Primary Endpoint Met in Hypertension Clinical Trial

ReCor Medical Inc.’s method for lowering blood pressure is a proven clinical success.

The company and Otsuka Medical Devices Co. Ltd., said the RADIANCE II FDA IDE trial evaluating the Paradise Ultrasound Renal Denervation (uRDN) System met its primary efficacy endpoint, resulting in a statistically significant reduction in daytime ambulatory systolic blood pressure. 
 
The RADIANCE II study is a randomized, sham-controlled clinical trial of the ReCor Paradise uRDN System for treating patients with uncontrolled hypertension. Two hundred twenty-four patients with mild-to-moderate uncontrolled hypertension, previously treated with up to two medications, were randomized while off medications at more than 60 study centers in eight countries.
 
“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,” said study principal investigators Ajay Kirtane, professor of Medicine at Columbia University, Vagelos College of Physicians and Surgeons/NewYork-Presbyterian Hospital and Michel Azizi, professor of Medicine at Université Paris Cité, Hôpital Européen Georges Pompidou, Paris, France. “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.”
 
RADIANCE II is the third and largest component of ReCor’s RADIANCE Global Program—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 RADIANCE-HTN SOLO (conducted in patients with mild-to-moderate hypertension) and TRIO (conducted in those 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 more than 500 patients randomized in the RADIANCE Global Program. ReCor has also begun the Global Paradise System (“GPS”) Registry—a real-world study of up to 3,000 patients with uncontrolled hypertension.

“We at Otsuka are very pleased with the positive outcome of the RADIANCE II study,” said Kazumichi Kobayashi, executive deputy president of Otsuka Medical Devices. “With three successful clinical trials of the Paradise uRDN System, we believe even more strongly that the Paradise System can become an important treatment option for patients and physicians struggling to control blood pressure.”
 
“ReCor is thrilled that the RADIANCE II trial met its primary efficacy endpoint. Following the positive SOLO and TRIO clinical trials, RADIANCE II adds to the evidence for the Paradise System as a potential future treatment for patients with uncontrolled hypertension,” ReCor President and CEO Andrew M. Weiss said. 
 
Headquartered in Palo Alto, ReCor Medical is a wholly owned subsidiary of Otsuka Medical Devices Co. Ltd. that is focused on transforming the management of hypertension. ReCor has pioneered the use of the Paradise ultrasound renal denervation (uRDN) system for the treatment of hypertension. The Paradise System is an investigational device in the United States and bears the CE mark in the European Union.  
 
Otsuka Medical Devices develops and commercializes medical care products including endovascular devices. Otsuka Medical Devices Co. Ltd. is a subsidiary of Otsuka Holdings Co. Ltd., a global healthcare company listed on the Tokyo Stock Exchange.