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Palo Alto, Calif. – September 18, 2023 – Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) today announced the launch of Recor’s refreshed brand identity. Recor is preparing for its anticipated premarket application (PMA) approval from the U.S. Food and Drug Administration (FDA) of its Paradise™ Ultrasound Renal Denervation (RDN) system.

The new look is an enlivened interpretation of the brand’s legacy, evolving the company logo, color palette and design elements to reflect a significant step forward. The Recor brand’s bold updated logo and warm colors make a strong statement, projecting the company’s confidence and vigor as a new stage in the business takes shape. Today’s brand unveiling also included refreshed social media visuals; the update will extend to a new website and other assets in the coming months.

“Recor’s story is one of unbridled enthusiasm, commitment and perseverance toward our goal as we achieved CE-mark and now approach PMA approval. Our journey has led us to an evolution of our brand that reflects what makes us unique and our goal to address significant unmet needs for patients worldwide,” said Lara Barghout, President and Chief Executive Officer, Recor Medical. “Our team has developed branding that visually represents who we are, where we are headed, and the higher standard to which we’ve always held ourselves. We look forward to sharing our new brand as we embark on our next chapter of growth.”

In August, the FDA Circulatory Systems Devices Panel of the Medical Devices Advisory Committee reviewed clinical trial data and voted favorably on the safety, efficacy, and benefit-to-risk profile of the Paradise Ultrasound RDN system. Hypertension puts people at risk for heart disease and stroke, which are leading causes of death in the U.S.^[1]

 

1. National Center for Health Statistics. Multiple Cause of Death 2018–2021 on CDC WONDER Database. Accessed February 2, 2023.

 

About Recor Medical, Inc.

Recor Medical, headquartered in Palo Alto, Calif., a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd., is a medical technology company focused on transforming the management of hypertension. Recor has pioneered the use of the Paradise Ultrasound Renal Denervation system for the treatment of hypertension. The Paradise system is an investigational device in the United States and Japan and bears the CE mark. Recor has reported positive outcomes in three independent, randomized, sham-controlled studies of the Paradise system in patients with mild-to-moderate and resistant hypertension. In addition, Recor has begun the Global Paradise System (“GPS”) Registry in the European Union and the UK, with plans to expand globally.

 

About Otsuka Medical Devices Co., Ltd.

Otsuka Medical Devices focuses on the global development and commercialization of medical care products including 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 global healthcare company listed on the Tokyo Stock Exchange (JP 4578).

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

 

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Annika Parrish

Health+Commerce

annika@healthandcommerce.com

Palo Alto, Calif. – August 22, 2023 – Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) announce the U.S. Food and Drug Administration (FDA) Circulatory Systems Devices Panel of the Medical Devices Advisory Committee met to discuss the pre-market approval application (PMA) for the Paradise™ Ultrasound Renal Denervation (RDN) system, indicated to reduce blood pressure in patients with hypertension. The overall vote from the committee was favorable that there was sufficient data to support the use of the device in patients with uncontrolled hypertension.

The committee voted 12 to 0 in favor of the Paradise Ultrasound RDN system with regard to safety and 8 to 3 in favor with regard to efficacy, with one vote abstaining. The committee also voted 10 to 2 in favor that the Paradise system benefits outweigh the risks.

If approved by the FDA, the Paradise Ultrasound RDN system could be the first FDA-approved renal denervation device in the U.S. indicated to reduce blood pressure in patients with uncontrolled hypertension.

“Hypertension is one of the leading causes of cardiovascular morbidity and mortality, and despite the widespread availability of effective medications and lifestyle modification, rates of blood pressure control are still poor,” said Dr. Ajay Kirtane, Professor of Medicine at Columbia University, Vagelos College of Physicians and Surgeons / NewYork-Presbyterian Hospital, who serves as co-primary investigator in the RADIANCE Global Program studying the Paradise system. “I was pleased to see that the advisory committee recognized the adjunctive benefits of the Paradise Ultrasound RDN system in lowering blood pressure – something that we sought to demonstrate definitively through the generation of high-level scientific evidence within the RADIANCE Global Program.”

“We are thankful to the FDA and advisory committee members for the thoughtful review and discussion of the Paradise system for the treatment of uncontrolled hypertension,” said Lara Barghout, President and Chief Executive Officer, Recor Medical. “We will continue to work closely with the FDA in advance of our anticipated PMA approval and feel confident in the impact that Paradise Ultrasound RDN could have in addressing a significant unmet need.”

The PMA submission included data from three clinical trials in the company’s RADIANCE Global Program, all of which are independently powered, randomized sham-controlled clinical trials of the Paradise Ultrasound RDN system. The studies included more than 500 patients with mild-to-moderate or resistant uncontrolled hypertension.

The Paradise Ultrasound RDN system bears the CE mark for the treatment of hypertension and is an investigational device in the United States and Japan.

Update on September 1, 2023

Two advisory committee panelists were not able to vote during the meeting, and their votes were counted afterward. The final voting results have been listed on the 24 Hour Summary issued by the FDA. The committee voted 14 to 0 in favor of the Paradise Ultrasound RDN system with regard to safety and 8 to 5 in favor with regard to efficacy, with one vote abstaining. The committee also voted 10 to 4 in favor that the Paradise system benefits outweigh the risks.

