of Americans recover from…

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Jul6Avinger Announces 510(k) Filing for New Pantheris In-Stent Restenosis Indication »


REDWOOD CITY, CA / ACCESSWIRE / July 6, 2021 / Avinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of Peripheral Artery Disease (PAD), today announced the submission of a 510(k) application to the U.S. Food & Drug Administration (FDA) for a new Pantheris clinical indication for the treatment of in-stent restenosis (ISR) in the lower extremity arteries.

 

Highlighting the importance of this submission, Jeff Soinski, Avinger's President and CEO commented, "We are extremely pleased with this milestone and the initial clinical data generated from the INSIGHT trial…

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Jun15'MyCare Medical' Continues Expansion of Service Area: Partners With 'South Florida Family Medicine' to Offer Services in Broward County »


TAMPA, Fla., June 15, 2021 /PRNewswire/ -- MyCare Medical announced the recent acquisition of South Florida Family Medicine (SFFM), located in Plantation, Florida. Greatly expanding MyCare's clinical footprint in South Florida, the addition of SFFM adds three new committed and experienced healthcare professionals to MyCare's growing network which now serves more than 50,000 patients statewide.

 

Founded by Dr. Sylvan Goldin, and currently led by Dr. Jarrod Frydman, SFFM has served the Broward community for over 50 years. "Our longstanding presence and growth in the community is attributed to referrals from our existing patients," said Dr. Frydman. "We treat multiple generations of the same families. This is a testament…

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Jun10VIVEVE ANNOUNCES ISSUANCE OF NEW DEVICE AND METHODS PATENT IN U.S. »


ENGLEWOOD, CO / ACCESSWIRE / June 10, 2021 / Viveve Medical, Inc. (NASDAQ:VIVE), a medical technology company focused on women's intimate health, today announced that the United States Patent and Trademark Office (USPTO) recently issued U.S. Patent No. 10,980,596 for Viveve's dual-energy technology device. The awarded patent further strengthens the Company's intellectual property portfolio and expands its patent claims in the U.S. 

 

"We are pleased to have secured the new patent for our Viveve® System in the U.S. The issued patent is the latest addition to our robust intellectual property portfolio, which was recently expanded by patents issued in two…

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May25Avinger Announces Issuance and Allowance of Seven U.S. Patents »


REDWOOD CITY, CA / ACCESSWIRE / May 25, 2021 / Avinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of Peripheral Artery Disease (PAD), today announced the issuance and allowance of seven U.S. patents to date in 2021.

 

These new U.S. patents include a wide range of claims relating to Avinger's proprietary optical coherence tomography (OCT) intravascular imaging system and its OCT-guided catheters for the treatment of vascular disease. With the addition of these patents and new filings made in 2021, Avinger's intellectual property portfolio now numbers 182 patents…

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May25P3 Health Partners to Become Publicly Traded via Merger with Foresight Acquisition Corp. »


NEW YORK, May 25, 2021 (GLOBE NEWSWIRE) --  P3 Health Partners (“P3”) and Foresight Acquisition Corp. (NASDAQ: FORE) (“Foresight”) have entered into a definitive agreement which would result in P3 becoming a publicly listed company.

 

Upon closing of the transaction, the combined entity will be renamed P3 Health Partners and is expected to remain listed on the Nasdaq Capital Market.

 

P3 is a patient-centered and physician-led population health management company that supports providers, physicians, and practices in their journey from traditional volume-based models to value-based systems of care and wellness. P3 believes its extensive experience managing Medicare Advantage (MA)…

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May25NavaDerm Secures Up To $30M in Debt Financing from CRG »


-- Portion of proceeds will be used to drive growth and expand footprint in NY and contiguous states --

 

New York, May 25, 2021 /PRNewswire/ -- NavaDerm Partners, LLC ("NavaDerm" or the "Company"), a dermatology platform and portfolio company of BelHealth Investment Partners, LLC ("BelHealth"), a healthcare private equity firm based in Fort Lauderdale, Florida, announced the completion of a financing with CRG, a healthcare investment firm.

 

Through the transaction with CRG, NavaDerm will initially access $20 million of debt and the proceeds will be used to retire existing debt and provide capital for immediate growth opportunities. The company has the option to…

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Apr26NeuroPace, Inc. Announces Closing of Initial Public Offering and Full Exercise of the Underwriters’ »


MOUNTAIN VIEW, Calif. April 26, 2021 (GLOBE NEWSWIRE) -- NeuroPace, Inc. (Nasdaq: NPCE), a commercial-stage medical device company focused on developing products to treat and transform the lives of patients suffering from epilepsy, today announced the closing of its initial public offering of 6,900,000 shares of its common stock, including the exercise in full of the underwriters’ option to purchase 900,000 additional shares of common stock, at the initial public offering price of $17.00 per share. The gross proceeds to NeuroPace, before deducting underwriting discounts and commissions and offering expenses, were approximately $117.3 million. NeuroPace’s common stock began trading on…

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Apr21New Publications Highlight Clinical Benefits of Avinger PAD Therapies »


Redwood City, CA / ACCESSWIRE / April 21, 2021 / Avinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of Peripheral Artery Disease (PAD), today announced the publication of two clinical studies in peer-reviewed journals, further supporting the clinical benefits of its therapeutic devices. The studies were based on separate clinical case series conducted by physicians at the Division of Cardiovascular Disease and Endovascular Medicine at the Einstein Medical Center in Philadelphia, Pennsylvania.

 

"These two studies demonstrate the utility of Avinger's OCT-guided approach for the treatment of PAD…

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Apr8Avinger Provides Update on Tigereye(TM) Commercial Launch »


Redwood City, CA / ACCESSWIRE / April 8, 2021 / Avinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of Peripheral Artery Disease (PAD), today provided an update on the commercial launch of Tigereye CTO Crossing catheters for the treatment of PAD.

 

Following limited launch in the fourth quarter of 2020, Avinger initiated full commercial launch of Tigereye in January 2021. Tigereye has now been launched in 30 clinical sites with more than 160 cases successfully performed. Avinger territory sales managers have opened an average of 2.7 sites…

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Mar30Healthgrades Announces Appointment of Jovan Willford as Chief Executive Officer to Lead New Phase of Growth »


Denver, Colo. – (March 30, 2021) – Healthgrades today announced the appointment of Jovan Willford as its Chief Executive Officer and a member of its Board of Directors, effective immediately. Mr. Willford brings more than 20 years’ experience in healthcare technology and advanced analytics as a dynamic leader known for growth, transformation and strong operational focus. Rob Draughon, who has served as Healthgrades CEO since 2018 and its President and/or CFO since 2012, will assume the role of CEO of Healthgrades Marketplace division, reporting directly to Mr. Willford.

 

“The addition of Jovan to our leadership team comes at a critical juncture…

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Mar25Alignment Healthcare Announces Pricing of Initial Public Offering »


Orange, Calif., March 25, 2021 (GLOBE NEWSWIRE) -- Alignment Healthcare, Inc. (“Alignment Healthcare” or the “Company”), a mission-based, tech-enabled Medicare Advantage company, today announced the pricing of its initial public offering of 27,200,000 shares of its common stock at $18.00 per share, including 5,500,000 shares of common stock to be sold by certain existing stockholders. As part of the offering, existing stockholders have granted to the underwriters a 30-day option to purchase up to an additional 4,080,000 shares of common stock at the initial public offering price, less underwriting discounts and commissions. The shares are expected to begin trading on…

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Mar16Leigh Feenburg Appointed CEO of Mid-Atlantic Dental Partners »


-- Leading DSO Positioned for Strategic Growth --

 

Plymouth Meeting, Pa.--(BUSINESS WIRE)--Mid-Atlantic Dental Partners, one of the nation’s largest dental support organizations (DSO), announced today the appointment of Leigh Feenburg to the role of Chief Executive Officer. Formerly COO of Mid-Atlantic, Feenburg will build upon the strong foundation set by Mitchell Goldman, founder and former CEO. Goldman will continue to be actively involved in the business and serve as Executive Chairman on the Board of Directors.

 

“The quality of our performance is based on the successful development of our team. Leigh represents the future of our company and will…

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Mar15Veracyte Completes Acquisition of Decipher Biosciences »


-- Further solidifies global leadership in differentiated, genomics-driven cancer diagnostics and expands TAM with presence in 7 of the 10 most common cancers

Tina Nova, Ph.D., named Veracyte’s general manager, urologic cancers --

 

South San Francisco, Calif.--(BUSINESS WIRE)--Mar. 15, 2021-- Veracyte, Inc. (Nasdaq: VCYT) today announced it has completed its acquisition of Decipher Biosciences, Inc. to further solidify its global leadership in genomic diagnostics, with an expanded reach into 7 of the 10 most common cancers in the United States, while accelerating revenue growth.

 

“Bringing Decipher into the Veracyte family marks a significant advance in achieving our vision of…

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Feb8EyePoint Pharmaceuticals Announces Closing of $115 Million Public Offering of Common Stock »


Watertown, Mass., Feb. 04, 2021 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a pharmaceutical company committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders, today announced the closing of an underwritten public offering of 10,465,000 shares of its common stock at a public offering price of $11.00 per share, including the exercise in full by the underwriters of their option to purchase up to 1,365,000 additional shares of common stock. The gross proceeds of the offering to the Company are approximately $115.1 million, before deducting the underwriting discounts and commissions and other estimated offering expenses.

 

Cowen and…

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Feb3Veracyte to Acquire Decipher Biosciences »


-- Further solidifies global leadership in differentiated, genomics-driven cancer diagnostics

Expands TAM with presence in 7 of the 10 most common cancers 

Expected to accelerate revenue growth 

Tina Nova, Ph.D., Decipher Biosciences’ president and CEO, has left Veracyte’s board and will become Veracyte’s GM, urologic cancers 

Investor conference call and webcast today at 8:00 a.m. Eastern Time --

 

South San Francisco, Calif., & San Diego, Calif.--(BUSINESS WIRE)--Feb. 3, 2021-- Veracyte, Inc. (Nasdaq: VCYT) and Decipher Biosciences, Inc., a commercial-stage precision oncology company focused on urologic cancers, today announced they have entered into a definitive agreement through which Veracyte will…

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Jan21Boston Scientific Announces Agreement To Acquire Preventice Solutions, Inc. »


-- Acquisition of external cardiac monitoring technologies and services provider to expand rhythm management diagnostics portfolio and capabilities --

 

Marlborough, Mass., Jan. 21, 2021 /PRNewswire/ -- Boston Scientific (NYSE: BSX) today announced that it has entered into a definitive agreement to acquire Preventice Solutions, Inc., a privately-held company which offers a full portfolio of mobile cardiac health solutions and services, ranging from ambulatory cardiac monitors – including short and long-term Holter monitors – to cardiac event monitors and mobile cardiac telemetry. The transaction consists of an upfront cash payment of $925 million, and up to an additional $300 million in a potential commercial milestone payment. Boston…

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Jan3EyePoint Pharmaceuticals Announces $15.7 Million Equity Investment by Asia Partner Ocumension Therapeutics »


Watertown, Mass., Jan. 03, 2021 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a pharmaceutical company committed to developing and commercializing innovative ophthalmic products, today announced that Ocumension Therapeutics, a China-based ophthalmic pharmaceutical company traded on the Stock Exchange of Hong Kong (1477.HK), has made a $15.7 million equity investment in EyePoint. Under the terms of the agreement, Ocumension has purchased approximately 3.01 million shares of EyePoint’s common stock at a five-day trailing volume weighted average price as of the close of trading on December 29, 2020 of approximately $5.22 per share.

 

“This investment underscores our continued strong partnership with Ocumension for YUTIQ and DEXYCU in Asia,” said Nancy Lurker, President and Chief Executive…

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Dec22Revelstoke Capital Partners Raises Single Asset Fund Dedicated to Rural Healthcare »


Denver, Dec. 22, 2020 /PRNewswire/ -- Revelstoke Capital Partners ("Revelstoke" or the "Firm"), a leading private equity firm focused on investing in healthcare services companies, announced today that it has completed fundraising for Revelstoke Single Asset Fund II, L.P. ("RSAF II" or the "Fund"). RSAF II, with $111 million of commitments, was oversubscribed.

 

Concurrently with the closing of RSAF II, the Fund acquired a minority equity interest in Fast Pace Health, with which Revelstoke has long had a successful partnership. Fast Pace Health is a leading provider of primary, walk-in, urgent care and multi-specialty services serving rural communities through a broad network of 127…

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Dec4Avinger Expands Tigereye(TM) Limited Launch »


Redwood City, CA / ACCESSWIRE / December 4, 2020 / Avinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of Peripheral Artery Disease (PAD), today provided an update on the limited launch of its Tigereye™ next generation image-guided chronic total occlusion (CTO) crossing system. Avinger is conducting a limited launch at clinical centers in the U.S. and Germany during the fourth quarter of 2020 prior to a planned expansion to full U.S. commercial distribution in the first quarter of 2021.

 

Following clearance by the U.S. Food and Drug Administration…

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Dec1Avinger Receives Nasdaq Extension, Recommends Stockholders Vote FOR All Proxy Proposals »


Redwood City, CA / ACCESSWIRE / December 1, 2020 / Avinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company marketing the first-ever image-guided, catheter-based system for the diagnosis and treatment of Peripheral Artery Disease (PAD), today announced the company has received an extension until May 19, 2021 to regain compliance with the Nasdaq minimum bid price requirement for continued listing. The company previously had until November 20, 2020 to regain compliance, and received its extension notice on November 24, 2020.

 

To ensure Avinger will successfully resolve its minimum bid price requirement, either through organic growth in its stock price or via…

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Nov19Healthgrades Debuts Telehealth Resource Center to Connect Consumers with Providers Virtually »


Denver, Colo. - Nov. 19, 2020 - Healthgrades, the leading resource that connects consumers, physicians and health systems, today announced the debut of the Telehealth Resource Center, the latest in a series of telehealth offerings on healthgrades.com aimed at helping consumers connect with providers virtually. With this new resource center, consumers can instantly connect with a board-certified provider through a number of trusted telehealth platforms.

 

Since the onset of COVID-19, telehealth has seen exponential growth as consumers embrace virtual care to safely connect with providers. As shown in the ongoing Healthgrades COVID-19 Patient Confidence Study, 83% of consumers are comfortable participating in a…

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Oct30SOC Telemed Closes Business Combination and Will Begin Trading on the Nasdaq Stock Exchange »


Reston, VA — October 30, 2020 — SOC Telemed, Inc. (“SOC”), one of the largest national providers of acute care telemedicine, today announced that it has completed its previously announced business combination with Healthcare Merger Corp. (“HCMC”) (NASDAQ: HCCO), a special purpose acquisition company. The business combination was approved at a special meeting of HCMC’s stockholders on October 30, 2020 and closed on October 30, 2020. The shares of Class A common stock and warrants to purchase shares of Class A common stock of SOC Telemed are expected to begin trading on the Nasdaq on November 2, 2020, under the symbol…

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Oct27Viveve Launches New Clinical Advisory Board in Urinary Incontinence »


-- Preeminent urology and urogynecology experts to help guide and advance the company's pivotal U.S. PURSUIT trial in Stress Urinary Incontinence --

 

Englewood, CO / ACCESSWIRE / October 27, 2020 / Viveve Medical, Inc. (NASDAQ:VIVE), a medical technology company focused on women's intimate health, today announced that it has formed a clinical advisory group of preeminent medical specialists in the field of urinary incontinence. The clinical advisory board will advise the company as it advances its stress urinary incontinence (SUI) clinical development program and pivotal PURSUIT trial.

 

"We are extremely fortunate to have assembled this elite group of researchers and…

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Sep22Viveve Announces Issuance of Novel U.S. Method Patent for Stress Urinary Incontinence »


-- New patent strengthens and expands Viveve's intellectual property portfolio for the treatment of stress urinary incontinence --

 

Englewood, CO / ACCESSWIRE / September 22, 2020 / Viveve Medical, Inc. (NASDAQ:VIVE), a medical technology company focused on women's intimate health, today announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 10,779,874 covering Viveve's unique method of treatment to address stress urinary incontinence (SUI) in women. The newly granted patent strengthens the Company's intellectual property portfolio in advance of the launch of its U.S. pivotal PURSUIT clinical trial for SUI in women.

 

Viveve's dual-energy technology has…

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Sep17Outset Medical Announces Closing of Initial Public Offering and Full Exercise of the Underwriters' Option to Purchase Additional Shares »


San Jose, Calif.--(BUSINESS WIRE)--Sep. 17, 2020-- Outset Medical, Inc. (Nasdaq: OM) (“Outset”) today announced the closing of its initial public offering of 10,293,777 shares of its common stock, including the exercise in full by the underwriters’ option to purchase 1,342,666 additional shares of common stock, at the initial public offering price of $27.00 per share. The gross proceeds to Outset, before deducting underwriting discounts and commissions and offering expenses, were approximately $277.9 million. The shares began trading on The Nasdaq Global Select Market on September 15, 2020, under the symbol "OM."

 

BofA Securities, Morgan Stanley and Goldman Sachs & Co. LLC acted as joint lead book-running managers for…

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Sep14Valneva and Dynavax Announce Commercial Supply Agreement for Inactivated, Adjuvanted COVID-19 Vaccine »


-- Dynavax will provide CpG 1018 to produce up to 190 million doses over a five year period to support Valneva's contract with the U.K. government --

 

-- Inactivated, adjuvanted SARS-COV-2 vaccine candidate scheduled to enter first clinical studies in December 2020 --

 

-- Combines Valneva's proven approach with Dynavax's advanced CpG 1018 adjuvant --

 

Saint-Herblain, France and Emeryville, Calif., Sept. 14, 2020 /PRNewswire/ -- Valneva SE ("Valneva"), a specialty vaccine company focused on prevention of diseases with major unmet needs, and Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines,…

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Aug31NeuroPace Raises $67 Million Financing to Support Commercial Expansion of the RNS® System for Refractory Epilepsy »


-- Funds will also support clinical trial to pursue new indication for the company’s life-changing neuromodulation technology --

 

Moutain View, Calif. – August 31, 2020 – NeuroPace, Inc., a Silicon Valley-based medical technology company, today announced it has raised $67 million in a funding round led by Accelmed Partners with participation from an unnamed strategic investor, Revelation Partners, Soleus Capital, and returning investors KCK Group and Orbimed Advisors. The financing includes $33 million of new equity capital and $34 million from convertible debt provided by current investors from a prior funding round. An additional $27 million in committed capital is available…

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Aug25Viveve Announces Positive Primary Efficacy Data from its SUI Feasibility Study and Positive Preclinical Outcomes that Support the Company’s New Sham Tip for Pivotal PURSUIT Trial »


-- Achievement of primary efficacy endpoint in 3-arm SUI feasibility study demonstrates significant separation between CMRF treatment arm and inert sham arm --

 

-- Positive in-vivo preclinical study validates new inert sham tip for use in upcoming pivotal PURSUIT Trial in U.S. --

 

Englewood, CO / ACCESSWIRE / August 25, 2020 /Viveve Medical, Inc. (NASDAQ:VIVE), a medical technology company focused on women's intimate health, today announced positive primary efficacy data from its three-arm, five-month Stress Urinary Incontinence (SUI) feasibility study to compare Viveve's Cryogen-cooled Monopolar Radiofrequency (CMRF) treatment and a cryogen-only sham treatment to an inert sham treatment for…

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Aug19ROADSTER 2 Data Publication in Stroke Demonstrates Compelling Patient Outcomes and Strong Safety Profile with TCAR »


Sunnyvale, Calif., Aug. 19, 2020 (GLOBE NEWSWIRE) -- Silk Road Medical, Inc. (Nasdaq: SILK), a company focused on reducing the risk of stroke and its devastating impact, today announced that ROADSTER 2 study results have been published in the latest edition of the American Heart Association’s journal, Stroke. The article, “Early Outcomes in the ROADSTER 2 Study of TransCarotid Artery Revascularization (TCAR) in Patients with Significant Carotid Artery Disease” demonstrates compelling patient outcomes with low stroke and combined stroke and death rates when utilizing TCAR.

