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How ReCor Medical is Taking Action to Confront Racism

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To Our Friends and Colleagues,

The Team at ReCor Medical believes that, in light of the horrific death of George Floyd and the subsequent protests it triggered around the United States and the world, we have a responsibility to publicly support our core values of mutual respect and social justice.

First – the core values at ReCor are based on mutual respect and care for all people – irrespective of race, color, age, religion, sex, sexual orientation, nationality, wealth or health status. Here in the United States, the death of Mr. Floyd is a stark reminder of the threat of institutional racism – especially to our Black fellow citizens – within our policing and judicial systems, within our systems of education, housing, and healthcare, and to the basic rights of safety, personal growth and liberty. As a pluralistic, civil democracy, we must do better: the responsibility of the majority is to care for the rights of the minorities. We can do more.

Second – we at ReCor believe that we are all members of our civil society, and that we all share responsibility to develop a more just society, where all people share the basic civil rights of housing, education, justice, fair policing, freedom of thought and expression, and access to healthcare. Healthcare access is especially relevant to the ReCor team, as innovation in healthcare is how we have chosen to devote our professional lives. We believe that healthcare access is a matter of social justice – and includes preventative care, mental healthcare, specialty care, long term care, geriatric care and more. Access to healthcare should be for all members of our society, independent of wealth, location and health status.

Third – we at ReCor are a diverse team of people from around the world. We work hard to promote mutual respect, integrity and fairness in our company. We are committed to further support social justice, with specific focus in the United States on the Black and Hispanic communities. We will seek numerous paths, including to advocate for social justice and healthcare access, to build opportunity paths for the under-served, to adjust our hiring practices to build diverse candidate slates, and to develop enhanced awareness of unconscious bias within our team.

In short – we at ReCor support the protestors around the world who have peacefully demonstrated for equal justice, civil rights and opportunity for all people.

We support you. We seek to do our part.

 

The Team at ReCor Medical

ReCor Medical Announces 6 Month On-Medication Results from RADIANCE-HTN SOLO Clinical Trial and the First Randomization in the RADIANCE-II Pivotal Study

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

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

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

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

 

About ReCor Medical, Inc.

ReCor Medical is a medical device company that designs and manufactures the Paradise System, a proprietary ultrasound ablation system for renal denervation (RDN). RDN is a new potential therapeutic approach for the treatment of hypertension, one of the most prevalent medical conditions. The Paradise System is approved for sale in the EU and bears a CE mark, but is not approved for sale in the United States. The System’s intravascular catheters denervate renal nerves by combining the protection of waterbased cooling of the renal artery with high intensity ultrasound energy for circumferential renal nerve ablation. The Paradise System has been studied in clinical trials of approximately 300 patients to date. Following the positive outcomes of the RADIANCE-HTN SOLO trial, ReCor will continue its evaluations of Paradise in RADIANCE-HTN TRIO (a feasibility study of patients with resistant hypertension), REQUIRE (a pivotal study of patients with resistant hypertension in Japan and Korea), and most recently with the launch the RADIANCE II pivotal study (a study of patients with moderate hypertension) in the United States and Europe.

About Otsuka Holdings Co., Ltd. and Otsuka Medical Devices Co., Ltd.

Otsuka Holdings Co., Ltd. is the holding company of the Otsuka group, a global healthcare group headquartered in Tokyo, Japan. With operations in pharmaceuticals, nutraceuticals, medical devices and other health-related businesses, the group generated worldwide sales of JPY1,292 billion in the fiscal year ended December 2018.

http://www.otsuka.com/en/

Established in 2011, Otsuka Medical Devices Co., Ltd. is a fully-owned subsidiary of Otsuka Holdings and one of its core operating subsidiaries. Otsuka Medical Devices focuses on the development and commercialization of endovascular devices that provide new therapeutic options in areas where patient needs cannot be met through pharmaceutical or other conventional treatment. Otsuka Medical Devices conducts the REQUIRE trial for renal denervation in hypertensive patients (n=140), who are uncontrolled on 3 or more medications including a diuretic, in Japan and Korea through its subsidiary JIMRO Co., Ltd.

