ReCor Medical last week added a $12 million contribution from Otsuka Pharmaceutical (TYO:4578) to the $10 million it raised from the Japanese conglomerate last year for a clinical trial of its Paradise renal denervation device for treating hypertension, ReCor president & CEO Andrew Weiss told MassDevice.com this morning.
In May 2016 Otsuka participated in a strategic investment of an unspecified amount; Weiss told us that that round and the $12 million debt financing added last week are earmarked for the Radiance-HTN efficacy study of the Paradise device, which is designed to use ultrasound waves rather than radiofrequency ablation of nerves lining the renal artery to treat high blood pressure. ReCor won an investigational device exemption from the FDA in February 2016 for the Radiance-HTN study, which launched in April of that year.
The sham-controlled trial consists of two 60-day arms, he said: One, the “Solo” cohort, evaluating the Paradise treatment in patients with moderate hypertension who take one or two drugs for it, and a second called “Trio” investigating the treatment in patients with resistant hypertension who take three or more medications.
Weiss said the study design calls for the Solo cohort to stop taking blood pressure medications for a month before being randomized to either Paradise or a sham procedure. The Trio group are taken off of their anti-hypertensive cocktail, stabilized for a month and then given the three-drug Exforge HCT pill made by Novartis before being randomized to treatment or sham. The endpoint is mean reduction in average daytime ambulatory systolic blood pressure at 60 days; there are 146 patients in each cohort, he said.
“We’ve had an overwhelming amount of interest in the [Solo] study,” Weiss told us, noting that some 200,000 people have expressed interest in joining the trial. “We have as many patients signing up as our centers can handle. We’ve enrolled 500 total and 100 have already been randomized.”
The Otuska infusion will largely be used to complete Solo, with outcome data expected “this time next year, perhaps earlier,” he said. Some of the funds will go toward the Trio portion of the study, but as there are many fewer patients in that population, meaning slower enrollment, more cash will be needed to see it to completion, Weiss added.
“That trial is also enrolling well, but will take another six months [to finish Trio] beyond the finish of the Solo study,” he said.
Last year’s deal with Otsuka also gave that company the right to run Paradise studies in Asia. Weiss told us that ReCor’s Japanese partner, which led ReCor’s $15 million Series D in April 2015, has trials under way in Japan and South Korea.
It’s not the 1st time Otsuka has inked a deal with a medtech concern. In April 2016 the FDA issued a complete response letter requesting more information about the combination of Proteus Digital Health‘s “smart pill” and Otsuka’s Abilify anti-depressant drug.