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/

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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.

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/

Media Contact

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/

 

 

 

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

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

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

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

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

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

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

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

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

About ReCor Medical, Inc.

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

 

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

http://www.recormedical.com/

About Otsuka Medical Devices Co., Ltd.

Otsuka Medical Devices focuses on the global development and commercialization of endovascular devices that provide new therapeutic options in areas where patient needs cannot be met through pharmaceutical or other conventional treatment. Otsuka Medical Devices Co., Ltd. is a subsidiary of Otsuka Holdings Co., Ltd. (www.otsuka.com/en), a leading global healthcare group listed on the Tokyo Stock Exchange (JP 4578).

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

 

Media Contact:

Gaelin White
Health+Commerce
gaelin@healthandcommerce.com

 

 

 

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

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

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

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

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

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

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

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

About ReCor Medical, Inc.

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

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

http://www.recormedical.com/

About Otsuka Medical Devices Co., Ltd.

Otsuka Medical Devices focuses on the global development and commercialization of endovascular devices that provide new therapeutic options in areas where patient needs cannot be met through pharmaceutical or other conventional treatment. Otsuka Medical Devices Co., Ltd. is a subsidiary of Otsuka Holdings Co., Ltd. (www.otsuka.com/en), a leading global healthcare group listed on the Tokyo Stock Exchange (JP 4578).

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

 

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

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

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

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

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

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

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

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

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

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

About ReCor Medical, Inc.

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

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

http://www.recormedical.com/

About Otsuka Medical Devices Co., Ltd.

Otsuka Medical Devices focuses on the global development and commercialization of endovascular devices that provide new therapeutic options in areas where patient needs cannot be met through pharmaceutical or other conventional treatment. Otsuka Medical Devices Co., Ltd. is a subsidiary of Otsuka Holdings Co., Ltd. (www.otsuka.com/en), a leading global healthcare group listed on the Tokyo Stock Exchange (JP 4578).

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

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

SOURCE ReCor Medical, Inc.

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

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

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

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

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