SurModics, Inc. announced that they have received a letter from the U.S. Food and Drug Administration (FDA) regarding their premarket approval (PMA) application for the SurVeil™ drug-coated balloon (DCB). This is a major milestone for the leading provider of medical device and in vitro diagnostic technologies to the health care industry, as they continue to strive to improve patient care and outcomes.
The FDA recently sent a letter to the company indicating that its PMA application is not currently approvable, however, it provided guidance on a path forward. The letter specified that additional information in the form of biocompatibility and labeling must be added to the PMA application in order to make it approvable. While this may require additional testing and analysis, the FDA did not question the human clinical data previously submitted, nor did it request any further human clinical data.
We are deeply disappointed by the FDA’s response to our PMA application for our SurVeil DCB, despite its impressive performance in the TRANSCEND clinical study. We plan to address the issues raised in the FDA’s letter and meet with Agency representatives to determine the best path forward. To reduce our cash burn, we are also evaluating various options. We will provide further updates during our upcoming first quarter fiscal 2023 earnings call.
About the SurVeil DCB and the TRANSCEND Clinical Study
The SurVeil DCB, a revolutionary device for the treatment of peripheral artery disease (PAD), utilizes a unique drug-excipient formulation and innovative process to achieve unparalleled coating uniformity. For more information on the Intermediate-Term (24-month) Results of the TRANSCEND Study, presented by Kenneth Rosenfield, MD, MHCDS, be sure to check out the Events & Presentation page of the Investors section of our website. Although currently only available for investigational use in the United States, the SurVeil DCB is sure to revolutionize the PAD treatment landscape.
About Surmodics, Inc.
At Surmodics, we strive to improve the detection and treatment of disease through our cutting-edge performance coating technologies and vascular intervention medical devices. Our in vitro diagnostic immunoassay tests and microarrays, as well as our proprietary surface modification and drug-delivery coating technologies, are designed to meet the most demanding requirements and address unmet clinical needs. With our headquarters located in Eden Prairie, Minnesota, we look to the future as we continue to develop and commercialize highly differentiated medical devices.
Safe Harbor for Forward-Looking Statements
Surmodics is excited to announce its intention to meet with the Agency and determine the appropriate path forward on the PMA application for its SurVeil DCB product. In addition, the company is exploring options to reduce its use of cash in order to help support its growth strategy. However, there are risks associated with this endeavor, including the availability of FDA personnel, Surmodics’ personnel, and Surmodics’ consultants to address the FDA letter, limitations on Surmodics’ ability to reduce its use of cash due to financial obligations of the company, and the factors identified under “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended September 30, 2022, and updated in our subsequent reports filed with the SEC. These reports are available in the Investors section of our website and at the SEC website. We look forward to seeing the results of our effort and hope to be able to deliver great value to our shareholders.