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) 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) 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
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.