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

Otsuka Medical Devices, Otsuka Holdings and ReCor Medical Announce Signing of Merger Agreement

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TOKYO and PALO ALTO, Calif., July 10, 2018 /PRNewswire-USNewswire/ — Otsuka Holdings Co., Ltd. (“Otsuka Holdings”), Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) and ReCor Medical, Inc. (“ReCor”) announce the signing of a merger agreement pursuant to which Otsuka Holdings will acquire the remaining shares in ReCor from its current holders. The transaction is subject to approval by ReCor’s shareholders.

Otsuka Holdings’ acquisition follows the announcement by ReCor on June 15 that the U.S. FDA has given its approval to initiate a pivotal clinical study, RADIANCE II, for the evaluation of the Paradise™ Renal Denervation System (“Paradise System”) for safe and effective reduction of blood pressure in patients with hypertension. Previously, on May 23rd, ReCor announced at EuroPCR 2018, with simultaneous publication in The Lancet, that its RADIANCE-HTN SOLO (“SOLO”) study of the Paradise System met its primary efficacy endpoint and demonstrated a statistically significant reduction in blood pressure in hypertensive patients.

Following the acquisition, ReCor plans to continue to develop and evaluate the Paradise System in patients with hypertension in preparation for worldwide commercialization, as well as explore its use in additional clinical applications such as heart failure, kidney disease and metabolic disorders, while also building the Otsuka Medical Devices’ incubation and clinical development hub in the U.S. and Europe.

Tatsuo Higuchi, President and Representative Director of Otsuka Holdings, said: “Our decision today reflects not only ReCor’s excellent clinical results, but also the close relationship we have built over the years. Our acquisition of ReCor represents an important step forward for Otsuka’s medical device business, leveraging an innovative technology with Otsuka’s expertise in pharmaceuticals and clinical development.” Kazumichi Kobayashi, Global Renal Denervation Project leader and board member of Otsuka Medical Devices, added: “ReCor’s statistically significant clinical results in the SOLO trial are convincing biological proof that renal denervation with ReCor’s ultrasound-based system is effective in reducing blood pressure in patients with hypertension. We are excited to commercialize this technology, which has the potential to become one of the great technological advancements in hypertension treatment together with the ReCor team.”

Andrew Weiss, President & CEO of ReCor, said: “We are very encouraged by the results of our clinical trials with the Paradise System, which have been conducted in the US and Europe – none of which would have been possible without Otsuka and the strong relationship between our teams. This transaction demonstrates that tremendous value can be created for companies and venture investors through strategic partnerships.” Mano Iyer, COO and Founder, added “We are grateful for the support ReCor has enjoyed from our co-founders Antoine Papiernik of SOFINNOVA Partners and Dr. Jacques Seguin, and our clinical study partners worldwide. We are excited to move forward in our collaboration with Otsuka to make the Paradise Renal Denervation System a standard of care for treatment of hypertensive patients worldwide.”

About ReCor Medical, Inc.

ReCor Medical is a medical device company that designs and manufactures the Paradise System, a proprietary ultrasound ablation system for renal denervation (RDN). RDN is a new potential therapeutic approach for the treatment of hypertension, one of the most prevalent medical conditions. The Paradise System is approved for sale in the EU and bears a CE mark, but is not approved for sale in the United States. The System’s intravascular catheters denervate renal nerves by combining the protection of water-based cooling of the renal artery with high intensity ultrasound energy for circumferential renal nerve ablation. The Paradise System has been studied in clinical trials of approximately 300 patients to date. Following the positive outcomes of the RADIANCE-HTN SOLO trial, ReCor will continue its evaluations of Paradise in RADIANCE-HTN TRIO (a feasibility study of patients with resistant hypertension) and REQUIRE (a pivotal study of patients with resistant hypertension in Japan and Korea), and launch the RADIANCE II pivotal study (a study of patients with moderate hypertension) in the United States and Europe.

https://www.recormedical.com/

About Otsuka Holdings Co., Ltd. and Otsuka Medical Devices Co., Ltd.

