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Surmodics Inc. (SRDX) drives innovation in medical device coatings and diagnostic solutions through partnerships with global healthcare leaders. This news center delivers verified updates on the company's financial developments, regulatory milestones, and technological breakthroughs shaping patient care.
Find curated press releases detailing SRDX's advancements in vascular intervention systems, diagnostic platform enhancements, and strategic collaborations. Track earnings reports and product launch announcements that highlight the company's transition from coating pioneer to comprehensive medical solution developer.
Our repository includes updates on FDA clearances, clinical study results, and manufacturing expansions critical for assessing SRDX's market position. Discover how the company's surface modification expertise addresses challenges in drug delivery systems and in-vitro diagnostics.
Bookmark this page for ongoing insights into Surmodics' role in medical innovation. Return regularly to stay informed about developments impacting the future of minimally invasive therapies and diagnostic accuracy.
Surmodics (NASDAQ: SRDX) announced the publication of the TRANSCEND clinical trial results in the European Journal of Vascular and Endovascular Surgery. The study demonstrates that their SurVeil™ drug-coated balloon (DCB) matches the safety and efficacy of IN.PACT™ Admiral™ DCB while using 75% less paclitaxel drug dose.
The global randomized study involved 446 patients across 65 sites in 9 countries, comparing treatments for femoropopliteal arterial disease. Key findings show comparable 12-month primary patency (82.2% vs 85.9%) and safety endpoints (91.8% vs 89.9%) between SurVeil and IN.PACT Admiral DCBs. The SurVeil DCB features a uniform microcrystalline coating with 2.0 μg/mm² drug load, compared to IN.PACT Admiral's 3.5 μg/mm².
The study's secondary outcomes through 24 months further confirmed the non-inferiority of the lower-dose SurVeil DCB, with 5-year follow-up data collection completed in 2024.
Surmodics (SRDX) has announced the commercial release of the Pounce™ XL Thrombectomy System, expanding their thrombectomy platform for peripheral arterial clot removal. The new system is designed for larger arteries (5.5-10mm diameter), complementing existing Pounce and Pounce LP systems.
The platform features dual-basket technology that enables clot removal without requiring aspiration, thrombolytics, or capital equipment. During market release since January 2025, the system demonstrated effectiveness in removing acute and subacute clots.
Clinical data from the PROWL registry showed promising results: in 74 patients, average use time was 20.3 minutes, with 79.7% requiring no additional clot removal treatment. Only one device-related adverse event was reported. The complete Pounce platform now covers vessel diameters from 2-10mm, offering a comprehensive solution for peripheral arterial thrombectomy.
Surmodics (SRDX) has responded to the U.S. Federal Trade Commission's challenge of its proposed acquisition by GTCR . The FTC's decision to challenge comes despite the previously announced merger agreement where GTCR would acquire Surmodics for $43.00 per share, valuing the company at approximately $627 million.
The merger, which received shareholder approval on August 13, 2024, would result in Surmodics becoming a private company and delisting from Nasdaq. GTCR, which has an equity investment in Biocoat Inc. (a medical coatings manufacturer), plans to finance the transaction through a combination of committed equity and debt financing.
Surmodics disagrees with the FTC's decision and intends to vigorously defend the case in court, maintaining that the merger is pro-competitive and beneficial to all stakeholders, including shareholders, customers, and patients.
Surmodics (SRDX) announced successful early clinical use of its Pounce™ XL Thrombectomy System, which received FDA 510(k) clearance in September 2024. The system is designed for non-surgical removal of thrombi and emboli from peripheral arteries ranging from 5.5-10 mm in diameter, typical of iliac and femoral arteries.
The Pounce XL complements existing Pounce and Pounce LP systems, which target smaller vessels (3.5-6 mm and 2-4 mm respectively). Dr. Walter Rizzoni at UPMC Hamot successfully used the device to restore blood flow in an 8mm thrombosed stent graft. The system is currently in market release, with full commercial launch planned afterward.
The expanded Pounce Thrombectomy Platform now offers a standalone solution for rapid clot removal throughout the lower extremity without requiring aspiration, thrombolysis, or capital equipment, potentially reducing hospitalization costs and follow-up procedures.
