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Surmodics Announces SWING Trial 12-Month Data to be Presented at ISET Conference on January 18

By: via Business Wire

35-subject SWING Trial evaluates the safety, performance of Surmodics’ Sundance™ Sirolimus Drug-Coated Balloon

Differentiated capabilities of Surmodics’ crystalline drug release platform to be discussed in connection with SWING trial 12-month data

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 performance of the Sundance™ Sirolimus Drug-Coated Balloon (DCB). The session will be held on Wednesday, January 18, at the 35th annual International Symposium on Endovascular Therapy (ISET) conference in Miami, Florida. Professor Varcoe will also discuss the differentiated capabilities of the Surmodics crystalline drug release platform for sirolimus-coated balloons (SCBs) in connection with 12-month data from the SWING trial.

TITLE: 12-Month Results from the SWING Multicentre Study: A Novel Sirolimus coated balloon for use below-the-knee

DATE: Wednesday, January 18

TIME: 5:30 – 5:40 PM (EST)

VENUE: Loews Miami Beach Hotel, Poinciana 3 & 4

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 performance 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 12-month data on Nov. 16 at the 49th Annual Symposium on Vascular and Endovascular Issues (VEITHsymposium).

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 performance coating technologies for intravascular medical devices and chemical and biological components for in vitro diagnostic immunoassay tests and microarrays. Surmodics also develops and commercializes highly differentiated vascular intervention 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 modification and drug-delivery coating technologies, along with its device design, development and manufacturing capabilities. The Company’s mission is to improve the detection and treatment of disease. Surmodics is headquartered in Eden Prairie, Minnesota. For more information, visit www.surmodics.com. The content of Surmodics’ website is not part of this press release or part of any filings that the company makes with the SEC.

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, 2022, 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.

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