According to a press release, Surmodics has completed enrolment in TRANSCEND, its pivotal clinical trial for the SurVeil drug-coated balloon (DCB).
“TRANSCEND is a rigorous level one, randomised controlled trial that comes at a very important time for the vascular and interventional community,” said Kenneth Rosenfield, a principal investigator of the TRANSCEND study. “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.”
The TRANSCEND trial enrolled 446 patients at 65 global sites. The randomised study will evaluate the safety and efficacy of the SurVeil DCB compared with a commercially available DCB in treating peripheral artery disease (PAD) in the upper leg. The results of the trial will also include long-term, patient-level data out to five years.
“I am excited about the potential of the SurVeil DCB to improve the treatment of PAD,” said Marianne Brodmann, a TRANSCEND principal investigator and the trial’s leading enroller with 44 randomisations. “Our focus now shifts to follow-up and monitoring of these patients and the collection of high-quality data.”
“Completing enrolment in the TRANSCEND trial marks an important milestone and brings us one step closer to bringing this next-generation treatment to PAD patients,” said Gary Maharaj, Surmodics’ president and chief executive officer. “I would like to thank our principal investigators—Kenneth Rosenfield, Marianne Brodmann, and William Gray—our trial advisor, 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 would not be here today.”
In February 2018, Surmodics entered into an agreement with Abbott that provided Abbott with exclusive worldwide commercialisation rights for the SurVeil DCB. Pursuant to the terms of the agreement, Surmodics received a US$25 million upfront payment and will receive a US$10 million milestone payment in connection with the completion of patient enrolment in the TRANSCEND trial. Approximately US$5 million from this milestone payment will be recognised as revenue in the company’s fiscal fourth quarter. Surmodics may earn an additional US$57 million for other various product development milestones.
Upon the regulatory approval of the device, Surmodics will be responsible for manufacturing clinical and commercial quantities of the product and will realise revenue from product sales to Abbott as well as a share of profits resulting from sales to third parties.