Surmodics, Inc. - SRDX STOCK NEWS

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.

Surmodics, Inc. (NASDAQ:SRDX) announced that findings from the TRANSCEND clinical trial will be shared at the Vascular InterVentional Advances (VIVA) conference on November 1, 2022. Dr. Kenneth Rosenfield will present 24-month data on the efficacy and safety of the SurVeil drug-coated balloon (DCB) compared to IN.PACT Admiral DCB. Initial results at 12 months indicated non-inferiority for SurVeil with a lower drug dose. Surmodics has an agreement with Abbott (NYSE: ABT) for commercialization rights.

Surmodics, Inc. (Nasdaq: SRDX) announced a new five-year credit agreement with MidCap Financial, offering up to $100 million in term loans and $25 million in revolving credit. CEO Gary Maharaj emphasized improved capital access on favorable, non-dilutive terms. The company initially drew $25 million from the term loan and $5 million from the revolving credit, boosting its cash balance by $19.5 million. Interest-only payments for the term loan are set for the first four years. Total interest expenses are expected to be approximately $3.4 million in fiscal 2023.

Surmodics, Inc. (NASDAQ:SRDX) announced promising 6-month results from the SWING study of its Sundance™ Sirolimus drug-coated balloon (DCB) at the Amputation Prevention Symposium in Lugano, Switzerland. The study reported an 88.5% primary patency rate and a Late Lumen Loss (LLL) of 1.0 mm across 35 lesions, indicating sustained efficacy. No major amputations or perioperative deaths were observed, and only one major re-intervention was needed among participants. The Sundance DCB employs innovative coating technology to enhance sirolimus delivery, aiming to reduce restenosis.

Surmodics, Inc. (NASDAQ:SRDX) announced the presentation of 6-month data from the SWING Trial, evaluating the safety and performance of the Sundance™ Sirolimus Drug-Coated Balloon. This first-in-human study will be presented by Professor Ramon Varcoe on October 11 at the Amputation Prevention Symposium in Switzerland. The Sundance Balloon aims to offer a new treatment for patients with Critical lower limb ischemia, potentially improving quality of life and reducing surgical intervention needs. The device is currently for investigational use only and not for sale.