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Tag: 2015

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...

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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...

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Dec1CRG Joins Existing Investors In New Financing Deal In Support Of Commercialization Plans »


Redmond, Washington. – EndoGastric Solutions® (EGS), a leader in incisionless procedural therapy for gastroesophageal reflux disease (GERD), announced today that it has secured additional new financing of up...

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Dec1EndoGastric Solutions Secures $50 Million In Financing »


CRG Joins Existing Investors In New Financing Deal In Support Of Commercialization Plans   Redmond, Washington. – EndoGastric Solutions® (EGS), a leader in incisionless procedural therapy for gastroesophageal...

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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...

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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...

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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...

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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...

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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...

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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...

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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...

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Oct20Silk Road Medical Announces up to $57 Million in New Funding for Novel Approach to Preventing Strokes »


Financing to Support Commercialization of First-in-Class Products for TransCarotid Artery Revascularization (TCAR) Procedure    Sunnyvale, Calif., Oct. 20, 2015 /PRNewswire/ -- Silk Road Medical, Inc., a company dedicated...

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Oct19CRG Enhances Healthcare Financing Investment Team with the Hiring of Scott Li »


HOUSTON, TX, October 19, 2015 – CRG, a healthcare-focused investment firm delivering pioneering growth capital solutions to the global healthcare market, announced today that Scott Li has joined the firm as a...

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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...

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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...

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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,...

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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...

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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,...

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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...

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Sep28GenomeDx Biosciences Secures Financing from CRG »


San Diego, September 28, 2015 – GenomeDx Biosciences announced today that it has secured expansion financing from CRG, a premier healthcare investment firm, in the form of a senior secured term loan. ...

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Sep23Avinger, Inc. Secures Up To $55M in Financing from CRG »


-- Financing to Support Commercial Launch of Pantheris™ --   Redwood City, California, September 23, 2015 – Avinger, Inc., (NASDAQ: AVGR) a developer and manufacturer of image-guided, catheter-based systems for the...

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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...

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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...

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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...

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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,...

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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...

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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...

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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...

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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...

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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...

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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...

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Aug4Trivascular Technologies, Inc. and CRG Modify Term Loan Agreement »


Provides up to $30 Million in Additional Borrowing Capacity    Santa Rosa, Calif., Aug. 4, 2015 (GLOBE NEWSWIRE) -- TriVascular Technologies, Inc. (NASDAQ:TRIV), manufacturer of the Ovation Prime® Abdominal Stent...

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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...

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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...

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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...

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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...

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Jun30ViewRay® Secures Up To $50M in Debt Financing From CRG »


Funding to Drive Global Expansion of its MRI-Guided Radiation Therapy Business   Cleveland, June 30, 2015 — ViewRay™, makers of MRIdian™, the world’s first and only clinical MRI-guided...

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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...

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Jun9Outset Medical Announces $91 Million in New Funding for First-Of-Its-Kind FDA-Cleared Dialysis Technology »


Financing To Support Commercial Launch and Ongoing Clinical Trials for Expanded Indications   San Jose, Calif. – June 9, 2015 – Outset Medical, a company focused on reimagining the experience of dialysis...

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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...

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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...

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May28Further US Investment in AFT Pharmaceuticals To Advance International Growth »


Specialty Australasian pharmaceutical sales and development company, AFT Pharmaceuticals Ltd (AFT), has finalised a follow-on equity capital raise with CRG (formerly Capital Royalty L.P.), Atkinson family, AFT board members,...

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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...

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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...

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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)...

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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...

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May7Ceterix Orthopaedics Announces $35 Million In New Funding »


MENLO PARK, Calif., May 7, 2015 -- Ceterix Orthopaedics today announced that it has entered into a term loan agreement with CRG and certain of its affiliate funds, providing Ceterix with up...

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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,...

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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...

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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...

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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...

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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.,...

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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 —...

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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...

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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...

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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...

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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...

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Mar5TearLab Announces $35 Million Term Loan Agreement With CRG »


San Diego, March 5, 2015 -- TearLab Corporation (Nasdaq:TEAR) (TSX:TLB) ("TearLab" or the "Company") today announced that it has entered into a term loan agreement (the "Agreement") with CRG and...

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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,...

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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...

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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...

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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...

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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...

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Jan9Capital Royalty Announces Corporate Name Change to "CRG" »


-- Rebrand underscores Firm’s emergence as a global healthcare-focused investment firm serving growth-stage companies --   HOUSTON, TX, January 9, 2015 – Capital Royalty L.P. announced today a corporate...

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