SRDX Stock Down Despite FDA Clearance for Pounce XL System
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Surmodics, Inc. SRDX received the FDA’s 510(k) clearance for its Pounce XL Thrombectomy System yesterday. Following the regulatory clearance, the Pounce Thrombectomy Platform can now likely be used to remove clots from peripheral arteries ranging from 2mm to 10 mm in diameter.
Surmodics expects to initiate a limited market release for the Pounce XL Thrombectomy System in the first half of 2025, with commercialization planned following the completion of the limited market release.
The latest FDA approval for the Pounce XL Thrombectomy System is expected to significantly boost Surmodics’ thrombectomy business and solidify its foothold in the niche space.
Likely Trend of SRDX Stock Following the News
Following the announcement yesterday, shares of the company moved nearly 0.9% south to $38.41 at yesterday’s close.
Historically, the company has gained a high level of synergies from its regulatory approvals and product launches. Although the latest regulatory clearance is likely to be beneficial for SRDX’s top-line growth going forward, the stock declined, continuing its downtrend since Monday.
Surmodics currently has a market capitalization of $547.9 million. It has a return on equity of 3.9% against the industry’s negative return. In the last reported quarter, SRDX delivered an earnings surprise of 12.9%.
Significance of the FDA Approval of Surmodics’ Pounce XL System
The Pounce XL Thrombectomy System is indicated for the non-surgical removal of thrombi (a blood clot that forms in a vein) and emboli (anything that moves through the blood vessels until it reaches a vessel that is too small to let it pass) from the peripheral arterial vasculature in vessels with diameter ranging from 5.5 mm to 10 mm. This makes it suitable for iliac, femoral, and other arteries within this range. Thus, the Pounce XL Thrombectomy System significantly increases the size range of the Pounce Thrombectomy Platform.
Surmodics’ management believes that the FDA clearance for the Pounce XL Thrombectomy System is a major step forward in having a complete mechanical thrombectomy solution for all peripheral arteries, especially for the critically ischemic lower extremity vessels. Management also believes that the Pounce Thrombectomy Platform will likely enable physicians to rapidly restore blood flow regardless of clot morphology. This is expected to potentially reduce the need for follow-up procedures and additional thrombolytic therapy requiring ICU admission.
Industry Prospects in Favor of SRDX
Per a report by Data Bridge Market Research, the global thrombectomy devices market was estimated to be $1.3 billion in 2022 and is anticipated to reach $2.06 billion by 2030 at a CAGR of 5.9%. Factors like the increasing cases of cardiac patients and an increase in sedentary lifestyles are likely to drive the market.