Otsuka Holdings Co., Ltd. is the holding company of the Otsuka group, a global healthcare group headquartered in Tokyo, Japan. With operations in pharmaceuticals, nutraceuticals, medical devices and other health-related businesses, the group generated worldwide sales of JPY1,240 billion in the fiscal year ended December 2017.

http://www.otsuka.com/en/

Established in 2011, Otsuka Medical Devices Co., Ltd. is a fully-owned subsidiary of Otsuka Holdings and one of its core operating subsidiaries. Otsuka Medical Devices focuses on the development and commercialization of endovascular devices that provide new therapeutic options in areas where patient needs cannot be met through pharmaceutical or other conventional treatment.

Otsuka Medical Devices conducts the REQUIRE trial for renal denervation in hypertensive patients (n=140), who are uncontrolled on 3 or more medications including a diuretic, in Japan and Korea through its subsidiary JIMRO Co., Ltd.

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

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

ReCor Medical Announces FDA Approval of IDE for Pivotal Study of Paradise™ Ultrasound Denervation System for Treatment of Hypertension

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PALO ALTO, Calif., July 2, 2018 /– ReCor Medical announced today that the US Food & Drug Administration approved the Company’s new pivotal study of the Paradise Ultrasound Denervation System for the treatment of hypertension: RADIANCE-II.

Building upon the recent positive results of the Company’s RADIANCE-HTN SOLO study, RADIANCE-II will be a randomized, sham-controlled, blinded study in patients with moderate hypertension, powered to demonstrate the safety and efficacy of the Paradise System’s ability to lower blood pressure.  ReCor expects to initiate enrollment in RADIANCE-II in October of this year.

“We have had a very constructive dialog with the FDA during the past 9 months to craft what we believe is a strong study to develop a robust set of clinical data to support the future FDA review for PMA approval,” commented Leslie Coleman, Vice President of Regulatory & Medical Affairs.  “At the time of PMA submission we plan to have 4 independently-powered, blinded, sham-controlled, randomized studies of the Paradise System in patients with different stages  of hypertension – our SOLO, TRIO, REQUIRE, and RADIANCE-II studies – approaching a total of nearly 500 subjects, with outcomes as long as 3 years.”

“Our Steering Committee and medical advisors have been instrumental in the design of the Global RADIANCE Clinical Program – including the RADIANCE-II pivotal study – for the US, Europe, Japan and Korea,” added Helen Reeve-Stoffer, Vice President of Clinical Affairs.  “Given the recent positive SOLO results, and subsequently the numerous review articles in medical journals, we recognize the potential impact the Paradise System may have in the treatment of hypertension for millions of patients world-wide.  Accordingly, ReCor is committed to conduct rigorous, randomized, controlled studies to demonstrate the safety and efficacy of the Paradise System to lower blood pressure, thus helping physicians to evaluate how, in whom, and when to use Paradise for the treatment of hypertension.”

 

About ReCor Medical, Inc.

ReCor Medical is a private, clinical-stage, medical device company that has developed the Paradise™ System, a proprietary, ultrasound-based system for endovascular denervation of the renal nerves (RDN).  RDN is a potential therapeutic option for treatment of hypertension, one of the most prevalent medical conditions.  The Paradise System bears a CE mark but is not approved for sale in the United States.  ReCor is conducting the RADIANCE-HTN clinical trial under an IDE from the US FDA in the United States and Europe, the REQUIRE trial in Japan and Korea with its partner Otsuka, and recently received approval from the FDA to conduct RADIANCE-II as a pivotal study of the Paradise System.

