Farmington Hills, Michigan, Oct. 23, 2025 (GLOBE NEWSWIRE) -- “We made every effort to bring this treatment to U.S. patients first,” said Cerezen Founder and CEO Manoj Bhargava. “However, it seems politics is more important than people’s lives. The current pharmaceutical approaches cost a fortune, and the patient still gets worse.”
In 2021, the U.S. Food and Drug Administration designated Cerezen™ a “Breakthrough Device,” acknowledging both its safety profile and its potential to meet a significant unmet medical need. But despite that recognition – and despite significant clinical data showing measurable improvement in patients’ cognition and daily function – the FDA has yet to approve it for use.
Cerezen™, headquartered in Farmington Hills, Michigan, has received CE certification under the European Union’s Medical Device Regulation (MDR 2017/745) for its non-invasive device to treat mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s disease. The approval makes it the first and only device certified under the new EU framework for the condition, giving European patients access to a therapy that remains out of reach in the United States.
The Michigan-based medical device company has achieved something that many Alzheimer’s researchers have been chasing for decades: a treatment that appears to not just slow – but in some cases reverse – the cognitive decline associated with the disease.
But for now, that treatment will be available only in Europe.
“It’s disheartening to know that American families still can’t access it,” said Bhargava. “We’ve proven it’s safe, effective and easy to use. The question is no longer whether it works – it’s when regulators will allow it here.”
A New Approach to a Stubborn Disease
Cerezen™ takes aim at Alzheimer’s from an unexpected angle. Rather than targeting the amyloid plaques that dominate most drug-based approaches, the device focuses on restoring vascular health in the brain, improving blood flow and oxygenation. Impaired vascular function – as noted by Dr. Alzheimer himself – is a root cause of the disease.
The non-invasive device has shown in clinical studies that patients with mild cognitive impairment or early Alzheimer’s can see meaningful improvement within six months. On average, participants gained five points on standard cognitive scales – an improvement roughly equivalent to regaining a year’s worth of lost 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.
The Stakes of Inaction
More than 7 million Americans currently live with Alzheimer’s disease, a number projected to surpass 8.5 million by 2030. The economic toll exceeds $400 billion annually, with caregivers – often family members – bearing much of the emotional and financial burden.
Despite decades of research and billions spent, most available treatments merely slow progression. Few offer improvement, and none come close to a cure. For families facing the disease, even small gains in memory, clarity or independence can make a profound difference.
Cerezen’s European certification means that patients there could begin receiving treatment in the near future. In the U.S., the timeline is uncertain. The company is re-engaging with FDA leadership to reopen its prior application.
“This is an American innovation,” said Bhargava “It was developed, tested, and proven here—but the first patients who’ll benefit live across the Atlantic. That’s a hard reality to accept.”
For more information – or to help spread the word about bringing this this treatment to America – please visit www.cerezen.com. To ask the FDA about approval status, email them at Industry.Devices@fda.gov.
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About Cerezen
Cerezen™ is a Michigan-based medical technology company dedicated to developing safe, non-invasive solutions for neurological and vascular conditions. The company’s proprietary device for Alzheimer’s disease represents a breakthrough approach targeting vascular health to improve cognitive outcomes.
To learn more about Cerezen and its mission to transform Alzheimer’s care, visit www.cerezen.com
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