Data analysis

ReCor Medical Announces Results of Pooled Data Analysis from RADIANCE SOLO and TRIO Studies in the Treatment of Hypertension with the Paradise™ Ultrasound Renal Denervation System

PALO ALTO, Calif.–(BUSINESS WIRE)– ReCor Medical, Inc. (“ReCor”) and Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”), a wholly owned subsidiary of Otsuka Holdings Co., Ltd., today announced that Dr. Ajay Kirtane presented an analysis of pooled data from ReCor’s two randomized controlled trials evaluating the Paradise™ Ultrasonic Renal Denervation System (uRDN) for the treatment of hypertension at the Annual Meeting of EuroPCR in Paris. The analysis demonstrated a statistically significant reduction in blood pressure (BP) across a wide range of hypertension severity, as shown in the RADIANCE-HTN SOLO and TRIO studies. The data was presented during a breaking news session titled “Hypertension Management in 2022: Control it, Live Longer” on World Hypertension Day.

The pooled analysis combined data from 282 patients randomized to ReCor’s two prospective controlled studies, enrolling two disparate patient populations: TRIO (patients with resistant hypertension) and SOLO (patients with mild to moderate hypertension). There were consistent benefits in both blood pressure reduction and drug burden across the entire patient population compared to sham. The combined dataset showed an overall difference between groups over 6 months favoring uRDN ​​in daytime ambulatory systolic BP of -4.8 mmHg (95% CI: -7.1 to -2.5, p

“The results of this pooled analysis clearly show the consistent blood pressure lowering effect that ultrasound renal denervation can have on varying severities of hypertension, regardless of trial design and whether patients enrolled whether or not they are taking antihypertensive drugs,” said lead researcher Ajay Kirtane. , professor of medicine at Columbia University, Vagelos College of Physicians and Surgeons, and NewYork-Presbyterian Hospital. “Assuming the continued safety of the procedure is demonstrated, ultrasonic renal denervation is a promising treatment option complementary to lifestyle modification and medication for patients with uncontrolled hypertension.”

The global RADIANCE program is a one-of-a-kind, multi-center, international initiative designed to explore the benefits of ultrasonic renal denervation (uRDN) in hypertension. The RADIANCE studies are double-blind, randomized, simulation-controlled trials designed to provide additional information about the ability of the Paradise uRDN ​​System to treat high blood pressure. RADIANCE-HTN includes the aforementioned SOLO and TRIO studies, which were individually powered for efficacy with a primary endpoint of daytime ambulatory systolic blood pressure (ABP) at two months. Both studies met their primary efficacy and safety endpoints at two months.

The global RADIANCE program also includes RADIANCE-II, a pivotal trial that recently completed patient recruitment. The results of the study will be presented to the scientific and medical communities later this year. The results will report on the safety and effectiveness of the Paradise uRDN ​​System in reducing blood pressure in patients with hypertension, in the absence of antihypertensive medications.

The Paradise uRDN ​​system is CE marked for the treatment of hypertension in Europe and is an investigational device in the United States. Hypertension is the largest contributor to the burden of disease worldwide, leading to increased cardiovascular morbidity and mortality, poorer quality of life and increased costs to healthcare systems.

About ReCor Medical, Inc.

ReCor Medical, headquartered in Palo Alto, Calif., is a medical technology company focused on transforming the management of hypertension, the world’s leading cardiovascular risk factor. ReCor 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 experimental device in the United States. It bears the CE mark in the EU. The company has performed two randomized, simulation-controlled studies of the Paradise System in patients with both moderate hypertension and patients resistant to standard medical treatments. ReCor is currently conducting its pivotal FDA IDE study, RADIANCE-II, in the US and Europe, and pending its completion will submit a PMA to the US FDA for commercial approval.

ReCor Medical is a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd.

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About Otsuka Medical Devices Co., Ltd.

Otsuka Medical Devices is focused on the development and worldwide commercialization of endovascular therapies that provide new treatment options in areas where patient needs cannot be met by pharmaceutical treatment. Otsuka Medical Devices Co., Ltd. is a subsidiary of Otsuka Holdings Co., Ltd., one of the world’s leading healthcare groups listed on the Tokyo Stock Exchange (JP 4578). With operations in pharmaceuticals, nutraceuticals, medical devices and other health-related businesses, the group has generated global app sales. US$13 billion in the fiscal year ending December 2021 and has a market capitalization of approx. 19 billion US dollars.

https://www.omd.otsuka.com/en/

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