ReCor Medical Announces Results from Landmark RADIANCE-HTN TRIO Study, Showing Clinically Significant Blood Pressure Reduction with the Paradise Ultrasound RDN System in Patients with Resistant Hypertension - Seite 2

"RADIANCE-HTN TRIO had an extremely rigorous study design, executed over a number of years by dozens of committed study centers in the US and Europe," added co-principal investigator Professor Michel Azizi, MD, PhD, Professor of Medicine at Université de Paris, Head of the ESH Hypertension Excellence Center, Hôpital Européen Georges Pompidou, Paris, France.  "By lowering blood pressure in resistant hypertensive patients, endovascular ultrasound renal denervation may become a valuable tool in the treatment of hypertension in this broad class of patients in need."

"ReCor is extremely pleased with the primary outcomes of the RADIANCE-HTN TRIO study, showing the positive treatment effect of the Paradise System," commented ReCor President & CEO, Andrew M. Weiss.  "ReCor believes that TRIO is a seminal study with the potential to change medical practice for patients who are resistant to oral antihypertensive medications."

The Paradise System bears the CE mark in Europe and is an investigational device in the United States.  The Paradise System is currently under investigation in the United States and Europe in the FDA IDE RADIANCE-HTN Clinical Study, and in the on-going FDA IDE pivotal study (RADIANCE-II) in patients with uncontrolled hypertension, with anticipated study completion of enrollment in 2021.

Hypertension is the leading contributor to disease burden worldwide, leading to increased cardiovascular morbidity and mortality, poorer quality of life, and increased cost burden 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 is approved for sales in the EU and bears a CE mark. 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, and pending successful completion will submit for PMA approval.

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

http://www.recormedical.com/

About Otsuka Medical Devices Co., Ltd.

Otsuka Medical Devices focuses on the global development and commercialization of endovascular devices that provide new therapeutic options in areas where patient needs cannot be met through pharmaceutical or other conventional treatment. Otsuka Medical Devices Co., Ltd. is a subsidiary of Otsuka Holdings Co., Ltd. (www.otsuka.com/en), a leading global healthcare group listed on the Tokyo Stock Exchange (JP 4578).

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

Contact: Andrew M. Weiss, [e-mail]