 

“The publication of the ROADSTER 2 data in Stroke provides further validation of the work we are doing to improve patient…

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Aug17Aerin Medical Announces Appointment of Matt Brokaw as President and CEO and Closing of $48MM Equity Financing »


Sunnyvale, CA, August 17, 2020.  Aerin Medical, a privately held medical device company focused on non-invasive procedures for treating nasal airway conditions, today announced the closing of a $48 million equity financing.  New investor Questa Capital led the round with participation by OrbiMed and existing investor KCK Group.  Proceeds from the financing will be used to accelerate commercial growth, support new clinical studies, and develop new products to better serve otolaryngologists (ear, nose and throat physicians or “ENTs”) and their patients. As part of the investment, Questa Capital Founder and Managing Partner Ryan Drant will join the Aerin board of…

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Aug4Treace Medical Concepts, Inc. Secures $50 Million Debt Facility and Expands Revolving Line of Credit »


Ponte Vedra, Fla.--(BUSINESS WIRE)--Aug 4, 2020--Treace Medical Concepts, Inc. (“Treace”), a medical device company focused on advancing the standard of care for hallux valgus (bunion) surgery, announced that it closed on a $50 million non-dilutive term loan agreement with CR Group L.P. (“CRG”), a healthcare focused investment firm. The Company also announced that it now has up to $10 million available under its revolving line of credit with Silicon Valley Bank (“SVB”).

 

Under the term loan with CRG, Treace received $30 million at closing and will have access to an additional $20 million in two tranches upon achieving certain…

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Aug3TriSalus Life Sciences Acquires Dynavax’s SD-101 Oncology Program in Purchase Agreement for up to $250 million in Milestone Payments plus Royalties on Future Net Sales »


-- SD-101 is a proprietary investigational, second-generation, Toll-like receptor 9 (TLR9) agonist CpG-C class oligodeoxynucleotide --

 

-- TriSalus plans to further develop SD-101 as an oncology therapeutic --

 

Westminster, Colo. and Emeryville, Calif., Aug. 03, 2020 (GLOBE NEWSWIRE) -- Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, and TriSalus Life Sciences (TriSalus), an emerging immunooncology company committed to transforming outcomes for liver and pancreatic tumors, today announced that they have entered into an asset purchase agreement under which TriSalus has purchased SD-101, a proprietary investigational, second-generation, Toll-like receptor 9 (TLR9) agonist…

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Jul27New Published Data Show NeuroPace’s RNS® System Provides Patients with Unprecedented Seizure Reduction and Improved Quality of Life »


-- Personalized, data-driven treatment for refractory focal epilepsy demonstrates unprecedented real-world results and exceptional long-term clinical data --

 

Mountain View, Calif. – July 27, 2020 – NeuroPace, Inc. today announced the publication of two seminal studies of the RNS System in prominent scientific journals Epilepsia and Neurology. The RNS System has been shown to dramatically reduce seizures and improve quality of life for people living with refractory epilepsy.

 

Real-World Data Demonstrating Unprecedented Efficacy Outcomes with the RNS System Published in Epilepsia

 

Real-world data from a multicenter clinical study of the RNS System were published in Epilepsia, demonstrating seizure reductions not seen with any…

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Jul15Preventice Solutions Announces $137 Million Series B Financing Led by Vivo Capital Company Sees Record Growth for Its Technology Powered by Deep Learning and Artificial Intelligence »


Minneapolis, July 15th, 2020 – Preventice Solutions, a leader in digital healthcare solutions and remote cardiac monitoring services powered by deep learning and artificial intelligence (AI), today announced that it has raised $137M in a Series B financing to accelerate investment in salesforce expansion, technology and product innovation and further development of clinical evidence supporting its flagship solution. The financing was led by new investor Vivo Capital with participation by another new investor Novo Holdings A/S as well as significant support from existing investors including Merck Global Health Innovation Fund, Boston Scientific and Samsung Catalyst Fund.

 

“Vivo is extremely pleased…

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Jul9Silk Road Medical Promotes Andrew Davis to Newly Created Position of Chief Commercial Officer »


Sunnyvale, Calif., July 09, 2020 (GLOBE NEWSWIRE) -- Silk Road Medical, Inc. (Nasdaq: SILK), a company focused on reducing the risk of stroke and its devastating impact, today announced that Andrew Davis has been promoted to Chief Commercial Officer.

 

In this newly created role, Mr. Davis will oversee Silk Road Medical’s global commercialization efforts. Mr. Davis joined Silk Road Medical as the company’s first commercial leader in 2015 and has successfully built the sales team to over 100 customer facing field members, achieving over $125 million in cumulative revenue. As Chief Commercial Officer, Mr. Davis is an integral member…

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Jun9Supernus Completes Acquisition of CNS Portfolio from US WorldMeds »


-- Creates leading CNS portfolio with five marketed products, two product candidates in late-stage development, and robust pipeline --

 

Rockville, Md., June 09, 2020 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced the closing of the acquisition of the CNS portfolio of US WorldMeds, a privately-held biopharmaceutical company. This transaction builds on Supernus’ experience in CNS diseases and expands its marketing and development efforts into Parkinson’s disease.

 

“This acquisition significantly expands our business in CNS and increases and diversifies our revenue and earnings streams,…

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Jun2Surgeons and Spine Societies Increase Patient Access to Barricaid® for Discectomy Surgery Following Recent Coding Successes and Recognition in Updated Guidelines »


-- Intrinsic Therapeutics Offers Virtual and Hands-On Training Sessions as Elective Surgeries Resume – via PR Newswire --

 

Woburn, Mass., June 2, 2020 – Intrinsic Therapeutics, Inc., a medical device company focused on delivering safe treatments to improve surgical efficacy, today announced growing enthusiasm among physicians for its Barricaid technology, which manages lumbar disc herniation.  While elective surgeries have been put largely on hold throughout the country as a result of the COVID-19 public health emergency, expert surgeons have been working behind the scenes to build on recent coding successes and recognition of the Barricaid procedure in key clinical specialty guidelines. As leading surgeons…

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May27ADVANZ PHARMA Corp. Limited Closes Acquisition of Specialty Pharmaceutical Company Correvio Pharma Corp. »


  • Provides ADVANZ PHARMA with an immediate and direct commercial and medical presence in Germany, France, Spain, Italy, and the Benelux region, while strengthening its existing presence in the Nordics and the United Kingdom
  • Further diversifies ADVANZ PHARMA's portfolio of medicines by adding established and innovative, high-quality brands that are sold in more than 60 countries around the world
  • Accelerates ADVANZ PHARMA's positioning as a leading Western European platform for niche- established medicines with enhanced organic and inorganic growth opportunities
  • ADVANZ PHARMA paid approximately $76 million for the acquisition with its cash on hand

 

LONDON, May 27, 2020 /CNW/ - ADVANZ PHARMA Corp. Limited ("ADVANZ PHARMA" or…

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May8Silk Road Medical Announces Closing of Follow-on Public Offering »


Sunnyvale, Calif., May 08, 2020 (GLOBE NEWSWIRE) -- Silk Road Medical, Inc. (Nasdaq: SILK) (“Silk Road Medical”), a company focused on reducing the risk of stroke and its devastating impact, today announced the closing of an underwritten public offering of 6,808,154 shares of its common stock at a public offering price of $39.00 per share. 1,923,076 shares in the offering were offered for sale by Silk Road Medical, and 4,885,078 million shares were offered for sale by certain selling securityholders. Gross proceeds from the offering to Silk Road Medical were approximately $75 million.  The selling stockholders granted the underwriters a 30-day option to purchase up to an additional 1,021,223 shares…

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Apr30Avinger Closes $3.15 Million Equity Offering »


Redwood City, CA / ACCESSWIRE / April 30, 2020 / Avinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of patients with Peripheral Artery Disease (PAD), today announced the closing of an underwritten public offering of 12,600,000 shares of its common stock at a price of $0.25 per share, for total gross proceeds of approximately $3.15 million, before deducting underwriting discounts, commissions and other offering expenses payable by the Company. Additionally, the Company has granted the underwriters a 45-day option to purchase up to 15% additional shares of common…

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Apr28Supernus to Acquire CNS Portfolio from US WorldMeds »


  • Expands and strengthens neurology portfolio with three marketed CNS products and late-stage pipeline
  • Diversifies revenue and operating cash flow base with 2019 net sales of approximately $150 million and operating earnings
  • of $45 million
  • Enhances long term growth with potential launch of late-stage product candidate in 2021.
  • Upfront cash payment of $300 million, plus cash milestone payments up to $230 million
  • Conference call and webcast at 8:30 a.m. ET April 29, 2020, to discuss the transaction

 

Rockville, Md., April 28, 2020 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a pharmaceutical company focused on developing and commercializing…

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Apr2Zealand Pharma Completes the Acquisition of Valeritas »


  • Zealand Pharma (NASDAQ: ZEAL) has acquired Valeritas Holdings, Inc. (NASDAQ: VLRX), a U.S. based commercial-stage company for a cash purchase price of $23 million
  • The marketed V-Go® wearable insulin delivery device, 110 employees, all supporting systems, processes and the majority of established contracts, and a site in Marlborough, Massachusetts, are transferred to Zealand Pharma
  • The purchase accelerates Zealand Pharma’s plans for establishing U.S. operations to support the anticipated launch of the dasiglucagon HypoPal® rescue pen

Copenhagen, April 2, 2020 – Zealand Pharma A/S (“Zealand” or the “Company”) (NASDAQ: ZEAL) (CVR-no. 20045078), a Copenhagen-based biotechnology company focused on the…

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Mar5Aerin Medical Announces FDA Clearance and U.S. Launch of Innovative Nonsurgical Procedure for Chronic Rhinitis »


-- RhinAer™ Procedure Promises Lasting Relief for Millions of Americans Suffering from Common Chronic Condition --

 

Austin, Texas--(BUSINESS WIRE)--Aerin Medical Inc., a company focused on minimally invasive solutions for chronic nasal conditions, today announced U.S. Food and Drug Administration (FDA) clearance and U.S. launch of the company’s second product, the RhinAer™ Stylus, an innovative device for nonsurgical treatment of chronic rhinitis.

 

More than 30 million Americans suffer from nonallergic rhinitis.1 Patients with the condition suffer from runny nose, post-nasal drip, congestion, chronic cough, and other symptoms. For many patients, management with medications and sprays is inadequate. The RhinAer procedure…

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Mar5NanoString Technologies Announces Pricing of Upsized Offering of $200 Million of Convertible Senior Notes »


Seattle, Wash.--(Business Wire)-- NanoString Technologies, Inc. (NASDAQ:NSTG), a leading provider of life science tools for translational research, today announced the pricing of $200 million aggregate principal amount of 2.625% convertible senior notes due 2025 in a private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”). NanoString also granted the initial purchasers of the notes a 13-day option to purchase up to an additional $30 million aggregate principal amount of the notes. The offering of the notes was upsized from the originally announced aggregate principal amount of $175 million. The sale of the notes is expected to close…

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Mar4Alignment Healthcare Raises $135 Million in Series C Funding to Bring its Model for Improved Care to More Seniors »


-- Medicare Advantage platform closes crossover round from Fidelity Investments, T. Rowe Price and Durable Capital Partners --

 

Orange, Calif. (March 4, 2020) – Alignment Healthcare, a mission-based Medicare Advantage insurance company founded in 2013, today announced that it raised $135 million from Fidelity Management & Research Company, funds and accounts advised by T. Rowe Price Associates, Inc., and Durable Capital Partners L.P. The Series C round brings Alignment’s funding to-date to $375 million, and will accelerate the growth of the company’s Medicare Advantage footprint while deepening its investments in its technology platform and plan offerings.
 
“Caring for our…

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Jan13Earlens Inks New Partnership With Verily »


Earlens Corporation, a medical technology company that has created the world’s first nonsurgical hearing solution that directly vibrates the eardrum, announced today that they have entered into a strategic agreement with Verily, an Alphabet company, to develop next-generation capabilities for the Earlens® Contact Hearing Solution. 

 

According to the Hearing Loss Association of America, about 20 percent of Americans, or 48 million people, report some degree of hearing loss. Yet, research estimates that only 1 in 5 individuals who might benefit from treatment seek help. A major factor in the underutilization of hearing aids is disappointment with the quality and clarity of sound that…

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Jan7Healthgrades Acquires Evariant »


-- Creates the Most Comprehensive, End-to-End Consumer and Physician Engagement Platform --

 

Denver, Colo (Jan 7, 2020) – Healthgrades, the leading resource that connects consumers, physicians and health systems, today announced it has acquired Evariant, a leading healthcare consumer and physician engagement company. With the combination of these two market leaders and innovators, Healthgrades will offer the most comprehensive end-to-end engagement platform in the healthcare industry, enhancing the company’s value proposition for its combined base of 2,000+ hospitals and life sciences customers. 

 

Healthgrades’ products and services enable physicians and health systems to optimize growth through smarter consumer acquisition, patient…

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Dec3Decipher Biosciences Achieves Major Medicare Milestone for Decipher Prostate Genomic Tests »


-- First Precision Oncology Company to Receive Medicare Coverage for Both Favorable and Unfavorable Intermediate Risk Prostate Cancer --

 

Decipher Biosciences, a leader in the field of urologic cancer genomics, today announced that Palmetto GBA, a Medicare Administrative Contractor (MAC), issued a final local coverage determination (LCD) for use of Decipher® Prostate Biopsy in men diagnosed with favorable and unfavorable intermediate-risk prostate cancer.

 

In 2019, an estimated 56,000 men in the U.S. will be diagnosed with intermediate-risk prostate cancer.  Most of these patients will receive surgery, radiation with or without hormone therapy, or will be carefully  monitored over…

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Oct21Mid-Atlantic Dental Partners Acquires DentalOne Partners »


-- Transaction makes Mid-Atlantic Dental Partners one of the largest DSOs in the U.S. --

 

Plymouth Meeting, Pa. & Plano, Texas--(Business Wire)--Mid-Atlantic Topco LLC, operating as Mid-Atlantic Dental Partners, a dental support organization (“DSO”) dedicated to improving the delivery of dental services for dentists and their patients and a portfolio company of S.C. Goldman & Company, LLC (“S.C. Goldman”), announced today that it has acquired DentalOne Partners (“DentalOne”) from Dental Investments, LLC.

 

Under the terms of the agreement, Mid-Atlantic Dental Partners acquired the equity of DentalOne’s operating subsidiaries in an all-cash deal.

 

Founded in 1981 and headquartered…

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Jun3Fast Pace Urgent Care to Partner With Calcasieu Urgent Care »


-- This partnership will help Fast Pace to accelerate growth and further expand its reach to provide underserved rural populations with access to high-quality, affordable health care --

 

Franklin, Tenn., June 3, 2019 /PRNewswire/ -- Fast Pace Urgent Care and Calcasieu Urgent Care, two of the nation's top affordable urgent care providers, announced today that they will form a partnership. The combination results in one of the largest urgent care providers in the United States, with 95 network clinics across the states of Tennessee, Kentucky, Mississippi and Louisiana.

 

"Fast Pace is looking forward to joining with Calcasieu to expand access to affordable quality healthcare in Louisiana," said Greg Steil, Fast Pace's CEO. "Partnering with…

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May28BioDelivery Sciences Strengthens Financial Position with Debt Refinancing »


-- New Agreement is Cash Flow Accretive, Lowers Cost of Capital and Extends Debt Maturity

Reduces Annual Interest Costs by Approximately $1.5 million

Increases Flexibility to Continue Growth Trajectory --

 

Raleigh, N.C., May 28, 2019 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI) (“BDSI”) today announced that it has successfully completed the refinancing of its existing debt agreement with a new facility from BioPharma Credit plc (“BPCR”). The new facility consists of a $60.0 million term loan and will generate an estimated $1.5 million in annual interest cost savings compared to the previous debt facility.

 

“We are pleased to announce this debt re-financing with BPCR, an investment fund…

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May21Aerin Medical Inc. Secures $50 Million Debt Facility »


Austin, Texas, May 21, 2019 /PRNewswire/ -- Aerin Medical, Inc. ("Aerin"), a medical technology company focused on improving the quality of life for patients suffering with nasal airway disorders through the development and commercialization of disruptive minimally-invasive treatments, announced that it closed on a $50 million non-dilutive term loan agreement with CRG LP, a healthcare focused investment firm.

 

Aerin received $35 million at closing and will receive an additional $15 million in two tranches upon achieving certain milestones. The Company used approximately $16.5 million of these proceeds to retire its existing debt. The remaining proceeds will be used to accelerate Aerin's sales and marketing reach and to launch its next product.

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May14Sutter Health and Alignment Healthcare Team Up In Northern California For Medicare Beneficiaries »


-- Not-for-profit health system and Medicare Advantage insurance provider seek to expand access to care and coverage, pending regulatory approval --

 

Orange, Calif. & Sacramento, Calif. (May 14, 2019) – Today, Sutter Health, a not-for-profit integrated health care system, and Alignment Healthcare, a Medicare Advantage insurance provider, announced the signing of an agreement that allows the two organizations to work together to offer more health care and insurance coverage options for Medicare-eligible residents in Northern California in 2020, pending regulatory approval.

Alignment has filed an application with the Centers for Medicare & Medicaid Services (CMS) to expand its…

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May9GE Healthcare and Preventice Solutions Collaborate to Extend the Heart Station Beyond the Hospital »


-- New alliance provides seamless connection between leading provider of hospital ECG products, including MUSE, and leader of ambulatory ECG services --

 

Boston – May 9, 2018 – GE Healthcare (NYSE:GE) is working with Preventice Solutions to provide customers with an extension of the hospital heart station and to expand GE Healthcare ECG services into the home, creating a more holistic solution for monitoring ambulatory ECG patients.
 
The collaboration offers a unified solution to providing in-hospital ECG, long-term Holter, cardiac Event Monitoring (CEM) & Mobile Cardiac telemetry (MCT) results into a single portal utilizing the GE Healthcare MUSE…

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Apr11Intrinsic Therapeutics Completes $52m Financing to Fuel Commercial Efforts in the United States to Benefit Lumbar Discectomy Patients »


Boston, April 11, 2019 /PRNewswire/ -- Intrinsic Therapeutics, Inc., a medical device company focusing on surgeries to treat leg and low back pain resulting from ruptured lumbar discs with large anular defects, today announced a $52mSeries Growth equity financing.  Questa Capital led the round, with participation from existing investors New Enterprise Associates (NEA), Greenspring Associates, Quadrille, and Delos Capital. 

 

"We are extremely pleased that Questa led this financing to support our U.S. commercialization efforts for the Barricaid® device," said Cary Hagan, CEO, Intrinsic Therapeutics.   "Meaningful clinical data demonstrate that treatment with Barricaid® can reduce reherniations and repeat surgeries for patients, and we're excited to welcome Questa…

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Apr3Silk Road Medical Announces Pricing of Initial Public Offering »


Sunnyvale, Calif., April 03, 2019 (GLOBE NEWSWIRE) -- Silk Road Medical, Inc. (Nasdaq:SILK) (“Silk Road Medical”) today announced the pricing of its initial public offering of 6,000,000 shares of common stock at a public offering price of $20.00 per share. All of the shares of common stock are being offered by Silk Road Medical. In addition, the selling stockholders have granted the underwriters a 30-day option to purchase up to an additional 900,000 shares of common stock at the initial public offering price, less the underwriting discounts and commissions. Silk Road Medical’s common stock is expected to begin trading on The Nasdaq…

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Mar19NanoString Technologies Announces Pricing of Public Offering of 4,500,000 Shares of Common Stock »


Seattle, March 19, 2019 (GLOBE NEWSWIRE) -- NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced the pricing of an underwritten public offering of 4,500,000 shares of its common stock at a price to the public of $23.00 per share pursuant to its shelf registration statement. NanoString will sell 2,500,000 shares of common stock, and Clarus Lifesciences II, L.P., a stockholder of NanoString, will sell 2,000,000 shares of common stock. NanoString has granted to the underwriters of the offering a 30-day option to purchase up to an additional 675,000 shares…

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Mar6Synergy Pharmaceuticals Announces Completion of Sale to Bausch Health »


New York, March 6, 2019 /PRNewswire/ -- Synergy Pharmaceuticals Inc. (NASDAQ: SGYP) (the "Company" or "Synergy"), a biopharmaceutical company focused on the development and commercialization of novel gastrointestinal (GI) therapies, today confirmed that the previously announced sale of certain assets to Bausch Health Companies Inc. is now complete. All rights to TRULANCE® (plecanatide), dolcanatide and the related intellectual property have been transferred to Bausch Health.