About Recor Medical, Inc.

Recor Medical, headquartered in Palo Alto, Calif., a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd., is a medical technology company focused on transforming the management of hypertension. Recor has pioneered the use of the Paradise Ultrasound Renal Denervation system for the treatment of hypertension. The Paradise system is an investigational device in the United States and Japan and bears the CE mark. Recor has reported positive outcomes in three independent, randomized, sham-controlled studies of the Paradise system in patients with mild-to-moderate and resistant hypertension. In addition, Recor has begun the Global Paradise System (“GPS”) Registry in the European Union and the UK, with plans to expand globally.

https://www.recormedical.com

 

About Otsuka Medical Devices Co., Ltd.

 Otsuka Medical Devices focuses on the global development and commercialization of medical care products including 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 global healthcare company listed on the Tokyo Stock Exchange (JP 4578).

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

 

Media Contact

 

Annika Parrish
Health+Commerce
annika@healthandcommerce.com

Treating hypertension is complex, and European guidelines reinforce the safety and effectiveness of renal denervation as a treatment option to improve hypertension control

Palo Alto, Calif. – July 14, 2023 – ReCor Medical, Inc. (“ReCor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) are pleased to see the updated and expanded recommendations for the management of arterial hypertension that The European Society of Hypertension (ESH) presented at their 32^nd annual European Meeting on Hypertension and Cardiovascular Protection. The new guidelines are designed to serve as a resource on the latest scientific evidence for healthcare professionals around the world who treat people with hypertension. Current rates of treatment and control of hypertension remain suboptimal, and the ESH guidelines assist clinicians and patients in achieving the goal of better health.

The 2023 ESH Guidelines for the Management of Arterial Hypertension, endorsed by the European Renal Association (ERA) and the International Society of Hypertension, were officially presented at ESH and simultaneously published in the Journal of Hypertension[1].  The guidelines include recommendations for the use of renal denervation, which can be considered, 1) as an additional treatment option for patients with resistant hypertension on three or more antihypertensive medications, 2) as a treatment option for patients with uncontrolled hypertension despite the use of antihypertensive drug combination therapy, or 3) if a patient’s drug treatment elicits serious side effects and poor quality of life.

“Recommendation of renal denervation by the recently published European Society of Hypertension (ESH) 2023 Guidelines is a significant milestone for the field of arterial hypertension management. The decision to consider renal denervation as a treatment option is based on the demonstrated efficacy and safety of the procedure in the published results of several rigorous randomized and sham-controlled trials,” said Michel Azizi, Professor of Medicine at Université Paris Cité, Hôpital Européen Georges Pompidou, Paris, France. “The recommendations state that renal denervation should be performed in experienced specialized centers, and that the process of patient selection should be done by a multidisciplinary team.”

__________________
[1] Mancia Chairperson G, Kreutz Co-Chair R, Brunström M, Burnier M, Grassi G, Januszewicz A, Muiesan ML, Tsioufis K, Agabiti-Rosei E, Algharably EAE, Azizi M, Benetos A, Borghi C, Hitij JB, Cifkova R, Coca A, Cornelissen V, Cruickshank K, Cunha PG, Danser AHJ, de Pinho RM, Delles C, Dominiczak AF, Dorobantu M, Doumas M, Fernández-Alfonso MS, Halimi JM, Járai Z, Jelaković B, Jordan J, Kuznetsova T, Laurent S, Lovic D, Lurbe E, Mahfoud F, Manolis A, Miglinas M, Narkiewicz K, Niiranen T, Palatini P, Parati G, Pathak A, Persu A, Polonia J, Redon J, Sarafidis P, Schmieder R, Spronck B, Stabouli S, Stergiou G, Taddei S, Thomopoulos C, Tomaszewski M, Van de Borne P, Wanner C, Weber T, Williams B, Zhang ZY, Kjeldsen SE; Authors/Task Force Members:. 2023 ESH Guidelines for the management of arterial hypertension The Task Force for the management of arterial hypertension of the European Society of Hypertension Endorsed by the European Renal Association (ERA) and the International Society of Hypertension (ISH). J Hypertens. 2023 Jun 21. doi: 10.1097/HJH.0000000000003480. Epub ahead of print. PMID: 37345492.

ReCor Medical has completed three global, independently powered, sham-controlled randomized clinical trials of the Paradise™ Ultrasound Renal Denervation (RDN) System in more than 500 patients with uncontrolled hypertension. The RADIANCE-HTN SOLO, RADIANCE-HTN TRIO and RADIANCE II clinical studies met their prespecified primary efficacy endpoints of blood pressure reduction, with positive safety outcomes.

