Today Surmodics, Inc. announced it has received CE Mark Certification in the European Union for its SurVeil™ drug-coated balloon (DCB).
“I am excited about the potential of the SurVeil™ DCB to improve the treatment of PAD,” said Professor Marianne Brodmann MD, PhD, interventional cardiologist at Medical University Graz (Austria) and a Principal Investigator in TRANSCEND, Surmodics’ pivotal clinical trial for the SurVeil DCB. “Drug-coated balloons have been widely utilized in Europe as a frontline treatment for PAD.”
The SurVeil DCB, a next-generation device that utilizes best-in-class technology in the treatment of peripheral artery disease (PAD), includes a proprietary drug-excipient formulation for a durable balloon coating and is manufactured using an innovative process to improve coating uniformity. Pre-clinical data have shown a more evenly distributed and durable drug effect, and lower incidence of downstream drug particles compared to the control drug-coated balloon.1
“This CE Mark is a critical milestone and an exciting step forward for Surmodics as we continue to demonstrate industry leadership in the development of pioneering vascular medical devices,” said Gary Maharaj, President and Chief Executive Officer of Surmodics. “The design of the SurVeil DCB reflects our dedication to providing innovative solutions that bring real clinical value – benefitting both clinicians and the patients that they treat. Congratulations go out to the entire Surmodics team on this well-deserved achievement.”
In February 2018, Surmodics entered into an agreement with Abbott (NYSE: ABT) that provided Abbott with exclusive worldwide commercialization rights for the SurVeil DCB. Pursuant to the terms of the agreement, Surmodics received a $25 million upfront payment and a $10 million milestone payment for the completion of patient enrollment in the TRANSCEND clinical trial. As a result of CE Mark attainment, Surmodics will receive an additional $10.8 million milestone payment. The company will recognize approximately $6.5 million as revenue in its fiscal third quarter and could earn up to an additional $45 million for future product development milestones. Surmodics is not forecasting material revenue from the sale of its SurVeil DCB product over the remainder of its fiscal year ending September 30, 2020.
Under the agreement, Surmodics will be responsible for the manufacture and supply of clinical and commercial quantities of the product and will realize revenue based on initial product sales to Abbott as well as a share of profits resulting from third-party sales. The SurVeil DCB is not available for sale and is for investigational use only in the United States.