SurModics Completes Trial Enrollment for SurVeil DCB

SurModics accomplished a huge milestone this week by completing enrollment for a pivotal trial of its SurVeil drug-coated balloon (DCB). About 446 peripheral artery disease (PAD) patients at 65 sites across the world will be evaluated in the TRANSCEND trial. The Eden Praire, MN-based company is seeking to treat PAD in the upper leg. Enrollment completion triggered a $10 million milestone payment from Abbott Laboratories. The agreement between the two companies was formed in February 2018 and 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 will receive a $10 million milestone payment in connection with the completion of patient enrollment in the TRANSCEND trial. About $5 million from this milestone payment will be recognized as revenue in the company’s fiscal fourth quarter. SurModics may earn an additional $57 million for other various product development milestones. With the completion of this milestone, SurModics said it now expects fiscal 2019 revenue to be in a range of $97 million to $99 million, this compares to the company’s previously expected revenue range of $92 million to $94 million. In the TRANSCEND trial, SurModics’ SurVeil will go up against Medtronic’s In.Pact DCB. In April of 2018, the Dublin-based company received a nod from FDA for the IN.PACT Admiral DCB t...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Source Type: news