“The ESH guidelines support the experience of European clinicians who are already using the Paradise Ultrasound RDN System for some patients who need an additional treatment option to achieve meaningful reductions in blood pressure,” said ReCor President and CEO, Lara Barghout. “The urgent global need to address the burden of uncontrolled hypertension remains, and we’re committed to revolutionizing the way hypertension is treated and bringing the benefits of ultrasound RDN to patients who need it. In the coming months, we will work with the FDA to complete their review of our PMA seeking approval of ultrasound RDN in the U.S.”                                                                                                                                                                                                                                                                                                                                                      In November 2022, ReCor Medical announced its submission of a pre-market approval application for the Paradise Ultrasound RDN System to the U.S. Food and Drug Administration (FDA). The FDA Circulatory Systems Devices Panel of the Medical Devices Advisory Committee will hold a meeting virtually on Aug. 22-23, 2023, to discuss, make recommendations and vote on devices indicated to reduce blood pressure in patients with hypertension.

The Paradise Ultrasound RDN System bears the CE mark for the treatment of hypertension in Europe and is an investigational device in the United States and Japan.

About ReCor Medical, Inc. 

ReCor Medical, headquartered in Palo Alto, CA, a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd., is a medical technology company focused on transforming the management of hypertension. ReCor has pioneered the use of the Paradise Ultrasound Renal Denervation (uRDN) System for the treatment of hypertension. The Paradise System is an investigational device in the United States and Japan and bears the CE mark in the EU. ReCor has reported positive outcomes in three independent, randomized, sham-controlled studies of the Paradise System in patients with mild-to-moderate and resistant hypertension, and has submitted an application for PMA approval in the United States with the U.S. FDA. In addition, ReCor has begun the Global Paradise System (“GPS”) Registry in the European Union, with plans to expand globally.

https://www.recormedical.com/ 

About Otsuka Medical Devices Co., Ltd. 

Otsuka Medical Devices focuses on the global development and commercialization of medical care products including 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 global healthcare company listed on the Tokyo Stock Exchange (JP 4578).

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

Media Contact

Annika Parrish
Health+Commerce
annika@healthandcommerce.com

ReCor Medical Announces Two Concurrent JAMA Network Publications of Study Results on the Paradise Ultrasound Renal Denervation System for the Treatment of Hypertension

Primary Results from RADIANCE II Trial Published in JAMA and Results of Pooled Analysis from Three RADIANCE Studies Published in JAMA Cardiology

Palo Alto, Calif. – February 28, 2023 – ReCor Medical, Inc. (“ReCor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) today announced that primary endpoint results from the RADIANCE II pivotal trial were published in the Journal of the American Medical Association (JAMA). Study results showed that the Paradise Ultrasound Renal Denervation (uRDN) System successfully reduced blood pressure compared to sham. In addition, pooled analysis results from the combined primary efficacy endpoint and safety data from RADIANCE SOLO, RADIANCE TRIO, and RADIANCE II were concurrently published in JAMA Cardiology. Results of the pooled analysis showed a consistent blood pressure lowering effect across a broad range of hypertension, including mild to moderate and resistant hypertension.

RADIANCE II is a randomized, sham-controlled US FDA IDE pivotal trial of the Paradise uRDN System in the treatment of patients with uncontrolled hypertension. Conducted as an international multicenter study at more than 60 study centers in eight countries, 224 patients with uncontrolled hypertension were randomized 2:1 to uRDN or a sham. Patients were to remain off antihypertensive medications throughout the two months of follow-up unless specified BP criteria were exceeded. At the two-month primary efficacy endpoint, patients treated with the Paradise uRDN system had a mean reduction in daytime ambulatory systolic blood pressure of -7.9 mmHg, compared to a reduction of -1.8 mmHg in the sham arm, corresponding to a statistically significant and clinically relevant between-group difference of -6.3 mmHg (p<0.0001). The study also achieved its primary safety composite outcome with no major adverse events observed.

Concurrently published in JAMA Cardiology, the RADIANCE Pooled Analysis includes data from more than 500 patients randomized in the three studies from ReCor’s RADIANCE Global Program: RADIANCE-HTN TRIO, which studied patients with resistant hypertension, and RADIANCE-HTN SOLO and RADIANCE II, which studied patients with mild-moderate hypertension. The combined dataset showed an overall reduction in daytime ambulatory systolic BP in the uRDN group of -8.5 mmHg with a difference between treatment and sham at two months of -5.9 mmHg (p<0.0001), favoring uRDN. Blood pressure results were similarly positive in the 24-hour, nighttime, home, and office measures. A favorable safety profile was consistently observed following uRDN treatment across the studies.

“The results of the RADIANCE clinical trials are meaningful in that they solidify the role of the Paradise uRDN System as an adjunctive therapy for hypertension treatment, in addition to medications and lifestyle modification. Having three consistent sham-controlled clinical trials demonstrating that the Paradise uRDN System can safely lower blood pressure across a range of patients is a very high bar to have met,” said study principal investigator Dr. Ajay Kirtane, Professor of Medicine at Columbia University, Vagelos College of Physicians and Surgeons and NewYork-Presbyterian Hospital.