ReCor Medical Announces RADIANCE-HTN SOLO Hypertension Study Meets Primary Efficacy Endpoint, Pivotal Study Submission, and New Principal Investigator

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Note: original press release first appeared on PCRonline.com 

 

May 23, 2018 – Palo Alto, CA, for immediate release – ReCor Medical announced today that the RADIANCE-HTN SOLO study met its primary efficacy endpoint and demonstrated a statistically significant reduction in blood pressure in hypertensive patients.  In addition, the company announced submission of an IDE supplement to the US FDA for a pivotal study of its Paradise System for the treatment of hypertension, and that Prof. Ajay Kirtane of New York-Presbyterian Hospital/Columbia University has taken the role of Co-Principal Investigator for RADIANCE-HTN.

Data presented at EuroPCR 2018, with simultaneous publication in The Lancet, showed that RADIANCE-HTN SOLO met its primary efficacy endpoint.  SOLO demonstrated a difference in ambulatory daytime systolic blood pressure changes between treatment and sham at 2 months of -6.3 mm Hg (p-value of 0.0001) with no major adverse events.  Additional endpoints including office, home, and 24-hour ambulatory blood pressure levels, and the percentage of patients with controlled blood pressure at 2 months were also improved in the Paradise group relative to sham.

“We are pleased with the outcomes of the RADIANCE-HTN SOLO trial,” commented co-Principal Investigator Prof. Laura Mauri, Brigham & Women’s Hospital, Boston, USA. “We believe that SOLO was designed and conducted in a rigorous manner. In patients with mild to moderate hypertension, previously treated with up to two medications and randomized while off medications, the Paradise System reduced blood pressure in comparison to a sham control.  In addition, the procedure was performed with an average ablation time of less than one minute and demonstrated a positive safety profile both acutely and at 30-day follow-up.”

Prof. Michel Azizi, Hôpital Européen Georges-Pompidou, Paris, France, Co-PI, commented, “The SOLO investigators are satisfied with the clinical outcomes in the study.  At 2-months, more than 66% of subjects treated with renal denervation experienced a 5 mmHg or greater reduction in daytime ambulatory systolic blood pressure, compared with 33% in the sham group.  RADIANCE-HTN SOLO also demonstrated a reduction in office blood pressure of 10 mmHg systolic, which if durable over time, has been shown to reduce the risk of cardiovascular diseases, including stroke and heart attack, in patients with hypertension.  The RADIANCE-HTN research program is ongoing, with extended follow-up for the SOLO patients and continued enrollment of the TRIO cohort patients with resistant hypertension.  Our goal is to demonstrate the effectiveness, safety, and durability of renal denervation in both important patient populations.”

“ReCor and the investigator teams are aware of the large potential patient population who may be interested in Paradise as a device-based hypertension therapy. An early indicator of this is the more than 500,000 people who sought information about the RADIANCE-HTN study,” commented Founder & COO, Mano Iyer.

ReCor also announced today that the company submitted a new protocol to the US FDA for a pivotal study: an independently-powered, sham-controlled, efficacy study of the Paradise System in patients with hypertension.

“We are very pleased with the progress of the RADIANCE program to assess the Paradise System as a potential treatment for hypertension.  Given the positive results from SOLO and the high level of interest from patients in the US and Europe for device-based hypertension therapy, we are encouraged to continue our work,” commented CEO Andrew M. Weiss.  “As Prof. Mauri is leaving her clinical position at Brigham & Women’s Hospital in Boston – and thus her role as co-PI – we have invited Prof. Kirtane to fill her role.  We thank Prof. Mauri for her leadership and support during the past 3 years, and welcome Prof. Kirtane to join Prof. Azizi as co-PI.”

About ReCor Medical, Inc.

ReCor Medical is a private, development-stage, medical device company with the Paradise System, a proprietary, ultrasound-based system for endovascular denervation of the renal nerves (RDN).  RDN is a potential therapeutic option for treatment of hypertension, one of the most prevalent medical conditions.  The Paradise System bears a CE mark but is not approved for sale in the United States.  ReCor is conducting the RADIANCE-HTN clinical trial under an IDE from the US FDA in the United States and Europe.  The RADIANCE-HTN SOLO trial is a randomized, sham-controlled, and blinded study of 146 hypertensive patients temporarily withdrawn from their hypertension medications, comparing the ReCor Paradise ultrasound-based Renal Denervation System to a sham procedure.

