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 to treat long superficial femoral artery (SFA) lesions up to 360mm in patients suffering from PAD.
In a release, Kenneth Rosenfield, MD, a principal investigator of the TRANSCEND study said “the [trial] is a rigorous level one, randomized controlled trial that comes at a very important time for the vascular and interventional community. 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.”
Enrollment completion for TRANSCEND comes shortly after Becton Dickinson & Co. revealed FDA rejected the application to approve the Lutonix paclitaxel-coated balloon to treat patients with below-the-knee (BTK) PAD.
Paclitaxel devices came into the spotlight in late December 2018 after a meta-analysis showed an increased risk of death for patients treated with these devices. After a two-day meeting of the Circulatory System Devices Panel, FDA concluded that there is a signal associated with an increase in mortality through five years of paclitaxel-coated devices as compared to non-coated devices. The agency was not, however, able to attribute this increased risk to a specific cause, and the committee was befuddled by data discrepancies.
Issues surrounding paclitaxel-coated devices likely contributed to FDA’s decision to reject Lutonix. But it hasn’t been doom and gloom for all DCBs, as evidenced by recent developments with Concept Medical. Earlier this month, the Tampa, FL-based company received breakthrough device designation from FDA for the MagicTouch PTA, a DCB catheter for the BTK treatment of PAD.