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SRDX 资讯
SRDX 事件
FTC Will Not Appeal Surmodics' Acquisition
Surmodics expects to close its previously announced its acquisition by an affiliate of GTCR promptly. The Federal Trade Commission, or FTC, and certain state regulators stated that they do not intend to appeal the November 10, 2025 ruling by the District Court denying the Plaintiffs' motion for a preliminary injunction to prevent the closing of the merger. Consummation of the merger remains subject to a Temporary Restraining Order under which the parties to the merger may not consummate the merger prior to 5:00 p.m. Central Time on Monday, November 17. The Plaintiffs, Surmodics, and GTCR have jointly moved the District Court to terminate this TRO. Consummation also remains subject to the satisfaction or waiver of closing conditions set forth in the agreement related to the merger, including the absence of any injunction or other legal restraint or prohibition that would prevent or prohibit the consummation of the merger, the absence of a "Company Material Adverse Effect" with respect to the company and other customary closing conditions.
Surmodics announces District Court's rejection of preliminary injunction request
Surmodics "announced that the United States District Court for the Northern District of Illinois has denied a request by the U.S. Federal Trade Commission and certain state regulators to issue a preliminary injunction that would have prevented the Company and GTCR LLC from consummating the proposed acquisition of the Company by an affiliate of GTCR. Consummation of the Merger remains subject to a Temporary Restraining Order under which the parties to the Merger agree not to consummate the Merger prior to 5:00 p.m. Central time on Monday, November 17. "
Surmodics' Pounce Thrombectomy System Demonstrates Effectiveness in Limb Ischemia Research
Surmodics announced that results from an analysis of 160 real-world patients with symptomatic infrainguinal limb ischemia from its PROWL registry study were presented on November 3rd at the 23rd Annual VIVA Conference in Las Vegas. PROWL is an open-label U.S. registry of the Surmodics Pounce Thrombectomy Platform for the non-surgical removal of emboli and thrombi in the peripheral arterial vasculature. The analysis examined subjects with symptomatic infrainguinal vessels followed through 30 days. The primary effectiveness endpoint, procedural success in target lesion with or without adjunctive treatment, was 91.7%. The primary safety endpoint, incidence of device-related major adverse events from procedure to 30-day follow up, was 0.6%. The vast majority - 94.8% - of patients experienced final core lab adjudicated post-procedural TIPI 2-3 blood flow restoration. Device technical success, restoration of blood flow to the target lesion(s) with less than50% residual obstruction without the need of other therapies, was 83.2%. Core lab adjudicated procedural thrombus removal was complete or substantial in 94.1% of patients upon procedure completion. In this diverse PROWL cohort of acute, subacute, and chronic thrombotic presentations, 78.8% of patients did not require adjunctive treatments for clot removal following use of the Pounce Platform. Product use was well tolerated, with only 1 patient experiencing a device-related adverse event. There were no device-related deaths.
Surmodics reveals findings from PROWL registry study
The company states: "Surmodics announced that results from a sex-specific analysis of 160 real-world acute, subacute, and chronic thrombotic limb ischemia patients from its PROWL registry study were presented by Dr. Peter Monteleone at the 37th Annual TCT Symposium in San Francisco, CA. PROWL is an open-label, retrospective, multi-center, U.S. registry of the Surmodics Pounce(TM) Thrombectomy Platform for the non-surgical removal of emboli and thrombi in the peripheral arterial vasculature. The registry is collecting real-world efficacy and safety outcomes data for endovascular interventions using the fully mechanical, non-aspiration-based Pounce Thrombectomy Platform for up to 500 patients at up to 30 sites. The core lab-adjudicated study is enrolling all patients treated with the Pounce Platform, including those with shortened life expectancy, history of cancer or COVID-19, prior interventions to the target limb, and symptom duration up to and beyond 28 days. The full results of the PROWL registry will be presented on November 3, 2025, at the VIVA Vascular Symposium. On October 28, 2025, study investigator Dr. Monteleone, on behalf of the PROWL investigators and National Co-Principal Investigators Dr. Sean Lyden, Chairman of the Department of Vascular Surgery, Cleveland Clinic, and Dr. Joseph Campbell, Interventional Cardiologist, OhioHealth, presented results from a sex-specific analysis of the 160-patient infrainguinal PROWL subset. Most patients in this subset were treated with the Pounce Thrombectomy System, indicated for use in peripheral arteries 3.5-6 mm in diameter. The analysis examined a subset of 160 patients (60 female, 100 male) who received Pounce Platform treatment in symptomatic, infrainguinal vessels, followed through 30 days. Procedural success, defined as restoration of pulsatile flow in the target lesion(s) with or without adjunctive treatment (patient level success), was achieved in 94.7% of female and 89.9% of male patients (p=0.3765). Technical success, defined as restoration of blood flow to the target lesion(s) with less than50% residual obstruction without the need to initiate catheter-directed thrombolysis or to proceed to open surgery or other endovascular thrombectomy devices (lesion-level success), was achieved in 91.4% and 78.3% of target lesions for female and male patients, respectively, and reflected a significant difference between groups (p=0.0261). Core lab adjudicated thrombus removal was complete or substantial in 93.8% of female patients and 94.3% of male patients, including 71.4% of female patients and 78.9% of male patients following use of the Pounce Thrombectomy Platform. These differences were not statistically significant between groups. Arterial flow improved in 97.2% of female patients and 93.4% of male patients (TIPI Grade 2/3). The composite outcome of freedom from all-cause major adverse events (MAEs), comprising mortality, major amputation, and clinically driven target lesion revascularization, was seen in 73.3% of female patients and 86.0% of male patients (p=0.0599)."
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