ReCor Medical To Release Clinical Trial Results May 23 at EuroPCR in Paris

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PALO ALTO, Calif., May 17, 2018 / — ReCor Medical announced today that it will present the primary outcomes data from the SOLO study of its RADIANCE Global Clinical Trial Program of the Paradise™  Ultrasound Renal Denervation System for patients with hypertension during the Late Breaker Sessions at the EuroPCR 2018 Meeting in Paris on 23 May.

The RADIANCE Global Clinical Trial Program includes RADIANCE-HTN, ReCor’s randomized study of the Paradise Renal Denervation System in hypertensive patients in the US and Europe and the REQUIRE study of the Paradise System in resistant hypertensive patients in Japan and Korea.  RADIANCE-HTN involves two study Cohorts: “SOLO” –  whose subjects studied in the absence of anti-hypertensive medications, and “TRIO” – whose subjects are studied on a standardized anti-hypertensive medication.  Both Cohorts are randomized, blinded, sham-controlled, and independently powered for efficacy.  Randomization of the RADIANCE-HTN SOLO cohort study was completed in December, 2017, while the TRIO cohort is currently enrolling in 35 centers in the US and Europe.

The SOLO Cohort primary results will be presented during the Late Breaker Sessions at EuroPCR on May 23rd in Paris, France, by Co-Principal Investigator Laura Mauri, MD, MSc, Brigham & Women’s Hospital, Boston, MA.  In addition, ReCor Medical is sponsoring an RDN Symposium on the same day, with additional analysis, technical review and initial assessment of clinical impact of the SOLO results provided by Michel Azizi, MD, George Pompidou Medical Center (co-PI); Felix Mahfoud, MD, University Hospital Saarland; Roland Schmieder, MD, University Hospital Erlangen; Ajay Kirtane, MD, Columbia University Medical Center and Dr. Mauri.

“We are very pleased to be able to present the SOLO primary outcome data at the EuroPCR meeting, and to have such a distinguished panel of hypertension specialists and cardiologists review the potential impact of the Paradise System in the treatment of hypertension,” commented Andrew M. Weiss, ReCor, President & CEO. “During the past two years more than 500,000 patients sought information about the RADIANCE-HTN study – a strong indication of patient interest in device-based hypertension treatment.  With the completion of the primary outcome phase of our SOLO study, and continued progress in the TRIO cohort of RADIANCE-HTN, we are optimistic about the continued progress of study of the Paradise System, to support the potential for future clinical use.”

 

About ReCor Medical, Inc.

ReCor Medical is a private, development-stage, medical device company with the Paradise™ System, a proprietary, ultrasound-based system for intravascular denervation of the renal nerves (RDN).  RDN is a potential therapeutic option for treatment of hypertension, one of the most prevalent medical conditions.  The Paradise System bears a CE mark but is not approved for sale in the United States.  ReCor is conducting the RADIANCE-HTN clinical trial under an IDE from the US FDA in the United States and Europe.

ReCor Medical Announces Completion of RADIANCE-HTN SOLO Hypertension Study

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January 5, 2018 – Palo Alto, CA, for immediate release, – ReCor Medical announced today randomization of its 146th, and final, subject in the SOLO cohort of its RADIANCE-HTN study.  RADIANCE-HTN, ReCor’s study of its Paradise Renal Denervation System in people with hypertension, involves two study cohorts: “SOLO” – whose subjects are removed from anti-hypertensive medication, and “TRIO” whose subjects are put on standardized medication.  Both cohorts are randomized, blinded, sham-controlled, and powered independently for efficacy.

The RADIANCE-HTN 40 study centers – located in the US, France, Belgium, the Netherlands, Germany and the UK – enrolled 1,000 and randomized 165 study subjects in 2017.  The final SOLO subject was randomized at Massachusetts General Hospital, under the lead of Joseph Garasic, MD, interventional cardiologist and Randall Zusman, MD, Director of the MGH Hypertension Clinic.

