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

NEWS RELEASE

November 30, 2022

Otsuka Medical Devices and ReCor Medical Announce Submission ofApplication for Pre-Market Approval of the Paradise™ Ultrasound Renal
Denervation (uRDN) System to the U.S. Food and Drug Administration

Filing of Pre-Market Application Follows Successful Pivotal Trial of the Paradise™ uRDN
System in the Treatment of Uncontrolled Hypertension

Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) and ReCor Medical, Inc.
(“ReCor”, subsidiary of Otsuka Medical Devices) announced the filing of the pre-marketapproval (PMA) application to the U.S. Food and Drug Administration (FDA) for the Paradise™
uRDN System in the treatment of uncontrolled hypertension.
The Paradise uRDN System is designed to reduce sympathetic nerve activity by denervating
nerves which surround the renal arteries with the goal of reducing blood pressure. ParadiseuRDN uses a combination of ultrasound energy to denervate the renal nerves and a water-filled
balloon to protect the renal artery. The Paradise uRDN System employs an interventional
procedure in which the Paradise catheter is placed in each of the main renal arteries, following
which two to three seven-second ultrasound emissions are delivered to denervate the surrounding
renal nerves, thereby reducing blood pressure.
Since 2009, ReCor has been focused on developing and testing the Paradise uRDN System totreat hypertension safely and effectively. ReCor has three global, independently powered, shamcontrolled randomized clinical trials of the Paradise uRDN System in more than 500 patientswith uncontrolled hypertension: RADIANCE-HTN SOLO, RADIANCE-HTN TRIO andRADIANCE II. Each RADIANCE trial met its prespecified primary efficacy endpoint of bloodpressure reduction, with positive safety.
RADIANCE II is the U.S. FDA IDE pivotal trial. In September of this year, ReCor and Otsuka
Medical Devices announced that the trial successfully reached its primary efficacy endpoint.
Results showed a reduction in daytime systolic ambulatory blood pressure of -7.9 mmHg in
those treated with uRDN and a difference between uRDN and sham of -6.3 mmHg (p <0.0001).
The results from the all three RADIANCE clinical trials have been included in the submissionfor approval to the U.S. FDA.
Hypertension is the leading contributor to disease burden worldwide, resulting in increased
cardiovascular morbidity and mortality, poorer quality of life, and higher costs to health systems.
The Paradise uRDN System bears the CE mark for the treatment of hypertension in Europe andis an investigational device in the United States and Japan.

1About Otsuka Medical Devices Co., Ltd.
Otsuka Medical Devices Co., Ltd. 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 conventional treatment.
Otsuka Medical Devices is a subsidiary of Otsuka Holdings Co., Ltd. (www.otsuka.com/en), aglobal healthcare company listed on the Tokyo Stock Exchange (JP 4578).

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 the management ofhypertension. ReCor has pioneered the use of the Paradise Ultrasound Renal Denervation(uRDN) System for the treatment of hypertension. The Paradise System is an investigational
device in the United States and Japan and bears the CE mark in the EU. ReCor has reported
positive outcomes in three independent, randomized, sham-controlled studies of the Paradise
System in patients with mild-to-moderate and resistant hypertension. In addition, ReCor has
initiated the Global Paradise System (“GPS”) Registry in the EU with plans to expand globally.

Company Profile
Otsuka Medical Devices Co., Ltd.
Established
CapitalPresident and Representative
Director
Head Office
Employees
Business Description：：

February 15, 2011
7.55 billion yen：Noriko Tojo：：：Website：

2-9 Kanda-Tsukasamachi, Chiyoda-ku, Tokyo
113 （as of June 30, 2022）
R&D, manufacture, and sales of medical devices andall related operations, as well as medical device
operational management for companies within theOtsuka grouphttps://www.omd.otsuka.com/en/

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ReCor Medical, Inc.
Established
CapitalPresident and CEO
Head Office
Employees
Business Descripiton

:::::
:

Website:May 1, 2009
93 million USD
Andrew Weiss
1049 Elwell Court Palo Alto, CA 94303, USA
147 (As of December 31, 2021)
Research and development, manufacturing, and sales ofRenal Denervation devices
https://www.recormedical.com/

Media contact:
OMD-PR@otsuka.jp

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