ReCor Medical’s RADIANCE-II Pivotal Trial of Paradise uRDN System Meets Primary Endpoint

July 26, 2022—ReCor Medical, Inc. and Otsuka Medical Devices Co., Ltd., a fully owned subsidiary of Otsuka Holdings Co., Ltd., announced that the RADIANCE-II pivotal trial evaluating the Paradise ultrasound renal denervation (uRDN) system as a treatment for hypertension met its primary efficacy endpoint, demonstrating a statistically significant reduction in daytime ambulatory systolic blood pressure between treatment and a sham procedure measured at 2 months.

The RADIANCE-II pivotal trial is being conducted in the United States under an FDA investigational device exemption.

According to the companies, the randomized, sham-controlled clinical trial of the ReCor Paradise uRDN system for the treatment of patients with uncontrolled hypertension is composed of 224 patients. The patients, who had mild-to-moderate uncontrolled hypertension previously treated with up to two medications, were randomized while off medications at > 60 study centers in eight countries.

The study’s Principal Investigators Ajay Kirtane, MD, and Michel Azizi, MD, commented in the company’s press release, “Despite the truly formidable challenges of conducting a complex clinical trial in the throes of the COVID-19 pandemic, we are thrilled to observe these positive results of RADIANCE-II, especially in light of those we have previously reported from RADIANCE-HTN SOLO and TRIO. We cannot adequately convey our thanks to the patients, coordinators, and study physicians for their collective efforts, and we very much look forward to being able to present and publish the complete study details in the near future.”

Dr. Kirtane is Professor of Medicine at Columbia University’s Vagelos College of Physicians and Surgeons/NewYork-Presbyterian Hospital in New York, New York. Dr. Azizi is Professor of Medicine at Université Paris Cité, Hôpital Européen Georges Pompidou, in Paris, France.

As noted in the companies’ announcement, RADIANCE-II is the third and largest component of ReCor’s RADIANCE Global program of randomized and sham-controlled studies evaluating the Paradise uRDN system in patients with hypertension. The first two studies in the series are the previously reported cohorts of RADIANCE-HTN: SOLO (conducted in patients with mild-to-moderate hypertension) and TRIO (conducted in patients who remained hypertensive despite being on antihypertensive therapy). Both studies met their primary effectiveness endpoints.

With RADIANCE-II, ReCor now has a third positive trial, with > 500 patients randomized in the RADIANCE Global program. ReCor has also begun the GPS registry—a real-world study of up to 3,000 patients with uncontrolled hypertension, advised the companies. ReCor has initiated the GPS registry in the European Union, with plans to expand on a global basis.

The Paradise system is an investigational device in the United States. In Europe, the device has received CE Mark approval. ReCor plans to submit results of the RADIANCE Global program as part of a premarket approval application to the FDA for market approval in the United States.