Surmodics (NSDQ:SRDX) said today that it’s due for a $10 million milestone payment from Abbott (NYSE:ABT) after closing enrollment for the Transcend pivotal trial of its SurVeil drug-coated balloon for treating peripheral artery disease.
Abbott in February 2018 paid $25 million up front for the global commercialization rights to the SurVeil device, which uses a proprietary paclitaxel-excipient formulation that’s designed to provide a more durable and uniform coating. The deal put another $67 million in milestones on the table, the first of which was triggered by the Transcend enrollment closure.
Eden Prairie, Minn.-based Surmodics said the 446-patient Transcend trial is designed to compare the SurVeil DCB with the In,Pact Admiral DCB made by Medtronic (NYSE:MDT) out to five years. The estimated primary completion date is April 2020, with a study completion date of April 2024.
“Completing enrollment in the Transcend trial marks an important milestone and brings us one step closer to bringing this next-generation treatment to PAD patients,” president & CEO Gary Maharaj said in prepared remarks. “I would like to thank our principal investigators – Dr. Kenneth Rosenfield, Professor Marianne Brodmann and Dr. William Gray – our trial advisor, Dr. Peter Schneider, and the entire steering committee for their leadership and guidance, all our investigators, support teams and, importantly, the patients we enrolled. Without their participation, we wouldn’t be here today.”
“Transcend is a rigorous level-one, randomized controlled trial that comes at a very important time for the vascular and interventional community,” added Rosenfield, of Boston’s Mass. General Hospital. “By providing a head-to-head comparison with today’s market leading DCB, this trial will provide data regarding the relative performance of the SurVeil DCB, which represents a new generation of DCB. Beyond the device itself, the new trial design will ultimately provide insight into clinically important questions regarding long-term results. There is great promise that this third-generation DCB will further improve upon current outcomes for this technology and provide additional benefit for clinicians and the patients that they treat.”
Surmodics said it plans to recognize $5 million of the Abbott milestone during its fiscal fourth quarter, which prompted it to raise its outlook on the rest of the year. The company said it now expects to post adjusted earnings per share of 69¢ to 77¢, up from 41¢ to 49¢ previously, on sales of $97.0 million to $99.0 million, compared with prior guidance for $92.0 to $94.0 million.
Shares of SRDX were up 4.1% to $44.54 apiece today early-morning trading.
Earlier this month, the FDA said it wanted more long-term safety and effectiveness studies to be done on paclitaxel-eluting stents and balloons after a December 2018 analysis from the Journal of the American Heart Assn. suggested that PAD patients treated with such devices could be at a higher risk for late death.