Treatment Supported by Evidence from Multiple Studies and Renal Denervation Position Paper from the European Society of Hypertension

Palo Alto, Calif. and Frankfurt, Germany – 6 October, 2021 – ReCor Medical, Inc. (“ReCor”), a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd., announced today that the company’s Paradise™ Ultrasound Renal Denervation System (the “Paradise™ System”) is now available for the treatment of uncontrolled hypertension in Germany. The first hospitals performing the procedure commercially are Heart Center Leipzig and Saarland University Hospital, Homburg/Saar.

“Despite the availability of antihypertensive medications, many patients fail to control their hypertension, a dangerous condition that can lead to heart attack and death. Clinical data from the ACHIEVE, RADIOSOUND, RADIANCE-HTN SOLO and TRIO trials show that ultrasound renal denervation with the Paradise System can lower blood pressure and is a new treatment option for physicians to help their selected patients,” said Prof. Felix Mahfoud of Saarland University Hospital and chairman of the Arterial Hypertension Working Group of the German Society of Cardiology (DGK), who served as study investigator for the RADIANCE-HTN SOLO and TRIO trials. “We are pleased to be one of the first hospitals in Europe to offer renal denervation with ultrasound.”

In Leipzig, the first procedure was successfully performed at the Heart Center Leipzig at the University Clinic for Cardiology. There, Prof. Dr. Philipp Lurz and PD Dr. Karl Fengler led the RADIOSOUND trial, and both have participated in the RADIANCE-HTN SOLO and TRIO studies in patients with uncontrolled hypertension.

Paradise ultrasound renal denervation is a device-based, minimally invasive procedure for the treatment of high blood pressure. During the procedure, which usually takes less than an hour, the Paradise catheter is placed in the renal artery. Typically, three doses of ultrasound energy lasting a few seconds are applied to each of the main arteries leading to the kidneys. The ultrasound emissions denervate the renal nerves and cause a reduction in sympathetic nervous system activity, which can result in lower blood pressure.

In September 2021, the European Society of Hypertension published an updated position paper stating that renal denervation “is effective in reducing or interrupting the sympathetic signals to the kidneys and decreasing whole body sympathetic activity.” The society noted that five independent sham-controlled randomized clinical trials—including RADIANCE-HTN SOLO and TRIO—provide “conclusive evidence” that renal denervation can lower ambulatory and office blood pressure both in patients with and without concomitant antihypertensive medication.

“The Paradise System has generated a significant body of clinical evidence in the ACHIEVE, RADIOSOUND, RADIANCE-HTN SOLO and TRIO studies—executed over a number of years in centers across the U.S. and Europe—showing a significant lowering of blood pressure in patients with uncontrolled hypertension,” said ReCor President and CEO Andrew M. Weiss. “The Paradise treatment offers patients and their caregivers a new option to treat their hypertension. We are pleased to make this new therapy available in Germany, and we look forward to introducing the Paradise System to more European countries soon.”

Hypertension is one of the leading contributors to disease burden worldwide, leading to increased cardiovascular morbidity and mortality, impaired quality of life, and increased cost to health systems. Based on meta-analyses of randomized trials using pharmacological treatments, a decrease of 10 mmHg in office systolic blood pressure is estimated to lower the incidence of cardiovascular events by 20%. Despite the broad availability of antihypertensive medications, access to drugs and adherence remain challenging for patients and physicians.

The Paradise System is an investigational device in the United States. ReCor is currently conducting an FDA IDE pivotal study (RADIANCE-II) in patients with uncontrolled hypertension.

About ReCor Medical, Inc.

ReCor Medical, headquartered in Palo Alto, Calif., is a medical technology company focused on transforming the management of hypertension, the leading cardiovascular risk factor in the world. With its Paradise System ReCor has pioneered the minimally invasive use of ultrasound in renal denervation to treat patients with hypertension. The Paradise System is an investigational device in the United States. It is approved for sale 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 medical therapies. ReCor is currently conducting its FDA IDE pivotal study, RADIANCE-II, and pending successful completion, will submit for PMA approval to market the therapy in the United States.

 

ReCor Medical is a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd.

http://www.recormedical.com/

About Otsuka Medical Devices Co., Ltd.

