Japan-based Otsuka Medical Devices, a subsidiary of Otsuka group, and its holding company Otsuka Holdings have entered into a merger agreement with US-based medical device firm ReCor Medical.
Under the terms of the agreement, which is subject to shareholder approval, Otsuka Holdings will buy the remaining shares in ReCor from French venture capital firm Sofinnova Partners.
ReCor designs and manufactures an ultrasound ablation device called Paradise System for renal denervation (RDN).
The company obtained the US Food and Drug Administration (FDA) approval last month to evaluate the safety and effectiveness of Paradise Renal Denervation System for decreasing blood pressure in hypertensive patients.
During the previous RADIANCE-HTN SOLO study in subjects with hypertension, the system met the primary efficacy endpoint of statistically significant blood pressure reduction.
Otsuka Holdings president and representative director Tatsuo Higuchi said: “Our decision today reflects not only ReCor’s excellent clinical results but also the close relationship we have built over the years.
“Our acquisition of ReCor represents an important step forward for Otsuka’s medical device business, leveraging an innovative technology with Otsuka’s expertise in pharmaceuticals and clinical development.”
After the completion of the merger, ReCor will continue developing and assessing the Paradise System in hypertension to support its plans for global commercialisation.
In addition, the system will be investigated for other clinical applications, including heart failure, kidney disease and metabolic conditions.
ReCor Medical president and CEO Andrew Weiss said: “We are excited to move forward in our collaboration with Otsuka to make the Paradise Renal Denervation System a standard of care for treatment of hypertensive patients worldwide.”
ReCor will also help construct Otsuka Medical Devices’ incubation and clinical development hub in the US and Europe.