Published on 23 Jan 2023 on Zacks via Yahoo Finance
Shares of Surmodics, Inc. SRDX have declined 31.8% since the close on Jan 18, following disappointing regulatory update related to its SurVeil drug-coated balloon (“DCB”). In fact, the company’s shares have declined 33.3% in the past six months against the industry’s 0.9% increase. The S&P 500 Index has declined 0.4% in the same time period.
Regulatory Update
Surmodics announced last week that it has received a letter from the FDA indicating that a premarket approval (“PMA”) application for its SurVeil DCB is not currently approvable. The company completed the submission of the PMA application for SurVeil DCB in the third quarter of 2021, based on data from clinical trial — TRANSCEND. The study evaluated the safety and efficacy of SurVeil DCB, a next-generation device for the treatment of peripheral artery disease (PAD). The study compared the results with Medtronic’s MDT IN.PACT Admiral DCB, which was evaluated in the comparator-arm, for non-inferiority.