Surmodics Announces First Patient Enrolled in TRANSCEND Pivotal Clinical Trial for SurVeil® Drug-Coated Balloon

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Comparing SurVeil® DCB to Medtronic IN.PACT® Admiral® DCB

Plan to enroll up to 446 patients at approximately 78 sites

Surmodics, Inc. (Nasdaq: SRDX), (medical device and in vitro diagnostic technologies), today announced enrollment of the first patient in TRANSCEND, the pivotal clinical trial for the SurVeil® drug-coated balloon (DCB). The randomized trial will evaluate the SurVeil DCB for treatment for peripheral artery disease (PAD) in the upper leg compared to a commercially available DCB treatment. Up to 446 patients will be randomized 1:1 to receive either the SurVeil DCB or Medtronic’s IN.PACT® Admiral® DCB at approximately 60 U.S. sites and 18 sites outside the United States.

Kenneth Rosenfield, M.D., section head, Vascular Medicine and Intervention at Massachusetts General Hospital, chair of the Surmodics Clinical Advisory Board and U.S. co-principal investigator for the TRANSCEND trial commented, “Based on the preclinical and early feasibility study results we have seen so far, I am excited about the potential of the Surveil DCB as a third-generation DCB to improve the treatment of PAD.”  He added, “TRANSCEND will be a rigorous Level One trial that will answer important questions about DCB technologies.”

The design of the Surveil DCB reflects Surmodics’ long-standing industry leadership in the development of surface technology for vascular medical devices. The device includes a proprietary drug-excipient formulation for the balloon coating and is manufactured using a proprietary process to improve coating uniformity. Pre-clinical data have shown a three to five times higher target tissue drug concentration, a more evenly distributed and durable drug effect, and lower incidence of downstream drug particles compared to control DCBs.1

“This is a major step in the right direction for Surmodics, as we apply and evaluate our unique technology with the goal of improving clinical outcomes for patients with peripheral artery disease,” said Gary Maharaj, president and CEO of Surmodics. “We’re thrilled to be underway with TRANSCEND and look forward to working with our investigators to execute an efficient and rigorous pivotal trial.”

The objective of the Surveil DCB pivotal trial, TRANSCEND, is to evaluate the safety and effectiveness of the device for treatment of subjects with symptomatic PAD due to stenosis of the femoral and/or popliteal arteries. The clinical study will be used to support regulatory approvals (U.S. and Europe) and reimbursement. The primary efficacy endpoint of the trial is primary patency, defined as a composite of freedom from restenosis and clinically-driven target lesion revascularization (TLR) through 12 months post-index procedure. All randomized subjects will be followed through 60 months post-index procedure.

The trial will be led by national co-principal investigators Kenneth Rosenfield, M.D., and Gary Ansel, M.D., system medical chief of the Vascular Program at OhioHealth. Marianne Brodmann, M.D., substitute head of the Division of Angiology, Department of Internal Medicine, Medical University of Graz, Graz, Austria, is the European principal investigator.

The Surveil DCB is not available for sale anywhere in the world, and is for investigational use only.