6-Month Data from the Surmodics SWING First-in-Human Study to be Presented at AMP Europe

Rhea-AI Summary

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.

Positive

• Presentation of promising 6-month data from the SWING Trial.
• Potential to improve treatment for Critical lower limb ischemia.
• Aiming to reduce the need for major bypass surgeries.

Negative

• The Sundance Drug-Coated Balloon is not yet available for sale.
• Currently only for investigational use, limiting revenue potential.

35-subject trial evaluating safety, performance of Surmodics’ Sundance™ Sirolimus Drug-Coated Balloon

EDEN PRAIRIE, Minn.--(BUSINESS WIRE)-- Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, announced today that Professor Ramon Varcoe will present 6-month data from the SWING Trial, a first-in-human study of the safety and performance of the Sundance™ Sirolimus Drug-Coated Balloon. The session will be held on Tuesday, October 11, at the Amputation Prevention Symposium (AMP) in Lugano, Switzerland.

TITLE: Surmodics SWING BTK Trial
DATE: Tuesday, October 11
TIME: 1:10 – 1:20 PM (CEST); 6:10 – 6:20 AM (CDT)
VENUE: Palazzo dei Congressi, Main Hall

Professor Varcoe, MBBS, MS, FRACS, PHD, MMed (ClinEpi), co-lead investigator of the SWING Trial, is a vascular surgeon at Sydney’s Prince of Wales and Prince of Wales Hospital where he is Director of Operating Theatres, and Director of Surgery and Anesthetics for the South East Sydney Health District. He will review safety and efficacy data collected through 6-months of follow-up for 35 patients with occlusive disease of the infra-popliteal arteries who were treated at study sites in Australia, New Zealand, or locations in Europe. Study subjects will be followed for 36 months after the index procedure. Professor Andrew Holden, MBChB, FRANZCR, EBIR, ONZM, Director of Northern Region Interventional Radiology Service at Auckland City Hospital in Auckland, New Zealand, is also a co-lead investigator for the SWING Trial.

The Sundance Sirolimus Drug-Coated Balloon utilizes a next-generation coating technology consisting of microcrystalline sirolimus and a proprietary excipient to maximize drug transfer, enhancing sirolimus delivery and sustaining therapeutic levels in the artery. Sirolimus, a potent anti-inflammatory and anti-proliferative compound, has been used successfully in coronary drug-eluting stents. The delivery of sirolimus to the vessel wall during mechanical dilatation provides an ancillary action of inhibiting the proliferation of cells, with the intended purpose of reducing restenosis. The Sundance Sirolimus Drug-Coated Balloon is not available for sale anywhere in the world, and currently is for investigational use only.

“The Sundance Sirolimus Drug-Coated Balloon represents a significant advancement in the treatment of patients with Critical lower limb ischemia and infrapopliteal arterial disease, providing a revascularization option that may lead to an improved quality of life, the reduced need for major bypass surgical intervention, and a decrease in the risk of amputation,” said Varcoe. “I am excited to present the 6-month SWING data to an audience of my peers at AMP Europe.”

About Surmodics, Inc.
Surmodics is a leading provider of surface modification technologies for intravascular medical devices and chemical components for in vitro diagnostic immunoassay tests and microarrays. Surmodics is pursuing development and commercialization of highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company’s expertise in proprietary surface technologies, along with enhanced device design, development, and manufacturing capabilities. The Company 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 the 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 for, and commercialize our proprietary 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 at the SEC 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221007005073/en/

Surmodics, Inc.

Tim Arens, 952-500-7000

ir@surmodics.com

Source: Surmodics, Inc.

FAQ

What is the significance of the SWING Trial for Surmodics (SRDX)?

The SWING Trial evaluates the safety and performance of the Sundance Sirolimus Drug-Coated Balloon, with 6-month data suggesting its potential to treat Critical lower limb ischemia.

When will Surmodics present data from the SWING Trial?

Surmodics will present the 6-month data from the SWING Trial on October 11 at the Amputation Prevention Symposium in Switzerland.

What is the current status of the Sundance Sirolimus Drug-Coated Balloon?

The Sundance Balloon is for investigational use only and not available for sale.

Who is Professor Ramon Varcoe in relation to Surmodics (SRDX)?

Professor Ramon Varcoe is a co-lead investigator of the SWING Trial and will present the trial data.

How does the Sundance Sirolimus Drug-Coated Balloon work?

It utilizes microcrystalline sirolimus to reduce restenosis, enhancing therapeutic levels in arterial treatments.