Surmodics has wrapped up enrollment for the TRANSCEND clinical trial for the SurVeil drug-coated balloon (SurVeil DCB) for the treatment of peripheral artery disease (PAD) in the upper leg.
Based in Minnesota, Surmodics is a provider of medical device and in vitro diagnostic technologies to the health care industry.
The TRANSCEND clinical trial has enrolled a total of 446 patients across 65 global sites.
The randomized clinical trial will assess the safety and efficacy of the SurVeil DCB in comparison to a commercially available drug-coated balloon. The results of the drug-coated balloon trial will also cover long-term, patient-level data out to five years.
Kenneth Rosenfield – principal investigator of the TRANSCEND study, commenting on the TRANSCEND clinical trial of SurVeil DCB, said: “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.”
Last February, Surmodics signed a deal with Abbott to provide the latter exclusive global commercialization rights for the SurVeil DCB. As per the agreement terms, Surmodics received an upfront payment of $25 million and will get a $10 million milestone payment having completed patient enrollment in the TRANSCEND clinical trial.
Surmodics is likely to earn a further $57 million for other various product development milestones.
If SurVeil DCB is approved, then Surmodics will handle manufacturing clinical and commercial quantities of the medical device and will realize revenue from product sales to Abbott along with a share of profits coming from sales to third parties.
Commenting on the TRANSCEND clinical trial of SurVeil DCB, Gary Maharaj, Surmodics president and CEO said: “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.
“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.”
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