35-subject trial evaluating the safety and performance of Surmodics Sundance™ Sirolimus Drug Coated Balloon
EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–#Acquisition–Surmodics, Inc. (NASDAQ: SRDX), a leading provider of medical devices and in vitro diagnostic technologies for the healthcare industry, today announced that Professor Ramon Varcoe will present the data of the SWING trial, a first-in-human study of the safety and performance of the drug-coated balloon Sirolimus Sundance™. The session will take place on Tuesday, October 11 at the Amputation Prevention Symposium (AMP) in Lugano, Switzerland.
TITLE: Surmodics Trial SWING BTK
DATE: tuesday october 11
TIME: 1.10 p.m. – 1.20 p.m. (CEST); 6:10 a.m. – 6:20 a.m. CDT
VENUE: Convention Center, main hall
Professor Varcoe, MBBS, MS, FRACS, PHD, MMed (ClinEpi), Co-Principal Investigator of the SWING trial, is a Vascular Surgeon at Prince of Wales and Prince of Wales Hospital in Sydney, where he is Director of Blocks Surgical Officers and Director of Surgery and Anesthesia for Sydney South East Health District. It will review safety and efficacy data collected during the 6-month follow-up of 35 patients with subpopliteal artery occlusive disease who were treated at study sites in Australia, New Zealand or Europe. Study subjects will be followed for 36 months after the indexing procedure. Professor Andrew Holden, MBChB, FRANZCR, EBIR, ONZM, Director of the Northern Region Interventional Radiology Department at Auckland City Hospital in Auckland, New Zealand, is also co-principal investigator of the SWING trial.
The Sundance Sirolimus drug-coated balloon uses next-generation coating technology comprised of microcrystalline sirolimus and a proprietary excipient to maximize drug transfer, improve sirolimus delivery, and maintain therapeutic levels in the artery. Sirolimus, a potent anti-inflammatory and anti-proliferative compound, has been used successfully in drug-eluting coronary stents. Delivery of sirolimus to the vessel wall during mechanical dilation provides an ancillary action of inhibiting cell proliferation, with the intended aim of reducing restenosis. The Sundance Sirolimus drug-coated balloon is not available for sale anywhere in the world and is currently intended for experimental use only.
“The Sundance Sirolimus drug-coated balloon represents a significant advance in the treatment of patients with critical lower extremity ischemia and infrapopliteal arterial disease, providing a revascularization option that may lead to improved quality of life, reduced need for major bypass surgery, and a decreased risk of amputation,” Varcoe said. “I am delighted to present the 6 month SWING data to an audience of my peers from AMP Europe.”
About Surmodics, Inc.
Surmodics is a leading supplier of surface modification technologies for intravascular medical devices and chemical components for in vitro immunodiagnostic assays and microarrays. Surmodics pursues the development and commercialization of highly differentiated medical devices designed to meet unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the company’s combination of expertise in proprietary surface technologies, along with enhanced device design, development and manufacturing capabilities. The Society’s mission remains to improve the detection and treatment of disease. Surmodics is headquartered in Eden Prairie, Minnesota. For more information, visit www.surmodics.com.
Safe Harbor for forward-looking statements
This press release contains forward-looking statements. Statements that are not historical or current facts, including statements about beliefs and expectations regarding Sundance™ Sirolimus DCB, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties, and important factors could cause actual results to differ materially from those anticipated, including (1) our ability to successfully develop, obtain regulatory approval and commercialize our exclusive products; and (2) the factors identified under “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended September 30, 2021, and updated in our subsequent reports filed with the SEC. These reports are available in the Investors section of our website at www.surmodics.com and on the SEC’s website at www.sec.gov. Forward-looking statements speak only as of the date they are made, and we undertake no obligation to update them in light of new information or future events.
Tim Arens, 952-500-7000