Completion of the SOLO cohort of RADIANCE marks the largest blinded, sham-controlled, randomized and powered clinical study of renal denervation in an “off-meds” study design.  Lead enrollers were Yale Wang, MD, at the Minneapolis Heart Center; Florian Rader, MD at Cedars Sinai, Los Angeles; Melvin Lobo, MD, at St Bartholomew’s Hospital, London; and Joost Daemen, MD, at the Erasmus Heart Center, Rotterdam, NL.

“Leaders in the hypertension field understand that patients struggle to persevere with multi-drug regimens required to attain and maintain target blood pressure levels over their lifetimes.  The completion of enrollment into the SOLO arm of RADIANCE-HTN is highly significant as this cohort represents the vast majority of hypertensive patients,” commented Melvin Lobo, MD, Director of Barts BP Center of Excellence at St Bartholomew’s Hospital, London.  “If SOLO proves positive, then there may be a pathway, with additional study, to a reduction of medications, increased longer-term therapeutic options, and improved blood pressure control for our patients.”

“ReCor is very pleased to have finished the SOLO cohort of RADIANCE-HTN in record time.  It is a testimony to the interest of patients, and to the support of our study centers in the US and Europe,” commented Helen Reeve-Stoffer, ReCor Medical, VP Clinical Affairs.  “Given the 60-day time point for the SOLO primary efficacy measure, ReCor anticipates outcome analysis and associated publications starting mid-year in 2018.”

 

ReCor Medical Announces 1000th Enrollment and 150th Randomization in RADIANCE-HTN Hypertension Study

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PALO ALTO, Calif., Oct. 30, 2017 /PRNewswire-USNewswire/ — ReCor Medical announced progress milestones in the study of its Paradise™ Renal Denervation System as a potential treatment for hypertension, including the 1000th consented and the 150th randomized subjects in the RADIANCE-HTN study, and publication of a study design review in the American Heart Journal.  In addition, ReCor reported 40 active study centers in 6 participating countries, and progress in the Otsuka-ReCor commercial partnership in Asia.

“RADIANCE-HTN is a blinded, randomized, sham-controlled study with powered efficacy endpoints designed to demonstrate the potential beneficial blood-pressure-lowering treatment effect of renal denervation using the Paradise System,” commented co-PI Laura Mauri, MD MSc of the Brigham & Women’s Hospital in Boston.  “The study involves two hypertensive patient groups, or “cohorts”; SOLO – for patients with hypertension who are taken off their antihypertensive medications to more precisely evaluate the BP lowering effect of renal denervation alone, and TRIO – for patients who are “resistant” to anti-hypertensive medical therapy, and to assess the additional benefit of Paradise system.  RADIANCE-HTN is progressing well, we are recruiting successfully in both cohorts, and we are confident that it will produce valuable data to evaluate the efficacy of the Paradise System.”

“ReCor is pleased with the progress of the RADIANCE-HTN study – in both SOLO and TRIO patient cohorts,” commented Mano Iyer, ReCor Medical Founder & COO.  “Working closely with our 40 study centers in the US and EU, we have achieved two major milestones: enrollment of the 1000th and randomization of the 150th study subjects.  Based on our current recruitment rates, we are on plan to complete SOLO in early 2018, and TRIO in late 2018.  In addition, the Steering Committee is pleased that the American Heart Journal recently published a design paper about the study, so that the broader medical community can understand its design and potential impact for future clinical treatment.”

“ReCor is very pleased with the global interest in the Paradise System, the potential for device-based treatment of hypertension, and the progress in our studies in the US, EU and Asia,” commented CEO Andrew M. Weiss. “RADIANCE-HTN progress is solid, and patient interest is very high in both SOLO and TRIO cohorts.  Achievement of our 1000th enrollment is a key milestone – and demonstrates that together with our study-center partners, we can complete this important study and evaluate Paradise as a potential hypertension treatment.  In addition, our partnership with Otsuka remains highly positive, and we are collaborating with them on their REQUIRE pivotal study of the Paradise System in Japan and Korea.  We are also now beginning to explore the next phase of our clinical efforts to ensure the medical communities world-wide have the information they need to assess how Paradise may become part of the future treatment paradigm for hypertension.”

