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, according to a Renew Bioscience press release.
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 oversight of a healthcare professional. 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.