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.
About the Surmodics Pounce platform
Surmodics introduced its Pounce system in 2021. The company designed Pounce for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature. It performs this removal in vessels between 3.5 mm and 6 mm in diameter.
Pounce LP, a new addition to the platform, treats vessels between 2 mm and 4 mm in diameter. These sizes represent vessels typically found below the knee. The Pounce system features three components: a 5 Fr delivery catheter, a basket wire and a funnel catheter.
The basket wire is delivered distal to the location of the thrombus and deploys two nitinol self-expanding baskets. Its baskets capture the clot and retract into the nitinol collection funnel. With the clot entrained, the system withdraws into a minimum 7 Fr guide sheath. Through this, the clot is removed through the body.
“We are excited to secure FDA clearance for the Pounce LP thrombectomy system, which will extend the range of treatment for our Pounce platform to include removal of organized thrombotic or embolic occlusions in smaller vessels below the knee,” said Gary Maharaj, President and CEO of Surmodics. “Catheter-directed thrombolysis in these vessels is limited against organized clot and requires ICU admission, while small-diameter aspiration thrombectomy devices may struggle to remove organized material in the distal lower extremity. By expanding the treatment range of the Pounce platform we are addressing tibial clots, an important component of treatment in this vulnerable patient population which fills a gap in care.”
Surmodics expects to initiate a limited market evaluation for Pounce LP by the end of December 2023. It plans for commercialization to follow the completion of that evaluation.