REQUIRE trial results published in Hypertension Research journal and simultaneously presented at Japanese Society of Hypertension (JSH) 43^rd Annual Meeting

Palo Alto, Calif. – 15 October, 2021 – Otsuka Medical Devices Co., Ltd. (OMD) a subsidiary of Otsuka Holdings, Inc., and its subsidiary, ReCor Medical, Inc. (“ReCor”), today announced that the findings from the REQUIRE trial of ReCor’s Paradise™ Ultrasound Renal Denervation System for the treatment of hypertension conducted in Japan and Korea were presented at the Japanese Society of Hypertension (JSH) meeting and published simultaneously in the Hypertension Research journal. The trial, “Catheter-based ultrasound renal denervation in patients with resistant hypertension: the randomized, controlled REQUIRE trial,” was conducted by OMD and its affiliate.

REQUIRE assessed the change in 24-hour ambulatory systolic blood pressure from baseline to 3 months in renal denervation and sham control groups. REQUIRE did not show a significant difference in blood pressure reduction between the two groups, and therefore did not meet its primary efficacy endpoint. There were no significant differences in adverse events in the renal denervation and sham groups, demonstrating no difference in safety risk.

“The lack of difference in blood pressure reductions between the renal denervation and sham groups, and in particular the blood pressure reduction in the sham group, were not what we expected,” said Professor Kazuomi Kario, M.D., REQUIRE principal investigator. “After in-depth analysis, we determined that the lack of effective medication stabilization and adherence control confounded the efficacy signal in both the treatment and sham groups.  This, and other important insights from the REQUIRE study are being taken into account as we design a future study of the Paradise System in Japan.”

“The REQUIRE results were not in line with the positive results we have observed in other trials with the Paradise System,” said Michael Weber, M.D., Professor of Medicine at SUNY Downstate College of Medicine. “As demonstrated in both RADIANCE-HTN SOLO and TRIO – two randomized, sham-controlled studies that met their blood pressure reduction primary endpoints – study design controls that reinforce medication adherence are necessary to reduce the variability of blood pressure results in both treatment and sham groups and are critical to assessing the true treatment effect in these trials. The REQUIRE study design did not standardize medications nor objectively measure adherence, which we believe thus caused the lack of a positive efficacy signal.”

“Based on the results from the RADIANCE-HTN SOLO and TRIO trials, the Paradise System has demonstrated a significant and clinically meaningful blood pressure reduction in a range of patients with uncontrolled hypertension,” said Andrew M. Weiss, President and CEO, ReCor Medical.  “After intense review from our advisors, we understand that inadequate medication control in REQUIRE likely caused the lack of an efficacy signal in that study.”

“Otsuka Medical Devices, ReCor and our scientific advisors are working to design a new randomized trial of the Paradise System in Japan,” commented Noriko Tojo, President of OMD. “Based on the strong positive results from RADIANCE-HTN SOLO & TRIO, the root cause assessment of the REQUIRE efficacy signals, and the strong REQUIRE safety results, we are working with the Japanese regulatory authorities to plan a new randomized, controlled trial in uncontrolled, ‘on-med’ hypertension patients.”

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 on-going FDA IDE pivotal study (RADIANCE-II) in patients with uncontrolled hypertension, with anticipated enrollment completion in 2022.

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

https://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/

 

 

 

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.

https://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.

https://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.

https://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.

PALO ALTO, Calif. and AMSTERDAM, May 16, 2016 /PRNewswire/ — ReCor Medical (“ReCor”) announced today the signing of a development and commercialization agreement, together with an additional investment, with Otsuka Holdings (“Otsuka Holdings”), a global healthcare group headquartered in Tokyo, Japan.  As part of the agreement, Otsuka Holdings obtained exclusive rights to commercialization of the ReCor Paradise™ ultrasound-based renal denervation system for Japan, China, Korea and other Asian countries. Otsuka Holding’s investment will be used to further ReCor’s clinical studies in the US and Europe.

Under the commercialization agreement, Otsuka will have exclusive rights to conduct clinical trials, regulatory activities and sales and marketing functions for commercialization of the ReCor Paradise technology for renal denervation in Asia.  Otsuka’s initial focus will be to conduct a clinical trial of the Paradise System in Japan to demonstrate its potential benefit in patients with treatment-resistant hypertension.

