Surmodics Provides Regulatory Update Related to its FDA Premarket Approval Application for the SurVeil™ Drug-Coated Balloon
Surmodics, Inc. (NASDAQ:SRDX) has received a non-approvable letter from the U.S. Food and Drug Administration regarding its SurVeil™ drug-coated balloon (DCB) premarket approval application. The FDA specified that additional information related to biocompatibility and labeling is required to make the application approvable. However, the FDA did not question the submitted human clinical data. CEO Gary Maharaj expressed disappointment but affirmed confidence in the SurVeil DCB's performance. Surmodics plans to discuss the FDA's feedback with the agency and evaluate options to conserve cash following this development.
- No further human clinical data required by FDA.
- Strong confidence in SurVeil DCB's performance as per TRANSCEND clinical study.
- PMA application for SurVeil DCB deemed non-approvable by FDA.
- Additional testing required for biocompatibility and labeling.
In the letter, the FDA indicated that the application is not currently approvable, while providing specific guidance as to a path forward. The letter stated that certain information within two general categories—biocompatibility and labeling—must be added by an amendment to the company’s PMA application to place it in approvable form. Although the information identified by the Agency to put the PMA application in approvable form would require additional testing and analysis, the letter did not question the human clinical data submitted nor request any further human clinical data.
“We are disappointed by the FDA’s response to our PMA application and continue to have confidence in our SurVeil DCB including its compelling performance in the TRANSCEND clinical study,” said
About the SurVeil DCB and the TRANSCEND Clinical Study
The SurVeil DCB, a next-generation device for the treatment of peripheral artery disease (PAD), includes a proprietary drug-excipient formulation using an innovative process to improve coating uniformity. A presentation on the Intermediate-Term (24-month) Results of the TRANSCEND Study, presented by
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Safe Harbor for Forward-Looking Statements
This press release contains forward-looking statements. Statements that are not historical or current facts, including statements about the company meeting with the Agency, determining the appropriate path forward on the PMA application for the SurVeil DCB product, the company’s intent to evaluate options to reduce its use of cash, and the company’s growth strategy, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties, and important factors could cause actual results to differ materially from those anticipated, 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
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