Abbott and Surmodics to Collaborate on SurVeil Drug-Coated Balloon

February 27, 2018—Abbott and Surmodics announced that the companies have entered into an agreement whereby Abbott will have exclusive worldwide commercialization rights for Surmodics' SurVeil drug-coated balloon (DCB) to treat peripheral artery disease in the superficial femoral artery. Separately, Abbott received options to negotiate agreements for Surmodics' below-the-knee and arteriovenous fistula DCB products, which are currently in preclinical development.

As part of the commercialization agreement, Surmodics will supply the SurVeil DCB to Abbott. The companies will collaborate on product development, clinical trials, and regulatory activities to obtain marketing approval in the United States and Europe. The SurVeil device is currently being evaluated in the TRANSCEND United States pivotal clinical trial. Commencement of enrollment in the trial was announced in November 2017. The SurVeil DCB is currently for investigational use only.

Pursuant to the terms of the agreement, Surmodics will receive a $25 million upfront payment and may earn an additional $67 million for various product development milestones. Upon regulatory approval of the device, 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, advised the companies.

According to the companies, the SurVeil DCB will complement Abbott's line of vascular devices for treating peripheral artery disease, including stents and vessel closure devices. The SurVeil DCB includes Surmodics' drug excipient formulation for the balloon coating and is manufactured using the company's process to improve coating uniformity. Preclinical 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 with control DCBs, noted the companies.