www.fdanews.com/articles/205227-fda-designates-renew-biosciences-alzheimers-treatment-a-breakthrough-device
FDA Designates Renew Bioscience’s Alzheimer's Treatment a Breakthrough Device
November 8, 2021
Renew Bioscience has received the FDA’s Breakthrough Device designation for its Cerezen device for treatment of mild cognitive impairment due to Alzheimer's disease or mild dementia of the Alzheimer's type.
Cerezen uses external counterpulsation therapy to enhance blood flow. During the therapy, a technician places inflatable cuffs on the patient's calves, thighs and hips that synchronize to inflate and deflate between heartbeats.
In a series of treatments, the noninvasive device simulates the physiological effects of vigorous exercise and stimulates endothelial cells that control vascular relaxation and contraction.