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

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

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

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

More information on RADIANCE-HTN can be found at:

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

About ReCor Medical, Inc.
ReCor Medical is a private, venture-backed, medical device company that designs and manufactures a proprietary ultrasound ablation system for renal denervation (RDN). RDN is a new potential therapeutic approach for the treatment of hypertension, one of the most prevalent medical conditions.    The Paradise System is approved for sale in the EU and bears a CE mark, but is not approved for sale in the United States.  The System’s intravascular catheters denervate renal nerves by combining the protection of water-based cooling of the renal artery with high intensity ultrasound energy for circumferential renal nerve ablation. The Paradise System has been studied in 3 clinical trials, and has been used in over 200 patients.

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

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

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

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

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

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

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

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

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

About ReCor Medical, Inc. 

ReCor Medical is a private, venture-backed, medical device company that designs and manufactures a proprietary ultrasound ablation system for renal denervation (RDN). RDN is a new potential therapeutic option for treatment of hypertension, one of the most prevalent medical conditions. The Paradise System is approved for sale in the EU and bears a CE mark, but is not approved for sale in the United States. The System’s intravascular catheters denervate renal nerves by combining the protection of water-based cooling of the renal artery with high intensity ultrasound energy for circumferential renal nerve ablation.

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

SOURCE: ReCor Medical

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

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

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

About ReCor Medical, Inc.

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

About Otsuka Holdings, Co. Ltd.

Otsuka Holdings Co., Ltd. is the holding company of the Otsuka group, a global healthcare group headquartered in Tokyo, Japan. With operations in pharmaceuticals, nutraceuticals, medical devices and other health-related businesses, the group generated worldwide sales of approximately JPY1,224 billion in the fiscal year ended December 2014. Under its corporate philosophy, “Otsuka – people creating new products for better health worldwide”, the Otsuka Group conducts research, development, manufacturing and marketing of innovative products that are uniquely positioned to provide advanced therapy, improve quality of life and support a healthy lifestyle. The Otsuka Group consists of 119 companies worldwide with 29,482 employees. Additional information can be found on http://www.otsuka.com/en/Medicine.