Data from RADIANCE-II will build on evidence from RADIANCE-HTN SOLO and TRIO studies to support pre-market application to the FDA
Palo Alto, Calif. – March 29, 2022 – ReCor Medical, Inc. (“ReCor”), a fully owned subsidiary of Otsuka Medical Devices Co., Ltd., announced today completion of enrollment in their RADIANCE-II pivotal trial of the Paradise Ultrasound Renal Denervation (uRDN) System for the treatment of uncontrolled hypertension. Subject to study outcomes, the RADIANCE-II results will be combined with the previously released data from the Company’s RADIANCE-HTN SOLO and TRIO studies in a pre-market application to the FDA for US market approval, and will be presented to the scientific and medical communities in publications and conferences later this year.
The RADIANCE-II pivotal trial is a randomized, sham-controlled clinical trial of ReCor’s Paradise uRDN System for the treatment of uncontrolled hypertension in patients on zero-to-two antihypertensive oral medications. After 4 weeks of washout from antihypertensive medications, patients are randomized at a 2:1 ratio to either Paradise uRDN or a sham procedure. The primary efficacy endpoint is the difference in daytime ambulatory systolic blood pressure between Paradise uRDN and sham measured at two months post-procedure, while the primary safety endpoint is a composite of 30-day major adverse events. More than 1,000 study subjects have been enrolled over 3 years at more than 50 study centers in 6 countries, with over 200 patients randomized to uRDN or a sham procedure.
“The RADIANCE-II pivotal trial was carefully designed to assess the BP-lowering efficacy and safety of treating uncontrolled hypertension with the Paradise uRDN System. We are grateful to the investigators and study participants across the globe for their work on the study – especially through the challenges created by the COVID-19 pandemic over the past two years. We look forward to their continued help in the coming months to complete this landmark study, and we are excited to assess trial outcomes later this year,” said co-principal investigators Michel Azizi and Ajay Kirtane. Michel Azizi is Professor of Medicine at Université Paris Cité, Head of the ESH Hypertension Excellence Center, Hôpital Européen Georges Pompidou, Paris, France and Ajay Kirtane is Professor of Medicine at Columbia University, Vagelos College of Physicians and Surgeons and NewYork-Presbyterian Hospital.
RADIANCE-II is the third component of ReCor’s RADIANCE Clinical Trial program in patients with hypertension, which includes the RADIANCE-HTN SOLO and TRIO studies. In the randomized and sham-controlled SOLO trial, 146 patients with mild-to-moderate hypertension were assessed in an “off-meds” setting. In the landmark TRIO trial, 136 patients who remained hypertensive, despite a standardized triple antihypertensive therapy, were randomized 1:1 to the Paradise uRDN treatment or sham. Both studies met their primary effectiveness endpoints. ReCor has begun the fourth component of their RADIANCE program with the launch of the Global Paradise System (“GPS”) Registry – a real-world study of patients with uncontrolled hypertension initiated in Germany earlier this year.
The Paradise uRDN System bears the CE mark for the treatment of hypertension in Europe and is an investigational device in the United States. Hypertension is the leading contributor to disease burden worldwide, leading to increased cardiovascular morbidity and mortality, poorer quality of life, and increased cost to health systems.
About ReCor Medical, Inc.
ReCor Medical, headquartered in Palo Alto, CA, is a medical technology company focused on transforming the management of hypertension, the leading cardiovascular risk factor in the world. ReCor has pioneered the minimally invasive use of ultrasound in renal denervation, and developed the Paradise System, to treat patients with hypertension. The Paradise System is an investigational device in the United States. It bears a CE mark in the EU. The company has completed two randomized, sham-controlled studies of the Paradise System in patients with both moderate hypertension and those resistant to standard medical therapies. ReCor is currently conducting its FDA IDE pivotal study, RADIANCE-II, in the United States and Europe, and pending successful completion will submit a PMA to the US FDA for market approval.
ReCor Medical is a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd.
About Otsuka Medical Devices Co., Ltd.
Otsuka Medical Devices focuses on the global development and commercialization of endovascular therapies that provide new therapeutic options in areas where patient needs cannot be met through pharmaceutical treatment. Otsuka Medical Devices Co., Ltd. is a subsidiary of Otsuka Holdings Co., Ltd., a leading global healthcare group listed on the Tokyo Stock Exchange (JP 4578). With operations in pharmaceuticals, nutraceuticals, medical devices and other health-related businesses, the group generated worldwide sales of app. US$13 billion in the fiscal year ended December 2021 and has a market capitalization of app. US$19 billion.