 

Synergy on December 12, 2018, initiated voluntary proceedings under Chapter 11 of the U.S. Bankruptcy Code in the U.S. Bankruptcy Court for the Southern District of New York to facilitate a sale and address…

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Feb13EyePoint Pharmaceuticals Secures Up to $60 Million Debt Facility »


-- Provides support for the product launches of YUTIQ™ and DEXYCU™ --

 

Waterton, Mass., Feb. 13, 2019 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc.(NASDAQ:EYPT), a specialty biopharmaceutical company committed to developing and commercializing innovative ophthalmic products, today announced that it has entered into a $60 million debt facility with CR Group L.P. (CRG) to retire existing debt and provide additional working capital to support the recent launch of YUTIQTM and the anticipated launch of DEXYCUTM expected later in the first quarter of 2019.

 

The new facility consists of an initial draw of $35 million, of which approximately $23 million will repay principal, prepayment fees and other costs associated with the secured term…

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Jan22Smith & Nephew completes acquisition of meniscal repair system developer Ceterix® Orthopaedics »


Smith & Nephew plc (LSE:SN, NYSE:SNN), the global medical technology business, announces it has completed the acquisition of Ceterix® Orthopaedics, Inc, the developer of the NovoStitch® Pro Meniscal Repair System. The acquisition supports the Company’s strategy to invest in innovative technologies that meet unmet clinical needs.

 

The cost of the acquisition is $50 million and up to a further $55 million over the next five years, contingent on financial performance.

 

NovoStitch Pro is a unique device that addresses complex meniscal tear patterns not adequately served by other repair systems. It allows surgeons to repair arthroscopically horizontal, radial, complex,…

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Oct22Earlens Corporation Raises $87M Led by KCK Medical Technologies Group »


Menlo Park, Calif., Oct. 22, 2018 /PRNewswire/ -- Earlens Corporation, Inc., a privately held medtech company committed to dramatically improving hearing aids, announced today it has completed an $87 million preferred stock financing round led by new investor KCK Ltd., a family investment fund.  Proceeds from this round of financing will be allocated to continued product development and the enhanced, 2019 commercial rollout.

 

Additional investors included Exor Seeds and previous investors Lightstone Ventures, CRG Partners, Windham Life Sciences Partners, Arch Healthcare, Relativity Health Fund, New Enterprise Associates, Aisling Capital, Vertex Global Healthcare, MS Pace LP, Cochlear, Mellon Foundation, Baltisches Haus Limited, GDN Holdings, Sightline Healthcare Opportunity,…

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Oct15NanoString Announces $100 Million Term Loan Facility with CRG »


Seattle, Oct. 15, 2018 -- NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced that it has entered into a new $100 million term loan facility with the CR Group L.P. (CRG), a health care focused investment firm. 

The proceeds of the initial draw under the CRG term loan facility, made in the aggregate principal amount of $60 million, will be used to refinance NanoString’s existing CRG term loan facility, under which approximately $50 million is currently outstanding, for working capital and general corporate purposes and for…

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Aug20SOC Telemed Acquires JSA Health, Becomes Largest Acute TelePsychiatry Provider in the U.S. »


Reston, Va. – August 20, 2018 –SOC Telemed (SOC), the leader in acute care telemedicine, today announces the acquisition of leading behavioral health telemedicine company JSA Health. The JSA team will join SOC Telemed in providing 24/7 access to high-quality telePsychiatry care for a wide variety of settings, including emergency departments, community health clinics, educational institutions and more. Already the largest teleNeurology provider in the nation, the acquisition also secures SOC’s position as the nation’s largest acute telePsychiatry provider.

 

“JSA achieved a strong foothold in the telePsychiatry industry, but as a single specialty practice the company sought scalability that SOC Telemed supports with its proven…

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Aug17ViewRay Announces Full Exercise of Underwriters' Option to Purchase Additional Shares and Closing of Public Offering of Common Stock »


Cleveland, Aug. 17, 2018 /PRNewswire/ -- ViewRay, Inc. (Nasdaq: VRAY), maker of the MRIdian, which combines MRI and external-beam radiation therapy to simultaneously image and treat cancer patients, today announced the completion of its previously announced underwritten public offering of 18,648,649 shares of common stock at a price to the public of $9.25 per share, for gross proceeds of approximately $172.5 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by ViewRay. All of the shares sold in the offering were sold by ViewRay. The shares sold included the full exercise of the underwriters' option to purchase additional shares.

 

ViewRay intends to use the net proceeds…

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Jul24ViewRay Appoints Scott Drake as President, Chief Executive Officer and a Member of the Board of Directors, Shar Matin as Chief Operating Officer, and D. Keith Grossman as a Member of the Board of Directors »


-- New Officers and Directors Bring Extensive Medical Company Growth Experience to ViewRay. ViewRay Pre-Releases Preliminary Second Quarter 2018 Revenue of $16 Million and Reaffirms Revenue Guidance of $80 to $90 Million for 2018 --

 

Cleveland, July 24, 2018 /PRNewswire/ -- ViewRay, Inc. (Nasdaq: VRAY), maker of the market-leading MRI-guided radiation therapy system, announced today the appointment of medical device industry veterans Scott Drakeas its President and Chief Executive Officer and Shar Matin as its Chief Operating Officer, effective immediately.  In connection with his appointment, Mr. Drake has also been appointed to the ViewRay Board of Directors.  In addition, ViewRay announced the appointment of D. Keith Grossman to the ViewRay Board of…

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Jul17NanoString Technologies Announces Pricing of Public Offering of 4,000,000 Shares of Common Stock »


Seattle, July 17, 2018 (GLOBE NEWSWIRE) -- NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced the pricing of an underwritten public offering of 4,000,000 shares of its common stock at a price to the public of $12.50 per share pursuant to its existing shelf registration statement. NanoString has granted to the underwriters of the offering a 30-day option to purchase up to an additional 600,000 shares of common stock at the public offering price. NanoString intends to use the net proceeds of the offering for the development and launch of the Company’s Digital Spatial Profiling platform, the continued commercialization of the…

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Jul10EndoGastric Solutions Secures $30.5 Million In New Financing »


-- Existing and New Investors Participated in Support of Rapid Commercialization --

 

Redmond, Washington - July 10, 2018 – EndoGastric Solutions® (EGS), a leader in incisionless procedural therapy for gastroesophageal reflux disease (GERD), announced today that it has secured $30.5 million in new financing led by existing EGS investors Advanced Technology Ventures (ATV), Canaan Partners, Canepa Healthcare, Chicago Growth Partners, CRG, Radius Ventures, Sightline Partners, and several new healthcare investors excited about EGS’ commercial advances.

 

“EGS continues to lay the foundation for success having achieved a number of important commercial milestones in recent months,” said Mike Carusi, General Partner,…

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Jun4Dynavax Reports Data for Phase 1b/2 Trial of SD-101 in Combination with KEYTRUDA® (pembrolizumab) in Advanced Melanoma at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting »


-- Overall Response Rate (ORR) of 70% and 6-month Progression Free Survival (PFS) rate of 76% in Patients Naïve to Anti-PD-1 Treatment who Received the ≤ 2mg Dose of SD-101 --

 

-- Combination showed Similar Rates of Immune-related Adverse Events as Seen with KEYTRUDA Monotherapy --

 

-- 2mg SD-101 Dose Selected for Phase 3 --

 

Berkeley, Calif., June 04, 2018 (GLOBE NEWSWIRE) -- Dynavax Technologies Corporation(NASDAQ:DVAX) today announced data from its ongoing Phase 1b/2 study investigating SD-101, Dynavax's intratumoral TLR9 agonist, in combination with KEYTRUDA® (pembrolizumab), an anti-PD-1 therapy developed by Merck (known as MSD outside the United States and Canada) in patients with advanced melanoma.

 

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May31T2 Biosystems Announces Pricing of Public O »


Lexington, Mass., May 31, 2018 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO) today announced the pricing of an underwritten registered public offering of 6,100,000 shares of common stock at a public offering price of $7.50 per share, before underwriting discounts, for gross proceeds of $45,750,000. T2 Biosystems has granted the underwriters a 30-day option to purchase up to an additional 915,000 shares of common stock at the public offering price, less the underwriting discount.  All of the shares of common stock to be sold in the offering will be issued by T2 Biosystems. The offering is expected to close on or…

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May22BioDelivery Sciences Announces Closing of $50 Million Equity Financing and Appointment of Peter Greenleaf as Chairman of the Board »


Raleigh, N.C., May 22, 2018 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ:BDSI) today announced it has closed its previously announced $50 million registered direct offering of newly designated Series B Non-Voting Convertible Preferred Stock.  The offering closed on May 21, 2018, yielding net proceeds of $48.9 million to BDSI.   

 

As previously announced, as part of the financing closing, Broadfin Capital Managing Partner Kevin Kotler joined BDSI’s board, along with pharmaceutical industry veterans Todd Davis and Peter Greenleaf, who were selected by Broadfin. 

 

Furthermore, Peter Greenleaf has been named as Chairman of the BDSI Board of Directors effective immediately.  Mr. Greenleaf is currently the Chief Executive Officer of Cerecor, Inc. (NASDAQ:CERC), and previously…

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May8GenomeDx Biosciences Announces Research Collaboration with Janssen Pharmaceuticals to Evaluate the Decipher® Classifier and Decipher GRID® for Drug Development »


San Diego – May 8, 2018 – GenomeDx Biosciences, a leader in the field of urologic cancer genomics, today announced a research collaboration with Janssen Pharmaceuticals. As part of the agreement, GenomeDx will test samples using its genome-wide expression assay from multiple Janssen prostate cancer clinical trials to examine the association of prognostic and predictive signatures available on the Decipher GRID® platform with clinical outcomes.

 

“We are excited to work together with Janssen on this important research collaboration, which we believe will accelerate the discovery and development of genomic solutions for the treatment and management of high-risk prostate cancer,” said Elai…

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Apr26Humana-Walmart Deal Would Be Brilliant On Many Levels: CRG’s Li »


April 26, 2018 - Bloomberg Markets AM with Pimm Fox and Lisa Abramowicz.

 

GUEST: Scott Li, principal at CRG, a healthcare private investment firm, to discuss investment opportunities in the healthcare landscape.

 

Running time 07:32

 

Humana-Walmart Deal Would Be Brilliant On Many Levels: CRG’s Li

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Apr24Valeritas Announces Pricing of $24 Million Public Offering of Common Stock »


Bridewater, N.J., April 24, 2018 (GLOBE NEWSWIRE) -- Valeritas Holdings, Inc. (NASDAQ:VLRX), a medical technology company which offers patients with type 2 diabetes V-Go® Wearable Insulin Delivery device, a simple, affordable, all-in-one insulin delivery option that is worn like a patch and can eliminate the need for taking multiple daily shots, today announced the pricing of its underwritten public offering of 13,700,000 shares of its common stock at a public offering price of $1.75 per share. The gross proceeds from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by Valeritas, are expected to be $24 million. In addition, Valeritas has granted…

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Apr6Cardiome Announces Amendment to Term Loan Agreement with CRG-Managed Funds »


Vancouver, April 6, 2018 /PRNewswire/ - Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) ("Cardiome" or the "Company") today announced that it has entered into a first amending agreement to its amended and restated term loan agreement with CRG Servicing LLC ("CRG") managed funds dated May 11, 2017 (the "Amending Agreement") to provide for certain adjustments to the financial covenants with respect to minimum revenue. Under the terms of the amended agreement, CRG has waived its right to receive payment of certain cash compensation of up to $6 million dollars that would have been required under the original agreement and has agreed to permit the divestiture of Cardiome's Canadian…

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Apr4bioMérieux Reinforces its Offering of High Medical Value Immunoassay Biomarkers With the Acquisition of Astute Medical »


-- bioMérieux, a world leader in the field of in vitro diagnostics, announces today the acquisition of Astute Medical Inc., a company dedicated to improving the diagnosis of high-risk medical conditions and diseases through the identification and validation of protein biomarkers. --

 

04 April, 2018 -- bioMérieux, a world leader in the field of in vitro diagnostics, announces today the acquisition of Astute Medical Inc., a company dedicated to improving the diagnosis of high-risk medical conditions and diseases through the identification and validation of protein biomarkers. In particular, Astute developed the NEPHROCHECK® test, an FDA-cleared test for the early risk assessment…

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Mar20Cipher Pharmaceuticals and Cardiome Pharma Announce Strategic Transaction for Canadian Business Portfolio of Cardiome »


-- Cipher to Acquire Cardiome's Canadian Business Portfolio, Comprised of Four Commercial and Pipeline Assets Targeting Cardiovascular and Anti-Infective Indications for Upfront Consideration of $25.5 Million CAD --

 

Mississagua, ON, and Vancouver, March 20, 2018 /PRNewswire/ - Cipher Pharmaceuticals Inc. (TSX: CPH) and Cardiome Pharma Corp. (Nasdaq:CRME and TSX: COM), today announced their entry into a definitive arrangement agreement pursuant to which Cipher will acquire the Canadian business portfolio of Cardiome.  The proposed transaction will be completed pursuant to the acquisition by Cipher of all of the outstanding shares of Cardiome, following a restructuring of Cardiome pursuant to a statutory plan of arrangement under the Canada Business Corporations Act. …

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Mar1Corium Prices Offering of $100 Million of 5% Convertible Senior Notes »


Menlo Park, Calif., March 01, 2018 (GLOBE NEWSWIRE) -- Corium International, Inc. (Nasdaq:CORI), a commercial-stage biopharmaceutical company focused on the development, manufacture and commercialization of specialty transdermal products, today announced the pricing of its offering of $100,000,000 aggregate principal amount of 5% Convertible Senior Notes due 2025 (the “notes”) in a private offering to qualified institutional buyers pursuant to the Securities Act of 1933, as amended (the “Securities Act”). Corium also granted the initial purchaser of the notes a 13-day option to purchase up to an additional $20,000,000 aggregate principal amount of notes. The sale of the notes is expected…

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Feb26ViewRay Announces $59 Million Equity Financing »


-- Financing to Further Support Growth of MRIdian Linac --

 

Cleveland, Feb. 26, 2018 /PRNewswire/ -- ViewRay, Inc. (Nasdaq: VRAY), makers of the world's first and only clinical MRI-guided radiation therapy system, announced today that it has entered into an agreement to sell its common stock and warrants to an affiliate of Fosun International Limited ("Fosun") in a direct registered offering for aggregate gross proceeds of approximately $59.1 million. With this transaction, Fosun is increasing its ownership of the Company from approximately 9.9% to 18.4% of the Company's outstanding shares of common stock immediately following the closing of the transaction…

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Feb22GenomeDx Announces Inclusion of Decipher Genomic Testing in NCCN Guidelines for Prostate Cancer »


-- Decipher testing recognized as standard-of-care in management of prostate cancer patients --

 

San Diego – February 22, 2018 – GenomeDx Biosciences, a leader in the field of urologic cancer genomics, today announced that its Decipher® Prostate Biopsy and Decipher Prostate RP molecular assays for prostate cancer are now included in the 2018 National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines in Oncology [Version 1.2018].

 

The NCCN Guidelines are the recognized clinical standard for cancer care, and are developed and revised by a panel of expert physicians from 27 leading U.S. cancer centers. The panel revises recommended practice guidelines according to current…

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Feb12Viveve Announces Closing of Public Offering of Shares of Common Stock »


Englewood, CO -- (Marketwired) -- 02/12/18 -- Viveve Medical, Inc. ("Viveve") (NASDAQ: VIVE), a medical technology company focused on women's intimate health, today announced the closing of its previously announced underwritten public offering of 11,500,000 shares of its common stock at a public offering price of $3.00 per share, including shares of common stock issued upon the full exercise by the underwriters of their option to purchase additional shares. The net proceeds to Viveve from the offering were approximately $32.4 million, after deducting underwriting discounts and commissions (but before deducting estimated offering expenses payable by the Company). Viveve intends to use…

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Feb9Tandem Diabetes Care Announces Pricing of $60 Million Underwritten Public Offering of Common Stock »


San Diego --(BUSINESS WIRE) --Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device company and manufacturer of the only touchscreen insulin pumps available in the United States, today announced the pricing of an underwritten public offering of 30 million shares of its common stock at a price to the public of $2.00 per share. The gross proceeds to Tandem from this offering are expected to be $60 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by Tandem. In addition, Tandem has granted the underwriters a 30-day option to purchase up to 4.5 million additional shares…

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Jan25Synergy Pharmaceuticals Announces FDA Approval of TRULANCE® (Plecanatide) for the Treatment of Irritable Bowel Syndrome with Constipation (IBSC) in Adults »


NEW YORK- (BUSINESS WIRE)-- Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) announced today that the U.S. Food and Drug Administration (FDA) has approved TRULANCE ®(plecanatide) 3 mg tablet for the once-daily treatment of irritable bowel syndrome with constipation (IBS-C) in adults. This is the second indication for TRULANCE, which is already approved for the treatment of adults with chronic idiopathic constipation (CIC).

 

This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180125005450/en/

 

“The IBS-C approval is a pivotal milestone for Synergy, representing the second approved indication for TRULANCE in the past 12 months,” said Troy Hamilton, Pharm.D., CEO of Synergy…

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Jan25Strongbridge Biopharma plc Announces Pricing of Public Offering of Ordinary Shares »


Dublin, Ireland and Trevose, Pa., Jan. 25, 2018 (GLOBE NEWSWIRE) -- Strongbridge Biopharma plc (NASDAQ:SBBP) (the “Company”) today announced that it has priced its previously announced underwritten public offering of 5 million ordinary shares at a price to the public of $6.75 per share. The offering is expected to close on or about January 30, 2018 subject to satisfaction of customary closing conditions. Strongbridge granted the underwriters a 30-day option to purchase up to an additional 750,000 ordinary shares. Before deducting the underwriting discount and estimated offering expenses payable by the Company, the Company expects to receive gross proceeds of approximately $33.8 million, assuming no exercise of the underwriters’ option…

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Jan17Strongbridge Biopharma plc Announces Acquisition of the U.S. and Canadian Rights to MACRILEN™ (macimorelin) from Aeterna Zentaris »


-- MACRILEN is the First and Only FDA-Approved Oral Drug Indicated For the Diagnosis of Adult Growth Hormone Deficiency, a Rare Endocrine Disorder --

-- MACRILEN is Strongbridge’s Second Commercial Product; Expands the Company’s Rare Endocrine Disease Portfolio and Complements its Late-Stage Clinical Development Program for RECORLEV™ (levoketoconazole) in Endogenous Cushing’s Syndrome --

-- Strongbridge Expands Structured Financing Facility with CRG to Support the Anticipated Commercial Launch of MACRILEN in Mid-2018 -- 

-- Strongbridge to Host Conference Call Today at 8:30 a.m. ET to Discuss the MACRILEN Acquisition --

 

Dublin, Ireland and Trevose, Pa., Jan. 17, 2018 (GLOBE NEWSWIRE) -- Strongbridge…

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Dec19Synergy Pharmaceuticals Appoints Troy Hamilton Chief Executive Officer »


-- Co-Founder Gary S. Jacob, Ph.D., Named Executive Chairman  --

 

New York - (BUSINESS WIRE) -- Synergy Pharmaceuticals Inc. (NASDAQ:SGYP), a biopharmaceutical company focused on the development and commercialization of novel gastrointestinal (GI) therapies, today announced that Troy Hamilton, Pharm.D., previously Executive Vice President, Chief Commercial Officer, has been appointed Chief Executive Officer, effective immediately. Gary S. Jacob, Ph.D., previously President, CEO and Chairman, has assumed the position of Executive Chairman of the Board of Directors.

