ReCor Medical Announces Results of 6 Months of RADIANCE-HTN SOLO Clinical Trial Drug Therapy and First Randomization of PIROTAL Radiology-II Pivotal Study

PALO ALTO, California, March 17, 2019 / PRNewswire / – ReCor Medical, Inc. ("ReCor") Announces Results of "Drug Therapy" Over 6 Months of its RADIANCE-HTN SOLO Clinical Trial with Concurrent Publication circulationand the first randomization of patients in her pivotal RADIANCE-II trial of her drug 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 "medication" results of the RADIANCE-HTN SOLO study cohort in which, as a result of the main result of positive blood pressure "out of medication" over 2 months, patients remained blind to treatment and returned to treatment after a recommended, pre-defined, medical protocol with phased care. The results showed that patients treated with the ReCor Paradise ultrasound denervation system received fewer antihypertensive drugs than those treated with a dummy procedure. In addition, the patients treated had lower blood pressure than the simulated arm. Dr. Kirtane further noted that at 6 months, the antihypertensive effect of the Paradise system was maintained and that there was no major adverse effect.

"Professor Michel Azizi (Paris, France), my co-investigator for the RADIANCE-HTN study, the RADIANCE-HTN Steering Committee and I are very pleased to report on the results achieved during the six months of the study's SOLO cohort, " commented Dr. Kirtane (Associate), Professor of Medicine at Columbia University Irving Medical Center). "These results are unique in that they represent randomized, blinded data demonstrating that renal ultrasonic denervation can potentially be an important adjunct to low blood pressure medications." We believe that, in addition to the SOLO results presented, previously, in patients' drugs, these new data contribute to the multiplication of evidence demonstrating that the Paradise system can lower blood pressure, either alone or in combination with antihypertensive drugs.If this is confirmed in the trial Ongoing larger and ongoing on RADIANCE II, this treatment would have the potential to help patients and physicians achieve their blood pressure goals, which is rarely achieved in clinical practice. "

"ReCor is encouraged by the 6-month SOLO outcome data as it is the first piece of randomized, blinded, and mock-controlled evidence of the efficacy of Paradise's renal denervation system badociated with a Antihypertensive Therapy Added: These data demonstrate the sustainability of the antihypertensive effect of the Paradise renal denervation system, alone or in combination with drugs, "commented the CEO. Andrew M. Weiss. "We are also pleased that we have begun to randomize the subjects of our pivotal RADIANCE-II study, which we plan to complete in 2020. The combination of our independent, blind and fictitiously controlled studies RADIANCE-HTN SOLO and TRIO, of the study REQUIRES to be run in Japan and in Korea, and our pivotal RADIANCE-II study will provide safety and efficacy results to over 600 patients, covering a wide range of patients with hypertension. If successful, we hope that in the future, these studies will support a new important 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, an exclusive ultrasound ablation system for renal denervation (RDN). RDN is a potential new 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 carries CE marking, but is not approved for sale in the EU. United States. The intravascular catheters of the system denervate the renal nerves by combining the protection of the water-based renal artery cooling with high intensity ultrasound energy for the removal of the circumferential renal nerve. The Paradise system has been studied in the context of clinical trials conducted on approximately 300 patients to date. Following the positive results of the RADIANCE-HTN SOLO trial, ReCor will continue its Paradise badessments in RADIANCE-HTN TRIO (a feasibility study in patients with resistant hypertension), REQUIRE (a pivotal study conducted Japan in Korea), and more recently with the launch of the RADIANCE II pivotal study (a study of patients with moderate hypertension) in United States and Europe .
http://www.recormedical.com/

About Otsuka Holdings Co., Ltd. and from Otsuka Medical Devices Co., Ltd.
Otsuka Holdings Co., Ltd. is the holding company of the Otsuka Group, a global health care group based in Tokyo, Japan. With activities in the pharmaceutical, nutraceutical, medical device and other health-related fields, the group has generated global sales of JPY 1,292 billion during the financial year ended December 2018.
http://www.otsuka.com/en/

Established in 2011, Otsuka Medical Devices Co., Ltd. is a wholly owned subsidiary of Otsuka Holdings and one of its principal operating subsidiaries. Otsuka Medical Devices focuses on the development and commercialization of endovascular devices offering new therapeutic options in areas where patient needs can not be met by pharmaceutical or other treatment.
Otsuka Medical Devices performs the REQUIRE trial on renal denervation in hypertensive patients (n = 140) not controlled by 3 or more drugs, including a diuretic, Japan and in Korea through its subsidiary JIMRO Co., Ltd.
http://www.omd.otsuka.com/en/

For more information on ReCor Medical, visit www.recormedical.com or contact Andrew M. Weiss, President and CEO of ReCor Medical, at the address [email protected] / + 1-650-542-7700.

SOURCE ReCor Medical, Inc.

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