A Japanese healthcare conglomerate is the lead investor ReCor Medical‘s $15 million Series D round ReCor plans to use to back a U.S. clinical trial of its ultrasound renal denervation device.
Otsuka Holdings (TYO:4578) was joined by Sofinnova Partners in the round. ReCor said it’s met with the FDA to discuss its plans for the study of its Paradise RDN system, which would be undertaken at 20 to 25 clinical sites in the U.S. and Europe.
ReCor said it hopes to finalize its clinical study design and start enrolling patients in the 2nd half of 2015.
"We are pleased to have attracted investment from 1 of Japan’s premier healthcare groups. This new relationship will support our upcoming U.S. clinical studies and open new potential for our technology in Japan and greater Asia. We are pleased to be positioned alongside Boston Scientific (NYSE:BSX) and Medtronic (NYSE:MDT), who have also recently announced new clinical trials in renal denervation for the treatment of hypertension," president & CEO Andrew Weiss said in prepared remarks.
Early in 2014, Medtronic announced its Symplicity renal denervation device missed its primary endpoint in the Symplicity-3 trial. Boston Scientific delayed its Vessix program in immediate response, and St. Jude Medical (NYSE:STJ) suspended its own trial. Covidien ceded the field entirely, winding down development of its OneShot renal denervation device, which already had E.U. regulatory approval, and closing its Rapid II trial.
What difference a year makes. Just this month, Medtronic launched a new RDN trial, aiming to settle the "confounding" issues raised during Symplicity-3. Boston Scientific is running 2 clinical programs for its Vessix device: The Reduce trial, evaluating Vessix in treating hypertension; and the Relieve series, evaluating the technology for other conditions, including end-stage renal disease, heart failure, atrial fibrillation and diabetes. And St. Jude is running trials of its EnligHTN device in hypertension.
ReCor is optimistic about its Paradise device, which has CE Mark approval in the European Union, arguing that it could have an advantage over rivals because it uses ultrasound energy rather than radiofrequency energy to ablate nerves lining the renal arteries.
"ReCor believes that our Paradise technology may have a distinct advantage over competitive RF-based RDN systems by providing active vessel protection and 360° energy delivery. We believe that we can demonstrate an important clinical effect in hypertension patients with the Paradise system," co-founder & CEOO Mano Iyer said in a press release. "We are working with leading hypertension experts and interventionalists to finalize our clinical study design, and plan to begin enrollment in the 2nd half of 2015."
Palo Alto- and Amsterdam-based ReCor said it’s tested Paradise in 3 clinical trials involving more than 200 patients, the company said.