 

This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171219005682/en/ 

 

Mr. Hamilton joined Synergy in July 2015, and has since been…

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Oct24NeuroPace Closes $74 Million Equity Funding to Accelerate Patient Access to the World’s First Brain-Responsive Neurostimulation System to Treat Epilepsy »


Mountain View, Calif. – October 24, 2017 – NeuroPace, Inc., a Silicon Valley-based medical technology company that developed the world’s first and only closed-loop brain-responsive neurostimulation system shown to significantly reduce seizure frequency, announced today that it closed a $74 million round of funding led by the KCK Group and OrbiMed Advisors. This funding provides the resources necessary to rapidly expand commercialization of the NeuroPace RNS®  System, a device approved by FDA to treat adults with partial (focal) onset seizures that are not well controlled by medication alone.

 

“The outstanding clinical results obtained with the RNS System provide very compelling evidence to…

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Oct24ViewRay Raises $50 Million through Sale of Common Stock »


-- Financing to Support Ongoing Commercialization of MRIdian Linac --

 

Cleaveland, Oct. 24, 2017 /PRNewswire/ -- ViewRay, Inc. (Nasdaq: VRAY), maker of the world's first and only clinical MRI-guided radiation therapy system, announced today that it has raised aggregate gross proceeds of approximately $50 million through the issuance and sale of 8,382,643 shares of its common stock in a direct registered offering. Participants in the financing consist of existing as well as new investors. Immediately following the closing, one of the new investors will own 9.9% of the Company's outstanding shares of common stock.

 

The purchase price for each…

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Oct4Strongbridge Biopharma plc Announces Pricing of Public Offering of Ordinary Shares »


Dublin, Ireland and Trevose, Pa., Oct. 04, 2017 (GLOBE NEWSWIRE) -- Strongbridge Biopharma plc (NASDAQ:SBBP) (the “Company”) today announced that it has priced its previously announced underwritten public offering of 4,000,000 ordinary shares at a price to the public of $6.25 per share. The offering is expected to close on or about October 6, 2017 subject to satisfaction of customary closing conditions. Strongbridge granted the underwriters a 30-day option to purchase up to an additional 600,000 ordinary shares. Before deducting the underwriting discount and estimated offering expenses payable by the Company, the Company expects to receive gross proceeds of approximately $25.0 million, assuming no exercise of the underwriters’ option to purchase…

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Sep5Anthem Issues Positive Coverage Decision for NanoString's Prosigna® Breast Cancer Assay »


Seattle, Sept. 05, 2017 (GLOBE NEWSWIRE) -- NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced that Anthem has issued a positive coverage decision for the Prosigna® Breast Cancer Gene Signature Assay.  This positive coverage decision is in line with updated ASCO guidelines released in February 2016.  The ASCO guidelines recommend the use of the Prosigna Breast Cancer assay to guide decisions on adjuvant systemic therapy for women with early-stage invasive breast cancer with known hormone receptor and HER2 status.  

 

"With this positive coverage decision from Anthem, Prosigna is now covered by every national…

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Aug8NanoString and Lam Research Announce Strategic Development Collaboration to Advance Hyb & Seq Next Generation Sequencing Platform »


Seattle and Fremont, Calif., Aug. 08, 2017 (GLOBE NEWSWIRE) -- NanoString Technologies, Inc. (Nasdaq:NSTG), a provider of life science tools for translational research and molecular diagnostic products, and Lam Research Corporation (Nasdaq:LRCX), a global supplier of innovative wafer fabrication equipment and services to the semiconductor industry, today announced a strategic collaboration to develop NanoString's proprietary Hyb & Seq™ next generation sequencing platform.

 

This collaboration brings together NanoString's proprietary sequencing chemistry and Lam's expertise in advanced systems engineering to enable nanoscale manufacturing, with the goal of building a clinical sequencer with the simplest workflow in the industry. The objectives of the collaboration are to complete the development…

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Jul18Silk Road Medical Announces $47 Million Financing Led By Norwest Venture Partners And Funds Managed By Janus Capital Management LLC »


-- Financing to Support Rapid Growth of TransCarotid Artery Revascularization (TCAR) Procedure --

 

Sunnyvale, Calif., July 18, 2017 /PRNewswire/ -- Silk Road Medical, Inc., a company dedicated to alleviating the devastating burden of stroke through surgical innovation, today announced it has received $47 million in new funding led by new investors Norwest Venture Partners and funds managed by Janus Capital Management LLC.  Existing investors Warburg Pincus, The Vertical Group, and CRG also participated in the round.  The new financing will be used to support the company's rapid commercial growth of its proprietary ENROUTE family of products for TransCarotid Artery Revascularization (TCAR) procedures. 

 

"Our syndicate of…

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Jul5NanoString Appoints J. Chad Brown as Senior Vice President of Sales and Marketing »


Seattle, July 05, 2017 (GLOBE NEWSWIRE) -- NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced that J. Chad Brown has been appointed Senior Vice President of Sales and Marketing, effective July 5, 2017.   

 

Mr. Brown is a senior healthcare executive with more than 35 years of experience in life science tools and clinical diagnostics. He most recently served as the President and Head of Commercial Operations for North America for Qiagen N.V.  From 2007 until 2015, Mr. Brown was with Roche Diagnostics Corporation, where he held a series of commercial leadership positions in the Applied Sciences and Centralized Diagnostics businesses, including as…

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Jun1NanoString Technologies Announces Pricing of Offering of 3,000,000 Shares of Common Stock »


Seattle, June 01, 2017 (GLOBE NEWSWIRE) -- NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced the pricing of an underwritten public offering of 3,000,000 shares of its common stock at a price of $16.75 per share pursuant to its existing shelf registration statement. NanoString has granted to the underwriter of the offering a 30-day option to purchase up to an additional 450,000 shares of common stock. NanoStringintends to use the net proceeds of the offering for general corporate purposes and working capital. The offering is expected to close on or about June 6, 2017, subject to customary closing conditions.

 

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May23Viveve Secures $30 million Debt Financing with CRG »


SUNNYVALE, CA -- 05/23/17 -- Viveve Medical, Inc. ("Viveve") (NASDAQ: VIVE), a medical technology company focused on women's health, today announced that it has entered into a senior credit facility with affiliates of CRG LP to retire its existing credit facility and provide additional capital for the company.

 

The new credit facility consists of $20 million to be drawn at closing and the ability to access additional funding of up to an aggregate of $10 million for a total of $30 million based on the achievement of certain revenue and market capitalization milestones through June 30, 2018. The term of…

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May12Maxigesic on Track to Access the Large United States Painkiller Market »


AFT Pharmaceuticals has been officially notified that the US Food and Drug Administration (FDA) has accepted its application to register its painkiller Maxigesictablets in the United States.

 

AFT Board Director and drug development expert, Dr Doug Wilson, says that this notification is a significant milestone in getting Maxigesic into the key US market.

 

“The FDA’s drug development and approval process basically has three stages,” says Dr Wilson. “The first is the opening of an Investigational New Drug Application (IND) which allows studies in patients to commence. The second is their acceptance of what is known as the ‘regulatory…

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May10NanoString Appoints Elisha W. Finney to Board of Directors »


Seattle, May 10, 2017 (GLOBE NEWSWIRE) -- NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced the appointment of Elisha W. Finney, former executive vice president and chief financial officer at Varian Medical Systems (NYSE: VAR), to its Board of Directors and Audit Committee. Ms. Finney brings more than 25 years of financial and life science expertise to NanoString.

 

Her responsibilities at Varian included corporate accounting; corporate communications and investor relations; internal financial and compliance audit; risk management; tax and treasury and corporate information systems. She joined Varian in 1988 and was named vice president of finance and CFO in April,…

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May3Outset Medical Announces $76.5 Million in Funding for Innovative Dialysis Technology »


-- Financing to Expand U.S. Commercial Introduction and Manufacturing --

 

SAN JOSE, Calif.--(BUSINESS WIRE)--Outset Medical, a commercial-stage company delivering first-of-its-kind technology into the $13 billion global dialysis market, today announced $76.5 million in Series C equity funding. A new investor, funds advised by T. Rowe Price Associates, Inc., led the round, which also included participation from existing investors Fidelity Management & Research Company, Partner Fund Management LP, Warburg Pincus, Perceptive Advisors and The Vertical Group.

 

Outset’s technology, the Tablo™ Hemodialysis System, is the first novel dialysis system to reach the U.S. market in more than 15 years. The…

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Mar23Tandem Diabetes Care Announces Pricing of Underwritten Public Offering of Common Stock »


SAN DIEGO--(BUSINESS WIRE)--Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device company and manufacturer of the only touchscreen insulin pumps available in the United States, today announced the pricing of an underwritten public offering of 18,000,000 shares of its common stock at a price to the public of $1.25 per share. The gross proceeds to Tandem from this offering are expected to be $22.5 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by Tandem. All of the shares of common stock to be sold in the offering are being offered by Tandem. In addition, Tandem…

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Mar23Valeritas Announces Pricing of $52.5 Million Public Offering of Common Stock »


BRIDGEWATER, N.J., March 23, 2017 (GLOBE NEWSWIRE) -- Valeritas Holdings, Inc. (OTCQB:VLRX) today announced the pricing of its underwritten public offering of 5,250,000 shares of its common stock at a public offering price of $10.00 per share. In addition, Valeritas has granted the underwriters a 30-day option to purchase up to an additional 787,500 shares of its common stock at the public offering price.  All of the shares of common stock are being offered by Valeritas.  The shares are expected to begin trading on the Nasdaq Capital Market on March 23, 2017, under the symbol “VLRX.” The offering is expected…

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Mar13Astute Medical Expands Relationship with bioMérieux, Inc. and Ortho Clinical Diagnostics to Enhance Nephrocheck Test Market Access »


San Diego – March 13, 2017 – Astute Medical, Inc. (“Company”), developer of biomarkers for better healthcare, today announced two agreements aimed at expanding global access to the NephroCheck Test, a biomarker-based risk assessment tool that is changing the way hospital physicians approach acute kidney injury (AKI), a common and dangerous complication. Astute Medical has expanded its agreement with Ortho Clinical Diagnostics (“Ortho”), adding more countries under a new European distribution deal. The Company has also entered into a distribution agreement with bioMérieux in the United States. As a result, both companies will promote Astute Medical’s NephroCheck® Test on the Astute140 Meter in the United…

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Mar9Autonomic Technologies Announces Expanded Indication in Europe (CE mark) for Disabling Migraine with Pulsante® SPG Microstimulator System »


Cluster headache therapy now indicated for pain relief in highly disabled migraine patients

 

Redwood City, CA (March 9, 2017) Autonomic Technologies, Inc. announced today that it has received an expanded indication (CE mark) in Europe for the Pulsante® SPG Microstimulator System to include pain relief for highly disabled migraine patients. Autonomic Technologies is a global medical device company focused on the development and commercialization of innovative therapies for the treatment of cranial autonomic disorders, initially severe headache.

 

The Pulsante® SPG Microstimulator System is the first implantable neurostimulation therapy to receive CE Mark for pain relief in both…

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Mar7Envision Healthcare Enters Definitive Agreement to Acquire Imaging Advantage »


Transaction to Expand Envision’s Radiology Physician Services

 

Nashville, Tenn. & Greenwood Village, Colo.--(BUSINESS WIRE)--Envision Healthcare Corporation (NYSE: EVHC) has entered into a definitive agreement to acquire Imaging Advantage LLC, a provider of comprehensive radiology services including hospital-based, outpatient and remote-reading services, in a transaction that will meaningfully expand Envision’s presence in radiology physician services across the country.

 

Imaging Advantage deploys an innovative and scalable cloud-based technology to optimize provider utilization and efficiency of more than 400 radiologists who provide services across a clinical network that includes more than 435 healthcare facilities.

 

“We believe the merger with Envision…

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Mar6TearLab Announces CE Marking for Next-Generation System »


SAN DIEGO, March 06, 2017 (GLOBE NEWSWIRE) -- TearLab Corporation (NASDAQ:TEAR) (TSX:TLB) (the “Company”) today announced that its next-generation in-vitro diagnostics testing platform is in conformity with all the applicable provisions of In Vitro Diagnostic Medical Devices Directive 98/79 EC enabling CE Marking of the device. CE Marking provides clearance in the European Union (EU) and European Free Trade Association (EFTA) member countries.

 

For the first time, the TearLab next-generation platform offers eye care professionals the ability to assess multiple biomarkers in human tears with a single nanoliter volume tear collection. The lab-on-a-chip platform provides quantitative measurements of tear…

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Feb27ViewRay Receives FDA 510(k) Clearance for MRIdian Linac »


-- Announces Fourth Quarter and Full Year 2016 Financial Highlights, including Record Revenue and $133.2 million in Backlog --

 

CLEVELAND, February 27, 2017 — ViewRay, Inc. (Nasdaq: VRAY) announced today that the company received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the MRIdian Linac system, the company’s next generation linear accelerator-based MRI-guided radiation therapy system.

 

“FDA clearance of the MRIdian Linac is a transformative milestone for ViewRay,” said Chris A. Raanes, president and chief executive officer of ViewRay. “We believe that availability of the world’s first commercial system to combine MRI for soft-tissue visualization…

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Feb16National Rheumatology Group AARA Embraces Exagen Diagnostics' Novel Method to Collect and Test for Widely Used Therapies in Lupus and Rheumatoid Arthritis »


Albuquerque, NM and San Diego, CA--(Marketwired - February 16, 2017) - Exagen Diagnostics, Inc. home of AVISE® testing announced today that AARA powered by Bendcare, a national organization of Rheumatologist in the United States with over 100 physician members, has recommended use of AVISE MTX (methotrexate polyglutamates) and AVISE HCQ (Whole blood Hydroxychloroquine) in routine practice.

 

AARA is reshaping Rheumatology with a focus on improving the patient journey through improved access, advocacy, technology, training, and education. Therapeutic drug monitoring and the new AVISE Touch collection method is perfectly aligned with AARA's objectives. Dr.Thierry Dervieux, Chief Scientific Officer at Exagen…

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Feb14AMAG and Endoceutics Enter Into an Exclusive U.S. License Agreement for Intrarosa™ (Prasterone) »


Recently approved first-of-its-kind, non-estrogen prescription therapy for a common symptom of menopause

 

Conference call scheduled for 8 a.m. ET today

 

WALTHAM, Mass. and QUEBEC, Feb. 14, 2017 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (Nasdaq:AMAG) and Endoceutics, Inc. today announced that they have entered into an exclusive license agreement that provides AMAG with U.S. commercial rights to Intrarosa™ (prasterone). Intrarosa is the only FDA-approved, locally administered, daily, non-estrogen product for the treatment of moderate-to-severe dyspareunia (pain during intercourse), a common symptom of vulvar and vaginal atrophy (VVA), due to menopause. Unlike conventional pharmacological estrogen-containing medications, Intrarosa does not carry a…

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Feb2Specialists On Call Announces Acquisition of NeuroCall, Reinforces Its Leadership Position in Tele-Neurology Services »


Reston, VA – February 02, 2017 – Specialists On Call, Inc. ("SOC"), a portfolio company of Warburg Pincus LLC and the nation’s leading provider of clinical telemedicine technology and services to acute care hospitals, announced today that it has acquired NeuroCall, Inc. the second leading provider in the space. Both organizations are Joint Commission accredited and focus on clinical excellence having cumulatively provided over 280,000 neurology teleconsultations to date. The combined organization will cover over 350 acute care hospitals and systems nationwide for tele-neurology consultations.

 

"Specialists on Call is pleased to have our NeuroCall colleagues join us as we…

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Feb2Corium Prices Follow-On Offering of Common Stock »


MENLO PARK, Calif., Feb. 02, 2017 (GLOBE NEWSWIRE) -- Corium International, Inc. (Nasdaq:CORI), a commercial-stage biopharmaceutical company focused on the development, manufacture and commercialization of specialty transdermal products, today announced the pricing of its underwritten public offering of 6,666,667 shares of common stock at a public offering price of $3.00 per share. Gross proceeds to Corium from this offering are expected to be approximately $20 million. Corium intends to use the net proceeds from this offering for product development and general corporate purposes, which may include funding research and development, increasing its working capital, reducing indebtedness, acquisitions or investments in businesses, products or technologies that are complementary…

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Jan31Humana Issues Positive Coverage Decision for NanoString's Prosigna® Breast Cancer Assay »


Seattle, Jan. 31, 2017 (GLOBE NEWSWIRE) -- NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced that Humana has issued a positive coverage decision for the Prosigna® Breast Cancer Gene Signature Assay. Humana and its more than 13 million members join other payors now covering Prosigna, collectively representing more than 175 million covered lives throughout the United States.

 

This positive coverage decision is in line with updated ASCO guidelines released in February of 2016, wherein Prosigna is considered medically necessary to assess the necessity of adjuvant chemotherapy in ER-positive, HER2-negative, node-negative breast cancer patients,…

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Jan16RainDance Technologies To Be Sold to Bio-Rad »


Billerica, Mass. — January 16, 2017 — RainDance Technologies, a life sciences tools company, announced today that its Board of Directors has entered into a definitive agreement to sell the company to Bio-Rad Laboratories, Inc.

 

Since its foundation in 2004, RainDance pioneered the development and application of droplet microfluidic technology for biological applications, and in the process built a substantial and foundational patent portfolio in the field. 
RainDance markets products for digital PCR and sample enrichment for Next Generation Sequencing (NGS) and has demonstrated feasibility for use of its droplet technology for digital ELISA, linked read NGS, single cell…

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Jan6Iroko Pharmaceuticals Announces Key Patent for VIVLODEX® »


Philadelphia, January 6, 2017 — Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, announced today the receipt of a patent for VIVLODEX®(meloxicam) capsules 5 mg and 10 mg. The patent, issued by the United States Patent and Trademark Office (USPTO), will be listed in FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations publication, or Orange Book, which includes all FDA-approved drugs, as well as patent and exclusivity information associated with this drug. The VIVLODEX® patent expires no earlier than 2033.

 

VIVLODEX®, a nonsteroidal anti-inflammatory drug (NSAID), is approved by the U.S. Food and Drug…

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Dec14Bio-Techne and Astute Medical Form Strategic Partnership »


Minneapolis, MN and San Diego, CA - Dec. 14, 2016 – Bio-Techne Corporation (NASDAQ: TECH) today closed on a strategic equity investment in Astute Medical, Inc. (San Diego, CA), a diagnostic company devoted to improving patient healthcare outcomes through the identification and validation of novel biomarkers. Certain existing Astute Medical investors also participated in the financing, which totaled $43 million. This transaction has been structured to allow Bio-Techne to build a strategic foundation in diagnostics, with an option to further expand the relationship. In addition to Bio-Techne’s equity investment in Astute Medical, Bio-Techne will receive certain manufacturing rights for future products…

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Dec13Biodesix® Tests Demonstrate Ability to Stratify Patients Treated with Immunotherapy »


VeriStrat® Test Shown To Have Clinical Utility in Predicting Overall Survival of Afatinib-Treated Patients With Lung Cancer

 

December 13, 2016, Boulder, Colorado… Two studies demonstrating the clinical utility of the VeriStrat® test in the management of patients with non-small cell lung cancer (NSCLC) were presented last week at the 17th World Conference on Lung Cancer, hosted by the International Association for the Study of Lung Cancer. A Biodesix investigational test developed with the Diagnostic Cortex™ platform was also evaluated in one of the studies, providing further data regarding the potential value of a proteomic test to help physicians stratify patients for immunotherapies.

