Amir SohailFarmington Hills, Michigan, (ZM NEWSWIRE) — Cerezen™, an innovative, non-invasive medical device designed to treat cognitive impairment and early-stage Alzheimer’s disease by increasing blood flow to the brain, today highlighted new peer-reviewed clinical validation and the cost-effectiveness of its treatment. Its clinical trials show that Cerezen is the first treatment to significantly improve memory, cognition and independent functioning in Alzheimer’s patients. Cerezen is an external counterpulsation (ECP) device, not a drug, and is already approved in the U.S. for the treatment of angina. It is also certified for use in the EU for the treatment of Alzheimer’s.
Clinical findings from Cerezen’s randomized controlled study were recently published in the American Journal of Alzheimer’s Disease & Other Dementias®, further supporting the therapy’s potential to improve cognitive function in patients with mild cognitive impairment (MCI) and early Alzheimer’s disease. The publication adds to a growing body of evidence linking improved cerebral blood flow with reduced dementia risk and better cognitive outcomes.
“In an FDA approved study, 78% of patients with mild cognitive impairment or early Alzheimer’s improved over their personal baseline after six months of this non-invasive treatment,” said Cerezen’s Chief Medical Advisor, Jack Juni, M.D. “On average, participants gained five points on standard cognitive scales – an improvement roughly equivalent to regaining one to two years’ worth of lost function.”
Addressing a Growing Economic and Public Health Crisis
Alzheimer’s disease remains one of the most significant public health and economic challenges in the United States. More than 7 million Americans age 65 and older are currently living with Alzheimer’s disease, representing approximately 11% of that population. The total economic burden exceeds $400 billion annually, while millions of family caregivers face substantial emotional, physical, and financial strain.
Against this backdrop, Cerezen’s non-pharmaceutical treatment approach has demonstrated promising clinical and economic value.
A study conducted by the University of California San Diego Herbert Wertheim School of Public Health and Human Longevity Science found Cerezen to be “cost-effective” to “highly cost-effective” for the treatment of Alzheimer’s disease, based on its incremental cost-effectiveness ratio, or ICER, per quality-adjusted life year, or QALY.
The findings compare favorably with currently available pharmaceutical therapies, which studies have rated “not cost-effective” while offering limited clinical benefit
Published Clinical Outcomes
Cerezen is designed to improve cerebral blood flow and oxygenation by addressing impaired vascular function — a factor increasingly recognized as a key contributor to Alzheimer’s disease progression.
In controlled clinical studies, patients with MCI or early Alzheimer’s disease demonstrated statistically significant and clinically meaningful improvements within six months of treatment. On average, participants experienced approximately a five-point improvement on standardized cognitive assessment scales, corresponding to roughly one to two years of regained cognitive function.
Crucially, these gains were achieved without major safety risks and without the need for costly PET scans or drug infusions. More than 70% of Alzheimer’s patients would qualify for the therapy – a stark contrast to the narrow eligibility and high costs associated with many of the approved drug treatments.
A video presentation of the science behind Cerezen™ and trial results are available on Cerezen.com.
U.S. Regulatory Milestones
Since 2018, Renew Research has engaged with the U.S. Food and Drug Administration (FDA) to advance Cerezen through the regulatory process. The FDA has previously acknowledged the potential of the Cerezen system through multiple designations and classifications, including:
- Breakthrough Device Designation (Q171834/S003, July 2021)
- De Novo Classification Review (DEN220004, January 2022)
- Recognition as a novel technology addressing a significant unmet medical need (January 2022)
- Confirmation of low-risk device status (January 2022)
Despite these acknowledgments and positive clinical outcomes from randomized, controlled U.S. trials, Cerezen has not yet received clearance for use in the United States.
European Certification
In contrast, Cerezen received certification in October 2025 under EU MDR 2017/745 (Certificate MDR 818385). The approved indication states “Cerezen is indicated for the treatment of mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s disease.”
The European review was based on the same clinical and technical data submitted to the FDA.
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