D ecember 10, 2020

Otsuka Announces Results of Two International Clinical Studies in Patients withTreatment Resistant Hypertension and Breakthrough Device Designation for ParadiseTM
Ultrasound Renal Denervation System for Uncontrolled Hypertension
Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”), a fully owned subsidiary of Otsuka Holdings
Co., Ltd., today announces the results of the RADIANCE-HTN TRIO (“TRIO”) trial （NCT02649426）,
conducted in the US and Europe, and of its REQUIRE study (NCT02918305), conducted in Japan and South
Korea, as well as the granting of Breakthrough Device Designation by the US FDA for ParadiseTM UltrasoundRenal Denervation System (the “ParadiseTM System”) for patients with uncontrolled hypertension , who may
be inadequately responsive to, or who are intolerant to anti-hypertensive medications. Both TRIO andREQUIRE were prospective, multi-center, randomized, blinded, sham-controlled trials with the objective ofevaluating the ParadiseTM System in patients with treatment resistant hypertension.
The TRIO trial evaluated the efficacy and safety of the ParadiseTM System in uncontrolled, treatment-resistant
hypertensive patients (n=136) wherein all subjects were placed on a single-pill combination-drug containing 3
hypertension medications (a calcium-channel blocker, an angiotensin II-receptor blocker, and a diuretic) andafter confirmation of treatment-resistant hypertension, were then randomized 1:1 with a ParadiseTM Systemtreatment compared to a sham procedure control group (“Sham”). A total of 53 study centers were involved in
the trial in 7 countries. TRIO results met the primary efficacy endpoint, thus showing a significant differencein the reduction in daytime blood pressure (Daytime ABPM) between baseline and 2-month follow-up in thetreatment arm compared to Sham. No major safety issues were observed.
RADIANCE-HTN TRIO is the second FDA IDE, randomized, sham-controlled study of the ParadiseTM
System in patients with hypertension (following the RADIANCE-HTN SOLO study) conducted by ReCor
Medical (a wholly-owned subsidiary of Otsuka Medical) to meet its primary efficacy endpoint anddemonstrate a positive treatment effect. In addition, ReCor Medical is conducting an FDA IDE pivotal study,RADIANCE-II, in patients with mild-to-moderate hypertension (n=225), with the goal to submit for PMA
approval.

Separately, the FDA granted the ReCor ParadiseTM System the Breakthrough Device Designation. Under theBreakthrough program, the FDA provides priority review and interactive communication during thepremarket review process, with the goal to accelerate regulatory path and commercialization in the UnitedStates.

-1-The REQUIRE trial evaluated the efficacy and safety of the ParadiseTM System in patients with uncontrolled,
treatment-resistant hypertension (n=143) on 3 or more hypertension medications measured by the difference
between baseline 24-hour ambulatory blood pressure (24-hour ABPM) and 24-hours ABPM at 3-months
following randomization in the treatment arm compared to sham. Whereas no major safety issues wereobserved, REQUIRE failed to meet its primary efficacy endpoint.
Additional information regarding both TRIO and REQUIRE will be announced in due course.
About Ultrasound Renal Denervation Therapy for the Treatment of Hypertension
Hypertension is one of the world’s most prevalent medical conditions. Despite many years of effort and theavailability of numerous medications for its treatment, millions of patients worldwide remain withuncontrolled hypertension, often resistant to medical therapy.

Renal denervation with the ParadiseTM System

is a new potential treatment of hypertension based on reducing renal sympathetic nerve overactivity, inpatients for whom conventional hypertension therapy has proven unsuccessful, through denervation of therenal nerves. The ParadiseTM System’s intravascular catheters denervate renal nerves by short, controlled,circumferential emissions of high intensity ultrasound energy for renal nerve ablation while protecting therenal artery with cooling from a water-filled balloon. The ParadiseTM System has been studied in clinical trialsof more than 400 patients to date.
About the FDA Breakthrough Devices Program
The FDA Breakthrough Devices Program is intended to help patients receive more timely access tobreakthrough medical technologies that have the potential to provide more effective treatment forlife-threatening or irreversibly debilitating diseases or conditions.

About Otsuka Medical Devices
Otsuka Medical Devices focuses on the global development and commercialization of endovascular devices thatprovide new therapeutic options in areas where patient needs cannot be met through pharmaceutical or otherconventional 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/-2-

About ReCor Medical
ReCor Medical, headquartered in Palo Alto, CA, is a wholly owned subsidiary of Otsuka Medical Devices Co.,

Ltd. focused on transforming the management of hypertension, one of the leading cardiovascular risk factors.
ReCor has pioneered the minimally invasive use of ultrasound in renal denervation, and developed the ParadiseTM
System, to treat patients with hypertension.

The ParadiseTM System is an investigational device in the UnitedStates. It is approved for sale in the EU and bears a CE mark. The company has completed two IDE randomized,
controlled studies of the ParadiseTM System in patients with 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.

http://www.recormedical.com/-3-