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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.
http://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.

http://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

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.

http://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.

http://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.

http://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. – 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.

http://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.

http://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

Data from RADIANCE-II will build on evidence from RADIANCE-HTN SOLO and TRIO studies to support pre-market application to the FDA

 

Palo Alto, Calif. – March 29, 2022 – ReCor Medical, Inc. (“ReCor”), a fully owned subsidiary of Otsuka Medical Devices Co., Ltd., announced today completion of enrollment in their RADIANCE-II pivotal trial of the Paradise Ultrasound Renal Denervation (uRDN) System for the treatment of uncontrolled hypertension. Subject to study outcomes, the RADIANCE-II results will be combined with the previously released data from the Company’s RADIANCE-HTN SOLO and TRIO studies in a pre-market application to the FDA for US market approval, and will be presented to the scientific and medical communities in publications and conferences later this year.

The RADIANCE-II pivotal trial is a randomized, sham-controlled clinical trial of ReCor’s Paradise uRDN System for the treatment of uncontrolled hypertension in patients on zero-to-two antihypertensive oral medications. After 4 weeks of washout from antihypertensive medications, patients are randomized at a 2:1 ratio to either Paradise uRDN or a sham procedure. The primary efficacy endpoint is the difference in daytime ambulatory systolic blood pressure between Paradise uRDN and sham measured at two months post-procedure, while the primary safety endpoint is a composite of 30-day major adverse events. More than 1,000 study subjects have been enrolled over 3 years at more than 50 study centers in 6 countries, with over 200 patients randomized to uRDN or a sham procedure.

“The RADIANCE-II pivotal trial was carefully designed to assess the BP-lowering efficacy and safety of treating uncontrolled hypertension with the Paradise uRDN System. We are grateful to the investigators and study participants across the globe for their work on the study – especially through the challenges created by the COVID-19 pandemic over the past two years. We look forward to their continued help in the coming months to complete this landmark study, and we are excited to assess trial outcomes later this year,” said co-principal investigators Michel Azizi and Ajay Kirtane. Michel Azizi is Professor of Medicine at Université Paris Cité, Head of the ESH Hypertension Excellence Center, Hôpital Européen Georges Pompidou, Paris, France and Ajay Kirtane is Professor of Medicine at Columbia University, Vagelos College of Physicians and Surgeons and NewYork-Presbyterian Hospital.

RADIANCE-II is the third component of ReCor’s RADIANCE Clinical Trial program in patients with hypertension, which includes the RADIANCE-HTN SOLO and TRIO studies.  In the randomized and sham-controlled SOLO trial, 146 patients with mild-to-moderate hypertension were assessed in an “off-meds” setting. In the landmark TRIO trial, 136 patients who remained hypertensive, despite a standardized triple antihypertensive therapy, were randomized 1:1 to the Paradise uRDN treatment or sham. Both studies met their primary effectiveness endpoints. ReCor has begun the fourth component of their RADIANCE program with the launch of the Global Paradise System (“GPS”) Registry – a real-world study of patients with uncontrolled hypertension initiated in Germany earlier this year.

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 a 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.

http://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/

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Annika Parrish
Health+Commerce
annika@healthandcommerce.com

RADIANCE-HTN TRIO and SOLO trial updates demonstrate the durability of blood pressure lowering effects of the Paradise Ultrasound Renal Denervation System in a broad spectrum of patients with hypertension.

Palo Alto, Calif. – 4 November, 2021 – Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”), a fully owned subsidiary of Otsuka Holdings Co., Ltd., and its subsidiary ReCor Medical, Inc. (“ReCor”) today announced the presentation of 6-month results from the RADIANCE-HTN TRIO (“TRIO”) study, a randomized sham-controlled trial in patients with resistant hypertension.  Reported in a late-breaking clinical trial session at the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting, patients treated with the Paradise™ Ultrasound Renal Denervation System maintained its blood pressure (BP) lowering effect over six months. In addition, data from the RADIANCE-HTN SOLO (“SOLO”) trial were presented in a poster session, demonstrating a durable BP lowering effect over 24 months for those patients treated with the Paradise System.

The seminal TRIO study evaluated the efficacy and safety of the Paradise System in patients with resistant hypertension who remained uncontrolled following treatment with a single pill containing 3 standardized antihypertensive medications. The 6-month follow-up data showed that the treatment was durable in patients who originally had an 8.0 mmHg median reduction in daytime ambulatory systolic BP at the 2-month primary endpoint. After primary endpoint collection, the second phase of the trial consisted of a sequential addition of standardized antihypertensive medications in both groups to lower BP to clinically recommended targets. At 6 months, the renal denervation group achieved lower home systolic BP and similar ambulatory systolic BP with fewer added medications, including less use of aldosterone antagonists, the recommended 4^th line antihypertensive medication for resistant hypertension. There were no differences in safety outcomes between the two groups.

The SOLO study measured the BP lowering effect of the Paradise System in patients with mild to moderate hypertension, taking no medications at study randomization. The study met its primary endpoint at two months when patients were off medications, and showed a persistent BP lowering effect at 6 and 12 months with fewer antihypertensive medications. The results at 24 months in the SOLO trial confirm the persistence of a clinically relevant BP reduction in the patients treated with the Paradise System. The treated arm achieved a substantial 17.1 mmHg mean reduction in office-measured systolic BP from baseline at 24 months, following introduction of an average of 1.2 oral antihypertensive medications. No adverse safety signals were observed.

“The RADIANCE-HTN TRIO study demonstrates the efficacy and 6-month safety outcomes of the Paradise Ultrasound Renal Denervation System in patients with resistant hypertension. After renal denervation, further reductions in blood pressure were achieved with fewer added medications, particularly aldosterone antagonists,” said co-principal investigator Ajay J. Kirtane, MD, SM, Professor of Medicine at Columbia University Vagelos College of Physicians and Surgeons. “These data lend further support for the Paradise System as a potential treatment option for patients with resistant hypertension.”

“Durability of the blood pressure lowering effect of renal denervation has been a focal point for many in the field of hypertension. The latest data from the RADIANCE-HTN SOLO trial show that the Paradise Ultrasound Renal Denervation System’s treatment effect is still present at 24 months with no risk to patient safety, consistent with other long-term observational data,” said 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.

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.

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

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.

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/