• Surmodics’ proprietary Crystalline Drug Release (CDR) platform enhances sirolimus stability, transfer, and retention in tissue CDR discussed in connection with 12-month data from Surmodics’ SWING trial of the Sundance™ Sirolimus-Coated Balloon

Surmodics, Inc. (NASDAQ:SRDX) (the “Company”), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced that the differentiated capabilities of its crystalline drug release (CDR) platform for sirolimus-coated balloons (SCBs) were discussed in connection with 12-month data from the Company’s SWING trial at the 35th annual International Symposium on Endovascular Therapy (ISET) in Miami, Florida. The SWING trial is a first-in-human feasibility study of the Company’s Sundance™ SCB.

At ISET, SWING co-lead investigator Professor Ramon Varcoe, MBBS, MS, FRACS, PHD, MMed (ClinEpi), reinforced key findings from the SWING trial. Twelve-month data from the 35 patients enrolled in the trial showed no perioperative deaths or major amputations at 30 days, and just one major re-intervention was reported among the trial subjects, and use of the Sundance™ SCB was associated with primary patency maintained at 12 months in 80% of the per protocol analysis population.

“The technical benefits of CDR are clearly evident via in vivo animal models, which show that the Sundance SCB provides enhanced drug transfer and enables longer drug retention in tissue at therapeutic levels compared with competitor SCBs,” said Prof. Varcoe. “The positive 12-month data from SWING suggest that the Sundance SCB’s CDR platform holds significant promise for treating real-world PAD patients.”

As noted by Prof. Varcoe, a long-standing challenge associated with use of sirolimus on drug-coated balloons is achieving sustained therapeutic levels of drug in arterial tissue. To combat this problem, some SCB manufacturers encapsulate sirolimus within particles of polymer or lipid. Encapsulation is a traditional mode of drug delivery and has been used for decades.

Rather than using encapsulation, the Sundance™ SCB delivers drug to target tissue via a coating of stable crystalline sirolimus with a proprietary excipient on the balloon surface, a method the Company describes as Crystalline Drug Release, or CDR. When inflated, the Sundance™ SCB transfers this crystalline drug form to the vessel wall, whereupon the crystalized drug itself serves as the drug depot in a process that eliminates the need for a polymer depot. CDR is new in the SCB space.

About the SWING Trial

The SWING Trial is a 35-subject prospective, multi-center, single-arm, feasibility study to evaluate the safety and performance of the Sundance SCB when used to treat occlusive disease of the infra-popliteal arteries. The Swing Trial enrolled subjects with stenotic or occluded lesions of the infrapopliteal arteries, a reference vessel diameter of 2 mm to 4 mm, and a total lesion length of ≤230 mm for treatment with the Sundance Sirolimus DCB at eight sites in Australia, New Zealand, and/or Europe. Subjects will be followed for 36 months post index procedure.

The primary safety endpoint is defined as the number of subjects with a composite of freedom from Major Adverse Limb Event (MALE) and perioperative death at 30 days following the index procedure. The primary efficacy endpoint is late lumen loss at 6 months, as assessed by quantitative vascular angiography. Both primary endpoints of the SWING Trial were achieved.

Primary safety endpoint data showed no perioperative deaths or major amputations at 30 days, and just one major re-intervention was reported among the 35 trial subjects. The per protocol (PP) population reported an 8.0% rate of major adverse events (two clinically driven target limb revascularizations) at 6 months, with no additional adverse events reported for PP subjects in the 12-month data. Primary efficacy data show late lumen loss of 1.0 mm (±.79 mm) across 35 lesions at 6 months, indicating that the large luminal gain achieved immediately after the procedure was sustained post procedure.

Target lesion primary patency rate, defined as freedom from target vessel occlusion or target lesion revascularization associated with deterioration of Rutherford Clinical Classification and/or increase in size of pre-existing wounds (or occurrence of new wounds), and lesion restenosis >50%, was 80% at 12 months in the PP population. The Rutherford Clinical Classification describes 7 categories of peripheral artery disease, including both the patient's clinical symptoms as well as objective findings, and is used to assess disease progression. To view the presentation, click here.

About the Sundance™ Sirolimus Drug Coated Balloon

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.

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 the promise of the Sundance™ Sirolimus Drug-Coated Balloon and that it warrants evaluation in a large-scale pivotal trial, 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.