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CVR obtains IRB OK to conduct CSS trials at Wake Forest

2019-04-08 10:23 ET - News Release

Mr. Peter Bakema reports


CVR Medical Corp. has received Internal Review Board (IRB) approval to conduct clinical trials for its carotid stenotic scan (CSS) device at the U.S. News and Report nationally ranked Wake Forest Baptist Health. Wake Forest Neuro Ultrasound lab at the medical centre, based in Winston-Salem, N.C., is working with CVR to finalize plans for the study, which will gather comparative clinical and user experience data on the novel device. Under the leadership of Dr. Charles Tegeler, medical director of the Neuro Ultrasound lab, and Ward A. Riley, Ultrasound Center Wake Forest Neuro Ultrasound lab continues to be a world leader in clinical practice, education and research in neurosonology. This lab provides more than 20 years of experience as an ultrasound reading centre for multicentre clinical trials.

The clinical trial will be performed under the direction of principal investigator Dr. Aarti Sarwal, MD. Dr. Sarwal is an associate professor of neurology at Wake Forest Baptist Health centre and is currently the medical director of Neurocritical Care Unit. Dr. Sarwal received her medical training from Government Medical College, Patiala (India), neurology residency at University of Missouri, and neurocritical care fellowship at Cleveland Clinic, Ohio. She is a passionate educator and the co-director of the ultrasound curriculum at Wake Forest School of Medicine. Dr. Sarwal's education, research and clinical interests focus on ultrasound applications in neurology and non-invasive multimodality monitoring in neurocritical care patients. She is also a faculty for several national and international ultrasound courses and participates in several clinical trials as an ultrasound expert. She is listed by U.S. News and World Report among its best doctors.

In discussing the upcoming trial, Dr. Sarwal detailed: "Wake Forest School of Medicine is keen to participate in clinical trials that have a potential of providing new diagnostic techniques in medicine. Our participation in this trial to evaluate a new device for carotid stenosis is another part of our commitment towards addressing the burden of cerebrovascular disease in our population."

CVR Medical chairman and chief executive officer Peter Bakema states: "Adding a leading research institution such as Wake Forest, led by a top-notch clinician like Dr. Sarwal, goes a long way to further the clinical awareness of the CSS. It is one thing to build and market a medical device, but the support and understanding of the practitioners on the front line of health care is what really matters to us. Their buy-in lets us know that we have designed a tool which can be effectively adopted in the battle with cardiovascular disease."

About CVR Medical Corp.

CVR Medical is a health care company that operates in the medical device industry focused on the commercialization of its disruptive, proprietary CSS device. The CSS device is a diagnostic tool that encompasses subsonic, infrasonic and low-frequency sound wave analysis technology. CVR is currently in pivotal clinical trials in preparation for its planned submission to the Food and Drug Administration. CVR is led by an experienced and proven team of professionals with extensive health care, medical device, international expansion, regulatory and sales experience.

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