Study principal investigator Michel Azizi, Professor of Medicine at Université Paris Cité, Hôpital Européen Georges Pompidou, Paris, France, added, “The pooled analysis of RADIANCE SOLO, TRIO, and RADIANCE II shows a remarkable consistency of effect in patients with mild to moderate hypertension and those with resistant hypertension. These results are in line with the new 2023 consensus statement of the European Society of Cardiology (ESC) Council on Hypertension and the European Association of Percutaneous Cardiovascular Interventions (EAPCI). The publication of these results in JAMA and JAMA Cardiology will bring the evidence of the performance of uRDN in the treatment of hypertension to a broad audience of physicians.”

“With hypertension being a leading cause of cardiovascular disease worldwide, it is vital that we help patients with an effective therapy to reduce blood pressure. We are pleased that the RADIANCE clinical trials have repeatedly shown that the Paradise uRDN System can successfully reduce blood pressure in a broad range of patients,” said ReCor President and CEO, Lara Barghout. “ReCor is focused on bringing the Paradise uRDN System to patients and their physicians as a treatment option in the near future.”

 

About ReCor Medical, Inc.

ReCor Medical, headquartered in Palo Alto, CA, a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd., is a medical technology company focused on transforming the management of hypertension. ReCor has pioneered the use of the Paradise Ultrasound Renal Denervation (uRDN) System for the treatment of hypertension. The Paradise System is an investigational device in the United States and Japan and bears the CE mark in the EU. ReCor has reported positive outcomes in three independent, randomized, sham-controlled studies of the Paradise System in patients with mild-to-moderate and resistant hypertension, and has submitted an application for PMA approval in the United States with the U.S. FDA. In addition, ReCor has begun the Global Paradise System (“GPS”) Registry in the European Union, with plans to expand globally.
https://www.recormedical.com/

About Otsuka Medical Devices Co., Ltd.
Otsuka Medical Devices focuses on the global development and commercialization of medical care products including 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 global healthcare company listed on the Tokyo Stock Exchange (JP 4578).
https://www.omd.otsuka.com/en/

Media Contact
Annika Parrish
Health+Commerce
annika@healthandcommerce.com

Palo Alto, Calif. – January 3, 2023 – ReCor Medical, Inc. (“ReCor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) today announced the appointment of Lara Barghout as President and Chief Executive Officer of ReCor. Ms. Barghout will lead the ReCor business strategy and organization in an exciting new direction: the global commercialization of ReCor’s Paradise™ Ultrasound Renal Denervation (“uRDN”) System for the treatment of hypertension.

Ms. Barghout brings more than 20 years of experience leading global businesses in the medical device industry. She joins ReCor from Siemens Healthineers, where she was Senior Vice President and Head of Advanced Therapies, successfully leading the image guided therapy business in North America. Prior to Siemens Healthineers, Ms. Barghout held several escalating roles at Terumo Cardiovascular, developing a wealth of experience in building high-performance global commercial organizations, leading cultural transformations, and rising to become Senior Vice President, Global Commercial Operations.

“I am honored to lead the extraordinary team at ReCor at an exciting time in the company’s growth,” said Ms. Barghout. “High blood pressure is a leading contributor to cardiovascular disease burden worldwide, resulting in increased patient risk and higher costs to health systems. I look forward to leading our focus to advance uRDN as a treatment for hypertension and the global commercialization of the Paradise uRDN System. We believe our Paradise uRDN technology to be a true game changer in improving hypertension therapy, with the potential to offer a new option for physicians to help improve blood pressure outcomes for their patients on a global scale.”

Ms. Barghout succeeds Andrew Weiss, who joined ReCor in 2013 and led ReCor in the development of the Paradise uRDN System from its early clinical trials, to the acquisition of ReCor by Otsuka in 2018, through the RADIANCE trial successes and the recent submission to the U.S. FDA for Pre-Market Approval.

“We are delighted to name Ms. Barghout President and CEO of ReCor. She is a highly experienced leader with a track record of commercial success across a range of medical device businesses, coupled with extensive experience in global leadership,” said Noriko Tojo, Executive Director of Otsuka Holdings Co., Ltd. and President of Otsuka Medical Devices. “We are very excited for Ms. Barghout to lead ReCor into its next phase of global growth. Her deep commercial experience and adept leadership make her ideal to build on the technology development and clinical trial successes of the ReCor team, guiding the business to realize its therapeutic and commercial potential. I would like to thank Andy for his outstanding leadership and countless contributions over the past 10 years.”

The Paradise uRDN System bears the CE mark for the treatment of hypertension in Europe and is an investigational device in the United States and Japan.

 

About ReCor Medical, Inc. 

ReCor Medical, headquartered in Palo Alto, CA, a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd., is a medical technology company focused on transforming the management of hypertension. ReCor has pioneered the use of the Paradise Ultrasound Renal Denervation (uRDN) System for the treatment of hypertension. The Paradise System is an investigational device in the United States and Japan and bears the CE mark in the EU. ReCor has reported positive outcomes in three independent, randomized, sham-controlled studies of the Paradise System in patients with mild-to-moderate and resistant hypertension, and has submitted an application for PMA approval in the United States with the U.S. FDA. In addition, ReCor has begun the Global Paradise System (“GPS”) Registry in the European Union, with plans to expand globally.

https://www.recormedical.com/

About Otsuka Medical Devices Co., Ltd.

