Otsuka Medical Devices Co., Ltd.
ReCor Medical, Inc.

NEWS RELEASE

July 26, 2022

Otsuka Medical Devices and ReCor Medical Announce Primary Endpoint
Met in the RADIANCE II US Pivotal Trial of the Paradise™ System
for the Treatment of Hypertension
Otsuka Medical Devices Co., Ltd., a fully owned subsidiary of Otsuka Holdings Co., Ltd.,and ReCor Medical, Inc. (“ReCor”) today announced that the RADIANCE II US FDA IDE
pivotal trial evaluating the Paradise™ Ultrasound Renal Denervation (uRDN) System as atreatment for hypertension met its primary efficacy endpoint, demonstrating a statisticallysignificant reduction in daytime ambulatory systolic blood pressure between treatment and asham procedure measured at two months.
The RADIANCE II US FDA IDE pivotal trial is a randomized, sham-controlled clinical trialof the ReCor Paradise uRDN System for the treatment of patients with uncontrolled
hypertension. 224 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 8 countries.
“Despite the truly formidable challenges of conducting a complex clinical trial in the throesof 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 SOLOand TRIO,” said Study Principal Investigators Ajay Kirtane, Professor of Medicine atColumbia 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 lookforward to being able to present and publish the complete study details in the near future.”“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 threesuccessful 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 pivotal 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 uncontrolledhypertension,” said ReCor president and CEO, Andrew M. Weiss. “We would like to express1

our gratitude to the Principal Investigators, Steering Committee and all investigators for theirefforts throughout this important trial.”
RADIANCE II is the third and largest component of ReCor’s RADIANCE GlobalProgram—randomized and sham-controlled studies evaluating the Paradise uRDN System inpatients with hypertension. The first two studies in the series are the previously reported
RADIANCE-HTN SOLO (conducted in patients with mild-to-moderate hypertension) andTRIO (conducted in those who remained hypertensive despite being on antihypertensivetherapy. 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—areal-world study of up to 3,000 patients with uncontrolled hypertension.

About Otsuka Medical Devices Co., Ltd.
Otsuka Medical Devices focuses on the global development and commercialization of
medical care products including endovascular devices that provide new therapeutic options inareas where patient needs cannot be met through pharmaceutical or other conventionaltreatment. Otsuka Medical Devices Co., Ltd. is a subsidiary of Otsuka Holdings Co., Ltd.
(www.otsuka.com/en), a global healthcare company listed on the Tokyo Stock Exchange (JP4578).
https://www.omd.otsuka.com/en/
About ReCor Medical, Inc.
ReCor Medical, headquartered in Palo Alto, CA, a wholly owned subsidiary of Otsuka
Medical Devices Co., Ltd., is a medical technology company focused on transforming themanagement of hypertension. ReCor has pioneered the use of the Paradise ultrasound renal
denervation (uRDN) system for the treatment of hypertension. The Paradise System is aninvestigational device in the United States and bears the CE mark in the EU. ReCor hasreported positive outcomes in three independent, randomized, sham-controlled studies of theParadise System in patients with mild-to-moderate and resistant hypertension and plans tosubmit results of its RADIANCE Global Program as part of a PMA to the US FDA formarket approval. In addition, ReCor has initiated the Global Paradise System (“GPS”)
Registry in the EU with plans to expand on a global basis.
http://www.recormedical.com/
Media contact:
OMD-PR@otsuka.jp

2