Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) today announced that the Centers for Medicare and Medicaid Services (CMS) have begun a National Coverage Analysis (NCA) of Renal Denervation (RDN), a medical device-based treatment for hypertension.

The initiation of an NCA is the first step in the National Coverage Determination (NCD) process towards the potential expansion of coverage of Recor’s Paradise® Ultrasound Renal Denervation (uRDN) system among Medicare beneficiaries. Recor appreciates CMS’ consideration of potential national coverage of RDN as a hypertension treatment option for Medicare beneficiaries and will continue to work closely with CMS throughout the NCD process.

Recor has been focused on developing and testing the Paradise uRDN system for the treatment of hypertension since 2009. The RADIANCE global program studied the Paradise system in three independently powered, sham-controlled, randomized clinical trials in over 500 patients with uncontrolled hypertension: RADIANCE II and RADIANCE-HTN SOLO, which studied patients with mild-moderate hypertension in an “off-meds” setting, and RADIANCE-HTN TRIO, which studied patients with resistant hypertension on standardized triple antihypertensive therapy. Each trial met its prescribed primary efficacy endpoint with a favorable safety profile consistently observed following ultrasound RDN treatment. Recor has also initiated the US Global Paradise System (GPS) Post-Approval Study to collect real-world clinical evidence with long-term follow-up in 1,000 patients with uncontrolled hypertension.

The Paradise uRDN system is currently commercially available for patients in the US having received FDA approval in November 2023. It is indicated to reduce blood pressure as an adjunctive treatment in hypertension patients in whom lifestyle modifications and antihypertensive medications do not adequately control blood pressure.

About the Paradise uRDN SystemThe Paradise uRDN system is a first-of-its-kind ultrasound-based RDN technology designed to lower blood pressure by denervating the sympathetic nerves surrounding the renal arteries, reducing the overactivity that can lead to hypertension. The Paradise uRDN system delivers two to three doses of 360-degree ultrasound energy — lasting seven seconds each — through the main renal arteries to the surrounding nerves. The Paradise catheter features the exclusive HydroCooling™ system, which circulates sterile water through the balloon catheter during the procedure to help protect the renal artery wall.

About Recor Medical, Inc.Recor Medical, headquartered in Palo Alto, Calif., a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd., is a medical technology company focused on transforming the management of hypertension. Recor has pioneered the use of the Paradise Ultrasound Renal Denervation system for the treatment of hypertension. The Paradise uRDN system is an investigational device in Japan, is FDA approved in the United States, and bears the CE mark. Recor has reported positive outcomes in three independent, randomized, sham-controlled studies of the Paradise uRDN system in patients with mild-to-moderate and resistant hypertension. In addition, Recor is conducting the Global Paradise System (“GPS”) Registry in the European Union and the UK, and has initiated the US GPS post-approval study in the United States.http://www.recormedical.com/About Otsuka Medical Devices Co., Ltd.Otsuka Medical Devices Co., Ltd. engages in the global development and commercialization of medical devices that provide new therapeutic options in areas where patient needs cannot be met through pharmaceutical or other conventional treatment. Otsuka Medical Devices is a subsidiary of Otsuka Holdings Co., Ltd. (www.otsuka.com/en), a global healthcare company listed on the Tokyo Stock Exchange (JP 4578).

https://www.omd.otsuka.com/en/Media ContactLisa OwensThe Mullings Grouplowens@mullingsgroup.com+1-210-601-6647

Lara Barghout
Recor Medical
+1 650 542 7700
lara.barghout@recormedical.com