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Dec5Good Start Genetics Announces Marketing Agreement with Roche Diagnostics for Carrier Screening in the United States »


Collaboration Marries Good Start’s Proprietary Technology with Roche Diagnostics’ Commercial Expertise for Broad Market Reach

 

CAMBRIDGE, Mass., December 5, 2016 /PRNewswire/ – Good Start Genetics, an information solutions company delivering best-in-class genetics offerings to growing families, today announced that it has entered into a collaborative agreement with global healthcare leader Roche (SIX: RO, ROG; OTCQX: RHHBY) to sell Good Start’s carrier screening service for inherited genetic disorders. Under the agreement, Roche Diagnostics will offer Good Start Genetics’ GeneVuTM carrier screening test service in conjunction with its HarmonyTM non-invasive prenatal test (NIPT) service to obstetricians and general practitioners caring…

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Dec4NeuroPace, Inc. Announces Results of 7 Years of Clinical Trial Follow-up Demonstrating 72 Percent Seizure Reduction with the RNS® System »


Study Presented at American Epilepsy Society Meeting Demonstrates Sustained Effectiveness in Adults with Drug-Resistant Partial Onset Epilepsy

 

Mountain View, Calif. & Houston --(BUSINESS WIRE)-- NeuroPace, Inc. today announced the results from 7 years of clinical trial follow-up, which demonstrated significant seizure reduction with the RNS® System among adults who have a common form of epilepsy that is difficult to treat with medication. Results from the study, presented today at the American Epilepsy Society meeting in Houston, include data on people with medically refractory partial onset epilepsy enrolled at 32 Comprehensive Epilepsy Centers in the United States. The median reduction…

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Nov30Valeritas Elects Joe Mandato, Ph.D., Experienced Medical Device Executive and Investor, to Board of Directors »


BRIDGEWATER, N.J., Nov. 30, 2016 (GLOBE NEWSWIRE) -- Valeritas Holdings, Inc. (OTCQB:VLRX) announced today the election of Joe Mandato, Ph.D., to the Company’s Board of Directors, effective December 1, 2016.  In conjunction with the appointment of Dr. Mandato, Nate Hukill, who represents CRG, will step down from the Board of Directors as of December 1, resulting in a Board with five independent directors on a Board comprising seven members.  Dr. Mandato has extensive experience in the medical device industry as an executive, investor, educator and board member and has led numerous companies to commercial success. He is currently a managing…

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Nov21Omeros Announces Successful Outcome of OMIDRIA® Pediatric Cataract Trial »


Six-Month Extension of Patent Exclusivity and Label Expansion Expected

 

Seattle --(BUSINESS WIRE)-- Nov. 21, 2016 -- Omeros Corporation (NASDAQ: OMER) today announced the successful outcome of its recently completed post-marketing clinical trial of the effect of OMIDRIA® (phenylephrine and ketorolac injection) 1% / 0.3% in pediatric patients undergoing cataract surgery. OMIDRIA is approved by the FDA for use in adult patients undergoing cataract or intraocular lens replacement surgery to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain and is not currently approved for use in patients less than 18 years of age.

 

This pediatric trial enrolled…

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Nov17FDA Approves Intrarosa for Postmenopausal Women Experiencing Pain During Sex »


The U.S. Food and Drug Administration approved Intrarosa (prasterone) to treat women experiencing moderate to severe pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Intrarosa is the first FDA approved product containing the active ingredient prasterone, which is also known as dehydroepiandrosterone (DHEA).

 

During menopause, levels of estrogen decline in vaginal tissues, which may cause a condition known as VVA, leading to symptoms such as pain during sexual intercourse.

 

"Pain during sexual intercourse is one of the most frequent symptoms of VVA reported by postmenopausal women," said Audrey Gassman, M.D.,…

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Nov2Good Start Genetics Brings First Next-Generation Sequencing (NGS) Test to Amazon Enabling Broad Access to Carrier Screening for Couples Starting a Family »


Company Establishes Direct Relationship with Largest Online Retailer to Democratize Genetic Testing

 

Cambridge, MA (November 2, 2016)- Today, Good Start Genetics announced it has launched its VeriYouTM genetic test for couples on Amazon. VeriYou is the Company’s saliva-based, NGS carrier screening test for two of the most common inherited genetic disorders: cystic fibrosis (CF) and spinal muscular atrophy (SMA). Carrier screening is an important option for couples, since one in every 19 people in the U.S. carries a CF or SMA mutation that could be passed on to their children. If both partners carry a variant for the…

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Oct14Cardiome Announces Initiation of Commercial Operations in Canada, EH »


Vancouver, Canada, October 14, 2016 -- Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) announced that it has initiated commercial sales operations in Canada. The Canadian sales force will immediately begin detailing AGGRASTAT® (tirofiban hydrochloride) to Canadian hospitals but is expected to expand its efforts to include the detailing of BRINAVESS® (vernakalant hydrochloride), XYDALBA™ (dalbavancin hydrochloride) and TREVYENT® (treprostinil sodium), if and when marketing approval for each respective drug is granted by Health Canada’s Therapeutic Products Directorate.

 

Commenting on the initiation of commercial operations in Canada, Hugues Sachot, SVP Commercial of Cardiome said, “This is a proud day for…

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Oct4GenomeDx and Bostwick Laboratories Announce Marketing Agreement for Decipher Prostate Cancer Classifier Test »


San Diego, CA, Uniondale, NY, October 4, 2016 – GenomeDx Biosciences and Bostwick Laboratories, Inc. today announced that Bostwick has entered into a marketing partnership agreement with GenomeDx, provider of the genomic Decipher® Prostate Cancer Classifier tests for men diagnosed with localized prostate cancer.

 

Bostwick Laboratories is a national, full-service laboratory specializing in uropathology, and is a leading resource for prostate and urologic biopsies. Under the agreement, Bostwick will offer Decipher Biopsy on their requisition forms, allowing for electronic ordering of the test and allowing their extensive customer base the ability to easily access Decipher.

 

“Bostwick Laboratories is a recognized…

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Sep22Industry Veteran Katherine D. Crothall, PhD to Join Valeritas Board of Directors »


BRIDGEWATER, N.J., Sept. 22, 2016 (GLOBE NEWSWIRE) -- Valeritas Holdings, Inc. (OTCQB:VLRX) announced today the election of Katherine D. Crothall, PhD, to the Company’s Board of Directors, effective October 10, 2016. Dr. Crothall will serve as an independent director, bringing the total number of independent directors to four. In conjunction with the appointment of Dr. Crothall, Cameron Hui, who represents CRG, will step down from the Board of Directors as of October 10, resulting in a Board with a majority of independent directors.

 

John Timberlake, President and Chief Executive Officer of Valeritas, said, “We are thrilled to welcome Kathy…

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Sep19ViewRay Receives CE Mark Approval for its MRIdian Linac System »


-- 510(k) Application Submitted to the FDA --

 

CLEVELAND, September 19, 2016 — ViewRay, Inc. (Nasdaq: VRAY)announced today that the company has received CE Mark approval for its next generation linear accelerator-based MRI-guided radiation therapy system, the MRIdian Linac. The MRIdian Linac builds on the first generation MRIdian system, but replaces cobalt with linear accelerator technology. 

 

The MRIdian is the world’s first and only clinical MRI-guided radiation therapy system.

 

In addition to receiving CE Mark approval for the MRIdian Linac in Europe, the company has also submitted its 510(k) application for the MRIdian Linac technology in the…

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Sep15Silk Road Medical Announces New Medicare Coverage Option for TransCarotid Artery Revascularization (TCAR) Procedures »


--Medicare to Cover Procedures within the TCAR Surveillance Project Sponsored by the Society for Vascular Surger--

 

SUNNYVALE, Calif., Sept. 15, 2016 /PRNewswire/ — Silk Road Medical, Inc., a company dedicated to surgical and endovascular innovation to prevent the devastating burden of stroke, announced the Centers for Medicare and Medicaid Services (CMS) has extended coverage for the TransCarotid Artery Revascularization (TCAR) procedure under the existing National Coverage Determination 20.7. TCAR is eligible for coverage when patients are treated with any FDA-approved proximal embolic protection device and FDA-approved carotid artery stent system indicated for the transcarotid approach and entered into the…

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Aug19ViewRay Announces $13.75 Million Private Placement »


--Company preparing for introduction of MRIdian Linear Accelerator Technology--

 

CLEVELAND, August 19, 2016 — ViewRay, Inc. (Nasdaq: VRAY)announced today that it has entered into a definitive agreement in connection with a private placement of its common stock and warrants that is expected to result in gross proceeds to the Company of approximately $13.75 million. The financing is being led by certain of the Company's existing investors, including OrbiMed Advisors, LLC; Xeraya Capital; and Kearny Venture Partners. It also includes investments from two independent members of the Company’s Board of Directors along with an equity investment from CRG, which has…

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Aug16Avinger, Inc. Announces Closing of Public Offering of Common Stock and Underwriters’ Full Exercise of Option to Purchase Additional Shares »


Redwood City, Calif., Aug. 16, 2016 (GLOBE NEWSWIRE) -- Avinger, Inc. (NASDAQ:AVGR) (the “Company”), a leading developer of innovative treatments for peripheral artery disease (“PAD”), today announced the closing of its previously announced public offering of 9,857,800 shares of Avinger’s common stock at a price to the public of $3.50 per share, which includes the exercise in full by the underwriters of their option to purchase an additional 1,285,800 shares of Avinger’s common stock. The total net proceeds from the offering are estimated to be approximately $31.7 million, after deducting underwriting discounts and commissions and estimated offering expenses payable by Avinger.

 

The Company expects to use…

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Aug9Cardiome Announces XYDALBA™ Single Dose Infusion Approval by European Medicines Agency »


Vancouver, Canada, August 9, 2016 -- Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) announced that XYDALBA™ (dalbavancin) has been approved by the European Medicines Agency (EMA) for administration as a single, 30 minute, 1500mg infusion (three 500mg vials). This single dosing regimen is in addition to the initially approved dosing regimen of 1000 mg (two 500mg vials) followed one week later by 500 mg (a single 500mg vial).

 

“We are pleased that the EMA has approved the single dose administration of XYDALBA™,” said Kiran Bhirangi, M.D., Cardiome’s Head of Medical Affairs. “This approval aligns the dosing regimen with…

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Jul26Cardiome Announces Pricing of Public Offering of 10,000,000 Common Shares »


Vancouver, Canada, July 26, 2016 – Cardiome Pharma Corp. (“Cardiome” or the “Company”) (NASDAQ: CRME / TSX: COM) announced today the pricing of its previously announced underwritten public offering (the “Offering”) of 10,000,000 common shares from treasury at a price to the public of US$3.00 per common share, for aggregate gross proceeds to the Company of US$30,000,000, before deducting the underwriting commission and estimated Offering expenses payable by the Company. In addition, Cardiome has also granted the underwriters of the Offering a 30-day option to purchase up to an additional 1,500,000 common shares on the same terms and conditions.

 

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Jul13Valeritas Appoints Brian K. Roberts to its Board of Directors »


BRIDGEWATER, N.J. , July 13, 2016 (GLOBE NEWSWIRE) -- Valeritas Holdings, Inc. (OTCQB:VLRX) announced today the appointment of Brian K. Roberts to the Company’s Board of Directors. Mr. Roberts will serve as Chairman of the Audit Committee, which will include existing independent Board members Peter Devlin and Rodney Altman , M.D.

 

John Timberlake , President and Chief Executive Officer of Valeritas, said, “We are pleased to welcome Brian to the Valeritas Board of Directors and announce that he will serve as Chairman of the Audit Committee. Brian is a seasoned financial executive in the healthcare industry and has served…

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Jun13Nevro Announces Full Exercise of Over-Allotment Option and Closing of Public Offering of $172.5 Million Convertible Senior Notes »


Redwood City, Calif., June 13, 2016 /PRNewswire/ -- Nevro Corp. (NYSE: NVRO), a global medical device company that is providing innovative evidence-based solutions for the treatment of chronic pain, today announced the closing of its previously announced offering, registered under the Securities Act of 1933, as amended, of $172.5 million aggregate principal amount of 1.75% convertible senior notes due 2021, which included the exercise in full of the underwriters' over-allotment option to purchase additional notes.

 

J.P. Morgan and Morgan Stanley acted as joint book-running managers for the offering. Leerink Partners and JMP Securities acted as co-managers.

 

Nevro intends to use a portion of the net proceeds from this offering to fund…

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May26Cigna Issues Positive Coverage Decision for NanoString's Prosigna® Breast Cancer Assay »


Seattle, May 26, 2016 (GLOBE NEWSWIRE) -- NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of molecular diagnostic testing products and life science tools for translational research, today announced that Cigna has issued a positive Medical Coverage Policy decision for the Prosigna® Breast Cancer Gene Signature Assay.  Cigna and its roughly 13 million members join other payors now covering Prosigna, collectively representing more than 135 million covered lives throughout the United States.

 

This positive coverage decision is in line with updated ASCO guidelines released in February, wherein Prosigna is considered medically necessary to assess the necessity of adjuvant chemotherapy in ER-positive, HER2-negative, node-negative breast cancer patients,…

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May19Two-Year Study Results Show the Pulsante® Microstimulator Provides Sustained, Longterm Relief for Cluster Headache Patients »


New hope for cluster headache sufferers

 

Redwood City, USA, May 19th, 2016 – A peer-reviewed paper* in the International Headache Society journal Cephalagia reported that cluster headache patients treated with the Pulsante® Microstimulator achieved effective pain relief for 24 months. Over 60% of patients enrolled in a follow-up of the original Pathway CH-1 study maintained their therapeutic response for two years.

 

A total of 5,956 attacks were evaluated across 33 chronic cluster headache patients in the open-label follow-up study. At two years, 45% of patients experienced acute effectiveness in ≥  50% of attacks by using only the Pulsante®…

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May12FDA Clears Next-Generation Version of EndoGastric Solutions’ EsophyX Device »


EsophyX® Z Fastener Delivery System requires fewer steps for Transoral Incisionless Fundoplication (TIF) procedures

 

REDMOND, Washington—EndoGastric Solutions® (EGS), a leader in incisionless procedural therapy for gastroesophageal reflux disease (GERD), today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the EsophyX® Z device.

 

Designed for compatibility with the company’s existing 7.5 mm SerosaFuse® Implantable Fastener cartridges, EsophyX Z allows physicians to reconstruct the gastroesophageal valve and then secure tissue with a trigger-like handle, making the device similar to stapler like devices often utilized in surgery.

 

EsophyX Z will enter a limited release…

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May9Aetna Issues Positive Coverage Decision for NanoString's Prosigna® Breast Cancer Assay »


SEATTLE, May 09, 2016 (GLOBE NEWSWIRE) -- NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of molecular diagnostic testing products and life science tools for translational research, today announced that Aetna has added the Prosigna® Breast Cancer Gene Signature Assay to its Tumor Markers Clinical Policy Bulletin.  Aetna and its more than 19 million members join other payors now covering Prosigna, collectively representing approximately 125 million covered lives throughout the United States.

 

This positive coverage decision is in line with updated ASCO guidelines released in February, wherein Prosigna is considered medically necessary to assess the necessity of adjuvant chemotherapy in ER-positive, HER2-negative, node-negative breast cancer patients,…

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May4TearLab Announces $17.3 Million Registered Public Offering »


SAN DIEGO, May 04, 2016 (GLOBE NEWSWIRE) -- TearLab Corporation (NASDAQ:TEAR) (TSX:TLB) (“TearLab” or the “Company”) announced today the pricing of a public offering of the Company’s common stock, resulting in total gross proceeds of approximately $17.3 million.  The offering is expected to close on or about May 9, 2016, subject to satisfaction of customary closing conditions.  

 

The offering was priced at $0.75 per share of common stock (or common stock equivalent), with each share of common stock coupled with a warrant to purchase one-half of one share of common stock. 

 

The warrants have an exercise price of…

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May4Valeritas Completes Alternative Public Offering and Raises Gross Proceeds of $25.2 Million »


--Funding Will Support Continued Commercialization of the V-Go® Disposable Insulin Delivery Device and Advance Next Generation Products--

 

BRIDGEWATER, New Jersey, May 4, 2016 – Valeritas Holdings, Inc. (OTCQB: VLRX) announced today its successful completion of an alternative public offering (APO). This was accomplished via a reverse merger of its wholly owned operating company, Valeritas, Inc. and a private placement of approximately 5 million shares of its unregistered common stock at $5.00 per share.

 

Under the terms of the reverse merger, which was completed on May 3, 2016, Valeritas Holdings, Inc. will trade on the OTC Markets under the…

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Apr25Peter J. Devlin Joins Valeritas Board of Directors as Independent Director »


BRIDGEWATER, New Jersey, April 25, 2016 – Valeritas, Inc. announced today that Peter J. Devlin has been elected to the company's Board of Directors as an independent director. Peter has more than 27 years of broad-based experience in the medical device and in-vitro diagnostics industries as well as extensive knowledge and expertise in diabetes. In addition, he has had great success with commercializing products that have a direct patient use connection.

 

"Peter is a highly motivated, growth-driven leader with proven ability to develop and implement successful strategies for global healthcare markets across a variety of medical specialties. His breadth…

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Apr25Exagen Points the Way for Patients with Difficult-to-Diagnose Lupus »


San Diego, CA – Exagen Diagnostics, a rheumatology specialty laboratory with offices in Vista, CA, and Albuquerque, NM, is focused on helping patients and their doctors get speedier and more accurate diagnoses. Today, they produce the only validated lupus test on the market incorporating scientifically proven CB-CAPS technology, and it is having a big impact with both doctors and patients.

 

Mardella Engen, a retired campaign manager for the nonprofit Veterans of Foreign Wars service organization who now lives in San Diego, is especially grateful for the diagnostic advancement. For almost a year, she had been traveling from one doctor’s…

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Apr19Rodney D. Altman, MD Joins Valeritas Board of Directors »


-- Valeritas Expands Its Board of Directors --

 

BRIDGEWATER, New Jersey, April 19, 2016 – Valeritas, Inc. announced today that Rodney D. Altman, MD has been elected to the company's board as an independent director. Dr. Altman brings a thorough understanding of the healthcare system with 16 years of venture capital, healthcare administrative and operations, as well as over 25 years of extensive clinical experience. He recently joined Spindletop Capital as a Managing Director. Dr. Altman also currently serves as board director at Siris Medical, and as an advisor to BDC Ventures and to several healthcare start-ups. Prior to…

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Apr12ViewRay® Appoints Dr. Henry A. McKinnell, Jr. to its Board of Directors »


--Former Pfizer Chairman and CEO Brings Extensive Experience in Life Sciences and Public Companies--

 

CLEVELAND, April 12, 2016 — ViewRay, Inc. (Nasdaq: VRAY) announced today the appointment of Henry A. McKinnell, Jr., Ph.D., former Chairman and Chief Executive Officer of Pfizer Inc., to the company’s Board of Directors.

 

“We are delighted to welcome Hank McKinnell to the ViewRay Board of Directors,” said Chris A. Raanes, President and Chief Executive Officer of ViewRay. “Hank’s vast experience in medical innovation, in running a business, and in working with governments and other key stakeholders will be invaluable as we take ViewRay…

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Apr4200 Million Americans Now Have Insurance Coverage for Biodesix’ VeriStrat Test »


VeriStrat®, Biodesix’ proteomic blood test for patients with advanced NSCLC, has received multiple positive coverage decisions in 2016. As a result, 200 million Americans now have insurance coverage for VeriStrat. The most recent positive coverage decisions include BlueCross BlueShield (BCBS) of Florida and Health Care Services Corporation (HCSC).

