Surmodics Inc - SRDX STOCK NEWS

Surmodics, Inc. (Nasdaq: SRDX) reported Q2 fiscal 2023 financial results showing total revenue of $27.2 million, a 4% increase year-over-year. However, the company reported a GAAP diluted earnings per share (EPS) loss of $(0.55) compared to $(0.29) in the same period last year. Non-GAAP EPS also declined to $(0.40) from $(0.22).

Key highlights include a 7% increase in Medical Device revenue to $19.7 million, driven by strong sales of the Pounce and Sublime platforms. Despite this growth, the company faced challenges with FDA approval for its SurVeil drug-coated balloon, which remains under review. Surmodics updated its fiscal year 2023 revenue guidance to between $103 million and $106 million, indicating an increase of 3% to 6% compared to the previous year.

Surmodics, Inc. (Nasdaq: SRDX) announces the enrollment of the first patient in the PROWL registry for the Pounce™ Thrombectomy System. This open-label, multi-center registry aims to collect real-world outcomes data for non-surgical emboli removal in up to 500 patients at 30 sites across the U.S. The primary endpoints include procedural success and device-related major adverse events over 30 days. National Co-Principal Investigators are Dr. Sean Lyden (Cleveland Clinic) and Dr. Joseph Campbell (OhioHealth). The PROWL study addresses the urgent medical need for effective treatment of acute limb ischemia, which poses significant risks of amputation and mortality. The Pounce system efficiently removes clots, potentially reducing the need for expensive adjunctive treatments in hospital settings.

Surmodics, Inc. (Nasdaq: SRDX) will announce its second quarter fiscal 2023 financial results before the market opens on April 26, 2023.

A live webcast and conference call will be conducted at 7:00 a.m. CT on the same day to discuss these results and accomplishments, including a Q&A session. The event can be accessed through the company’s website under “Events & Presentations.” An audio replay will be available from 11:00 a.m. CT on April 26 until 11:00 a.m. CT on May 10.

Surmodics specializes in performance coating technologies for medical devices and in vitro diagnostics and aims to enhance disease detection and treatment.

Surmodics, Inc. (NASDAQ:SRDX) has introduced the industry’s first suite of torqueable peripheral microcatheters through its Sublime Radial Access Platform. Dr. Ankur Lodha and Dr. Pradeep Nair were the first physicians to utilize the Sublime™ microcatheter, which is currently in limited market evaluation, with a full launch expected in FY 2024. This new line includes microcatheters designed for superior navigation of complex lesions in both transradial and transfemoral procedures. Notably, these microcatheters boast features like Pristyne™ hydrophilic coating and dual stainless steel locked-braid layers for enhanced torque control. The company’s commitment to expanding its endovascular devices portfolio aims to address unmet clinical needs and improve patient outcomes in peripheral artery disease.

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.