Surmodics Announces SWING Trial 12-Month Data to be Presented at VEITHsymposium on November 16

Rhea-AI Summary

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.

Positive

• 12-month data from SWING Trial presented at VEITHsymposium, indicating progress in clinical evaluation.
• Sundance DCB employs advanced coatings to enhance drug delivery, potentially improving patient outcomes.

Negative

• Sundance DCB is not yet commercially available, indicating ongoing development risks.
• Dependent on regulatory approvals which involve inherent uncertainties.

35-subject SWING Trial evaluates the safety, efficacy 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 12-month data from the SWING Trial, a first-in-human study of the safety and efficacy of the Sundance™ Sirolimus Drug-Coated Balloon (DCB). The session will be held on Wednesday, November 16, at the 49^th Annual Symposium on Vascular and Endovascular Issues (VEITHsymposium) in New York City.

SESSION TITLE: The SWING Trial: First-in-Human Use of a Sirolimus DCB in Arteries Below-the-Knee
DATE: Wednesday, November 16
TIME: 9:24 – 9:29 AM (EST); 8:24 – 8:29 AM (CST)
VENUE: New York Hilton Midtown - Grand Ballroom East, 3rd Floor

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 12 months of follow-up for 35 subjects with occlusive disease of the infra-popliteal arteries who were treated at study sites in Australia, New Zealand, and 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.

Professor Varcoe recently presented SWING Trial 6-month data on October 11 as part of the Amputation Prevention Symposium (AMP) in Lugano, Switzerland.

The Sundance Sirolimus Drug-Coated Balloon utilizes a next-generation coating technology consisting of microcrystalline sirolimus and a proprietary excipient designed 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 balloon 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.

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 Drug-Coated Balloon, 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 drug-coated balloon 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/20221111005069/en/

Surmodics Investor Inquiries

Jack Powell, Investor Relations

ir@surmodics.com

Source: Surmodics, Inc.

FAQ

What is the SWING Trial related to SRDX?

The SWING Trial evaluates the safety and efficacy of Surmodics’ Sundance™ Sirolimus Drug-Coated Balloon in patients with infra-popliteal artery occlusive disease.

When will the 12-month data from the SWING Trial be presented?

The 12-month data will be presented on November 16 at the VEITHsymposium in New York City.

Who is leading the SWING Trial presentation?

Professor Ramon Varcoe, a vascular surgeon, will present the data.

Is the Sundance DCB available for sale?

No, the Sundance DCB is currently for investigational use only and not available for sale.

What are the key features of the Sundance DCB?

The Sundance DCB incorporates microcrystalline sirolimus and a proprietary excipient aimed at maximizing drug transfer to reduce restenosis.