 

VeriStrat provides physicians with prognostic and predictive information to guide treatment of advanced NSCLC. VeriStrat results inform likely patient benefit from certain treatments, and can facilitate patient-physician conversations about prognosis, life expectancy, and treatment recommendations. The test is clinically proven for use in patients with advanced NSCLC and has been recommended…

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Mar8GenomeDx Biosciences Launches Decipher Biopsy Test »


New Predictor of Prostate Cancer Disease Progression Now Available for Newly Diagnosed Patients

 

San Diego – March 8, 2016 – GenomeDx Biosciences today announced the launch of Decipher Biopsy, a genomic test that evaluates RNA expression-based biomarkers to predict the risk of high-grade disease, metastasis and cancer-specific death at the time of biopsy in men with prostate cancer. The launch brings the Decipher Prostate Cancer Classifier, already clinically adopted and extensively validated following surgery, to newly diagnosed patients at initial biopsy. Decipher Biopsy is the only genomic test available to assess tumor aggressiveness across very low, low, intermediate, and high…

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Feb25Valeritas Announces Leadership and Board of Directors Changes »


-- John Timberlake Named as Interim CEO --

 

BRIDGEWATER, New Jersey, February 25, 2016 – Valeritas, Inc. announced today changes to its executive team this week. John Timberlake has been named the company’s new Interim Chief Executive Officer. Former CEO Kris Peterson is leaving Valeritas to pursue other opportunities and will continue to consult with the company.

 

Valeritas also announced today changes in its Board of Directors. Luke Duster, Managing Director of CRG, will join the board along with Nate Hukill, President of CRG, Cameron Hui, Associate of CRG, and John Timberlake.

 

“We would like to thank…

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Feb4GenomeDx Publishes First Study Supporting Use of Decipher Test in Prostate Biopsy »


-- Company’s Proprietary Genomic Classifier Demonstrates Unprecedented Accuracy in Diagnostic Biopsies Study Published in Urology --

 

San Diego, Feb 4, 2016 -- GenomeDx Biosciences today announced publication of results that show Decipher Prostate Cancer Classifier, which is validated and commercially available for patients following prostate surgery, can also predict the risk of metastasis and high-grade disease at the time of biopsy. These results, currently available online and anticipated to be published in the April 2016 issue of Urology, are part of a study conducted by the Cleveland Clinic Foundation. This is the first validation study that demonstrates the potential…

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Feb1TearLab Announces Proposed Public Offering of Common Stock »


San Diego, Feb. 01, 2016 (GLOBE NEWSWIRE) -- TearLab Corporation (NASDAQ: TEAR) (TSX: TLB) (“TearLab” or “the Company”) announced today its intention to offer, subject to market and other conditions, shares of its common stock in an underwritten public offering. The Company currently estimates the size of the offering at $15.0 million.  In addition, TearLab intends to grant the underwriters of the offering the right for a period of 30 days to purchase up to an additional $2.25 million of shares of common stock at the public offering price, less underwriting discounts and commissions. The proceeds of the offering will…

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Jan7NanoString Technologies Enters Into Collaboration Agreement With Medivation and Astellas to Develop Novel Companion Diagnostic Test »


-- NanoString Eligible to Receive up to $22 Million for Technology Access, Near-Term Milestones and Development Funding -- 

 

SAN FRANCISCO, CA and SEATTLE, WA-- (Marketwired - Jan 7, 2016) - Medivation, Inc. (NASDAQ: MDVN) and NanoString Technologies, Inc., (NASDAQ: NSTG) today announced they have entered into a collaboration, together with Astellas Pharma Inc., to pursue the translation of a novel gene expression signature algorithm from Medivation into a companion diagnostic assay using NanoString's nCounter® Dx Analysis System. Under the terms of the collaboration agreement, NanoString will be responsible for developing and validating the diagnostic test and, if the parties…

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Jan7GenomeDx’s Decipher® Test Validated to Predict Metastasis from Prostate Cancer Biopsies »


-- Data to Be Presented at 2016 Genitourinary Cancers Symposium --

 

San Diego, Jan. 7, 2016 -- GenomeDx Biosciences today announced the first validation data supporting use of the Decipher® Prostate Cancer Classifier in analysis of diagnostic needle core biopsies to help guide the management of newly diagnosed men with prostate cancer. The data will be presented at the 2016 Genitourinary Cancers Symposium in San Francisco by Eric Klein, M.D., Chairman of the Glickman Urological and Kidney Institute at Cleveland Clinic.

 

Decipher, which has been extensively validated in over 3,000 patients for metastasis prediction after radical prostatectomy, accurately…

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Jan6Benvenue Medical Secures $60 Million Financing »


-- Spine Company to Accelerate Commercialization of Luna® 3D Interbody Fusion System and Kiva® VCF Treatment System --
 

SANTA CLARA, Calif. -- January 6, 2016

 

Benvenue Medical, Inc., a developer of minimally invasive solutions for spine repair, announced it completed a $60 million round of financing. The spine company intends to use the proceeds to accelerate U.S. commercialization activities for its two innovative minimally invasive products – the Luna^® 3D Interbody Fusion System for treating degenerative disc disease and the Kiva^® VCF Treatment System for treating vertebral compression fractures (VCFs).

 

The financing is a combination of…

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Dec10CMS Approves Transitional Pass-Through Payment for Outpatient Use of Nevro's Senza® Spinal Cord Stimulation System »


Redwood City, Calif., Dec. 10, 2015 /PRNewswire/ - Nevro Corp. (NYSE: NVRO), a global medical device company that is providing innovative evidence-based solutions for the treatment of chronic pain, today announced that the Centers for Medicare & Medicaid Services (CMS) have approved a transitional pass-through payment for High Frequency Stimulation under the Medicare hospital outpatient prospective payment system effective beginning January 1, 2016.  This pass-through payment for HF10™ therapy will be in addition to the established reimbursement for spinal cord stimulation devices.  CMS determined the Senza SCS System delivering HF10 therapy met the criteria for a new device category based…

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Dec7RainDance Technologies and Blood Systems Research Institute Collaborate to Develop Ultra-sensitive Assays to Detect and Quantify HIV Latency »


Collaboration provides new amfAR Institute for HIV Cure Research with access to RainDance’s unified Next-Generation Sequencing and Digital PCR platform 

 

Billerica, Mass. — December 7, 2015 — RainDance Technologies, Inc., a genomics tools company dedicated to simplifying the analysis of complex genetic diseases, and Blood Systems Research Institute (BSRI) today announced a research collaboration to develop blood-based assays and protocols for the precise measurement of the human immunodeficiency virus (HIV) latent reservoir using RainDance’s RainDrop® Digital PCR and ThunderBolts™ Next-Generation Sequencing (NGS) Enrichment Systems. As part of this collaboration, BSRI will provide access to the RainDance products to key…

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Dec1Avinger Announces Filing of 510(k) Application for Enhanced Version of Pantheris(TM) »


REDWOOD CITY, Calif., - Dec. 1, 2015 - (GLOBE NEWSWIRE) -- Avinger, Inc., (NASDAQ:AVGR) a developer and manufacturer of image-guided, catheter-based systems for the treatment of peripheral arterial disease (PAD) and pioneer of the lumivascular approach to treating vascular disease, today announced that it has filed a 510(k) pre-market notification with the U.S. Food and Drug Administration (FDA) for an enhanced version of its Pantheris™Catheter.

 

On October 14, 2015, Avinger received 510(k) clearance from the FDA for the Pantheris System for the treatment of patients with PAD. This new 510(k) application covers subsequent modifications to enhance the catheter, including…

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Nov30Nevro Announces the U.S. Patent and Trademark Office's Denial of Boston Scientific Petitions for Inter Partes Review of U.S. Patent No. 8,359,102 »


Redwood City, Calif., Nov. 30, 2015 /PRNewswire/ -- Nevro Corp. (NYSE: NVRO), a global medical device company that is providing innovative evidence-based solutions for the treatment of chronic pain, today announced that the Patent Trial and Appeals Board (PTAB) at the U.S. Patent and Trademark Office (USPTO) has denied instituting an inter partes review (IPR) of U.S. Patent No. 8,359,102 (the '102 patent).

 

On May 14, 2015, a unit of Boston Scientific Corporation filed two petitions challenging the validity of certain claims of the '102 patent.  In its written decision, however, the PTAB determined that Boston Scientific failed to…

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Nov27AFT Pharmaceuticals IPO Confirmed »


AFT Pharmaceuticals IPO Confirmed and Product Disclosure Statement Lodged


Demand for AFT shares strong, final share price set at $2.80

 

Investors will soon be able to buy shares in growing New Zealand and Australian-based multinational pharmaceutical company, AFT Pharmaceuticals Limited (“AFT”).

 

AFT today confirmed its IPO and lodged a Product Disclosure Statement for the initial public offering of ordinary shares in the company (the “Offer”). The Product Disclosure Statement and link to the Register Entry containing additional material information about the Offer will be available at www.aftpharmshares.com. AFT intends to list on both the NZX Main…

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Nov5NanoString Technologies Expands 3D Biology Portfolio With the Commercial Launch of Seven New nCounter PanCancer Profiles to Deeply Probe Cancer Biology »


Focused Gene Expression Panels Are Designed to Combine With Protein Expression Modules and Target Seven Key Aspects of Cancer Biology Including Immuno-Oncology 

 

Seattle, Nov. 5, 2015 (GLOBE NEWSWIRE) -- NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced the expansion of its 3D Biology™ portfolio with the commercial launch of the nCounter® PanCancer Profiles, seven new gene expression panels each designed to interrogate a focused area of cancer biology including immuno-oncology. The panels are focused on Adaptive Immunity, Cancer Metabolism, Intracellular Signaling, Cellular Profiling, Wnt Pathway, Innate Immunity, and…

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Nov2Avinger Successfully Completes VISION IDE Trial for Pantheris(TM) »


-- Final Six-Month VISION Data Presented at VIVA 2015 –

 

REDWOOD CITY, Calif., Nov. 2, 2015 (GLOBE NEWSWIRE) -- Avinger, Inc., (NASDAQ:AVGR) a developer and manufacturer of image-guided, catheter-based systems for the treatment of peripheral arterial disease (PAD) and pioneer of the lumivascular approach to treating vascular disease, today announced that its Pantheris™ system has achieved all safety and efficacy endpoints in six-month follow-up data for its VISION IDE clinical trial. VISION was designed to evaluate the safety and effectiveness of Pantheris to perform directional atherectomy while for the first time ever allowing physicians to use real-time intravascular imaging…

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Oct29Smith & Nephew Makes Strategic Investment in Surgical Robotics with Acquisition of Blue Belt »


Smith & Nephew (LSE:SN, NYSE:SNN), the global medical technology business, announces it has agreed to acquire Blue Belt Holdings, Inc. (“Blue Belt Technologies”) for $275 million, securing a leading position in the fast-growing area of orthopaedic robotics-assisted surgery.

 

“Our experience working with Blue Belt Technologies and our customer insight has convinced us that robotics will become increasingly mainstream across orthopaedic reconstruction in the foreseeable future,” said Olivier Bohuon, Chief Executive Officer of Smith & Nephew. “This acquisition is a compelling strategic move, with the combination of complementary products and R&D programmes creating a platform from which we can shape…

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Oct26Endologix, Inc. and TriVascular Technologies, Inc. Announce Merger to Create a Leading Cardiovascular Growth Company Focused on the Treatment of Aortic Disorders »


Combined Product Portfolio to Provide Clinicians With a Broad Range of Endovascular AAA Devices

 

Will Expand U.S. and European Sales Organizations to Enhance Growth and Provide Excellent Clinical Support 

 

Irvine, Calif., and Santa Rosa, Calif., Oct. 26, 2015 (GLOBE NEWSWIRE) -- Endologix, Inc. (Nasdaq:ELGX) and TriVascular Technologies, Inc. (Nasdaq:TRIV) announced today that they have entered into a definitive merger agreement under which Endologix and TriVascular will combine in a stock and cash transaction. The transaction is valued at $9.10 per TriVascular share, or a total of approximately $211 million, based on Endologix's closing stock price of $13.81 per…

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Oct18ViewRay® Receives Regulatory Approval to Sell MRI-Guided Radiation Therapy System in Korea »


First Patient Outside of the United States Treated at Seoul National University Hospital 

 

Cleveland, October 18, 2015 — ViewRay, Inc. (OTCQB:VRAY) announced today that the company has received regulatory approval from the Ministry of Food and Drug Safety (MFDS) – formerly known as the Korean Food and Drug Administration (KFDA) – to sell its ViewRay system in Korea. On October 13, 2015, the first patient treatments commenced less than four weeks after the system completed installation at Seoul National University Hospital (SNUH), a leading healthcare facility in Korea.

 

The first treatment at SNUH was for a patient with…

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Oct14Good Start Genetics Establishes National Relationship with UnitedHealthcare »


CAMBRIDGE, Mass., October 14, 2015 – Good Start Genetics®, Inc., a commercial-stage molecular genetics information company, announced today that it has established a new national relationship with UnitedHealthcare to serve as an in-network laboratory partner for a variety of genetic screening tests. UnitedHealthcare is the largest insurer in the country, providing health benefits to over 43 million covered lives. The agreement is effective October 15, 2015.

 

Good Start Genetics’ versatile screening options will help people better prepare for pregnancies and healthy families. Good Start Genetics is committed to offering more accurate carrier screening tests for guideline-recommended…

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Oct14Avinger, Inc. Receives FDA 510(k) Clearance for Pantheris(TM) »


-- Image-Guided Atherectomy Device Cleared to Treat Patients Suffering From PAD --

 

REDWOOD CITY, Calif., Oct. 14, 2015 (GLOBE NEWSWIRE) -- Avinger, Inc., (NASDAQ:AVGR) a developer and manufacturer of image-guided, catheter-based systems for the treatment of peripheral arterial disease (PAD) and pioneer of the Lumivascular approach to treating vascular disease, today announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) to commence U.S. commercialization of its Pantheris image-guided atherectomy system for the treatment of patients with PAD. Pantheris combines directional atherectomy with real-time, intravascular visualization and is designed to empower physicians to…

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Oct12Astute Medical Announces Signing of Distribution Agreement with Fosunpharma for Nephrocheck® Test in China with $20 Million Financing »


Deal Expands Global Access to First-Of-Its-Kind FDA-Cleared Test for Acute Kidney Injury Risk

 

San Diego – October 12, 2015 -- Astute Medical, Inc., today announced the signing of an agreement with Shanghai Fosun Long March Medicine Science Co. Ltd. (Fosun Long-March), a wholly-owned subsidiary of Shanghai Fosun Pharmaceutical (Group) Co. Ltd. (FOSUNPHARMA), for distribution of Astute’s NephroCheck® Test on the Astute140® Meter in China. In addition to its planned launch of the NephroCheck® Test in China, FOSUNPHARMA invested $20 million in Astute.

 

The agreement with Fosun Long-March will expand the global presence of the NephroCheck® Test, the only test that has received U.S. regulatory clearance as an aid…

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Oct9Medical Necessity of Tear Osmolarity Testing in the Diagnosis and Management of Dry Eye Disease Confirmed in Recently Published Medicare Local Coverage Determination »


San Diego, Oct. 9, 2015 (GLOBE NEWSWIRE) -- TearLab Corporation (Nasdaq:TEAR) (TSX:TLB) ("TearLab" or the "Company") announced today that First Coast Service Options, Inc. (the Medicare Area Contractor for Florida, Puerto Rico and the US Virgin Islands) has published a Local Coverage Determination (LCD) that confirms the role of tear osmolarity testing in the diagnosis and management of moderate to severe dry eye patients.

 

The First Coast LCD- L36232, titled "Diagnostic Evaluation and Medical Management of Moderate-Severe Dry Eye Disease (DED)," was recently published on the CMS website. The LCD states that tear osmolarity testing remains medically reasonable and…

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Sep29Good Start Genetics Announces EmbryVu »


-- Good Start Genetics Launches EmbryVu™, Affordable PGS Testing --

 

Cambridge, MA (September 29, 2015) – Good Start Genetics, Inc., a commercial-stage molecular genetics information company, announced today the availability of EmbryVu, a new preimplantation genetic screening (PGS) test. PGS improves the chances of successful in vitro fertilization (IVF) by identifying embryos that have an increased chance of implantation and successful pregnancy. Good Start Genetics is offering EmbryVu at considerably lower prices than other PGS tests currently on the market.

 

The process begins with the safe removal of a few cells from embryos created during the IVF process.…

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Sep22Ceterix Announces FDA Clearance & U.S. Commercial Availability of Next-Gen Meniscus Repair Device »


-- NovoStitch Plus Enables Meniscus Preservation for More Patients --

 

MENLO PARK, Calif. – Sept. 22, 2015 – Ceterix® Orthopaedics, Inc., a developer of novel surgical tools that improve a surgeon’s ability to perform minimally invasive orthopaedic procedures, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance and U.S. commercial availability of the company’s NovoStitch® Plus meniscal repair system.

 

Patients with meniscus tears often undergo meniscectomy – total or partial removal of the meniscus – due to the difficulty of access and limitations of current arthroscopic instruments. However, meniscectomy significantly increases the risk of arthritis or total…

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Sep17NICE Evaluation and Tariff Code Announcements to Increase UroLift® System Availability in UK NHS Patients with Enlarged Prostate »


Pleasanton, CA, US – NeoTract, Inc., today welcomed the announcement by NICE that its UroLift® System (Prostatic Urethral Lift) to treat an enlarged prostate (benign prostatic hyperplasia) saves the National Health Service (NHS) up to £286 ($443) per patient as a day case, compared to the most commonly used surgical intervention. NICE acknowledged the UroLift System has unique benefits, including preservation of sexual function, improved quality of life, reduced recovery time and the ability to treat high risk patients.

 

In its report, which assessed both clinical and economic benefits, NICE’s Medical Technologies Evaluation Program committee noted that the UroLift…

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Sep10NanoString Technologies Expands Immuno-Oncology Portfolio With Commercial Launch of Innovative nCounter RNA:Protein PanCancer Immune Profiling Panel »


-- Breakthrough RNA:Protein Technology Enables Sensitive, Simultaneous Measurement of Gene and Protein Expression, Driving a New Paradigm in Tumor Profiling -- 

 

SEATTLE, Sept. 10, 2015 (GLOBE NEWSWIRE) -- NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced the commercial launch of the nCounter® RNA:Protein PanCancer Immune Profiling Panel. The panel can be analyzed on the full line of nCounter Analysis Systems, including the new nCounter SPRINT™ Profiler, utilizing breakthrough technology, which simultaneously measures both RNA and Protein expression through multiplexed digital counting. Data generation from an early access program…

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Sep9ESMO Clinical Practice Guidelines for Breast Cancer Recommend the Use of Prosigna/PAM50 Assay for Determining Potential Benefit From Chemotherapy »


SEATTLE, Sept. 9, 2015 (GLOBE NEWSWIRE) -- NanoString Technologies, Inc., (NASDAQ:NSTG) a provider of life science tools for translational research and molecular diagnostic products, today announced that the PAM50 gene signature, commercialized as the Prosigna® Breast Cancer Gene Signature Assay, has been added to the European Society for Medical Oncology (ESMO) Clinical Practice Guidelines. The updated guidelines recognize Prosigna's value to provide additional prognostic and predictive information that complements the pathologic assessment predicting the benefit of adjuvant chemotherapy.