Otsuka Medical Devices focuses on the global development and commercialization of medical care products including 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 global healthcare company listed on the Tokyo Stock Exchange (JP 4578).

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

Media Contact

Annika Parrish
Health+Commerce
annika@healthandcommerce.com

Filing of Pre-Market Application Follows Successful Pivotal Trial of the Paradise uRDN System in the Treatment of Uncontrolled Hypertension

Palo Alto, Calif. – November 29, 2022 – ReCor Medical, Inc. (“ReCor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) today announced the filing of the pre-market approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the Paradise™ uRDN System in the treatment of uncontrolled hypertension.

The Paradise uRDN System is designed to reduce sympathetic nerve activity by denervating nerves which surround the renal arteries with the goal of reducing blood pressure. Paradise uRDN uses a combination of ultrasound energy to denervate the renal nerves and a water-filled balloon to protect the renal artery. The Paradise uRDN System employs an interventional procedure in which the Paradise catheter is placed in each of the main renal arteries, following which two to three seven-second ultrasound emissions are delivered to denervate the surrounding renal nerves, thereby reducing blood pressure.

Since 2009, ReCor has been focused on developing and testing the Paradise uRDN System to treat hypertension safely and effectively. ReCor has three global, independently powered, sham-controlled randomized clinical trials of the Paradise uRDN System in more than 500 patients with uncontrolled hypertension: RADIANCE-HTN SOLO, RADIANCE-HTN TRIO and RADIANCE II. Each RADIANCE trial met its prespecified primary efficacy endpoint of blood pressure reduction, with positive safety.  

RADIANCE II is the U.S. FDA IDE pivotal trial. In September of this year, ReCor and Otsuka Medical Devices announced that the trial successfully reached its primary efficacy endpoint. Results showed a reduction in daytime systolic ambulatory blood pressure of -7.9 mmHg in those treated with uRDN and a difference between uRDN and sham of -6.3 mmHg (p <0.0001). The results from the three RADIANCE clinical trials have been included in the submission for approval to the U.S. FDA. 

Hypertension is the leading contributor to disease burden worldwide, resulting in increased cardiovascular morbidity and mortality, poorer quality of life, and higher costs to health systems. The Paradise uRDN System bears the CE mark for the treatment of hypertension in Europe and is an investigational device in the United States and Japan. 

About ReCor Medical, Inc.

ReCor Medical, headquartered in Palo Alto, CA, a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd., is a medical technology company focused on transforming the management of hypertension. ReCor has pioneered the use of the Paradise Ultrasound Renal Denervation (uRDN) System for the treatment of hypertension. The Paradise System is an investigational device in the United States and Japan and bears the CE mark in the EU. ReCor has reported positive outcomes in three independent, randomized, sham-controlled studies of the Paradise System in patients with mild-to-moderate and resistant hypertension. In addition, ReCor has begun the Global Paradise System (“GPS”) Registry in the European Union, with plans to expand globally.

https://www.recormedical.com/

About Otsuka Medical Devices Co., Ltd.

Otsuka Medical Devices focuses on the global development and commercialization of medical care products including 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 global healthcare company listed on the Tokyo Stock Exchange (JP 4578).

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

Media Contact

Annika Parrish
Health+Commerce
annika@healthandcommerce.com

 Compiled Data from RADIANCE Global Program Show Consistent Treatment Effect and Safety Across Broad Patient Population

Palo Alto, Calif. – November 6, 2022 – ReCor Medical, Inc. (“ReCor”) and its parent company, Otsuka Medical Devices Co., Ltd. today announced consistent and significant blood pressure (“BP”) lowering results across a range of patients with uncontrolled hypertension, including across differences in age, sex, baseline blood pressure, medication level and ethnicity. The results come from analysis of the pooled data from ReCor’s RADIANCE Global Clinical Trial Program: three prospectively powered, randomized and sham-controlled clinical trials which evaluated the endovascular Paradise™ Ultrasound Renal Denervation (“uRDN”) System in patients with uncontrolled hypertension. The results were presented at the 2022 American Heart Association (“AHA”) annual meeting by Dr. Ajay Kirtane, Professor of Medicine at Columbia University, Vagelos College of Physicians and Surgeons and an interventional cardiologist at NewYork-Presbyterian/Columbia University Irving Medical Center.

The RADIANCE Pooled Analysis includes data from more than 500 patients randomized in the three studies from ReCor’s RADIANCE Global Program: RADIANCE-HTN TRIO, which studied patients with resistant hypertension, and RADIANCE-HTN SOLO and RADIANCE II, which studied patients with mild-moderate hypertension. The combined dataset showed an overall reduction in daytime ambulatory systolic BP in the uRDN group of -8.5 mmHg (p<0.0001) with a difference between treatment and sham at two months of -5.9 mmHg (p<0.0001), favoring uRDN. Blood pressure results were similarly positive in the 24-hour, nighttime, home, and office measures. A favorable safety profile was consistently observed following uRDN treatment across the studies.

