Otsuka Medical Devices Co., Ltd.

NEWS RELEASE

September 20, 2022

Otsuka Medical Devices Announces Results of RADIANCE II Pivotal Trial
at TCT 2022 Annual Meeting
Study of the Paradise™ Ultrasound Renal Denervation System Shows significant Reduction inBlood Pressure in Patients with Uncontrolled Hypertension
Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) a wholly owned subsidiary ofOtsuka Holdings today announced the detailed results from the RADIANCE II US FDA IDE
pivotal trial evaluating the endovascular Paradise™ Ultrasound Renal Denervation (uRDN)
System as a treatment for hypertension. Principal Investigator Ajay J. Kirtane, MD, Professor ofMedicine at Columbia University, Vagelos College of Physicians and Surgeons / NewYorkPresbyterian Hospital, presented the study results in a Late Breaking Clinical Science session at
the TCT 2022 Annual Meeting. The highly anticipated results follow ReCor’s announcement inJuly that the RADIANCE II study met its primary efficacy endpoint, demonstrating a statisticallysignificant reduction in daytime ambulatory systolic blood pressure at two months betweenuRDN and a sham procedure.
Conducted as an international, multicenter study, RADIANCE II is a US FDA IDE, randomized,
sham-controlled pivotal trial of the Paradise uRDN System in the treatment of patients withuncontrolled hypertension. Among 1038 patients screened for eligibility at more than 60 study
centers in 8 countries, 224 patients with uncontrolled hypertension were randomized 2:1 touRDN or a sham. Patients were to remain off antihypertensive medications throughout the 2months of follow-up unless specified BP criteria were exceeded. At the 2-month primary
efficacy endpoint, patients treated with the Paradise uRDN system had a mean reduction indaytime ambulatory systolic blood pressure of -7.9 mmHg, compared to a reduction of -1.8mmHg in the sham arm, corresponding to a statistically significant between-group difference of 6.3 mmHg (p<0.0001). Similar reductions in blood pressure were observed in nighttime and 24hour measures, as well as measurements taken at home and in the physician office. No major
adverse events were seen at 30 days, the primary safety endpoint will be measured at 6 months,
and patients will be followed for 60-months.
“These results are important to the field of hypertension treatment. RADIANCE II is the thirdand largest randomized, sham-controlled study to show that the Paradise uRDN System delivers
meaningful reductions in blood pressure in patients with uncontrolled hypertension,” said Study
Principal Investigator Ajay Kirtane. “On behalf of my co-principal investigator Professor MichelAzizi and the entire steering committee, I would like to thank the study patients, investigators,
and coordinators who gave so much of themselves—including during the COVID pandemic—inorder to complete this rigorously conducted trial.”1

Echoing these thoughts, study principal investigator Michel Azizi, Professor of Medicine atUniversité Paris Cité, Hôpital Européen Georges Pompidou, Paris, France said, “The results fromRADIANCE II provide further evidence for uRDN as a potential therapy option for
hypertension. The RADIANCE II results are strongly consistent across all measures of bloodpressure within the study and are also consistent with the prior SOLO (off-medication) and TRIO
(on triple antihypertensive combination treatment) trials—adding confidence in the treatment
effect of the Paradise uRDN system across a broad spectrum of hypertension severity. Theseresults align well with the recent consensus statement from the European Society of Cardiology,
supporting the use of renal denervation for treatment of uncontrolled hypertension. Additionally,
if these results are maintained over the long-term—as already shown by the 36-month results of
the SOLO trial and 24-month results of the TRIO trial—the reductions in blood pressure seen in
the RADIANCE trials are of a magnitude previously shown in hypertension drug trials to be
associated with cardiovascular risk reduction.”“The results represent progress toward establishing a new treatment option for patients withhypertension.” said Kazumichi Kobayashi, Executive Deputy President of Otsuka MedicalDevices. “Through our global R&D efforts, we will continue to develop unique solutions forpatients whose medical needs and conditions have not yet been met by existing treatments.”“We are thrilled with the results from RADIANCE II. This is further evidence that the ParadiseuRDN System lowers blood pressure in a wide range of patients who are struggling to control
their hypertension,” said ReCor president and CEO, Andrew M. Weiss. “ReCor looks forward toworking with physicians and regulating bodies around the world to make the Paradise Systemtreatment available to patients and their physicians who are seeking better control of theirhypertension.”
About Otsuka Medical Devices Co., Ltd.
Otsuka Medical Devices focuses on the global development and commercialization of medicalcare products including 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 global healthcare company listed on the Tokyo Stock Exchange (JP4578).
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 theUnited States 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 mildto-moderate and resistant hypertension and plans to submit results of its RADIANCE Global
Program as part of a PMA to the US FDA for market approval. In addition, ReCor has initiatedthe Global Paradise System (“GPS”) Registry in the EU with plans to expand on a global basis.

2Company ProfileOtsuka Holdings Co., Ltd.
Established
CapitalPresident and RepresentativeDirector, CEO
Head Office
Employees
Business Descripiton::

July 8, 2008
81.69 billion yen:

Tatsuo Higuchi:::

Website:

2-9 Kanda-Tsukasamachi, Chiyoda-ku, Tokyo
137 (as of December 31, 2021)
Strategic management and oversight of the groupcompanies, and provision of specialized businessservices as a holding company of the grouphttps://www.otsuka.com/en/

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）
Overseeing medical device operations within theOtsuka group and the business activities of companies
engaged in related businesses, as well as all operations
incidental to the foregoing activities.
https://www.omd.otsuka.com/en/

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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