 

"In cases of clinical uncertainty, the decision to use chemotherapy in early stage breast cancer patients is a challenge. Chemotherapy can…

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Sep9Tandem Diabetes Care Announces FDA Approval of t:slim G4 Insulin Pump with CGM Integration »


The First and Only CGM-enabled Touch-Screen Pump 

 

San Diego, Sept. 9, 2015 /PRNewswire/ -- Tandem Diabetes Care®, Inc. (NASDAQ: TNDM) today announced U.S. Food and Drug Administration approval of the t:slim G4™ Insulin Pump, the first and only touch-screen pump with continuous glucose monitoring (CGM) integration, for use by people 12 years of age or older who use insulin. It combines features of the t:slim® Insulin Pump and  Dexcom G4® PLATINUM CGM System, devices that have consistently ranked #1 in independent surveys1, into a single device that is simple to use. The t:slim G4 Pump is the only pump…

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Sep8 Blue Belt Technologies Announces Support for Smith & Nephew’s ZUK knee on the Navio Surgical System »


Minneapolis, MN. (September 8th, 2015) - Blue Belt Technologies, a medical device company specializing in advanced technology solutions for orthopedic surgery, announces commercial support for Smith & Nephew’s ZUK unicompartmental (uni) knee on Blue Belt’s Navio robotics-assisted system.

 

The ZUK is a clinically established uni knee replacement introduced globally in 2004.

 

“Smith & Nephew’s ZUK uni implant is a market leader with a clinically proven record,” said Eric Timko, President and CEO of Blue Belt Technologies. “It makes an excellent addition to Navio’s supported implant platform and provides Smith & Nephew’s ZUK users with a robotics-assisted option that…

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Aug19ViewRay® Completes Private Placement, Raises Aggregate of $29.4 Million »


Total Financing in Last Two Months Reaches Up To Almost $80 Million 

 

Cleveland, Aug. 19, 2015 /PRNewswire/ -- ViewRay, Inc. (OTCQB: VRAY) announced today the completion of its private placement offering as part of its alternative public offering announced on July 23, 2015. Shares of the company's common stock are currently quoted on the OTC Markets under the symbol "VRAY."

 

Together with the initial closing of the private placement previously announced on July 23, ViewRay has raised aggregate gross proceeds of $29.4 million for the issuance and sale of approximately 5.88 million shares of its common stock at…

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Aug13NanoString Technologies Receives Favorable Final Local Coverage Determination by Palmetto GBA for Its Prosigna Breast Cancer Assay »


Seattle, Aug. 13, 2015 (GLOBE NEWSWIRE) -- NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced that Palmetto GBA, a Medicare Administrative Contractor (MAC) that assesses molecular diagnostic technologies through its MolDx program, has issued a favorable final local coverage determination (LCD) for the Prosigna® Breast Cancer Assay.

 

"We are delighted by the favorable LCD published today by Palmetto's MolDx team. The policy decision is expected to increase patient access across Prosigna's entire intended use population, including patients with both node-negative and node-positive breast cancer," said Brad Gray, President…

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Aug5Corium Prices Follow-On Offering of Common Stock »


MENLO PARK, Calif., Aug. 5, 2015 (GLOBE NEWSWIRE) -- Corium International, Inc. (Nasdaq:CORI), a commercial-stage biopharmaceutical company focused on the development, manufacture and commercialization of specialty transdermal products, today announced the pricing of its underwritten public offering of 4,000,000 shares of common stock at a public offering price of $13.00 per share. Gross proceeds to Corium from this offering are expected to be approximately $52 million. Corium intends to use the net proceeds from this offering for general corporate purposes, which may include funding research and development, increasing its working capital, acquisitions or investments in businesses, products or technologies that…

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Aug4TriVascular Technologies, Inc. Receives FDA Approval of the Ovation iX(TM) Abdominal Stent Graft System »


Next Generation Aortic Body Delivery System Approval Continues Strong Cadence of New Product Introductions 

 

Santa Rosa, Calif., Aug. 4, 2015 (GLOBE NEWSWIRE) -- TriVascular Technologies, Inc. (NASDAQ:TRIV) announced today that the U.S. Food and Drug Administration (FDA) approved the Ovation iX Abdominal Stent Graft System. Delivery system enhancements of Ovation iX, which stands for integrated exchange, are designed to provide physicians with additional flexibility for even more predictable deployment and greater ease of use. A new, built-in procedural option is available to replace retrograde cannulation of the main body device, facilitating placement of the contralateral iliac stent graft. A…

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Jul30Tandem Diabetes Care Announces Development Agreement with Dexcom for Integration of Future Generation CGM Systems »


San Diego, July 30, 2015 /PRNewswire/ -- Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device company and manufacturer of the t:slim® and t:flex™ Insulin Pumps, today announced that it has entered into non-exclusive Development Agreements with Dexcom, Inc. to allow the integration of future generation Tandem insulin pumps with the Dexcom G5 and G6 continuous glucose monitoring ("CGM") systems.

 

"Integrating Tandem's next generation pump platform with Dexcom's future CGM systems is an important step in aligning our technologies to be used in automated insulin delivery applications," said Kim Blickenstaff, President and Chief Executive Officer of Tandem Diabetes Care.…

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Jul23ViewRay Completes Alternative Public Offering, Raises $26.7 Million »


Funding to Support Further Innovation and Commercialization of MRI-Guided Radiation Therapy System 

 

Cleveland — July 23, 2015 — ViewRay, Inc. (OTCQB: VRAY) announced today its successful completion of a reverse merger with ViewRay Technologies, Inc. The combined entity will focus solely on the business of ViewRay, the makers of MRIdian™, the world’s first and only MRI-guided radiation therapy system that images and treats cancer patients simultaneously. ViewRay will trade on the OTC Markets under the symbol “VRAY.”

 

ViewRay also announced today that it has consummated a private placement with gross proceeds of approximately $26.7 million for the issuance…

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Jul16NCCN Clinical Practice Guidelines for Breast Cancer Acknowledge Prosigna/PAM50 as Clinically Validated for Prediction of Prognosis »


SEATTLE, July 16, 2015 (GLOBE NEWSWIRE) -- NanoString Technologies, Inc., (NASDAQ:NSTG) a provider of life science tools for translational research and molecular diagnostic products, today announced that the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for breast cancer have been updated to acknowledge that the PAM50 gene signature, commercialized as the Prosigna® Breast Cancer Prognostic Gene Signature Assay, has been clinically validated for prediction of prognosis.

 

"In line with our expectations, Prosigna is now recognized in the NCCN guidelines as providing clinically validated prediction of a woman's risk of breast cancer recurrence," said Brad Gray, President…

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Jul15NanoString Technologies Launches New nCounter SPRINT(TM) Profiler Designed to Meet Needs of the Individual Researcher »


Expanded nCounter® Instrument Product Line Expected to Reach Deeper Into Cancer Research Market  

 

Seattle, July 15, 2015 (GLOBE NEWSWIRE) -- NanoString Technologies, Inc. (Nasdaq:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced the expansion of the nCounter Analysis System product portfolio with the launch of the nCounter SPRINT Profiler. Sales of the new system have already begun, with the first two SPRINT systems being purchased in late June by a major academic research center.

 

The new nCounter SPRINT represents a major step forward in making nCounter technology more broadly accessible…

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Jun15TriVascular Technologies, Inc. Announces FDA Approval of Ovation iX(TM) Iliac Stent Graft »


Enhancements to Iliac Stent Graft Technology Are Designed to Improve Ease of Use and Expand Patient Applicability 

 

Santa Rosa, Calif., June 15, 2015 (GLOBE NEWSWIRE) -- TriVascular Technologies, Inc. (Nasdaq:TRIV) announced today that the U.S. Food and Drug Administration (FDA) has approved the Ovation iX Iliac Stent Graft for the Ovation Prime® Abdominal Stent Graft System, together with manufacturing enhancements that will facilitate a broader commercial launch of the product. Building upon the strength of the Ovation® and Ovation Prime iliac technology, the Ovation iX iliac stent graft is engineered to promote patency even in hostile anatomy. Ovation iX…

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Jun2Nevro Announces Pricing of Upsized Public Offering of Common Stock »


Public Offering of 4,705,880 Shares of Common Stock at $51.00 per Share, Resulting in Aggregate Proceeds of Approximately $240.0 Million 

 

Menlo Park, Calif., June 2, 2015 /PRNewswire/ -- Nevro Corp. (NYSE: NVRO), a global medical device company that is providing innovative evidence-based solutions for the treatment of chronic pain, today announced the pricing of an upsized underwritten public offering of its common stock at a public offering price of $51.00 per share, before underwriting discounts. The offering consists of 1,764,705 shares to be sold by Nevro and 2,941,175 shares to be sold by certain of its stockholders, resulting in…

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May29In New Cardiac Surgery Study Nephrocheck® Kidney Biomarkers Rise To The Occasion »


-- JAMA-Published Study Shows Significant Reduction in Acute Kidney Injury; Supports Utility of TIMP-2 AND IGFBP-7 --

 

SAN DIEGO – May 29, 2015  

 

An intervention known as remote ischemic preconditioning (RIPC) significantly reduced the occurrence of acute kidney injury (AKI) in cardiac surgery patients and confirmed that post-operative elevations of two kidney biomarkers act as an alarm for risk of AKI, according to a study published online today in the Journal of the American Medical Association.

 

Investigators in the study used Astute Medical, Inc.’s NephroCheck® Test to obtain measurements of the two biomarkers, tissue inhibitor of metalloproteinase 2 (TIMP-2) and insulin-like growth factor binding protein…

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May28Merck and NanoString Announce Clinical Research Collaboration to Develop an Immune-Related Gene Expression Assay for Use in the Development Program for KEYTRUDA® (pembrolizumab) »


Collaboration Builds on Merck's R&D and NanoString's Biomarker Development Leadership Positions in Immuno-Oncology

 

Early Data Evaluating Immune-Related Signatures with KEYTRUDA in Multiple Cancers to be Presented for the First Time at 2015 ASCO Annual Meeting

 

Kenliworth, N.J. & Seattle --(BUSINESS WIRE)-- Merck (NYSE:MRK), known as MSD outside the United States and Canada, and NanoString Technologies, Inc. (NASDAQ:NSTG) today announced a clinical research collaboration to develop an assay that will optimize immune-related gene expression signatures and evaluate the potential to predict benefit from Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in multiple tumor types. The collaboration between NanoString Technologies, Inc., a…

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May19Tandem Diabetes Care Launches t:flex™ Insulin Pump »


Largest Capacity Insulin Pump Available in U.S. - For People with Greater Insulin Needs

 

San Diego, May 19, 2015 /PRNewswire/-- Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device company and manufacturer of the t:slim® Insulin Pump, today announced that it is now taking orders for the t:flex™ Insulin Pump, with shipments planned to begin in June. The 480-unit t:flex Pump, cleared by the U.S. Food and Drug Administration in January 2015, is the largest capacity insulin pump currently offered in the United States.

 

"Two-thirds of the healthcare providers we interviewed prior to developing the t:flex Pump cited…

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May12St. Gallen International Breast Cancer Guidelines Recognize Power of Prosigna/PAM50 to Inform Treatment Decisions and Spare Low Risk Breast Cancer Patients Unnecessary Chemotherapy »


Prosigna Only Test Identified as Clearly Prognostic Both During First Five Years and Beyond Five Years Following Diagnosis  

 

Seattle, May 12, 2015 (GLOBE NEWSWIRE) -- NanoString Technologies, Inc., (Nasdaq:NSTG) a provider of life science tools for translational research and molecular diagnostic products, today announced that the PAM50 gene signature, commercialized as the Prosigna® Breast Cancer Prognostic Gene Signature Assay, was included for the first time in the St. Gallen International Breast Cancer Guidelines. PAM50 was recognized among other multi-parameter molecular assays for its unique ability to estimate risk of recurrence both during the first five years…

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May8Nevro Receives FDA Approval for Senza® Spinal Cord Stimulation System Delivering HF10 Therapy »


Menlo Park, Calif., May 8, 2015 — Nevro Corp. (NYSE: NVRO), a medical device company that is providing innovative evidence-based solutions for the treatment of chronic pain, today announced that it has received approval from the United States Food and Drug Administration (FDA) for its Senza spinal cord stimulation (SCS) system. Nevro also announced that it will now be releasing financial results for the first quarter of 2015 before market open on Monday, May 11, 2015. The Company will be hosting a conference call beginning at 8:30 a.m. Eastern Time to discuss both the FDA approval and first quarter operating…

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May5Pacific Biosciences and RainDance Technologies Partner to Co-Develop and Commercialize Novel Solution For de novo Whole Genome Assembly »


Partnership combines Pacific Biosciences’ Single Molecule, Real-Time (SMRT®) Sequencing and informatics capabilities with RainDance’s proprietary digital droplet and single molecule barcoding technology 

 

Menlo Park, Calif. and BILLERICA, Mass.  — May 5, 2015 — Pacific Biosciences of California, Inc. (Nasdaq:PACB), provider of the PacBio® RS II Sequencing System, and RainDance Technologies, Inc., a genomics tools company dedicated to simplifying the analysis of complex genetic diseases, today announced their entry into a co-development and co-marketing agreement to commercialize novel solutions for de novo whole genome assembly.

 

These solutions will combine the power of RainDance’s proprietary digital droplet technology and single-molecule…

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Apr30NeoTract Announces Positive Guidelines from European Association of Urology for Minimally Invasive Treatment for Benign Prostatic Hyperplasia »


UroLift System Recognized for High Level of Clinical Evidence 

 

Pleasanton, Calif. – April 30, 2015– NeoTract, Inc., a medical device company focused on addressing unmet needs in the field of urology, today announced that the European Association of Urology (EAU) has given the UroLift® System a positive recommendation for the treatment of patients with benign prostatic hyperplasia (BPH) in its newly updated “Guidelines for the Management of NonNeurogenic Male Lower Urinary Tract Symptoms, Including Benign Prostatic Obstruction,” published in European Urology.

 

The guidelines assist practicing urologists in Europe in making informed decisions based on the highest-quality scientific…

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Apr28Aequus and Corium Enter Into Product Development Collaboration Focused on CNS »


MENLO PARK, Calif. and VANCOUVER, British Columbia, April 28, 2015 (GLOBE NEWSWIRE) -- Aequus Pharmaceuticals Inc., (Aequus) (TSX-V:AQS), a specialty life sciences company focused on providing patients with differentiated and enhanced delivery systems for existing and approved drugs, and Corium International, Inc. (Corium) (Nasdaq:CORI), a commercial-stage biopharmaceutical company focused on the development, manufacture and commercialization of specialty transdermal products, announced today that they have entered into a collaboration agreement under which the parties may co-fund new transdermal products with an initial focus on neurological disorders. Under the terms of this agreement, for each product selected for development the parties will…

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Apr21Biodesix Receives Carefirst Bluecross Blueshield (bcbs) Coverage for Veristrat Test »


-- Diagnostic deemed medically necessary to guide treatment decisions for patients with advanced non-small cell lung cancer (NSCLC) --

 

Biodesix , Inc. today announced that its VeriStrat® test received  a positive coverage decision from CareFirst Blue Cross Blue Shield (BCBS). CareFirst announced its position to extend coverage to the VeriStrat blood-based test for use as “a marker to aid in predicting patient response to EGFR-TKI drugs,” as described in the Health Care Policy section of BlueLink in March 2015, and published a positive coverage policy on April 20, 2015 on its website

 

VeriStrat is a blood-based…

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Apr20RainDance Launches ThunderBolts Next-Gen Sequencing Panel to Research Genetic Mutations for Myeloid Malignancies »


Hematologic oncology research experts to present ThunderBolts Myeloid Panel performance data at American Association for Cancer Research (AACR) Annual Meeting 

 

Billerica, Mass. — April 20, 2015 — RainDance Technologies, Inc., a genomics tools company simplifying the analysis of complex genetic diseases, today announced global availability of the ThunderBolts Myeloid Panel, a next-generation sequencing (NGS) research assay designed to rapidly detect and cost-effectively analyze genetic mutations associated with AML (Acute Myeloid Leukemia), MDS (Myelodysplastic Syndromes), MPN (Myeloproliferative Neoplasms) and other myeloid cancer research. The research assay was developed with the RainDance HemOnc Consortium, a select group of hematologic oncology experts…

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Apr16RainDance Technologies Extends Global Commercial Reach with Distributor Appointments in Europe and Middle East »


BioTech-Europe, Diatech, Labgene Scientific, and Neo-Science embrace company’s award-winning droplet technology platform to meet growing demand for liquid biopsy research applications 

 

Billerica, Mass. — April 16, 2015 — RainDance Technologies, Inc., a genomics tools company simplifying the analysis of complex genetic diseases, today announced agreements with BioTech-Europe, Diatech Pharmacogenetics srl, Labgene Scientific, and Neo-Science & Group, enabling these companies to distribute RainDance products in Central and Eastern Europe, Italy, Switzerland, the Kingdom of Bahrain, State of Kuwait, Sultanate of Oman, State of Qatar, Kingdom of Saudi Arabia, and State of the United Arab Emirates. These agreements are the latest…

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Apr16NanoString Technologies Empowers Cancer Researchers With Three Innovative New Products for the nCounter Analysis System »


Introduction of RNA: Protein Profiling Panel Focused on Immuno-Oncology Addresses the Next Generation of Tumor Profiling

 

Launch of Two New PanCancer Gene Expression Panels Strengthens Portfolio of Tools to Thoroughly Analyze the Hallmarks of Cancer and Expands Offerings in Immuno-Oncology 

 

Seattle, April 16, 2015 (GLOBE NEWSWIRE) -- NanoString Technologies, Inc. (Nasdaq:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced the expansion of its rapidly growing product portfolio focused on cutting edge genomic—and now proteomic—cancer research with the introduction of three new products for the nCounter® Analysis System. These products include the…

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Apr13Good Start Genetics Enters Exclusive License Agreement with Johns Hopkins University for Noninvasive Prenatal Testing (NIPT) »


Proprietary Technology to Enable Simpler Workflows and Decreased Costs for the Detection of Fetal Chromosomal Abnormalities from a Maternal Blood Sample 

 

CAMBRIDGE, Mass., April 13, 2015 - Good Start Genetics®, Inc., a commercial-stage molecular genetics information company, today announced that it has expanded its exclusive relationship with Johns Hopkins University (JHU) for FAST-SeqS, Fast Aneuploidy Screening Test-Sequencing System, to include applications in noninvasive prenatal testing (NIPT) and related know-how. The technology was invented by Drs. Bert Vogelstein, Ken Kinzler, Isaac Kinde and Nickolas Papadopoulos of JHU. In December, the company announced an exclusive license to the technology for preimplantation…

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Mar18NanoString Technologies' Prosigna Breast Cancer Assay Included in German Breast Cancer Treatment Guidelines »


Eligibility for German Government Reimbursement to Begin for Qualifying Patients 

 

Seattle, March 18, 2015 (GLOBE NEWSWIRE) -- NanoString Technologies, Inc. (Nasdaq:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced that its Prosigna® Breast Cancer Assay is now acknowledged within the treatment guidelines of the German Association of Gynecological Oncology (AGO). In addition, under a recent decision by the German Joint Federal Committee (G-BA), qualifying German breast cancer patients with statutory government insurance will be eligible for coverage for gene expression testing, such as Prosigna, to inform therapy decisions.

 

"The inclusion of…

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Mar17Astute Medical, Inc. Lauds Launch of Global Initiative To End Acute Kidney Injury »


-- Company Joins in Call to Eliminate Preventable Deaths by 2025 --

 

SAN DIEGO – March 17, 2015 – Astute Medical, Inc. today hailed the launch of a collaborative global initiative calling for the elimination of preventable deaths from acute kidney injury (AKI) by 2025. The Company cited the publication of a new Commission1 from The Lancet and the International Society of Nephrology (ISN), along with the release of results from the 0by25 AKI “Global Snapshot” study, as key steps forward in the effort to reduce the global burden of AKI.

