Otsuka Holdings Co., Ltd.
Otsuka Medical Devices Co., Ltd.
ReCor Medical, Inc.
November 04, 2021
Reported latest data from landmark renal denervation clinical trials at
TCT Annual Meeting
RADIANCE-HTN TRIO and SOLO trial updates demonstrate the durability of blood pressure
lowering effects of the Paradise™ Ultrasound Renal Denervation System in a broad spectrum ofpatients with hypertension.
Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”), a fully owned subsidiary ofOtsuka Holdings Co., Ltd., and its subsidiary ReCor Medical, Inc. (“ReCor”) today announcedthe presentation of 6-month results from the RADIANCE-HTN TRIO (“TRIO”) study, arandomized sham-controlled trial in patients with resistant hypertension. Reported in a latebreaking clinical trial session at the Transcatheter Cardiovascular Therapeutics (“TCT”) annualmeeting, patients treated with the Paradise™ Ultrasound Renal Denervation System(“Paradise™ System”) maintained its blood pressure (“BP”) lowering effect over six months. Inaddition, data from the RADIANCE-HTN SOLO (“SOLO”) trial were presented in a postersession, demonstrating a durable BP lowering effect over 24 months for those patients treatedwith the Paradise™ System.
The seminal TRIO study evaluated the efficacy and safety of the Paradise™ System in patientswith resistant hypertension who remained uncontrolled following treatment with a single pillcontaining 3 standardized antihypertensive medications. The 6-month follow-up data showedthat the treatment was durable in patients who originally had an 8.0 mmHg median reduction indaytime ambulatory systolic BP at the 2-month primary endpoint. After primary endpointcollection, the second phase of the trial consisted of a sequential addition of standardized
antihypertensive medications in both groups to lower BP to clinically recommended targets. At 6months, the renal denervation group achieved lower home systolic BP and similar ambulatory
systolic BP with fewer added medications, including less use of aldosterone antagonists, therecommended 4th line antihypertensive medication for resistant hypertension. There were nodifferences in safety outcomes between the two groups.
The SOLO study measured the BP lowering effect of the Paradise™ System in patients withmild to moderate hypertension, taking no medications at study randomization. The study met its
primary endpoint at two months when patients were off medications, and showed a persistent
BP lowering effect at 6 and 12 months with fewer antihypertensive medications. The results at1

24 months in the SOLO trial confirm the persistence of a clinically relevant BP reduction in thepatients treated with the Paradise™ System. The treated arm achieved a substantial 17.1 mmHg
mean reduction in office-measured systolic BP from baseline at 24 months, followingintroduction of an average of 1.2 oral anti-hypertensive medications. No adverse safety signals
were observed.
“The RADIANCE-HTN TRIO study demonstrates the efficacy and 6-month safety outcomesfrom the Paradise™ Ultrasound Renal Denervation System in patients with resistant
hypertension. After renal denervation, further reductions in blood pressure were achieved withfewer added medications, particularly aldosterone antagonists” said co-principal investigator
Ajay J. Kirtane, MD, SM, Professor of Medicine at Columbia University Vagelos College ofPhysicians and Surgeons. “These data lend further support for the Paradise™ System as apotential treatment option for patients with resistant hypertension.”“Durability of the blood pressure lowering effect of renal denervation has been a focal point for
many in the field of hypertension. The latest data from the RADIANCE-HTN SOLO trial showthat the Paradise™ Ultrasound Renal Denervation System’s treatment effect is still present at 24months with no risk to patient safety, consistent with other long-term observational data,” said
co-principal investigator Professor Michel Azizi, MD, PhD, Professor of Medicine at Universitéde Paris, Head of the ESH Hypertension Excellence Center, Hôpital Européen Georges
Pompidou, Paris, France.
The Paradise™ System bears the CE mark in Europe and is an investigational device in theUnited States. The Paradise™ System is currently under investigation in the United States andEurope in the on-going FDA IDE pivotal study (RADIANCE-II) in patients with uncontrolled
hypertension, with anticipated enrollment completion in 2022.
Hypertension is the leading contributor to disease burden worldwide, leading to increased
cardiovascular morbidity and mortality, poorer quality of life, and increased cost to healthsystems.
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 is approved for sales in the EU and bears a CE
mark. The company has completed two randomized, sham-controlled studies of the Paradise™
System in patients with both moderate hypertension and those resistant to standard medicaltherapies. ReCor is currently conducting its FDA IDE pivotal study, RADIANCE-II, andpending successful completion will submit for PMA 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 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 leading global
healthcare group listed on the Tokyo Stock Exchange (JP 4578).
https://www.omd.otsuka.com/en/
About Otsuka Holdings Co., Lrd.
Established
President and Representative
Director, CEO
Head OfficeBusiness Descripiton:

July 8, 2008:

Tatsuo Higuchi::

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Media contact:
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