“Pooling the data from the RADIANCE program demonstrates that treatment with the Paradise uRDN System results in a consistent reduction in blood pressure across differing severities of hypertension. The consistent and clinically meaningful BP reduction across multiple patient groups increases our interest in the use of uRDN as a potential therapeutic option, when added to lifestyle modification and medications for our patients with uncontrolled blood pressure,” said study co-principal investigator Ajay Kirtane.

“It is very important that the RADIANCE pooled analysis demonstrated a consistent blood pressure reduction in patients across a range of hypertension and both with and without antihypertensive medication, thus broadening the potential applicability of uRDN. Just as important, more than 50% of patients treated with uRDN in the pooled analysis either achieved daytime ambulatory BP control or had a greater than 10 mmHg decrease in daytime ambulatory systolic BP at two months, showing the potential benefits of uRDN as an element of a treatment regimen for patients with uncontrolled hypertension,” said study principal investigator Michel Azizi, Professor of Medicine at Université Paris Cité, Hôpital Européen Georges Pompidou, Paris, France.

The RADIANCE Global Program is an international, multicenter, first-of-its-kind initiative designed to explore the benefits of ultrasound renal denervation in hypertension. The RADIANCE studies are double-blind, randomized, sham-controlled trials designed to provide information about the ability of the Paradise uRDN System to treat high blood pressure. All three studies in the RADIANCE Global Program were individually powered for efficacy with a primary endpoint of daytime systolic ambulatory blood pressure at two months, and all three met their primary efficacy endpoint with statistical significance at two months.

If maintained in the long-term, the blood pressure reductions demonstrated in the RADIANCE pooled analysis correlate to a potential 25% reduction in cardiovascular risk as shown in a meta-analysis of the cardiovascular benefits of antihypertensive medications. 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.

The Paradise uRDN System bears the CE mark for the treatment of hypertension in Europe and is an investigational device in the United States and Japan.

About ReCor Medical, Inc.

ReCor Medical, headquartered in Palo Alto, CA, a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd., is a medical technology company focused on transforming the management of hypertension. ReCor has pioneered the use of the Paradise ultrasound renal denervation (uRDN) system for the treatment of hypertension. The Paradise System is an investigational device in the United States and Japan, and bears the CE mark in the EU. ReCor has reported positive outcomes in three independent, randomized, sham-controlled studies of the Paradise System in patients with mild-to-moderate and resistant hypertension and plans to submit results of its RADIANCE Global Program as part of a PMA to the US FDA for market approval.  In addition, ReCor has initiated the Global Paradise System (“GPS”) Registry in the EU with plans to expand on a global basis.

https://www.recormedical.com/

About Otsuka Medical Devices Co., Ltd.

Otsuka Medical Devices focuses on the global development and commercialization of medical care products including 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 global healthcare company listed on the Tokyo Stock Exchange (JP 4578).

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

Media Contact

Annika Parrish
Health+Commerce
annika@healthandcommerce.com

Study of the Paradise™ Ultrasound Renal Denervation System Shows Significant Reduction in Blood Pressure in Patients with Uncontrolled Hypertension

Palo Alto, Calif. – September 18, 2022 – ReCor Medical, Inc. (“ReCor”), a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd., today announced the detailed results from the RADIANCE II US FDA IDE pivotal trial evaluating the endovascular Paradise™ Ultrasound Renal Denervation (uRDN) System as a treatment for hypertension. Principal Investigator Ajay J. Kirtane, MD, Professor of Medicine at Columbia University, Vagelos College of Physicians and Surgeons / NewYork-Presbyterian Hospital, presented the study results in a Late Breaking Clinical Science session at TCT 2022, the annual scientific symposium of the Cardiovascular Research Foundation. The highly anticipated results follow ReCor’s announcement in July that the RADIANCE II study met its primary efficacy endpoint, demonstrating a statistically significant reduction in daytime ambulatory systolic blood pressure at two months between uRDN and a sham procedure.

Conducted as an international, multicenter study, RADIANCE II is a US FDA IDE, randomized, sham-controlled pivotal trial of the Paradise uRDN System in the treatment of patients with uncontrolled hypertension. Among 1038 patients screened for eligibility at more than 60 study centers in 8 countries, 224 patients with uncontrolled hypertension were randomized 2:1 to uRDN or a sham. Patients were to remain off antihypertensive medications throughout the 2 months of follow-up unless specified BP criteria were exceeded. At the 2-month primary efficacy endpoint, patients treated with the Paradise uRDN system had a mean reduction in daytime ambulatory systolic blood pressure of -7.9 mmHg, compared to a reduction of -1.8 mmHg in the sham arm, corresponding to a statistically significant between-group difference of -6.3 mmHg (p<0.0001). Similar reductions in blood pressure were observed in nighttime and 24-hour measures, as well as measurements taken at home and in the physician office. No major adverse events were seen at 30 days, the primary safety endpoint will be measured at 6 months, and patients will be followed for 60-months.

“These results are important to the field of hypertension treatment. RADIANCE II is the third and largest randomized, sham-controlled study to show that the Paradise uRDN System delivers meaningful reductions in blood pressure in patients with uncontrolled hypertension,” said Study Principal Investigator Ajay Kirtane. “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 who gave so much of themselves—including during the COVID pandemic—in order to complete this rigorously conducted trial.”