 

The AKI “Global Snapshot” is the first in a series of landmark…

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Mar4Tandem Diabetes Care Announces Closing of Underwritten Public Offering of Common Stock »


SAN DIEGO, March 4, 2015 /PRNewswire/ -- Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device company and manufacturer of the t:slim® and t:flex™ Insulin Pumps, today announced the closing of its previously announced underwritten public offering of 6,037,500 shares of common stock at a price to the public of $11.50 per share, which includes the exercise in full by the underwriters of their option to purchase up to an additional 787,500 shares. All of the shares in the offering were offered by Tandem.

 

BofA Merrill Lynch and Piper Jaffray acted as joint book-running managers for the offering. Deutsche Bank…

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Feb25RainDance Expands ThunderBolts Portfolio with Launch of Low-Cost, Low-Input Next-Gen Sequencing Enrichment System for Liquid Biopsy »


ThunderBolts™ System ensures accurate and precise detection of somatic mutations as low as 1% in circulating cell-free DNA

 

Billerica, Mass. — February 25, 2015 — RainDance Technologies, Inc., a genomics tools company dedicated to simplifying the analysis of complex genetic diseases, today announced the launch and availability of the ThunderBolts™ Next-Generation Sequencing (NGS) Target Enrichment System. The ThunderBolts System enables researchers to rapidly detect and cost-effectively analyze somatic mutations from liquid biopsy samples (circulating tumor DNA) or precious FFPE (formalin-fixed Paraffin-Embedded) tissue samples. RainDance recently showcased the new ThunderBolts System and performance data at the International Molecular Medicine Tri-Conference, and will highlight the ThunderBolts…

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Feb9NeoTract Receives Reimbursement Coverage from Noridian Healthcare Solutions for Minimally Invasive Treatment for Enlarged Prostate »


UroLift System Treatment Now Covered for 6.6 Million Medicare Beneficiaries in Thirteen States 

 

Pleasanton, Calif. – February 9, 2015 – NeoTract, Inc., a medical device company focused on addressing unmet needs in the field of urology, today announced that Medicare Administrative contractor Noridian Healthcare Solutions, LLC has approved coverage for the company's UroLift® System for the treatment of benign prostatic hyperplasia (BPH).

 

Noridian Medicare coverage, which is retroactively effective as of January 1, 2015, represents the first system wide coverage for the UroLift System from a Medicare Administrative Contractor. The Noridian Medicare jurisdictions include Washington, Oregon, Idaho, Alaska,…

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Feb4Nevro Receives Expanded MR-Conditional Labeling for Senza® Spinal Cord Stimulation System in Europe and Australia »


Senza is the first implantable spinal cord stimulator system that is 3 Tesla MRI compatible 

 

Menlo Park, Calif., Feb. 4, 2015 /PRNewswire/ -- Nevro Corp. (NYSE: NVRO), a medical device company that has developed and commercialized an innovative, evidence-based neuromodulation platform for the treatment of chronic pain, today announced that it has received CE Mark for expanded MR-conditional labeling. The labeling expansion now permits the Senza spinal cord stimulation (SCS) system to be marketed in Europe and Australia for scans of the head and extremities with both 1.5 and 3 Tesla (T) MRI machines under specified conditions for…

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Jan22bioMérieux and Astute Medical sign a global agreement to develop and market NEPHROCHECK® Test »


Marcy l’Etoile, (France) and San Diego, California (United States), January 22, 2015 - bioMérieux, a world leader in the field of in vitro diagnostics, and Astute Medical, Inc., a company dedicated to improving the diagnosis of high-risk medical conditions and diseases through the identification and validation of protein biomarkers, today announced that they have signed a global, semi-exclusive agreement regarding the development of a test for the early risk assessment of acute kidney injury (AKI). This innovative test, known as the NephroCheck® Test, detects the presence of two biomarkers: TIMP-2 (Tissue Inhibitor Metalloproteinases-2) and IGFBP-7 (Insulin-like Growth Factor-Binding Protein-7).

 

AKI is a major public…

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Jan22Nevro Receives Approvable Letter from U.S. Food and Drug Administration for Senza® SCS »


MENLO PARK, Calif., Jan. 22, 2015 — Nevro Corp. (NYSE: NVRO), a medical device company that has developed and commercialized an innovative, evidence-based neuromodulation platform for the treatment of chronic pain, today announced that it has received a letter from the U.S. Food and Drug Administration (FDA) informing the company of the approvability of its Premarket Approval Application (PMA) for the Senza spinal cord stimulation (SCS) system. According to the approvable letter, approval of the PMA is subject to satisfaction of regulatory inspections and audits of manufacturing facilities, methods and controls for Senza to ensure compliance with the FDA’s Quality…

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Jan12Tandem Diabetes Care Announces FDA Clearance of the t:flex™ Insulin Pump »


SAN DIEGO, Jan. 12, 2015 /PRNewswire/ -- Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device company and manufacturer of the t:slim® Insulin Pump, today announced that the U.S. Food and Drug Administration (FDA) has granted the Company clearance to market the t:flex™ Insulin Pump. At 480 units, the insulin reservoir of the t:flex Pump has the largest capacity currently available in the United States.

 

"In recognizing that one size does not fit all, the t:flex Pump was developed using Tandem's proprietary technology platform to bring t:slim's benefits to people with greater insulin needs," said Kim Blickenstaff, President and Chief…

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Dec17Ortho-Clinical Diagnostics, Inc. Introduces the Astute NEPHROCHECK® Test System »


-Early knowledge of AKI risk may prompt closer patient monitoring and help prevent permanent kidney damage or death-

 

RARITAN, NJ – December 17, 2014 – Ortho-Clinical Diagnostics, Inc. today announced the nationwide availability to hospitals of the NephroCheck® Test Systemdesigned to help healthcare providers identify patients at risk of developing moderate or severe acute kidney injury (AKI) within 12 hours of patient assessment.

 

AKI is a common, costly and potentially fatal complication in hospitalized patients. In comparing patients with AKI to patients without AKI, hospital and the intensive care unit (ICU) lengths of stay double, as do costs of care and readmission rates.…

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Dec10Good Start Genetics, IviGen and Igenomix Announce Exclusive Relationship in Reproductive Testing »


Partner on Expansive Suite of Advanced, Genetics-based Products to Manage Infertility 

 

CAMBRIDGE, Mass. and VALENCIA, Spain, December 10, 2014 -- Good Start Genetics®, Inc., a commercial-stage molecular genetic information company, IviGen LLC®, and its parent company iGenomix®, providers of advanced services in reproductive genetics, today announced an exclusive relationship to bring a breadth of advanced offerings in reproductive genetics to the reproductive health community. The relationship brings together a suite of leading products for in vitro fertilization (IVF) specialists and the broader women’s health community, including obstetrics and gynecology (OBGYN) and maternal fetal medicine (MFM) physicians, across the US…

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Dec8NanoString Technologies Updates Prosigna FDA Labeling to Provide Greater Insight into Probability of Breast Cancer Recurrence Between Year 5 and 10 After Diagnosis »


The Prosigna Score Provides Important Information for Node-Negative and Node-Positive (1-3 Nodes) Breast Cancer Patients in the First 5 Years and 5 to 10 Years After Diagnosis 

 

Seattle --(BUSINESS WIRE)-- NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced that the U.S. Food and Drug Administration (FDA) has cleared a labeling update for the Prosigna® Breast Cancer Gene Signature Assay. The labeling update is derived from the analysis of data by researchers from the Austrian Breast and Colorectal Cancer Study Group Trial 8 (ABCSG-8), who previously reported…

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Nov10NeoTract, Inc. Announces CMS Reimbursement for Innovative Minimally Invasive Procedure for Enlarged Prostate »


Category I CPT Codes Will Expand Patient Access to Novel Treatment for Common Condition that Significantly Impacts Quality of Life

 

Pleasanton, Calif. – November 10, 2014 – NeoTract, Inc., a medical device company focused on addressing unmet needs in the field of urology, announced today that the Department of Health and Human Services, through the Centers for Medicare and Medicaid Services (CMS), has approved two new Category I Current Procedure Terminology (CPT®) codes for the UroLift® System treatment for benign prostatic hyperplasia (BPH), effective January 1, 2015.

 

BPH, also known as enlarged prostate, is a medical condition in…

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Nov6Nevro Corp. Announces Pricing of Initial Public Offering »


Menlo Park, Calif., Nov. 6, 2014 — Nevro Corp. (NYSE:NVRO), a medical device company that has developed and commercialized an innovative, evidence-based neuromodulation platform for the treatment of chronic pain, today announced the pricing of its initial public offering of 7,000,000 shares of its common stock at a public offering price of $18.00 per share, before underwriting discounts. In addition, Nevro has granted the underwriters a 30-day option to purchase up to an additional 1,050,000 shares of common stock at the same price solely to cover over-allotments, if any. The company’s shares are expected to begin trading on the New…

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Oct27Biodesix Announces Inclusion of VeriStrat in Updated NCCN Guidelines »


Guidelines provide evidence-based, consensus-driven recommendations for managing cancer

 

Biodesix Inc., a molecular diagnostics company dedicated to advancing precision medicine and improved patient care, today announced that its VeriStrat® blood-based prognostic and predictive proteomics test has been approved for inclusion in the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer (NSCLC).

 

NCCN Guidelines provide evidence-based, consensus-driven management recommendations that seek to ensure all patients receive preventive, diagnostic, treatment and supportive services that are most likely to lead to optimal outcomes.

 

The updated NCCN Guidelines recommend clinicians’ use of VeriStrat — a non-invasive, blood-based…

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Oct15TriVascular Announces FDA Approval of CustomSeal(TM) Technology for the Ovation Prime(R) System »


Customized Sealing Technology Enables Faster Procedure Times, Preserves the Aortic Neck and Provides an Optimized Seal Tailored to Each Patient's Specific Anatomy 

 

Santa Rosa, Calif., Oct. 15, 2014 (GLOBE NEWSWIRE) -- TriVascular Technologies, Inc. (Nasdaq:TRIV) announced today that the U.S. Food and Drug Administration (FDA) has approved CustomSeal Technology for the Ovation Prime System. With the Ovation Prime endograft system, physicians create a customized seal by filling the conformable O-rings with the CustomSeal polymer, effectively completing the last step of the manufacturing process in vivo. The CustomSeal technology was designed with the same biocompatible components as the Ovation Prime…

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Sep9Biodesix Receives Highmark Blue Cross Blue Shield Coverage for VeriStrat Test »


-- Lung cancer diagnostic deemed medically necessary to guide treatment decisions –

 

Biodesix, Inc., a fully integrated molecular diagnostics company dedicated to personalizing medicine, today announced that its VeriStrat® test received a positive coverage decision from Highmark Inc., a Blue Cross Blue Shield (BCBS) affiliate organization and one of the largest insurance companies in the United States. Highmark announced its intention to extend coverage to the VeriStrat blood-based test to help guide second-line treatments for patients with advanced non-small cell lung cancer (NSCLC) who do not have an epidermal growth factor receptor (EGFR) mutation, or whose mutation status is…

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Jun9Exagen Diagnostics Launches Prognostic Panel »


Albuquerque, N.M., June 9, 2014 – Exagen Diagnostics Inc., a leading medical diagnostic company focused in rheumatology, today announced the addition of the Avise SLE Prognostic panel to its testing services.

 

Designed to supplement the Avise SLE+ Connective Tissue diagnostic, Avise SLE Prognostic is a comprehensive prognostic panel that helps physicians assess potential risk for lupus nephritis, neuropsychiatric lupus, thrombosis and cardiovascular events. The prognostic panel was developed in response to physician requests to help fulfill an unmet need in the rheumatology space.

 

Lupus is a chronic autoimmune disease that affects 1.5 million Americans according to the Lupus…

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May6NanoString Technologies Receives Canadian Market Approval for its Prosigna Breast Cancer Prognostic Gene Signature Assay »


The Prosigna Assay on the nCounter Dx Analysis System Provides Compelling Clinical Data, Clear Patient Report, and Localized Processing in Qualified Canadian Labs 

 

Seattle --(BUSINESS WIRE)-- NanoString Technologies, Inc., (NASDAQ:NSTG) a provider of life science tools for translational research and molecular diagnostic products, today announced that it has received a Class III Medical Device License from Health Canada, clearing the company to market its Prosigna® Breast Cancer Prognostic Gene Signature Assay for assessing a woman's 10-year risk of distant recurrence and accurately identifying the intrinsic biologic subtype of the tumor.

 

"With Canadian market authorization, which mirrors the CE-marked…

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Apr29TriVascular Announces FDA-Approved Expansion of Ovation® and Ovation Prime™ Indication Statements »


More Patients Now Have Access to a Less Invasive, On-Label, Clinically Proven Endovascular Aortic Repair (EVAR) Solution

 

Santa Rosa, Calif., April 29, 2014 (GLOBE NEWSWIRE) -- TriVascular Technologies, Inc. (Nasdaq:TRIV), announced today FDA-approved changes to the indication statement for the Ovation and Ovation Prime Abdominal Stent Graft Systems (Ovation system). The expanded indication for use statement eliminates the minimum aortic neck length requirement and also includes clarification on appropriate vascular access techniques. The Ovation Abdominal Stent Graft System received FDA PMA approval in October 2012. The PMA-S approval for the Ovation Prime Abdominal Stent Graft System followed in December…

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Apr22TriVascular Technologies, Inc. Announces the Closing of Its Initial Public Offering »


Santa Rosa, Calif., April 22, 2014 (GLOBE NEWSWIRE) -- TriVascular Technologies, Inc. (Nasdaq:TRIV), manufacturer of the Ovation Prime™ Abdominal Stent Graft System, today announced the closing of its initial public offering of 7,475,000 shares of its common stock at a public offering price of $12.00 per share, including 975,000 shares sold pursuant to the underwriter's option to purchase additional shares. The company's shares began trading on The NASDAQ Global Select Market on April 16, 2014 under the ticker symbol "TRIV."

 

J.P. Morgan Securities LLC and Credit Suisse Securities (USA) LLC acted as joint book-running managers for the offering. Canaccord…

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Apr10AVEO and Biodesix Partner to Co-Develop and Commercialize Ficlatuzumab with a Companion Diagnostic for Treatment of NSCLC »


Biodesix to Fund Proof of Concept Study 

 

AVEO Oncology (NASDAQ: AVEO) and Biodesix, Inc. today announced that they have entered into a worldwide agreement to develop and commercialize AVEO’s hepatocyte growth factor (HGF) inhibitory antibody ficlatuzumab, with a Biodesix® companion diagnostic test. This agreement and the clinical development program will leverage VeriStrat®, a serum protein test that is commercially available to help physicians guide treatment decisions for patients with advanced non-small cell lung cancer (NSCLC). VeriStrat will be used as the selection assay to identify NSCLC patients most likely to benefit from ficlatuzumab.

 

An exploratory analysis from AVEO’s…

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Mar17Good Start Genetics Announces Collaboration with PerkinElmer to Bring GoodStart Select ™ Carrier Screening Tests to Broader Women’s Health Market »


Agreement Will Greatly Expand Access to Reproductive Health Community 

 

CAMBRIDGE, Mass., March 17, 2014 - Good Start Genetics®, Inc., an innovative molecular genetic information company, today announced a strategic agreement with PerkinElmer, Inc. (NYSE:PKI) to expand access to GoodStart Select™ genetic carrier screening tests beyond the in vitro fertilization (IVF) setting to the broader women’s health community, including obstetrics and gynecology (OBGYN) and maternal fetal medicine (MFM) physicians.

 

GoodStart Select is a menu of genetic carrier screening tests offered by Good Start Genetics that uses sophisticated technologies, including proprietary next-generation DNA sequencing (NGS), to provide highly accurate and…

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Mar3RainDance Technologies Closes Series E Financing with GE »


GE Ventures support RainDance’s vision to make liquid biopsy a commercial reality

 

Billerica, Mass. – March 3, 2014 – RainDance Technologies, Inc., an innovative genomics tools company making molecular testing of complex diseases more standardized and readily available, today announced that it has closed a $16.5 million Series E financing round extension. New investors include GE Ventures and Northgate Capital; all existing financial investors also participated in this round of financing.

 

The additional investment accelerates RainDance’s commercial expansion and assay development initiatives for the company’s products:

 

RainDrop™ digital PCR system, which provides unparalleled sensitivity for research into…

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Mar3Biodesix Receives CE Mark for VeriStrat Specimen Collection and Shipping Kit »


-- Blood-based protein diagnostic predicts differential treatment outcomes for non-small cell lung cancer --

 

Mar 3, 2014 - Biodesix, Inc., a fully integrated molecular diagnostics company dedicated to personalizing medicine, today announced that it has obtained the CE Mark for its VeriStrat® specimen collection and shipping kit, clearing the company to make VeriStrat results available to physicians in the European Union and other countries recognizing the CE Mark. VeriStrat is a non-invasive, blood-based protein diagnostic that predicts differential treatment outcomes between two types of therapies for second-line treatment of non-operable, advanced non-small cell lung cancer (NSCLC): chemotherapy or the…

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Jan13Good Start Genetics Announces Contract with Tufts Health Plan to Cover GoodStart Select ™ Carrier Screening Test »


CAMBRIDGE, Mass., January 13, 2014 -- Good Start Genetics®, Inc., an innovative molecular diagnostics company harnessing a powerful, proprietary next-generation DNA sequencing (NGS) capability, today announced that the company has signed a coverage agreement with Tufts Health Plan for its GoodStart Select™ carrier screening test.

 

The information provided through carrier screening is often used to help guide reproductive decisions, so it is important that the information physicians and prospective parents receive from these tests is not only accurate, but comprehensive as well. The agreement covers the full menu of carrier screening tests developed by Good Start Genetics to screen…

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Nov18TriVascular Secures $40 Million in Equity Financing »


November 18, 2013—TriVascular, Inc. (Santa Rosa, CA) announced the close of a $40 million Series E Preferred Stock equity financing that the company will use to support worldwide commercialization, product development, and clinical research efforts for minimally invasive endovascular aneurysm repair (EVAR) devices.

 

The company is seeking to build on its Ovation and Ovation Prime platforms, which are currently available in the United States and other international markets for EVAR of abdominal aortic aneurysms (AAAs), in order to provide a minimally invasive option for patients who are not eligible for this treatment with available devices. TriVascular advised that of…

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Nov13RainDance RainDrop System Proven to be Industry’s Most Precise Digital PCR Platform for Measuring Chromosomal Copy Number »


Company presents results demonstrating accurate detection of small chromosomal differences at CNAPS VIII Conference and showcases technology at AMP 2013 Annual Meeting

 

Billerica, Mass. – Nov. 13, 2013 –RainDance Technologies, Inc. today announced that it has added a High-Precision Chromosomal Copy Number Variation (CNV) Measurement application to its industry-leading RainDrop™ Digital PCR System. The latest application provides researchers with a simple and highly accurate method of detecting low frequency chromosomal CNVs and trisomy events from circulating tumor cells or cell-free DNA. Recent studies have demonstrated the RainDrop System’s ability to detect CNVs with greater than 99 percent confidence when the sample makes up as low as…

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Jan21TriVascular Receives U.S. FDA Approval for the Ovation Prime™ Abdominal Stent Graft System »


Innovative Delivery System Further Enhances Ease of Use

 

Santa Rosa, CA, January 21, 2013 – TriVascular, Inc. today announced U.S. Food & Drug Administration (FDA) approval of the Ovation Prime Abdominal Stent Graft System for the treatment of abdominal aortic aneurysms (AAA). Ovation Prime builds upon the strong clinical experience of TriVascular’s Ovation stent graft by improving delivery system attributes to further enhance ease of use. Delivered through a 14 French (4.7 mm) outer diameter catheter, Ovation Prime is the lowest profile commercially available system for endovascular aortic repair (EVAR).

 

Ovation Prime utilizes innovative polymer-filled sealing ring technology and has…

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