Surmodics (NSDQ:SRDX) announced today that it received CE Mark approval in Europe for its SurVeil drug-coated balloon (DCB).
SurVeil is a next-generation DCB designed for treating peripheral artery disease (PAD) with a proprietary drug-excipient formulation for a durable balloon coating. Pre-clinical data shows a more evenly distributed and durable drug effect and lower incidence of downstream drug particles compared to control DCBs, according to a news release.
In February 2018, Abbott (NYSE:ABT) paid $25 million up front for the global commercialization rights to the SurVeil device. The deal put another $67 million in milestones on the table, the first of which was triggered when Surmodics closed enrollment for its Transcend pivotal trial in August 2019.
Obtaining CE Mark approval clinches another milestone payment in the agreement, as Surmodics is now set to receive $10.8 million. The company said it will recognize approximately $6.5 million as revenue in its fiscal third quarter, with an additional $45 million remaining on the table for future milestones.
Under the agreement, Surmodics is responsible for the manufacture and supply of clinical and commercial quantities of the product, with revenue to be realized on initial product sales to Abbott and a share of profits from third-party sales.
“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,” Surmodics president & CEO Gary Maharaj said in the release. “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.”
Surmodics is not forecasting material revenue from the sale of the SurVeil DCB over the remainder of its fiscal year ending Sept. 30, 2020.