ReCor plans to use the Otsuka funding to advance its IDE-approved RADIANCE-HTN study for evaluation of the Paradise System in patients with hypertension in the US and EU.  The study recently began enrolling at sites in the United States, The Netherlands, and the UK, and additional sites are planned for France and Germany.

Tatsuo Higuchi, President and Representative Director 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.”

Andrew M. Weiss, President & CEO of ReCor, commented: “We highly value Otsuka’s development and marketing capabilities in Asia – one of the most important potential markets for our Paradise technology.  Otsuka has been one of our most important investors since leading our Series D financing, joining Sofinnova Partners and RICA Universal in funding ReCor.  This latest investment is designed to fund our RADIANCE-HTN study, which we hope will demonstrate the blood-pressure lowering effect of the Paradise System in patients with hypertension.”

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.

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.

Additional information can be found on http://www.otsuka.com/en/

SOURCE ReCor Medical, Inc.

PALO ALTO, Calif. and AMSTERDAM, April 7, 2016 /PRNewswire-USNewswire/ — ReCor Medical announced today the enrollment of the first subjects in the FDA IDE-approved RADIANCE-HTN clinical trial to evaluate the effect of the ReCor Paradise™ Renal Denervation System on blood pressure in patients with hypertension.

RADIANCE-HTN is a blinded, randomized and sham-controlled trial designed to evaluate the blood pressure lowering effect of the Paradise System in two patient populations: the SOLO cohort will evaluate subjects with essential hypertension on two or fewer antihypertensive medications, and the TRIO cohort will evaluate subjects with treatment-resistant hypertension on a minimum of 3 antihypertensive medications.
The first TRIO patient was enrolled at the Erasmus University Medical Center in Rotterdam, the Netherlands by Dr. Joost Daemen. “We are excited to have enrolled the first patient in this very important study,” commented Dr. Daemen. “We have significant experience using the Paradise System and believe that the RADIANCE-HTN study is well designed to demonstrate the System’s treatment effect.  If RADIANCE-HTN is positive, then, given the existing CE-marking, we would consider Paradise as an essential tool to treat patients with resistant hypertension here at Erasmus.”

The first SOLO patient was enrolled at Sutter Health, Sacramento, CA, USA by Dr. Pei-Hsiu Huang. “The SOLO cohort represents a large population of hypertension patients, many of whom are seeking alternative methods to manage a lifetime of hypertension treatment,” added Dr. Huang. “We are excited to be part of this important study and by the possibility that RADIANCE-HTN could demonstrate the efficacy of renal denervation with the Paradise System, and open a path to new treatment options for our hypertension patients.”

RADIANCE-HTN is approved to enroll 292 subjects at up to 40 investigational sites, and will be conducted in the US, UK, France, Germany, and The Netherlands.

More information on RADIANCE-HTN can be found at:

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

About ReCor Medical, Inc.
ReCor Medical is a private, venture-backed, medical device company that designs and manufactures 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 3 clinical trials, and has been used in over 200 patients.

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. and AMSTERDAM, Feb. 22, 2016 /PRNewswire/ — ReCor Medical, Inc. announced today that it has received FDA IDE approval for the RADIANCE-HTN clinical trial to evaluate the effect of the ReCor Paradise™ Renal Denervation System on blood pressure in patients with hypertension.

RADIANCE-HTN is a blinded, randomized and sham-controlled trial designed to evaluate the blood pressure lowering effect of the Paradise System in two patient populations: those with essential hypertension on two or fewer antihypertensive medications, and those with treatment-hypertension on a minimum of 3 antihypertensive medications.

“RADIANCE-HTN will be led by two Co-Primary Investigators (Co-PIs): Professor Michel Azizi, MD PhD (Georges Pompidou Hospital, Paris, France) and Dr. Laura Mauri, MD, MSc (Brigham & Women’s Hospital, Boston, MA). The study is approved to enroll 292 patients at up to 40 investigational sites, and will be conducted in the US, UK, France, Germany, and The Netherlands. Initial patient enrollment is anticipated in the first quarter of 2016.