Echoing these thoughts, study principal investigator Michel Azizi, Professor of Medicine at Université Paris Cité, Hôpital Européen Georges Pompidou, Paris, France said, “The results from RADIANCE II provide further evidence for uRDN as a potential therapy option for hypertension. The RADIANCE II results are strongly consistent across all measures of blood pressure within the study and are also consistent with the prior SOLO (off-medication) and TRIO (on triple antihypertensive combination treatment) trials—adding confidence in the treatment effect of the Paradise uRDN system across a broad spectrum of hypertension severity. These results align well with the recent consensus statement from the European Society of Cardiology, supporting the use of renal denervation for treatment of uncontrolled hypertension. Additionally, if these results are maintained over the long-term—as already shown by the 36-month results of the SOLO trial and 24-month results of the TRIO trial—the reductions in blood pressure seen in the RADIANCE trials are of a magnitude previously shown in hypertension drug trials to be associated with cardiovascular risk reduction.”

“We are thrilled with the results from RADIANCE II. This is further evidence that the Paradise uRDN System lowers blood pressure in a wide range of patients who are struggling to control their hypertension,” said ReCor president and CEO, Andrew M. Weiss. “ReCor looks forward to working with physicians and regulating bodies around the world to make the Paradise System treatment available to patients and their physicians who are seeking better control of their hypertension.”

About ReCor Medical, Inc.

 ReCor Medical, headquartered in Palo Alto, CA, a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd., is a medical technology company focused on transforming the management of hypertension. ReCor has pioneered the use of the Paradise ultrasound renal denervation (uRDN) system for the treatment of hypertension. The Paradise System is an investigational device in the United States and bears the CE mark in the EU. ReCor has reported positive outcomes in three independent, randomized, sham-controlled studies of the Paradise System in patients with mild-to-moderate and resistant hypertension and plans to submit results of its RADIANCE Global Program as part of a PMA to the US FDA for market approval.  In addition, ReCor has initiated the Global Paradise System (“GPS”) Registry in the EU with plans to expand on a global basis.

https://www.recormedical.com/

 About Otsuka Medical Devices Co., Ltd.

 Otsuka Medical Devices focuses on the global development and commercialization of medical care products including 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 global healthcare company listed on the Tokyo Stock Exchange (JP 4578).

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

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Annika Parrish
Health+Commerce
annika@healthandcommerce.com

Palo Alto, Calif. – July 26, 2022 – ReCor Medical, Inc. (“ReCor”) and Otsuka Medical Devices Co., Ltd., a fully owned subsidiary of Otsuka Holdings Co., Ltd., today announced that the RADIANCE II US FDA IDE pivotal trial evaluating the Paradise™ Ultrasound Renal Denervation (uRDN) System as a treatment for hypertension met its primary efficacy endpoint, demonstrating a statistically significant reduction in daytime ambulatory systolic blood pressure between treatment and a sham procedure measured at two months.

The RADIANCE II US FDA IDE pivotal trial is a randomized, sham-controlled clinical trial of the ReCor Paradise uRDN System for the treatment of patients with uncontrolled hypertension. 224 patients with mild-to-moderate uncontrolled hypertension, previously treated with up to two medications, were randomized while off medications at more than 60 study centers in 8 countries.

“Despite the truly formidable challenges of conducting a complex clinical trial in the throes of the COVID-19 pandemic, we are thrilled to observe these positive results of RADIANCE II, especially in light of those we have previously reported from RADIANCE-HTN SOLO and TRIO,” said Study Principal Investigators Ajay Kirtane, Professor of Medicine at Columbia University, Vagelos College of Physicians and Surgeons / NewYork-Presbyterian Hospital and Michel Azizi, Professor of Medicine at Université Paris Cité, Hôpital Européen Georges Pompidou, Paris, France. “We cannot adequately convey our thanks to the patients, coordinators, and study physicians for their collective efforts, and we very much look forward to being able to present and publish the complete study details in the near future.”

“We at Otsuka are very pleased with the positive outcome of the RADIANCE II study,” said Kazumichi Kobayashi, Executive Deputy President of Otsuka Medical Devices. “With three successful clinical trials of the Paradise uRDN System, we believe even more strongly that the Paradise System can become an important treatment option for patients and physicians struggling to control blood pressure.”

“ReCor is thrilled that the RADIANCE II trial met its primary efficacy endpoint. Following the positive SOLO and TRIO clinical trials, RADIANCE II adds to the evidence for the Paradise System as a potential future treatment for patients with uncontrolled hypertension,” said ReCor president and CEO, Andrew M. Weiss. “We would like to express our gratitude to the Principal Investigators, Steering Committee and all investigators for their efforts throughout this important trial.”