Surmodics (SRDX) reported Q1 FY2025 financial results with total revenue of $29.9 million, representing a 2% year-over-year decrease. The company posted a GAAP net loss of $3.7 million, compared to a $0.8 million loss in the prior year period.
Key highlights include FDA 510(k) clearance for the Pounce™ XL Thrombectomy System and early positive results from the PROWL registry study. The company's pending acquisition by GTCR for $43.00 per share ($627 million) awaits FTC approval.
Medical Device revenue decreased 1% to $23.3 million, while In Vitro Diagnostics revenue fell 5% to $6.6 million. Product gross margin improved to 55.1% from 53.2%. Operating expenses increased 13% to $25.0 million, primarily due to $2.3 million in merger-related charges.
Surmodics (SRDX) reported Q4 2024 financial results with total revenue of $33.2 million, up 19% year-over-year. The company posted a GAAP net loss of $(3.4) million compared to net income of $6.7 million in the prior-year period. For fiscal 2024, total revenue was $126.1 million with a net loss of $(11.5) million. Medical Device segment showed strong performance with product revenue growth of nearly 40% year-over-year. The company has entered into a definitive agreement to be acquired by GTCR for $43.00 per share in cash, representing an equity value of $627 million, expected to close in Q2 2025.
Surmodics (SRDX) announced early results from its PROWL registry study evaluating the Pounce™ Thrombectomy System in treating limb ischemia. A subset analysis of 60 patients demonstrated 96.8% procedural flow restoration, with 81.7% requiring no additional thromboemboli removal treatment within 30 days. The study showed 90.0% procedural success and 80.8% technical success. Notably, 66.7% of patients avoided ICU admission, and 81.7% were discharged home. The study included patients with acute (60.0%), subacute (16.7%), and chronic (23.3%) limb ischemia, demonstrating effectiveness across various clot chronicity levels.
Surmodics (Nasdaq: SRDX) has received FDA 510(k) clearance for its Pounce™ XL Thrombectomy System, expanding its Pounce Thrombectomy Platform to treat peripheral arteries up to 10 mm in diameter. This new system is designed for non-surgical removal of thrombi and emboli in vessels 5.5–10 mm, including iliac and femoral arteries. The Pounce Thrombectomy Platform already includes systems for 2–6 mm arteries. The Pounce XL aims to address critically ischemic lower extremity vessels, providing a rapid solution for various clot morphologies without thrombolytics. market release is expected in early 2025, followed by full commercialization.
Surmodics (Nasdaq: SRDX) reported Q3 FY2024 financial results. Total revenue was $30.3M, down 42% from $52.5M in the prior-year period, which included a $24.6M license fee upon FDA approval of SurVeil™ DCB. Excluding this, revenue increased 10% YoY to $29.2M. GAAP net loss was $(7.6)M, compared to net income of $7.3M last year. Adjusted EBITDA was $1.6M, down from $24.6M.
Medical Device revenue fell 49% to $23.4M but grew 10% YoY excluding the SurVeil DCB fee. In Vitro Diagnostics revenue rose 8% to $7.0M. Gross profit increased 4% to $9.1M, with margins declining to 51.9% from 55.8%. Operating costs rose 13% to $27.3M due to merger-related charges.
The company is being acquired by GTCR for $43/share, with a shareholder vote on August 13, 2024. Surmodics also secured a new agreement with Premier for thrombectomy products. FY2024 guidance is suspended due to the pending acquisition.
Surmodics (Nasdaq: SRDX), a provider of medical device and in vitro diagnostic technologies, has secured a group purchasing agreement for thrombectomy products with Premier. Effective June 1, 2024, this agreement allows Premier members to access special pricing and terms for Surmodics' Pounce™ and Pounce™ Venous Thrombectomy Systems. These systems, which remove arterial and venous clots without the need for capital equipment, aim to enhance procedural efficiency and reduce the necessity for thrombolytic drugs. The partnership with Premier, which includes 4,350 U.S. hospitals and 300,000 other providers, is expected to expand Surmodics' market reach and support high-quality, cost-effective care.
