TOKYO and PALO ALTO, Calif., July 10, 2018 /PRNewswire-USNewswire/ — Otsuka Holdings Co., Ltd. (“Otsuka Holdings”), Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) and ReCor Medical, Inc. (“ReCor”) 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 (“Paradise System”) for safe and effective reduction of blood pressure in patients with hypertension. Previously, on May 23^rd, ReCor announced at EuroPCR 2018, with simultaneous publication in The Lancet, that its RADIANCE-HTN SOLO (“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.”

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.”

About ReCor Medical, Inc.

ReCor Medical is a medical device company that designs and manufactures the Paradise System, a proprietary ultrasound ablation system for renal denervation (RDN). 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. The Paradise System has been studied in clinical trials of approximately 300 patients to date. Following the positive outcomes of the RADIANCE-HTN SOLO trial, ReCor will continue its evaluations of Paradise in RADIANCE-HTN TRIO (a feasibility study of patients with resistant hypertension) and REQUIRE (a pivotal study of patients with resistant hypertension in Japan and Korea), and launch the RADIANCE II pivotal study (a study of patients with moderate hypertension) in the United States and Europe.

http://www.recormedical.com/

About Otsuka Holdings Co., Ltd. and Otsuka Medical Devices 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 JPY1,240 billion in the fiscal year ended December 2017.

http://www.otsuka.com/en/

Established in 2011, Otsuka Medical Devices Co., Ltd. is a fully-owned subsidiary of Otsuka Holdings and one of its core operating subsidiaries. Otsuka Medical Devices focuses on the development and commercialization of endovascular devices that provide new therapeutic options in areas where patient needs cannot be met through pharmaceutical or other conventional treatment.

Otsuka Medical Devices conducts the REQUIRE trial for renal denervation in hypertensive patients (n=140), who are uncontrolled on 3 or more medications including a diuretic, in Japan and Korea through its subsidiary JIMRO Co., Ltd.

http://www.omd.otsuka.com/en/

For more information about ReCor Medical, please visit www.recormedical.com or contact Andrew M. Weiss, President & CEO, ReCor Medical at aweiss@recormedical.com / +1-650-542-7700.

PALO ALTO, Calif., July 2, 2018 /– ReCor Medical announced today that the US Food & Drug Administration approved the Company’s new pivotal study of the Paradise Ultrasound Denervation System for the treatment of hypertension: RADIANCE-II.

Building upon the recent positive results of the Company’s RADIANCE-HTN SOLO study, RADIANCE-II will be a randomized, sham-controlled, blinded study in patients with moderate hypertension, powered to demonstrate the safety and efficacy of the Paradise System’s ability to lower blood pressure.  ReCor expects to initiate enrollment in RADIANCE-II in October of this year.

“We have had a very constructive dialog with the FDA during the past 9 months to craft what we believe is a strong study to develop a robust set of clinical data to support the future FDA review for PMA approval,” commented Leslie Coleman, Vice President of Regulatory & Medical Affairs.  “At the time of PMA submission we plan to have 4 independently-powered, blinded, sham-controlled, randomized studies of the Paradise System in patients with different stages  of hypertension – our SOLO, TRIO, REQUIRE, and RADIANCE-II studies – approaching a total of nearly 500 subjects, with outcomes as long as 3 years.”

“Our Steering Committee and medical advisors have been instrumental in the design of the Global RADIANCE Clinical Program – including the RADIANCE-II pivotal study – for the US, Europe, Japan and Korea,” added Helen Reeve-Stoffer, Vice President of Clinical Affairs.  “Given the recent positive SOLO results, and subsequently the numerous review articles in medical journals, we recognize the potential impact the Paradise System may have in the treatment of hypertension for millions of patients world-wide.  Accordingly, ReCor is committed to conduct rigorous, randomized, controlled studies to demonstrate the safety and efficacy of the Paradise System to lower blood pressure, thus helping physicians to evaluate how, in whom, and when to use Paradise for the treatment of hypertension.”

 

About ReCor Medical, Inc.

ReCor Medical is a private, clinical-stage, medical device company that has developed the Paradise^® System, a proprietary, ultrasound-based system for endovascular denervation of the renal nerves (RDN).  RDN is a potential therapeutic option for treatment of hypertension, one of the most prevalent medical conditions.  The Paradise System bears a CE mark but is not approved for sale in the United States.  ReCor is conducting the RADIANCE-HTN clinical trial under an IDE from the US FDA in the United States and Europe, the REQUIRE trial in Japan and Korea with its partner Otsuka, and recently received approval from the FDA to conduct RADIANCE-II as a pivotal study of the Paradise System.

Note: original press release first appeared on PCRonline.com 

 

May 23, 2018 – Palo Alto, CA, for immediate release – ReCor Medical announced today that the RADIANCE-HTN SOLO study met its primary efficacy endpoint and demonstrated a statistically significant reduction in blood pressure in hypertensive patients.  In addition, the company announced submission of an IDE supplement to the US FDA for a pivotal study of its Paradise System for the treatment of hypertension, and that Prof. Ajay Kirtane of New York-Presbyterian Hospital/Columbia University has taken the role of Co-Principal Investigator for RADIANCE-HTN.

