Otsuka gets in on ReCor Medical’s Paradise renal denervation device

ReCor Medical said it landed a strategic investment from Japanese conglomerate Otsuka Pharmaceutical (TYO:4578) that will bring to Asia its Paradise renal denervation device for treating hypertension. Neither side is disclosing financial terms, but the deal calls for Otsuka to receive exclusive rights to pursue clinical trials, regulatory approval and commercialization of ReCor’s Paradise device in Japan, China, Korea and elsewhere in Asia. For starters, Otsuka will test Paradise in Japan to see if it can help patients with treatment-resistant hypertension. Paradise uses ultrasound energy to ablate nerve endings in the lining of the renal arteries. Otsuka led ReCor’s $15 million Series D in April 2015. The Palo Alto, Calif., and Amsterdam-based company plans to use the new money to help fund its IDE-approved Radiance-HTN study, which will test the Paradise system in patients with hypertension in the U.S. and E.U. ReCor won the investigational device exemption from the FDA in February, and announced in April that it enrolled the 1st patients in the 292-patient study. ReCor’s new study is a blinded, randomized and sham-controlled trial designed to test Paradise in patients with essential hypertension taking 2 or fewer medications, and patients with treatment-resistant hypertension on at least 3 drugs. There are two arms to the trial: The Solo cohort (the essential hypertension patients) and the Trio cohort (the treatment-resistant group). ReCor Presiden...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Clinical Trials Drug-Device Combinations Funding Roundup Pharmaceuticals Otsuka Pharmaceutical ReCor Medical Source Type: news