{"id":764552,"date":"2023-06-20T06:33:21","date_gmt":"2023-06-20T10:33:21","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/surmodics-receives-fda-approval-for-the-surveil-drug-coated-balloon\/"},"modified":"2023-06-20T06:33:21","modified_gmt":"2023-06-20T10:33:21","slug":"surmodics-receives-fda-approval-for-the-surveil-drug-coated-balloon","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/surmodics-receives-fda-approval-for-the-surveil-drug-coated-balloon\/","title":{"rendered":"Surmodics Receives FDA Approval for the SurVeil\u2122 Drug-Coated Balloon"},"content":{"rendered":"

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Surmodics Receives FDA Approval for the SurVeil\u2122 Drug-Coated Balloon<\/b><\/p>\n

Surmodics to receive $27 million milestone payment from Abbott<\/i><\/p>\n

EDEN PRAIRIE, Minn.–(BUSINESS WIRE<\/a>)–
\nSurmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced the receipt of U.S. Food and Drug Administration (FDA) approval for the SurVeil\u2122 drug-coated balloon (DCB).<\/p>\n

\nThe SurVeil DCB may now be marketed and sold in the U.S. to physicians for percutaneous transluminal angioplasty, after appropriate vessel preparation, of de novo or restenotic lesions (\u2264 180 mm in length) in femoral and popliteal arteries having reference vessel diameters of 4 mm to 7 mm. The SurVeil DCB received CE Mark Certification in the European Union in June 2020.<\/p>\n

\n\u201cObtaining FDA approval for our SurVeil DCB is one of the most important achievements in Surmodics\u2019 history,\u201d said Gary Maharaj, President and CEO of Surmodics. \u201cIt represents a major milestone in our efforts to develop next-generation products to help millions of people affected by peripheral artery disease and the physicians that treat them. I would like to thank our internal SurVeil DCB team and our external advisors, investigators and partners for their multi-year efforts to make this achievement possible.\u201d<\/p>\n

\nAbbott has exclusive worldwide commercialization rights for the SurVeil DCB. Surmodics will manufacture and supply the product and realize revenue from product sales to Abbott and a share of profits from Abbott\u2019s third-party sales. Surmodics will also receive a $27 million milestone payment from Abbott. The company expects to recognize approximately $24.0 to $24.5 million of revenue related to the milestone payment in the third quarter of its fiscal year 2023.<\/p>\n

\nMr. Maharaj continued, \u201cBuilding on our recent progress, Surmodics remains focused on supporting Abbott and its exclusive worldwide commercialization rights for the SurVeil DCB. We\u2019ll discuss details on the developments and update our fiscal year 2023 financial guidance during our third quarter earnings call.\u201d<\/p>\n

\n\u201cI am excited that the Surveil DCB will be available to treat patients in the US,\u201d said Kenneth Rosenfield, M.D., co-principal investigator of the TRANSCEND clinical trial. \u201cThe Surveil DCB is the next generation DCB as established by results from the TRANSCEND trial which is the only head-to-head pivotal study that has been conducted vs the market-leading DCB. The Surveil DCB successfully demonstrated non-inferior safety and effectiveness at two years post-treatment with a substantially lower drug dose.\u201d<\/p>\n

SurVeil DCB TRANSCEND Trial Results Summary<\/b><\/p>\n

\n24-month clinical trial results demonstrated the sustained durability of SurVeil DCB safety and efficacy outcomes.1<\/sup> SurVeil DCB remained non-inferior to market-leading IN.PACT\u00ae Admiral\u00ae DCB at a substantially lower drug dose. At 24 months:<\/p>\n