Otsuka Medical Devices focuses on the global 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 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/

 

Media Contact:

Gaelin White
Health+Commerce
gaelin@healthandcommerce.com

 

 

 

May 16, 2021 – Palo Alto, CA.  ReCor Medical, Inc. (“ReCor”), a wholly-owned subsidiary of Otsuka Medical Devices Co., Ltd., today presented the primary endpoint data from the randomized sham-controlled RADIANCE-HTN TRIO (“TRIO”) study.  In subjects with resistant hypertension, those treated with the Paradise^TM Ultrasound Renal Denervation System had a greater drop in blood pressure than those who received a sham procedure. TRIO results were presented today at the American College of Cardiology meeting (https://accscientificsession.acc.org/) and published simultaneously in The Lancet.

The TRIO study evaluated the efficacy and safety of the Paradise Ultrasound Renal Denervation System in hypertensive patients who were all treated with a single pill containing 3 standardized anti-hypertension medications (a calcium-channel blocker, an angiotensin II receptor blocker, and a thiazide diuretic).  After confirmation of inadequately controlled hypertension despite these medications, patients were then randomly assigned to treatment with the Paradise System or a sham procedure, with no changes to medications through two months.

The study met its primary efficacy endpoint at two months, demonstrating that patients who received Paradise renal denervation had a median reduction of 8.0 mmHg in daytime ambulatory systolic blood pressure, a 4.5 mmHg greater drop as compared with patients who had the sham procedure. Similar reductions were observed in 24-hour blood pressure, nighttime blood pressure, and office blood pressure. In addition, there were no significant differences in adverse events in the renal denervation and sham groups.

“RADIANCE-HTN TRIO is the first study of its kind – a sham-controlled study where all patients were placed on a guideline-recommended regimen of three antihypertensive medications and then confirmed to have hypertension resistant to this regimen,” commented co-principal investigator Ajay J. Kirtane, MD, SM, Professor of Medicine at Columbia University Vagelos College of Physicians and Surgeons.  “These data confirm the blood pressure-lowering effect of the Paradise Ultrasound Renal Denervation System in patients with resistant hypertension.”

“RADIANCE-HTN TRIO had an extremely rigorous study design, executed over a number of years by dozens of committed study centers in the US and Europe,” added co-principal investigator Professor Michel Azizi, MD, PhD, Professor of Medicine at Université de Paris, Head of the ESH Hypertension Excellence Center, Hôpital Européen Georges Pompidou, Paris, France.  “By lowering blood pressure in resistant hypertensive patients, endovascular ultrasound renal denervation may become a valuable tool in the treatment of hypertension in this broad class of patients in need.”

“ReCor is extremely pleased with the primary outcomes of the RADIANCE-HTN TRIO study, showing the positive treatment effect of the Paradise System,” commented ReCor President & CEO, Andrew M. Weiss.  “ReCor believes that TRIO is a seminal study with the potential to change medical practice for patients who are resistant to oral antihypertensive medications.”

The Paradise System bears the CE mark in Europe and is an investigational device in the United States.  The Paradise System is currently under investigation in the United States and Europe in the FDA IDE RADIANCE-HTN Clinical Study, and in the on-going FDA IDE pivotal study (RADIANCE-II) in patients with uncontrolled hypertension, with anticipated study completion of enrollment in 2021.

Hypertension is the leading contributor to disease burden worldwide, leading to increased cardiovascular morbidity and mortality, poorer quality of life, and increased cost burden to health systems.

About ReCor Medical, Inc.

ReCor Medical, headquartered in Palo Alto, CA, is a medical technology company focused on transforming the management of hypertension, the leading cardiovascular risk factor in the world. ReCor has pioneered the minimally invasive use of ultrasound in renal denervation, and developed the Paradise System, to treat patients with hypertension.  The Paradise System is an 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 medical therapies.  ReCor is currently conducting its FDA IDE pivotal study, RADIANCE-II, and pending successful completion will submit for PMA approval.

ReCor Medical is a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd.

http://www.recormedical.com/

About Otsuka Medical Devices Co., Ltd.

Otsuka Medical Devices focuses on the global 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 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/

 

PALO ALTO, Calif., Dec. 10, 2020 /PRNewswire/ — ReCor Medical, Inc. (“ReCor”), a wholly-owned subsidiary of Otsuka Medical Devices, announced today that its Paradise™ Ultrasound Renal Denervation System (the “Paradise System”) demonstrated positive results in the RADIANCE-HTN TRIO (“TRIO”) study, and, separately, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with uncontrolled hypertension who are inadequately responsive to anti-hypertensive medications.

