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.
About Surmodics Inc.
Surmodics Inc. (SRDX) is a company deeply embedded in the medical device, diagnostic, and life sciences sectors. Known for its significant contributions in coating technologies and now its evolving whole-product solutions, the company partners with leading and emerging players to transform how medical devices address complex challenges. With a robust background in developing advanced coatings, Surmodics has built a reputation for innovating in areas crucial to improving the detection and treatment of diseases.
Business Model & Core Solutions
Historically, Surmodics has specialized in the development of coating technologies that enhance the performance and safety of a wide range of medical devices. The company has now broadened its scope to provide comprehensive product solutions. This transformation is driven by a strategy of integrating innovative coatings with additional functionalities that help in the detection and treatment of diseases. At its core, the company leverages deep scientific expertise and cutting-edge engineering to deliver solutions that address critical challenges in the healthcare industry.
Partnerships and Industry Expertise
Surmodics collaborates with some of the world's most respected medical device, diagnostic, and life sciences companies. These partnerships enable the company to remain at the forefront of technological advancements across multiple sectors. By combining industry-specific insights with a history of research and development excellence, Surmodics consistently addresses industry needs with customized solutions. The company’s commitment to quality and innovation underscores its standing as a trusted partner in the healthcare ecosystem.
Competitive Landscape and Market Position
Operating within a competitive and innovation-driven industry, Surmodics distinguishes itself through its ability to move beyond traditional coating technologies. Its strategic acquisitions and broadened product offerings have repositioned the company to offer whole-product solutions that cater to complex medical challenges. Surmodics’ systematic approach to problem solving, which integrates both advanced coatings and product development, provides a unique competitive edge. This repositioning allows the company to respond effectively to the evolving needs of healthcare providers.
Technological Innovations and Operational Excellence
The evolution at Surmodics is marked by continual investment in research and development, targeted at solving critical issues in medical devices and diagnostics. The company employs advanced technologies and engineering practices to enhance product performance and reliability. By addressing the intricate demands of medical technology through innovation and strategic problem solving, Surmodics serves as a prime example of how scientific research can be translated into practical, life-improving solutions. Its operational model emphasizes steady improvements, robust quality control, and a continuous drive to adapt to emerging technological trends.
Integrated Solutions for a Changing Industry
Surmodics’ transformation from being a provider of coating technologies to a developer of whole-product offerings is a response to the increasing complexity of medical device challenges. The company integrates several facets of product design, from innovative materials science to detailed engineering processes, ultimately delivering products that meet detailed clinical requirements. This holistic view enables Surmodics to streamline the process of medical device development, thereby ensuring that the products not only perform reliably but also contribute significantly to improving patient outcomes through enhanced disease detection and treatment capabilities.
Commitment to Technological Excellence and Healthcare Impact
At its foundation, Surmodics is dedicated to improving healthcare delivery by addressing difficult challenges inherent in medical device performance. The continuous drive for technological excellence and the willingness to evolve have kept the company relevant in an era where healthcare innovation is paramount. Surmodics’ ability to combine technical expertise with strategic partnerships places it in an advantageous position to assist clients in overcoming hurdles associated with medical device development. Investors and industry professionals can view this approach as a reaffirmation of the company’s commitment to operational excellence and impactful technology solutions.
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.
Surmodics, Inc. (NASDAQ: SRDX) will release its fourth quarter and fiscal year 2022 financial results on November 9, 2022, before market opens. A live webcast and conference call will take place at 7:00 a.m. CT on the same day, discussing the financial outcomes and company achievements. Investors can access the call via their website or by dialing in. An audio replay will be available until November 23, 2022. Surmodics specializes in surface modification technologies for medical devices and diagnostic tests, focusing on clinical needs.
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