In 2015, when Otsuka led Recor Medical’s $15m series B round, renal denervation was a very risky bet. Medtronic’s first-in-class device had tanked in its pivotal US trial and all renal denervation devices, including Recor’s Paradise system, were considered almost defunct. But Recor, alone among the smaller denervation groups, held faith, and when Medtronic’s next-generation device posted good results a year ago the Silicon Valley-based company was well placed to capitalise on the giant’s success. Positive mid-stage trial results with Paradise followed this May, and last week the FDA approved the start of a US approval trial of Paradise, Radiance-II. The sham-controlled study will test Paradise in patients with moderate hypertension; enrolment is to start in October but it is not yet clear how big this trial will be or when it might report. Otsuka’s purchase of Recor, announced today, is therefore a much safer – and likely much more expensive, though the deal’s value was not disclosed – use of its money.
|Trial name||Status||Sponsors||Sham control?||N||NCT ID||Results|
|Radiance-II (US pivotal)||Yet to start||Otsuka||Yes||-||-||Unknown; trial to start in October|
|Require||Recruiting||Jimro (Otsuka subsidiary)||Yes||140||NCT02918305||Expected December 2018|
|Radiance-HTN||Recruiting||Recor Medical||Yes||292||NCT02649426||Solo cohort hit in May 2018; Trio cohort data expected August 2018|