The RADIANCE-HTN TRIO trial evaluated the efficacy and safety of the Paradise System – a catheter-based system designed to denervate the renal nerves with ultrasound energy – to reduce blood pressure in hypertensive patients (n=136) wherein all subjects were placed on a single-pill combination-drug containing 3 anti-hypertension medications (a calcium-channel blocker, an angiotensin II-receptor blocker, and a diuretic).  After confirmation of inadequately controlled hypertension despite these medications, patients were then randomly assigned to Paradise System treatment or a sham (placebo) procedure.

The trial met its primary efficacy endpoint of a greater reduction in daytime blood pressure (Daytime ABPM) between baseline and 2-month follow-up with the Paradise System as compared with the sham procedure.

“ReCor is very pleased with the TRIO outcomes, which demonstrate a clear Paradise treatment effect versus sham,” commented President & CEO, Andrew M. Weiss.  “ReCor believes that TRIO is a unique randomized, sham-controlled study in hypertension given the use of single pill triple medication to set a common baseline medication level in all study subjects, thus helping to establish that the Paradise RDN procedure can provide an additional clinical benefit to patients who are resistant to anti-hypertensive medications.”

“The RADIANCE-HTN TRIO results very nicely complement the previously presented RADIANCE-HTN SOLO trial data, now demonstrating efficacy of renal denervation in a higher-risk cohort of patients with treatment-resistant hypertension,” commented co-principal investigator Ajay J. Kirtane MD, SM, Professor of Medicine at the Columbia University Vagelos College of Physicians and Surgeons.  “On behalf of my co-principal investigator Professor Michel Azizi and the entire steering committee, I would like to thank the study patients, investigators, and coordinators from more than 50 study centers in 7 countries who gave so much of themselves in order to complete this rigorously conducted trial, especially in the throes of a pandemic. We eagerly look forward to fully presenting and publishing the data in the near future.”

Additional, detailed analyses are being prepared for presentation and publication in 2021.

Separately, ReCor received notice from the US FDA that the Paradise System has been granted designation as a Breakthrough Device for the treatment of hypertensive patients who may not be sufficiently responsive, or are intolerant, to anti-hypertensive medical therapy. The FDA Breakthrough Devices Program is intended to help patients receive more timely access to breakthrough medical technologies that have the potential to provide more effective treatment for life-threatening or irreversibly debilitating diseases or conditions. Under the program, the FDA will provide ReCor with priority review and interactive communication during the premarket review process.

“ReCor is pleased that the FDA granted the Breakthrough Designation to the Paradise System,” commented Leslie Coleman, Vice President of Regulatory and Medical Affairs at ReCor. “ReCor believes that Paradise is truly innovative and has the potential to provide an important and innovative therapy option to hypertensive patients worldwide.”

The Paradise System is an investigational device in the United States and has been studied in two FDA IDE clinical trials, RADIANCE-SOLO and RADIANCE-TRIO. ReCor is currently conducting an FDA IDE pivotal study (RADIANCE-II HTN) in patients with uncontrolled hypertension.

Hypertension is one of the leading contributors to disease burden worldwide, leading to increased cardiovascular morbidity and mortality, poorer quality of life, and increased cost burden to health systems.

About ReCor Medical, Inc.

ReCor Medical, headquartered in Palo Alto, CA, is a medical technology company focused on transforming the management of hypertension, the leading cardiovascular risk factor in the world. ReCor has pioneered the minimally invasive use of ultrasound in renal denervation, and developed the Paradise™ System, to treat patients with hypertension.  Paradise is an investigational device in the United States. It is approved for sales in the EU and bears a CE mark. The company has completed two ID randomized, controlled studies of Paradise in patients with both moderate hypertension and those resistant to standard medical therapies.  ReCor is currently conducting its FDA IDE pivotal study, RADIANCE-II, pending successful completion will submit for PMA approval.

ReCor Medical is a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd.

http://www.recormedical.com/

About Otsuka Medical Devices Co., Ltd.

Otsuka Medical Devices focuses on the global 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 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/

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.

SOURCE ReCor Medical, Inc.

The purpose of this note is to provide an update on the status of the RADIANCE Clinical Program, including RADIANCE-HTN SOLO, RADIANCE-HTN TRIO and RADIANCE-II.

At the point of enrollment suspension, we had randomized 95 patients in our RADIANCE-II pivotal trial. We are excited that many of our centers are now taking the first steps to resume clinical trial activity, and we are working with each individual site to begin enrollment in a responsible and efficient manner. We anticipate that RADIANCE-II will restart in Q3, with a goal to complete enrollment within 2021.

