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) reported Q1 fiscal 2023 results with total revenue of $24.9 million, an 8% increase year-over-year. The GAAP diluted EPS was $(0.56), down from $(0.20) a year prior. Highlights include a 12% revenue jump in the Medical Device segment and a new five-year credit agreement with MidCap Financial. However, the FDA indicated that the SurVeil drug-coated balloon (DCB) PMA application is not currently approvable, prompting a spending reduction plan, including a 13% workforce cut, to save approximately $10-11 million this fiscal year. Updated guidance for fiscal 2023 projects revenue between $102 million and $106 million.
Surmodics, Inc. (NASDAQ: SRDX) will hold its Annual Meeting of Shareholders on February 9 at 4 p.m. CT. The meeting will be virtual, led by chair Sue Knight and CEO Gary Maharaj, who will discuss business updates and strategic initiatives. Shareholders can attend by logging on to www.virtualshareholdermeeting.com/SRDX23 at least five minutes before the meeting. A replay will be available until February 9, 2024. Surmodics specializes in medical device technologies and aims to enhance disease detection and treatment.
Surmodics, Inc. (Nasdaq: SRDX) will release its first quarter fiscal year 2023 financial results after the market closes on February 6. Following this, a live webcast and conference call will take place at 4:00 p.m. CT to discuss results and achievements, including a Q&A session. Access to the webcast is available on the Company’s website, specifically under the 'Events & Presentations' section. An audio replay will be available post-call until February 20. Surmodics provides advanced medical device technologies and is focused on improving disease detection and treatment.
Surmodics, Inc. (NASDAQ:SRDX) announced the successful 12-month results of its SWING trial for the Sundance™ Sirolimus-Coated Balloon (SCB) at the ISET symposium in Miami. The trial, which included 35 patients, reported no perioperative deaths and only one major re-intervention. Notably, the primary patency rate remained at 80% after a year, demonstrating the efficacy of the company's Crystalline Drug Release (CDR) platform. CDR enhances sirolimus delivery and retention in tissues compared to traditional methods. The SWING trial marks a significant step in advancing medical technology for peripheral artery disease treatment.
Surmodics, Inc. (NASDAQ:SRDX) has received a non-approvable letter from the U.S. Food and Drug Administration regarding its SurVeil™ drug-coated balloon (DCB) premarket approval application. The FDA specified that additional information related to biocompatibility and labeling is required to make the application approvable. However, the FDA did not question the submitted human clinical data. CEO Gary Maharaj expressed disappointment but affirmed confidence in the SurVeil DCB's performance. Surmodics plans to discuss the FDA's feedback with the agency and evaluate options to conserve cash following this development.
Surmodics, Inc. (NASDAQ:SRDX) announced the presentation of 12-month data from the SWING Trial, evaluating the safety and performance of its Sundance™ Sirolimus Drug-Coated Balloon (DCB). This first-in-human study will be discussed by Professor Ramon Varcoe on January 18 at the 35th International Symposium on Endovascular Therapy in Miami, Florida.
The Sundance DCB utilizes a microcrystalline sirolimus coating to enhance drug delivery and reduce restenosis. Currently, this product is for investigational use only and not available for sale globally.
Surmodics, Inc. (NASDAQ:SRDX) announced promising results from the SWING Trial of its Sundance™ Sirolimus drug-coated balloon (DCB), a treatment for occlusive infra-popliteal disease. Presented at the VEITHsymposium in New York, 12-month data showed an 80% primary patency rate in the per protocol population. The trial, which followed 35 subjects, reported no perioperative deaths and only one major re-intervention. The efficacy endpoint of late lumen loss was measured at 1.0 mm at six months, indicating sustained results. The DCB is currently for investigational use only and not yet available for sale.
Surmodics, Inc. (NASDAQ:SRDX) will present 12-month safety and efficacy data from the SWING Trial for its Sundance™ Sirolimus Drug-Coated Balloon (DCB) on November 16 at the VEITHsymposium in New York City. The trial, which is a first-in-human study, involves 35 subjects with occlusive disease of infra-popliteal arteries and aims to evaluate the DCB's performance over 36 months. The Sundance DCB is currently investigational and not available for sale. The presentation will be made by Professor Ramon Varcoe, co-lead investigator alongside Professor Andrew Holden.
Surmodics, Inc. (Nasdaq: SRDX) reported its fourth quarter and fiscal year 2022 financial results, posting a total revenue of $26.0 million, an 8% increase year-over-year. However, the company recorded a GAAP net loss of $(14.7) million, or $(1.06) per diluted share, including a $(10.2) million tax expense. Fiscal year revenue totaled $100.0 million, down 5% from the previous year. Surmodics targets 2023 revenue between $103 million and $107 million, with expected losses per share from $(2.80) to $(2.40>,
and potential milestone payments of up to $30 million linked to FDA approval of its SurVeil drug-coated balloon.
Surmodics announced positive results from the 24-month follow-up of its TRANSCEND clinical trial at the VIVA conference in Las Vegas. The study involved 446 patients and compared the SurVeil DCB with the leading IN.PACT Admiral DCB. Results show that SurVeil achieved a primary patency rate of 70.8% versus 70.4% for IN.PACT, with comparable safety profiles. SurVeil uses a significantly lower dose of paclitaxel, which may enhance patient outcomes. Surmodics holds a partnership with Abbott (ABT) for commercialization upon FDA approval.