Welcome to our dedicated page for Surmodics news (Ticker: SRDX), a resource for investors and traders seeking the latest updates and insights on Surmodics stock.
Surmodics, Inc. (SRDX) generates news as a provider of medical device technologies, vascular intervention devices, and in vitro diagnostic components. Company announcements frequently highlight developments in its performance coating technologies for intravascular devices, its Pounce™ Thrombectomy Platform, and its SurVeil™ drug-coated balloon (DCB), as well as financial results and corporate transactions.
Investors and industry observers following Surmodics news can expect updates on clinical and real-world evidence for its vascular intervention products. The company has reported data from the PROWL registry, an open-label, multi-center U.S. registry evaluating the Pounce Thrombectomy Platform for non-surgical removal of emboli and thrombi in the peripheral arterial vasculature. News coverage includes analyses of 160-patient cohorts with symptomatic limb ischemia and sex-specific outcomes, presented at conferences such as the VIVA Vascular Symposium and the TCT Symposium.
Surmodics also issues press releases on product milestones, including the commercial release and early clinical use of the Pounce XL Thrombectomy System, which is intended for thrombus and embolus removal in peripheral arteries of larger diameters. Additional news has covered publication of the TRANSCEND clinical trial, which evaluated the SurVeil DCB in femoropopliteal arterial disease.
Financial news from Surmodics includes quarterly earnings releases, segment revenue trends in its Medical Device and In Vitro Diagnostics businesses, and updates to fiscal year guidance. The company has also reported on a pending and subsequently completed acquisition by an affiliate of GTCR LLC, including regulatory actions, court decisions related to the Federal Trade Commission’s attempt to block the transaction, and steps toward delisting from Nasdaq and transitioning to private ownership.
By monitoring this news feed, readers can track Surmodics’ product performance data, regulatory and legal developments, and financial disclosures as the company advances its mission to improve the detection and treatment of disease.
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.