Professor Azizi, Co-PI and lead author of the landmark DENER-HTN study, commented; “Many patients across the hypertension spectrum, together with their physicians, are struggling to control their blood pressure. The RADIANCE-HTN trial design will allow us to evaluate the efficacy of the Paradise System in a broad population of hypertensive patients across the hypertension spectrum.”

“There is strong scientific rationale for this study to evaluate renal denervation as a treatment for hypertension,” added Co-PI Dr. Mauri. “We believe that the Paradise System, with its unique combination of circumferential, ultrasound-based nerve ablation and water-based cooling for arterial protection, will be able to denervate the renal nerves with a low incidence of adverse events. RADIANCE-HTN’s blinded, randomized trial design, including standardization of antihypertensive treatment, will allow a robust assessment of the blood pressure reductions important to patients and their physicians.”

Leslie Coleman, DVM, ReCor Vice President of Regulatory and Medical Affairs commented; “We believe that our innovative trial design, evaluating patients both off and on a standard antihypertensive drug regimen, will provide unique insights into the blood pressure effect of our Paradise System.”

“FDA IDE approval of the RADIANCE-HTN trial positions ReCor as one of the few companies in the field who are investing in randomized, blinded and sham-controlled studies with the co-leadership from the hypertension and interventional physician communities,” commented ReCor CEO Andrew M. Weiss. “We believe that this physician partnership is essential for the future establishment of RDN as a standard of care for the treatment of hypertension.”

More information on RADIANCE-HTN can be found at: https://clinicaltrials.gov/ct2/show/NCT02649426?term=radiance&rank=3

About ReCor Medical, Inc. 

ReCor Medical is a private, venture-backed, medical device company that designs and manufactures a proprietary ultrasound ablation system for renal denervation (RDN). RDN is a new potential therapeutic option for 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.

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

PALO ALTO, Calif., April 10, 2015 /PRNewswire-USNewswire/ — ReCor Medical, Inc., a Palo Alto- and Amsterdam-based medical device firm, announced today a Series D investment of approximately $15M led by Otsuka Holdings Co., Ltd., the parent company of Otsuka Pharmaceutical and the Otsuka group of healthcare companies. Otsuka Holdings, one of the leading healthcare groups in Japan, joined Sofinnova Partners in the Series D round. In addition, ReCor has met with the US FDA regarding a new randomized controlled trial of its Paradise Renal Denervation (“RDN”) System in hypertensive patients to demonstrate its effect on blood pressure in conjunction with, and in the absence of, hypertensive drug therapy. The Company is planning to conduct the new study at 20 – 25 sites in the US and EU.

“The Series D investment led by Otsuka Holdings shows renewed interest in the renal denervation field and confidence in our ultrasound-based Paradise System,” commented Andrew M. Weiss, President and CEO of ReCor. “We are pleased to have attracted investment from one of Japan’s premier healthcare groups. This new relationship will support our upcoming US clinical studies and open new potential for our technology in Japan and greater Asia. We are pleased to be positioned alongside Boston Scientific and Medtronic, who have also recently announced new clinical trials in renal denervation for the treatment of hypertension.”

“ReCor believes that our Paradise technology may have a distinct advantage over competitive RF-based RDN systems by providing active vessel protection and 360 degree energy delivery. We believe that we can demonstrate an important clinical effect in hypertension patients with the Paradise system,” added Mano Iyer, ReCor COO and co-founder, “We are working with leading hypertension experts and interventionalists to finalize our clinical study design, and plan to begin enrollment in the second half of 2015.”

About ReCor Medical, Inc.

ReCor Medical is a Palo Alto- and Amsterdam-based clinical-stage medical device company with a proprietary ultrasound system for renal denervation called the Paradise System. Paradise™, which has CE mark, uses 6Fr or 5Fr catheters for intravascular denervation of the renal nerves by combining water-based cooling of the renal artery and high intensity ultrasound energy for circumferential renal nerve ablation. The Paradise System has been studied in 3 clinical trials, and has been used in over 200 patients. For additional information see: www.recormedical.com

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 JPY1,224 billion in the fiscal year ended December 2014. 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. The Otsuka Group consists of 119 companies worldwide with 29,482 employees. Additional information can be found on http://www.otsuka.com/en/Medicine.