FDA grants Breakthrough status for Alzheimer’s treatment
November 2, 2021
FOR IMMEDIATE RELEASE
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FARMINGTON HILLS, MI. – Renew Bioscience, a commercial stage medical technology company, announced it has received Breakthrough Device Designation status from the U.S. Food and Drug Administration (FDA) for the Cerezen® Device, a novel treatment for Mild Cognitive Impairment due to Alzheimer’s Disease (MCI) and mild dementia of the Alzheimer’s type (mild AD).
An important risk factor for cognitive impairment and dementia is poor vascular health, with cerebral blood flow and endothelial function believed to play a significant role in vascular health. The Renew Cerezen® Device is a drug-free, non-invasive technology, designed to improve cerebral vascular health by enhancing circulation, simulating the physiological effects of vigorous exercise, and stimulating endothelial cell function through a series of treatment sessions.
The Cerezen® Device utilizes ECP (External Counterpulsation) therapy that enhances blood flow and overall vascular efficiency. During the therapy, a technician wraps inflatable cuffs (similar to blood pressure cuffs) around the patient’s calves, thighs and hips. The cuffs then synchronize to inflate and deflate between heartbeats. The external counter-pulsation process delivers more oxygenated blood to the body and brain. The process is soothing and relaxing for patients, like a massage. Cerezen® must be used under the oversite of a healthcare professional.
Renew Bioscience COO, Tony Robinson, elaborates upon the recent development, “We are extremely pleased with the progress related to the Cerezen® Device, specifically receiving the Breakthrough designation from the FDA. We truly believe that Cerezen® represent a momentous potential advancement in the treatment of Alzheimer’s and dementia, and we look forward to sharing some of the data from our recently completed pivotal study at the Clinical Trials on Alzheimer’s Disease (CTAD) Conference next month in Boston.”
The FDA Breakthrough Device Program is designed to expedite the process of helping patients receive faster access to cutting-edge technologies that have the potential to provide more effective treatment/diagnosis of life threatening or irreversibly debilitating diseases. The intended purpose is to speed up the development, assessment, and review of these critical devices while preserving the statutory standards consistent with the agency’s mission to protect and promote public health. Under this designation, the FDA will provide Renew Bioscience with priority review of their upcoming De Novo submission for market clearance in the United States.
ABOUT RENEW BIOSCIENCE:
Renew Bioscience is a commercial-stage medical technology company dedicated to the clinical advancement and distribution of technologies associated with improved clinical outcomes related to cardiovascular, neurological, and overall anatomical functionality and wellness. By focusing on the foundational principal of improving cardiovascular functionality and circulatory efficiency, Renew Bioscience is revolutionizing the way patients and clinicians’ approach both prevention and treatment of some of the most harmful diseases faced today.
Renew Bioscience – 38955 Hills Tech Drive, Farmington Hills, MI. 48331. USA