June 8, 2020
Surmodics SurVeil DCB Receives CE Mark Approval
June 8, 2020—Surmodics, Inc. announced it has received European CE Mark approval for its SurVeil drug-coated balloon (DCB), a next-generation device for the treatment of peripheral artery disease (PAD).
Professor Marianne Brodmann MD, an interventional cardiologist at Medical University Graz in Graz, Austria, served as a Principal Investigator in the TRANSCEND pivotal clinical trial for the SurVeil DCB. “I am excited about the potential of the SurVeil DCB to improve the treatment of PAD,” commented Prof. Brodmann in the company's announcement. “DCBs have been widely utilized in Europe as a frontline treatment for PAD."
In the United States, the SurVeil DCB is not available for sale and is for investigational use only.
In February 2018, Surmodics announced it entered into an agreement with Abbott that provided Abbott with exclusive worldwide commercialization rights for the SurVeil DCB.
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. Surmodics received a $25 million upfront payment and a $10 million milestone payment for the completion of patient enrollment in the TRANSCEND clinical trial.
Surmodics advised that as a result of attaining CE Mark certification, it 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.