We are also excited to announce that thanks to your persistence and continued support, enrollment is now complete in the TRIO cohort of RADIANCE-HTN. This study has been evaluating patients with treatment resistant hypertension – a population that we strongly believe needs alternatives to medication therapy. The conclusion of enrollment means that we are now one step closer to understanding the impact of ultrasound-based renal denervation in this important population. Many of you have been on this journey with us since 2016, so thank you for your partnership throughout this time.

Finally, we wanted to highlight ReCor’s presence at this year’s PCR e-course. First, Dr. Ajay Kirtane will present results from the RADIANCE-HTN SOLO cohort crossover patient population during a Late-Breaker Clinical Trial session on Friday, June 26^th at 14:00 CEST/ 8:00 EDT. Second, Dr. Kirtane and Profs. Azizi and Mahfoud will lead an online symposium that will further review the crossover data, as well as how it adds to the growing body of evidence supporting renal denervation. Third, Dr. Philipp Lurz will discuss his experience with the various renal denervation therapies and what he considers to be the benefits of an ultrasound-based approach.

We are excited with all the progress that has been made in this field, none of which would have been possible without your help. We remain committed to high quality product development efforts and rigorous clinical studies in order to create a strong foundation for future clinical adoption.

March 17, 2019 – Palo Alto, CA, for immediate release – ReCor Medical, Inc. (“ReCor”) announced the 6 month “on-medication” results from its RADIANCE-HTN SOLO clinical trial with simultaneous publication in Circulation, and the first randomization of patients in its RADIANCE-II pivotal trial of its Paradise Renal Denervation System for the treatment of uncontrolled hypertension.

Today at the ACC Meeting in New Orleans, Co-principal Investigator Ajay Kirtane presented the 6 Month “on-meds” results from the RADIANCE-HTN SOLO study cohort in which, following the positive 2-month “off-meds” blood pressure primary outcome, patients remained blinded to treatment assignment and were put back on medications following a recommended, pre-set, stepped care, medical titration protocol. The results demonstrated that patients treated with the ReCor Paradise Ultrasound Denervation System were prescribed fewer anti-hypertensive medications than those treated with a sham procedure, and accounting for this difference, treated patients had greater blood pressure drops than those in the sham arm. Dr Kirtane additionally noted that at 6 months the blood-pressure lowering effect of the Paradise System was maintained and that there were no major adverse events.

“Professor Michel Azizi (Paris, France), my Co-PI for the RADIANCE-HTN study, the RADIANCE-HTN Steering Committee and I are very pleased to report the 6 month “onmeds”results from the SOLO cohort of the study”, commented Dr. Kirtane (Associate Professor of Medicine at Columbia University Irving Medical Center). “These results are unique in that they represent blinded randomized data demonstrating that ultrasound renal denervation may have the potential to serve as an important adjunct to medications to lower blood pressure. We believe that in addition to the previously presented SOLO results in patients who were “off” medications, these new data contribute to the growing body of evidence demonstrating that the Paradise System can lower blood pressure, either alone or in combination with anti-hypertensive medications. If confirmed in the larger and ongoing RADIANCE II trial, this therapy would have the potential to help patients and physicians reach their blood pressure goals – something that is frequently not achieved in clinical practice.”

“ReCor is encouraged by the SOLO 6 month outcome data as it is the first randomized, blinded, sham-controlled evidence of the effectiveness of the Paradise renal denervation system in combination with added anti-hypertensive medication. These data demonstrate the 6 month durability of the blood pressure lowering effect of the Paradise renal denervation system, either alone or in combination with medications,” commented CEO Andrew M. Weiss. “We are also excited that we have begun to randomize subjects in our RADIANCE-II pivotal study, which we plan to complete in 2020. The combination of our independent, blinded and sham-controlled RADIANCE-HTN SOLO and TRIO studies, the REQUIRE study being run in Japan and Korea, and our pivotal RADIANCE-II study will provide safety and efficacy outcomes on more than 600 patients, covering a broad range of patients with hypertension. If successful, we hope that, in the future, these studies may support an important new treatment option for millions 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 waterbased 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), REQUIRE (a pivotal study of patients with resistant hypertension in Japan and Korea), and most recently with the launch the RADIANCE II pivotal study (a study of patients with moderate hypertension) in the United States and Europe.

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 JPY1,292 billion in the fiscal year ended December 2018.

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/

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.

https://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.