Surmodics Inc Stock Price, News & Analysis

Surmodics, Inc. (Nasdaq: SRDX) has announced its participation in the 22nd Annual Needham Virtual Healthcare Conference, taking place from April 17-20, 2023. Management will present on April 20 at 10:15 a.m. ET. Investors can access the live webcast of the presentation via the company’s website under the 'Events & Presentations' section. A replay will be available for 90 days post-event.

Surmodics specializes in performance coating technologies for medical devices and in vitro diagnostic tests, with a focus on developing solutions for unmet clinical needs. Headquartered in Eden Prairie, Minnesota, the company aims to enhance disease detection and treatment through innovative technologies.

Surmodics, Inc. (NASDAQ:SRDX) has received formal feedback from the FDA about its SurVeil™ drug-coated balloon (DCB) application, enabling a streamlined amendment process for its PMA application. The feedback clarifies the necessary requirements, significantly reducing the anticipated time and costs involved. CEO Gary Maharaj expressed optimism regarding the progress, stating that they do not foresee additional biocompatibility studies, allowing for an expected submission in Q3 of fiscal 2023 and aiming for approval in Q4 of the same year. This advancement is crucial for Surmodics’ mission to address unmet clinical needs in treating peripheral artery disease.

Surmodics, Inc. (Nasdaq: SRDX), a provider of medical device and diagnostic technologies, announced its participation in two upcoming investor conferences. The 33rd Oppenheimer Annual Healthcare Conference will be held virtually from March 13-15, 2023, with Surmodics presenting on March 15 at 10:40 a.m. ET. The Sidoti Small-Cap Conference is scheduled for March 22-23, 2023, featuring 1x1 investor meetings but no formal presentation. Investors can access a live webcast of the presentation through the company's website, with replays available for 90 days.

Surmodics focuses on innovative vascular intervention devices and diagnostic technologies, aiming to enhance disease detection and treatment.

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.