Surmodics (Nasdaq: SRDX) today announced that it received FDA 510(k) clearance for its Pounce low-profile (LP) thrombectomy system.
News of the regulatory nod comes just one day after Needham analysts upgraded Surmodics stock from “Hold” to “Buy.” The analysts cited positive developments pointing toward the likely approval of Surmodics’ SurVeil platform sooner than previously thought. As of March, the company expected FDA premarket approval for the SurVeil drug-coated balloon in the fourth quarter of 2023.
Mike Matson of Needham said analysts upgraded Surmodics’ stock because of the expectation for SurVeil as “a meaningful growth driver.” They predict the drug-coated balloon should bridge the gap until Sublime and the newly approved Pounce contribute to growth.
Shares of SRDX fell 1.4% at $25.95 apiece in midday trading today.
Get the full story at our sister site, Medical Tubing & Extrusion.