 

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

More information about the REQUIRE study can be found at: https://clinicaltrials.gov/ct2/show/NCT02918305?term=REQUIRE&rank=1

ReCor Medical adds another $12m for trial of Paradise renal denervation device

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PALO ALTO, Calif., Aug 16, 2017 / ReCor Medical last week added a $12 million contribution from Otsuka Pharmaceutical to the $10 million it raised from the Japanese conglomerate last year for a clinical trial of its Paradise renal denervation device for treating hypertension, ReCor president & CEO Andrew Weiss told MassDevice.com.

Read the interview with CEO Andrew Weiss and MassDevice.com here.

 

About ReCor Medical, Inc.

ReCor Medical is a private medical device company that designs and manufactures a proprietary ultrasound ablation system for renal denervation (RDN) called the Paradise System™. RDN is a new potential therapeutic approach for the treatment of hypertension, one of the most prevalent medical conditions. The Paradise System is approved for sale in the EU and bears a CE mark, but is not approved for sale in the United States. The System’s intravascular catheters denervate renal nerves by combining the protection of water-based cooling of the renal artery with high intensity ultrasound energy for circumferential renal nerve ablation. ReCor has initiated enrollment in its RADIANCE-HTN study, en IDE-approved, randomized, sham-controlled trial to demonstrate the efficacy of the Paradise System in patients with hypertension.  RADIANCE-HTN is being conducted in approximately 35 centers in the United States, Netherlands, UK, France and Germany.

More information on RADIANCE-HTN can be found at:

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

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

 

ReCor Medical Announces Collaboration and Investment with Otsuka Holdings for Asian Commercialization and Clinical Studies in the US and Europe

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

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

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

Tatsuo Higuchi, President and Representative Director of Otsuka Holdings, said, “We are excited to commercialize ReCor’s unique ultrasound-based renal denervation technology in Asia. This collaboration demonstrates Otsuka’s strategy of leveraging our expertise in select disease areas for the development of medical device-based solutions with the potential to address medical needs that cannot be met by pharmaceutical treatment alone.”

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

About ReCor Medical, Inc.

ReCor Medical is a private medical device company that designs and manufactures a proprietary ultrasound ablation system for renal denervation (RDN) called the Paradise System™. RDN is a new potential therapeutic approach for the treatment of hypertension, one of the most prevalent medical conditions. The Paradise System is approved for sale in the EU and bears a CE mark, but is not approved for sale in the United States. The System’s intravascular catheters denervate renal nerves by combining the protection of water-based cooling of the renal artery with high intensity ultrasound energy for circumferential renal nerve ablation. ReCor has initiated enrollment in its RADIANCE-HTN study, en IDE-approved, randomized, sham-controlled trial to demonstrate the efficacy of the Paradise System in patients with hypertension.  RADIANCE-HTN is being conducted in approximately 35 centers in the United States, Netherlands, UK, France and Germany.

More information on RADIANCE-HTN can be found at:

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

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

About Otsuka Holdings Co., Ltd.

Otsuka Holdings Co., Ltd. is the holding company of the Otsuka group, a global healthcare group headquartered in Tokyo, Japan. With operations in pharmaceuticals, nutraceuticals, medical devices and other health-related businesses, the group generated worldwide sales of approximately JPY1,445 billion in the fiscal year ended December 2015. Under its corporate philosophy, “Otsuka – people creating new products for better health worldwide”, the Otsuka Group conducts research, development, manufacturing and marketing of innovative products that are uniquely positioned to provide advanced therapy, improve quality of life and support a healthy lifestyle.

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

SOURCE ReCor Medical, Inc.