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

NEWS RELEASE

November 7, 2022

Announced Consistent Reduction of Blood Pressure
in Pooled Analysis of Three Clinical Trials at AHA 2022
Compiled Data from RADIANCE Global Program Show Consistent Treatment Effect and Safety
Across Broad Patient Population
Otsuka Medical Devices Co., Ltd. and ReCor Medical, Inc. (subsidiary of Otsuka MedicalDevices) announced consistent and significant blood pressure (“BP”) lowering results across arange of patients with uncontrolled hypertension, including across differences in age, sex,
baseline blood pressure, medication level and ethnicity. The results come from analysis of thepooled data from RADIANCE Global Clinical Trial Program: three prospectively powered,randomized and sham-controlled clinical trials which evaluated the endovascular Paradise™
Ultrasound Renal Denervation (uRDN) System in patients with uncontrolled hypertension. The
results were presented at the 2022 American Heart Association annual meeting by Dr. Ajay
Kirtane, Professor of Medicine at Columbia University, Vagelos College of Physicians andSurgeons and an interventional cardiologist at NewYork-Presbyterian/Columbia University
Irving Medical Center.
The RADIANCE Pooled Analysis includes data from more than 500 patients randomized in thethree studies from RADIANCE Global Program: RADIANCE-HTN TRIO, which studied
patients with resistant hypertension, and RADIANCE-HTN SOLO and RADIANCE II, which
studied patients with mild-moderate hypertension. The combined dataset showed an overall
reduction in daytime ambulatory systolic BP in the uRDN group of -8.5 mmHg (p<0.0001) witha difference between treatment and sham at two months of -5.9 mmHg (p<0.0001), favoring
uRDN. Blood pressure results were similarly positive in the 24-hour, nighttime, home, and officemeasures. A favorable safety profile was consistently observed following uRDN treatment acrossthe studies.
“Pooling the data from the RADIANCE program demonstrates that treatment with the ParadiseuRDN System results in a consistent reduction in blood pressure across differing severities ofhypertension. The consistent and clinically meaningful BP reduction across multiple patientgroups increases our interest in the use of uRDN as a potential therapeutic option, when added tolifestyle modification and medications for our patients with uncontrolled blood pressure,” said
study co-principal investigator Ajay Kirtane.
“It is very important that the RADIANCE pooled analysis demonstrated a consistent bloodpressure reduction in patients across a range of hypertension and both with and withoutantihypertensive medication, thus broadening the potential applicability of uRDN. Just asimportant, more than 50% of patients treated with uRDN in the pooled analysis either achieved

1daytime ambulatory BP control or had a greater than 10mmHg decrease in daytime ambulatory
systolic BP at 2 months, showing the potential benefits of uRDN as an element of a treatment
regimen for patients with uncontrolled hypertension,” said study principal investigator MichelAzizi, Professor of Medicine at Université Paris Cité, Hôpital Européen Georges Pompidou,Paris, France.
The RADIANCE Global Program is an international, multicenter, first-of-its-kind initiative
designed to explore the benefits of ultrasound renal denervation in hypertension. TheRADIANCE studies are double-blind, randomized, sham-controlled trials designed to provide
information about the ability of the Paradise uRDN System to treat high blood pressure. All threestudies in the RADIANCE Global Program were individually powered for efficacy with a
primary endpoint of daytime systolic ambulatory blood pressure at 2 months, and all three met
their primary efficacy endpoint with statistical significance at 2 months.
If maintained in the long-term, the blood pressure reductions demonstrated in the RADIANCE
pooled analysis correlate to a potential 25% reduction in cardiovascular risk as shown in a metaanalysis of the cardiovascular benefits of antihypertensive medications.
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.

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 theUnited 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 inpatients with mild-to-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 initiated the Global Paradise System (“GPS”) Registry in the EU with plans to expand
on a global basis.
Media contact:
OMD-PR@otsuka.jp

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