Otsuka Holdings Co., Ltd. , Otsuka Medical Devices Co., Ltd. and ReCor Medical, Inc. announce the signing of a merger agreement pursuant to which Otsuka Holdings will acquire the remaining shares in ReCor from its current holders. The transaction is subject to approval by ReCor’s shareholders.
Otsuka Holdings’ acquisition follows the announcement by ReCor on June 15 that the U.S. FDA has given its approval to initiate a pivotal clinical study, RADIANCE II, for the evaluation of the Paradise® Renal Denervation System for safe and effective reduction of blood pressure in patients with hypertension. Previously, on May 23rd, ReCor announced at EuroPCR 2018, with simultaneous publication in The Lancet, that its RADIANCE-HTN SOLO study of the Paradise System met its primary efficacy endpoint and demonstrated a statistically significant reduction in blood pressure in hypertensive patients.
Following the acquisition, ReCor plans to continue to develop and evaluate the Paradise System in patients with hypertension in preparation for worldwide commercialization, as well as explore its use in additional clinical applications such as heart failure, kidney disease and metabolic disorders, while also building the Otsuka Medical Devices’ incubation and clinical development hub in the U.S. and Europe.
Tatsuo Higuchi, President and Representative Director of Otsuka Holdings, 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.” Kazumichi Kobayashi, Global Renal Denervation Project leader and board member of Otsuka Medical Devices, added: “ReCor’s statistically significant clinical results in the SOLO trial are convincing biological proof that renal denervation with ReCor’s ultrasound-based system is effective in reducing blood pressure in patients with hypertension. We are excited to commercialize this technology, which has the potential to become one of the great technological advancements in hypertension treatment together with the ReCor team.”
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Andrew Weiss, President & CEO of ReCor, said: “We are very encouraged by the results of our clinical trials with the Paradise System, which have been conducted in the US and Europe – none of which would have been possible without Otsuka and the strong relationship between our teams. This transaction demonstrates that tremendous value can be created for companies and venture investors through strategic partnerships.” Mano Iyer, COO and Founder, added “We are grateful for the support ReCor has enjoyed from our co-founders Antoine Papiernik of SOFINNOVA Partners and Dr. Jacques Seguin, and our clinical study partners worldwide. 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.”
Date: July 16, 2018
Source: CISION
