After FDA Rejection, Surmodics' SurVeil Drug-Coated Balloon Scores FDA Approval

The FDA has approved Surmodics Inc's SRDX SurVeil drug-coated balloon (DCB), a next-generation device for peripheral artery disease.

The SurVeil DCB may now be marketed and sold in the U.S. for percutaneous transluminal angioplasty, after appropriate vessel preparation, of de novo or restenotic lesions (≤ 180 mm in length) in femoral and popliteal arteries having reference vessel diameters of 4 mm to 7 mm. 

Also Read: Second Time May Be a Charm: Analyst Is Bullish As Surmodics Resubmits SurVeil DCB Application.

The SurVeil DCB received CE Mark Certification in the European Union in June 2020.

Abbott Laboratories ABT 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's 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 FY23.

24-month clinical trial results demonstrated the sustained durability of SurVeil DCB safety and efficacy outcomes. SurVeil DCB remained non-inferior to Medtronic Plc's MDT IN.PACT Admiral DCB at a substantially lower drug dose. 

Price Action: SRDX shares are up 4.82% at $26.29 on the last check Tuesday.