Funding Supports FDA Approval Process and Global Market Access
BOSTON, May 10, 2017 /PRNewswire/ -- Intrinsic Therapeutics, Inc. a medical device company that has developed a product to improve outcomes in lumbar discectomy patients, announced today that it recently closed a $49 million round of financing. The financing included a $28 million equity round co-led by New Enterprise Associates (NEA) and Delos Capital, coupled with a $21 million debt facility with CRG. Other investors include Greenspring Associates, Quadrille Capital and a corporate strategic. The Company's Barricaid Anular Closure Device is designed to prevent repeat herniation in patients undergoing lumbar discectomy surgery to treat sciatic pain caused by a herniated disc. Luke Dϋster with CRG commented, "We are very happy to join with a prestigious group of investors to support Intrinsic as they bring this important technology to the market in the U.S. and around the world. In today's changing healthcare environment, technologies that conserve resources and reduce costs to the healthcare system will fit squarely within the paradigm of hospital and payer cost-containment."
In December 2016, the Company successfully filed a Pre-Market Application (PMA) with FDA for approval in the United States. This filing is based on the outcomes of a two-year, multi-center, prospective randomized superiority trial of 554 subjects at the greatest risk of reherniation and reoperation. This is the first superiority trial for such a spinal device.
Jeani Delagardelle, who has joined Intrinsic's Board representing Delos, commented, "We are extremely excited to be investing in Intrinsic at this later stage of their development. The company has generated conclusive clinical data which supports a large global opportunity including the US market as early as next year."
Describing the market opportunity, Prof. P. Douglas Klassen, Chief of Neurosurgery at St. Bonifatius Hospital, Lingen, Germany stated, "Approximately 1 million discectomies are performed every year around the globe and 40% of these patients will leave the operating room after discectomy with a large hole remaining in the outer rim of the disc, the anulus. By simply sealing these large defects, patient outcomes can be improved significantly."
"We are excited to welcome Delos and CRG as partners as we continue the process toward US market access," said Cary Hagan, Intrinsic's President and Chief Executive Officer. "The additional capital will allow us to continue our development efforts on reimbursement pathways for this compelling new technology with a sharp focus on demonstrating clear health economic value to surgeons, payers and hospital systems."
About Intrinsic Therapeutics
Intrinsic Therapeutics is a medical device company focused on delivering a safe treatment to improve efficacy in patients who are at a disproportionately high risk of requiring repeat surgeries due to reherniation following lumbar discectomy surgery. Intrinsic currently markets and sells the Barricaid in Europe, Australia, Mexico, S. America, the Middle East and selected countries in other regions around the world. In the United States, Intrinsic Therapeutics is seeking regulatory approval of the Barricaid Anular Closure device. See http://www.in-thera.com for more information.
Barricaid is a registered trademark of Intrinsic Therapeutics, Inc.
New Enterprise Associates, Inc. (NEA) is a global venture capital firm focused on helping entrepreneurs build transformational businesses across multiple stages, sectors and geographies. With nearly $17 billion in cumulative committed capital since inception NEA invests in technology and healthcare companies at all stages in a company's lifecycle, from seed stage through IPO. The firm's long track record of successful investing includes more than 200 portfolio company IPOs and more than 320 acquisitions. www.nea.com.
CRG is a premier healthcare-focused investment firm with more than $3 billion of assets under management across more than 45 portfolio companies. The firm seeks to commit between $20 to $300 million in each company and invests across the healthcare spectrum, including: medical devices, biopharmaceuticals, tools & diagnostics, services and information technology. CRG provides growth capital in the form of long-term debt and equity to support innovative, commercial-stage healthcare companies that address large, unmet medical needs. The firm partners with public and private companies to provide flexible financing solutions and world-class support to achieve exceptional growth objectives with minimal dilution. CRG maintains offices in Boulder, Houston and New York. For more information, please visit www.crglp.com.
About Delos Capital, LLC
Delos Capital is a healthcare-focused fund that invests in growth platforms in Greater China and innovation in the US in the areas of therapeutics and medical technology. Delos Capital seeks to achieve returns through supporting these companies in their development and also helping to create additional value from collaboration between these companies. Founded in 2014, Delos Capital operates from its main office in Hong Kong.
This press release contains forward-looking statements. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements, including and without limitation, statements relating to the potential approval by the FDA of the Company's PMA submissions for the Barricaid Anular Closure device and the success of the Company's launch preparedness efforts. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Intrinsic does not undertake any obligation to update any forward-looking statements as a result of new information, future events, changed assumptions or otherwise.
SOURCE Intrinsic Therapeutics, Inc.