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Surmodics Announces SWING Trial 12-Month Data to be Presented at ISET Conference on January 18
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Surmodics, Inc. (NASDAQ:SRDX) announced the presentation of 12-month data from the SWING Trial, evaluating the safety and performance of its Sundance™ Sirolimus Drug-Coated Balloon (DCB). This first-in-human study will be discussed by Professor Ramon Varcoe on January 18 at the 35th International Symposium on Endovascular Therapy in Miami, Florida.
The Sundance DCB utilizes a microcrystalline sirolimus coating to enhance drug delivery and reduce restenosis. Currently, this product is for investigational use only and not available for sale globally.
Positive
Presentation of promising 12-month results from the SWING Trial.
Innovative technology may enhance drug delivery and treat occlusive disease effectively.
Negative
Sundance DCB not yet approved for commercial sale; currently investigational only.
Forward-looking statements indicate potential risks in development and commercialization.
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
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 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.
Surmodics Investor Inquiries
Jack Powell, Investor Relations
ir@surmodics.com
Source: Surmodics, Inc.
FAQ
What are the key findings from the SWING Trial for the Sundance Sirolimus Drug-Coated Balloon (SRDX)?
The SWING Trial presented 12-month data showing the safety and performance of the Sundance DCB, highlighting its potential effectiveness.
When will the results of the SWING Trial be presented?
The 12-month results will be presented on January 18 at the 35th International Symposium on Endovascular Therapy in Miami.
What does the Sundance Sirolimus Drug-Coated Balloon aim to achieve?
The Sundance DCB aims to reduce restenosis by delivering sirolimus, a potent anti-inflammatory and anti-proliferative compound, during balloon dilatation.
Is the Sundance Sirolimus Drug-Coated Balloon available for purchase?
No, the Sundance DCB is currently for investigational use only and is not available for sale.
What risks are associated with the development of the Sundance DCB?
There are inherent risks and uncertainties in the development and commercialization of the Sundance DCB, as noted in Surmodics' forward-looking statements.
