Cerezen Device Gets Breakthrough Designation in Alzheimer Disease, MCI


The Renew Biosciences device is designed to enhance circulation and improve cerebrovascular health by stimulating the physiological effects of exercise and the function of endothelial cells.

Tony Robinson, chief operating officer, Renew Bioscience

Tony Robinson

According to an announcement from Renew Biosciences, the FDA has granted a breakthrough device designation to the medical technology company’s Cerezen Device for the treatment of mild cognitive impairment (MCI) due to Alzheimer disease (AD) and for mild AD dementia.1

The nonpharmacologic and noninvasive technology is designed to improve cerebrovascular health through the enhancement of circulation, and the simulation of vigorous exercise’s physiological effects and endothelial cell function. The pathology of AD has long been associated with cerebrovascular risk factors, with Renew citing the role that cerebral blood flow and endothelial function are believed to play.

"We are extremely pleased with the progress related to the Cerezen Device, specifically receiving the Breakthrough designation from the FDA,” Tony Robinson, chief operating officer, Renew Bioscience, said in a statement.1 “We truly believe that Cerezen represents 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 device offers a 4-step process for its use, beginning with the securing of the device’s inflatable cuffs to the patient’s hips, thighs, and calves; and followed by the inflation of the cuffs to compress blood vessels and enhance blood flow. Afterward, the cuffs deflate, in order to reduce the effort needed for the heart to pump oxygenated blood throughout the body. The Renew Biosciences device uses external counterpulsation in order to do this, in a process that must be conducted under the supervision of a physician, but that the company calls “soothing and relaxing for patients, like a massage.”

READ MORE: ADMET 2 Trial Shows Positive Impact With Methylphenidate on Alzheimer Apathy

Although not a pharmacologic intervention, this news about the Cerezen Device comes after a slew of breakthrough designations in the field of AD, with several pharmacologic agents being granted them since the June 2021 approval of the firs therapy 2 decades. Most recently, Eli Lilly announced the initiation of a rolling biologics license application (BLA) submission for donanemab for accelerated approval in early AD.2 At the time, Lilly noted its plans to conduct the TRAILBLAZER-ALZ 4 study, a phase 3 head-to-head trial comparing donanemab to the most recently approved therapy for AD. Previously, in June 2021, the FDA had granted donanemab breakthrough labeling.3

Just a few weeks prior to the late October donanemab news, the FDA awarded Genentech/Roche’s investigational antiamyloid-ß (Aß) antibody agent, gantenerumab, breakthrough therapy designation for the treatment of individuals with AD, as well, offering it the potential to become the first subcutaneous medicine for the treatment of this population.4 Months earlier, in June, Eisai and its partner company announced that their second investigational Alzheimer product had been granted a breakthrough therapy designation,5 and in October, announced that they had begun the process of completing a rolling BLA submission.6 Their application is supported by data from the phase 2b clinical trial, known as Study 201 (NCT01767311), which demonstrated a reduction in brain amyloid accompanied by a consistent reduction of decline across several clinical and biomarker end points in patients with mild cognitive impairment (MCI) due to Alzheimer disease (AD) or Alzheimer dementia.

1. FDA grants Breakthrough status for Alzheimer's treatment. News release. Renew Biosciences. November 2, 2021. Accessed November 2, 2021. https://www.prnewswire.com/news-releases/fda-grants-breakthrough-status-for-alzheimers-treatment-301412262.html
2. Lilly reports robust third-quarter 2021 financial results as pipeline success strengthens future growth potential. News release. October 26, 2021. Accessed November 2, 2021. https://investor.lilly.com/news-releases/news-release-details/lilly-reports-robust-third-quarter-2021-financial-results
3. Lilly’s donanemab receives US FDA’s breakthrough therapy designation for treatment of Alzheimer disease. News release. Eli Lilly. June 24, 2021. Accessed November 2, 2021. https://www.prnewswire.com/news-releases/lillys-donanemab-receives-us-fdas-breakthrough-therapy-designation-for-treatment-of-alzheimers-disease-301318931.html
4. Ad hoc announcement pursuant to Art. 53 LR: Genentech’s anti-amyloid beta antibody gantenerumab granted FDA breakthrough therapy designation in Alzheimer disease. News release. Genentech. October 8, 2021. Accessed November 2, 2021. https://www.businesswire.com/news/home/20211008005371/en/Ad-hoc-announcement-pursuant-to-Art.-53-LR-Genentech%E2%80%99s-Anti-Amyloid-Beta-Antibody-Gantenerumab-Granted-FDA-Breakthrough-Therapy-Designation-in-Alzheimer%E2%80%99s-Disease
5. Eisai and Biogen announces US FDA grants breakthrough therapy designation for lecanemab (BAN2401), an anti-amyloid beta protofibril antibody for the treatment of Alzheimer disease. News release. June 23, 2021. Accessed November 2, 2021. https://www.prnewswire.com/news-releases/eisai-and-biogen-inc-announce-us-fda-grants-breakthrough-therapy-designation-for-lecanemab-ban2401-an-anti-amyloid-beta-protofibril-antibody-for-the-treatment-of-alzheimers-disease-301318796.html
6. Eisai Initiates Rolling Submission to the U.S. FDA for Biologics License Application of Lecanemab (ban2401) For Early Alzheimer’s Disease Under the Accelerated Approval Pathway. Eisai. News release. September 28, 2021. Accessed November 2, 2021. https://eisai.mediaroom.com/2021-09-27-Eisai-Initiates-Rolling-Submission-To-The-U-S-FDA-For-Biologics-License-Application-Of-Lecanemab-BAN2401-For-Early-Alzheimers-Disease-Under-The-Accelerated-Approval-Pathway
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