RADIANCE II is the third and largest component of ReCor’s RADIANCE Global Program—randomized and sham-controlled studies evaluating the Paradise uRDN System in patients with hypertension. The first two studies in the series are the previously reported RADIANCE-HTN SOLO (conducted in patients with mild-to-moderate hypertension) and TRIO (conducted in those who remained hypertensive despite being on antihypertensive therapy). Both studies met their primary effectiveness endpoints. With RADIANCE II, ReCor now has a third positive trial, with more than 500 patients randomized in the RADIANCE Global Program. ReCor has also begun the Global Paradise System (“GPS”) Registry—a real-world study of up to 3,000 patients with uncontrolled hypertension.

About ReCor Medical, Inc. 

ReCor Medical, headquartered in Palo Alto, CA, a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd., is a medical technology company focused on transforming the management of hypertension. ReCor has pioneered the use of the Paradise ultrasound renal denervation (uRDN) system for the treatment of hypertension. The Paradise System is an investigational device in the United States and bears the CE mark in the EU. ReCor has reported positive outcomes in three independent, randomized, sham-controlled studies of the Paradise System in patients with mild-to-moderate and resistant hypertension and plans to submit results of its RADIANCE Global Program as part of a PMA to the US FDA for market approval.  In addition, ReCor has initiated the Global Paradise System (“GPS”) Registry in the EU with plans to expand on a global basis.

https://www.recormedical.com/

 About Otsuka Medical Devices Co., Ltd. 

Otsuka Medical Devices focuses on the global development and commercialization of medical care products including 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 global healthcare company listed on the Tokyo Stock Exchange (JP 4578).

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

Media Contact

Annika Parrish
Health+Commerce
annika@healthandcommerce.com

Results presented at EuroPCR 2022 show notable reduction of blood pressure in patients on and off medications at six months

Palo Alto, Calif. – May 17, 2022 – ReCor Medical, Inc. (“ReCor”) and Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) a fully owned subsidiary of Otsuka Holdings Co., Ltd., today announced that Dr. Ajay Kirtane presented a pooled data analysis from ReCor’s two randomized, sham-controlled trials evaluating the Paradiseä Ultrasound Renal Denervation (uRDN) System for the treatment of hypertension at the EuroPCR annual meeting in Paris. The analysis demonstrated a statistically significant reduction in blood pressure (BP) across a broad range of hypertension severity as represented in the RADIANCE-HTN SOLO and TRIO studies. The data was presented in a late-breaking session titled “Hypertension management in 2022: control it, live longer” on World Hypertension Day.

The pooled analysis combined data from 282 patients randomized in ReCor’s two prospectively powered, sham-controlled studies enrolling two disparate patient populations: TRIO (patients with resistant hypertension) and SOLO (patients with mild-moderate hypertension). There were consistent benefits in both blood pressure reduction and medication burden across the pooled patient population compared to sham. The combined dataset showed an overall between-group difference through 6 months favoring uRDN in daytime ambulatory systolic BP of -4.8 mmHg (95% CI: -7.1 to -2.5, p<0.001) and home systolic BP of -5.4 mmHg (95% CI: -7.3 to -3.6, p<0.001).

“The results of this pooled analysis make clear the consistent blood pressure-lowering effect that ultrasound renal denervation can have across differing severities of hypertension, regardless of trial design and whether the enrolled patients are on or off antihypertensive medications,” said principal investigator Ajay Kirtane, Professor of Medicine at Columbia University, Vagelos College of Physicians and Surgeons and NewYork-Presbyterian Hospital. “Assuming continued safety of the procedure is demonstrated, ultrasound renal denervation is a promising treatment option complementary to lifestyle modification and medications for patients with uncontrolled hypertension.”

The RADIANCE Global Program is an international, multicenter, first-of-its-kind initiative designed to explore the benefits of ultrasound renal denervation (uRDN) in hypertension. The RADIANCE studies are double-blind, randomized, sham-controlled trials designed to provide additional information about the ability of the Paradise uRDN System to treat high blood pressure. RADIANCE-HTN includes the aforementioned SOLO and TRIO studies, which were individually powered for efficacy with a primary endpoint of daytime systolic ambulatory blood pressure (ABP) at 2 months. Both studies met their primary efficacy and safety endpoints at 2 months.

The RADIANCE Global Program also includes RADIANCE-II, a pivotal trial which recently completed patient enrollment. Study outcomes will be presented to the scientific and medical communities later this year. Results will report on the safety and effectiveness of the Paradise uRDN System to reduce blood pressure in patients with hypertension, in the absence of antihypertensive medications.

The Paradise uRDN System bears the CE mark for the treatment of hypertension in Europe and is an investigational device in the United States. 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 bears the CE mark in the EU. 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, in the United States and Europe, and pending successful completion will submit a PMA to the US FDA for market 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 therapies that provide new therapeutic options in areas where patient needs cannot be met through pharmaceutical treatment. Otsuka Medical Devices Co., Ltd. is a subsidiary of Otsuka Holdings Co., Ltd., a leading global healthcare group listed on the Tokyo Stock Exchange (JP 4578). With operations in pharmaceuticals, nutraceuticals, medical devices and other health-related businesses, the group generated worldwide sales of app. US$13 billion in the fiscal year ended December 2021 and has a market capitalization of app. US$19 billion.

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

Media Contact
Annika Parrish
Health+Commerce
annika@healthandcommerce.com