Otsuka Medical Devices Co., Ltd.
ReCor Medical, Inc.
May 18, 2022

Announced Results of Pooled Data Analysis from RADIANCE SOLO andTRIO Studies in Treating Hypertension with the Paradise Ultrasound Renal
Denervation SystemResults presented at EuroPCR 2022 show notable reduction of blood pressure in patients on
and off medications at six months
Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) a fully owned subsidiary ofOtsuka Holdings Co., Ltd., and ReCor Medical, Inc. (“ReCor”) today announced that Dr. Ajay
Kirtane presented a pooled data analysis from ReCor’s two randomized, sham-controlled trials
evaluating the Paradise Ultrasound Renal Denervation (uRDN) System for the treatment ofhypertension at the EuroPCR annual meeting in Paris. The analysis demonstrated a statisticallysignificant reduction in blood pressure (BP) across a broad range of hypertension severity as
represented in the RADIANCE-HTN SOLO and TRIO studies. The data was presented in a latebreaking session titled “Hypertension management in 2022: control it, live longer” on World
Hypertension Day.
The pooled analysis combined data from 282 patients randomized in ReCor’s two prospectivelypowered, sham-controlled studies enrolling two disparate patient populations: TRIO (patientswith resistant hypertension) and SOLO (patients with mild-moderate hypertension). There wereconsistent benefits in both blood pressure reduction and medication burden across the pooled
patient population compared to sham. The combined dataset showed an overall between-groupdifference through 6 months favoring uRDN in daytime ambulatory systolic BP of -4.8 mmHg
(95% CI: -7.1 to -2.5, p<0.001) and home systolic BP of -5.4 mmHg (95% CI: -7.3 to -3.6,p<0.001).
“The results of this pooled analysis make clear the consistent blood pressure-lowering effect thatultrasound renal denervation can have across differing severities of hypertension, regardless oftrial design and whether the enrolled patients are on or off antihypertensive medications,” saidprincipal investigator Ajay Kirtane, Professor of Medicine at Columbia University, Vagelos
College of Physicians and Surgeons and NewYork-Presbyterian Hospital. “Assuming continued
safety of the procedure is demonstrated, ultrasound renal denervation is a promising treatment1option complementary to lifestyle modification and medications for patients with uncontrolled
hypertension.”
The RADIANCE Global Program is an international, multicenter, first-of-its-kind initiative
designed to explore the benefits of ultrasound renal denervation (uRDN) in hypertension. The
RADIANCE studies are double-blind, randomized, sham-controlled trials designed to provide
additional information about the ability of the Paradise uRDN System to treat high bloodpressure. RADIANCE-HTN includes the aforementioned SOLO and TRIO studies, which wereindividually powered for efficacy with a primary endpoint of daytime systolic ambulatory bloodpressure (ABP) at 2 months. Both studies met their primary efficacy and safety endpoints at 2months.
The RADIANCE Global Program also includes RADIANCE-II, a pivotal trial which recentlycompleted patient enrollment. Study outcomes will be presented to the scientific and medical
communities later this year. Results will report on the safety and effectiveness of the ParadiseuRDN System to reduce blood pressure in patients with hypertension, in the absence ofantihypertensive medications.
The Paradise uRDN System bears the CE mark for the treatment of hypertension in Europe andis an investigational device in the United States. Hypertension is the leading contributor todisease burden worldwide, leading to increased cardiovascular morbidity and mortality, poorer
quality of life, and increased cost to health systems.

About ReCor Medical, Inc.
ReCor Medical, headquartered in Palo Alto, CA, is a medical technology company focused ontransforming the management of hypertension, the leading cardiovascular risk factor in theworld. ReCor has pioneered the minimally invasive use of ultrasound in renal denervation, anddeveloped the Paradise System, to treat patients with hypertension. The Paradise System isan investigational device in the United States. It bears the CE mark in the EU. The company hascompleted two randomized, sham-controlled studies of the Paradise System in patients withboth moderate hypertension and those resistant to standard medical therapies. ReCor is currently
conducting its FDA IDE pivotal study, RADIANCE-II, in the United States and Europe, andpending successful completion will submit a PMA to the US FDA for market approval.
ReCor Medical is a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd.
http://www.recormedical.com/

2About Otsuka Medical Devices Co., Ltd.
Otsuka Medical Devices focuses on the global development and commercialization ofendovascular therapies that provide new therapeutic options in areas where patient needs cannot
be met through pharmaceutical treatment. Otsuka Medical Devices Co., Ltd. is a subsidiary ofOtsuka Holdings Co., Ltd., which is listed on the Tokyo Stock Exchange (JP 4578).
https://www.omd.otsuka.com/en/
Media Contact
OMD-PR@otsuka.jp

3