Data presented at EuroPCR 2018, with simultaneous publication in The Lancet, showed that RADIANCE-HTN SOLO met its primary efficacy endpoint.  SOLO demonstrated a difference in ambulatory daytime systolic blood pressure changes between treatment and sham at 2 months of -6.3 mm Hg (p-value of 0.0001) with no major adverse events.  Additional endpoints including office, home, and 24-hour ambulatory blood pressure levels, and the percentage of patients with controlled blood pressure at 2 months were also improved in the Paradise group relative to sham.

“We are pleased with the outcomes of the RADIANCE-HTN SOLO trial,” commented co-Principal Investigator Prof. Laura Mauri, Brigham & Women’s Hospital, Boston, USA. “We believe that SOLO was designed and conducted in a rigorous manner. In patients with mild to moderate hypertension, previously treated with up to two medications and randomized while off medications, the Paradise System reduced blood pressure in comparison to a sham control.  In addition, the procedure was performed with an average ablation time of less than one minute and demonstrated a positive safety profile both acutely and at 30-day follow-up.”

Prof. Michel Azizi, Hôpital Européen Georges-Pompidou, Paris, France, Co-PI, commented, “The SOLO investigators are satisfied with the clinical outcomes in the study.  At 2-months, more than 66% of subjects treated with renal denervation experienced a 5 mmHg or greater reduction in daytime ambulatory systolic blood pressure, compared with 33% in the sham group.  RADIANCE-HTN SOLO also demonstrated a reduction in office blood pressure of 10 mmHg systolic, which if durable over time, has been shown to reduce the risk of cardiovascular diseases, including stroke and heart attack, in patients with hypertension.  The RADIANCE-HTN research program is ongoing, with extended follow-up for the SOLO patients and continued enrollment of the TRIO cohort patients with resistant hypertension.  Our goal is to demonstrate the effectiveness, safety, and durability of renal denervation in both important patient populations.”

“ReCor and the investigator teams are aware of the large potential patient population who may be interested in Paradise as a device-based hypertension therapy. An early indicator of this is the more than 500,000 people who sought information about the RADIANCE-HTN study,” commented Founder & COO, Mano Iyer.

ReCor also announced today that the company submitted a new protocol to the US FDA for a pivotal study: an independently-powered, sham-controlled, efficacy study of the Paradise System in patients with hypertension.

“We are very pleased with the progress of the RADIANCE program to assess the Paradise System as a potential treatment for hypertension.  Given the positive results from SOLO and the high level of interest from patients in the US and Europe for device-based hypertension therapy, we are encouraged to continue our work,” commented CEO Andrew M. Weiss.  “As Prof. Mauri is leaving her clinical position at Brigham & Women’s Hospital in Boston – and thus her role as co-PI – we have invited Prof. Kirtane to fill her role.  We thank Prof. Mauri for her leadership and support during the past 3 years, and welcome Prof. Kirtane to join Prof. Azizi as co-PI.”

About ReCor Medical, Inc.

ReCor Medical is a private, development-stage, medical device company with the Paradise System, a proprietary, ultrasound-based system for endovascular denervation of the renal nerves (RDN).  RDN is a potential therapeutic option for treatment of hypertension, one of the most prevalent medical conditions.  The Paradise System bears a CE mark but is not approved for sale in the United States.  ReCor is conducting the RADIANCE-HTN clinical trial under an IDE from the US FDA in the United States and Europe.  The RADIANCE-HTN SOLO trial is a randomized, sham-controlled, and blinded study of 146 hypertensive patients temporarily withdrawn from their hypertension medications, comparing the ReCor Paradise ultrasound-based Renal Denervation System to a sham procedure.

 

About ReCor Medical, Inc.

ReCor Medical is a private, development-stage, medical device company with the Paradise® System, a proprietary, ultrasound-based system for intravascular denervation of the renal nerves (RDN).  RDN is a potential therapeutic option for treatment of hypertension, one of the most prevalent medical conditions.  The Paradise System bears a CE mark but is not approved for sale in the United States.  ReCor is conducting the RADIANCE-HTN clinical trial under an IDE from the US FDA in the United States and Europe.

PALO ALTO, Calif., Aug 16, 2017 / ReCor Medical last week added a $12 million contribution from Otsuka Pharmaceutical to the $10 million it raised from the Japanese conglomerate last year for a clinical trial of its Paradise renal denervation device for treating hypertension, ReCor president & CEO Andrew Weiss told MassDevice.com.

Read the interview with CEO Andrew Weiss and MassDevice.com here.

 

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, en IDE-approved, randomized, sham-controlled trial to demonstrate the efficacy of the Paradise System in patients with hypertension.  RADIANCE-HTN is being conducted in approximately 35 centers in the United States, Netherlands, UK, France and Germany.

More information on RADIANCE-HTN can be found at:

https://clinicaltrials.gov/ct2/show/NCT02649426?term=radiance&rank=3

For more information about ReCor Medical, please visit www.recormedical.com or contact Andrew M. Weiss, President & CEO, ReCor Medical at aweiss@recormedical.com / +1-650-542-7700.