Otsuka Holdings Co Ltd announced the signing of a development and commercialization agreement with ReCor Medical Inc. (“ReCor”), together with an additional investment. As part of the agreement, Otsuka Holdings obtained exclusive rights to the commercialization of ReCor’s ultrasound renal denervation technology initially targeting patients with drug-resistant hypertension in Japan, China, Korea and other Asian countries. In Japan, commercialization, including clinical studies, will be conducted by JIMRO Co., Ltd., a subsidiary of Otsuka Medical Devices Co., Ltd., the holding company for Otsuka’s activities in the area of medical devices.
ReCor has already initiated the RADIANCE-HTN study, an FDA IDE-approved, randomized, controlled trial of the Paradise System in patients with hypertension in the US and Europe.
Andrew Weiss, President & CEO of ReCor, commented: “We highly value Otsuka’s clinical development and marketing expertise in Asia, including in the area of cardiovascular disorders. Otsuka has been one of our major investors since leading our Series D financing, and we are delighted to extend our relationship with them to the commercialization of our Paradise® System in Asia.”
Tatsuo Higuchi, President and Representative Director, CEO of Otsuka Holdings, said: “We are excited to commercialize ReCor’s unique ultrasound-based renal denervation technology in Asia. This collaboration demonstrates Otsuka’s strategy of leveraging our expertise in select disease areas for the development of medical device-based solutions with the potential to address medical needs that cannot be met by pharmaceutical treatment alone.”
About ReCor Medical, Inc.
ReCor Medical is a private, medical device company that designs and manufactures a proprietary ultrasound ablation system for renal denervation (RDN) called the Paradise® System. RDN is a new potential therapeutic approach for the treatment of hypertension, one of the most prevalent medical conditions. The Paradise System is approved for sale in the EU and bears a CE mark, but is not approved for sale in the United States. The System’s intravascular catheters denervate renal nerves by combining the protection of water-based cooling of the renal artery with high intensity ultrasound energy for circumferential renal nerve ablation. ReCor has initiated enrollment in its RADIANCE-HTN study, an IDE-approved, randomized, sham-controlled clinical trial to demonstrate the efficacy of the Paradise System in patients with hypertension. RADIANCE-HTN is being conducted in approximately 35 centers in the US, Netherlands, UK, France and Germany.
About Otsuka Holdings Co., Ltd.
Otsuka Holdings Co., Ltd. is the holding company of the Otsuka group, a global healthcare group headquartered in Tokyo, Japan. With operations in pharmaceuticals, nutraceuticals, medical devices and other health-related businesses, the group generated worldwide sales of approximately JPY1,445 billion in the fiscal year ended December 2015. Under its corporate philosophy, “Otsuka – people creating new products for better health worldwide”, the Otsuka Group conducts research, development, manufacturing and marketing of innovative products that are uniquely positioned to provide advanced therapy, improve quality of life and support a healthy lifestyle.
