Brain photobiomodulation: a potential treatment in Alzheimer’s and Parkinson’s diseases

Published on 15/09/2025 Reading time : 5 minutes

RegenLife – A Pre-CE Marking Clinical Investigation for Photobiomodulation Therapy

Authors: Guillaume Blivet¹, Benjamin Touchon², Hugo Cavadore³, Sara Guillemin⁴, Frédéric Pain⁵, Michael Weiner⁶, Marwan Sabbagh⁷, Cécile Moro², Jacques Touchon³

Affiliations:

¹REGEnLIFE SAS, Montpellier, France. Electronic address: blivet_guillaume@yahoo.fr.
²CEA-Clinatec, Grenoble, France.
³University of Montpellier, Montpellier, France.
⁴RCTs, Lyon, France.
⁵Université Paris-Saclay, Institut d’Optique Graduate School, CNRS, Laboratoire Charles Fabry, Palaiseau, France.
⁶University of San Francisco, San Francisco, United States.
⁷Barrow Neurological Institute, Phoenix AZ, United States.

The RegenLife study illustrates RCTs’ expertise in conducting complex pre-CE marking clinical investigations for innovative medical devices. This pilot trial evaluated the safety and performance of a photobiomodulation device designed to treat sportspeople suffering from acute concussion syndrome.

RegenLife is a randomized, controlled, open-label, pilot clinical investigation conducted across 10 countries, involving 128 sites and 3,604 patients. The primary objective was to assess the safety and performance of photobiomodulation therapy in real-world conditions before CE marking approval.

Acute concussion syndrome is a growing concern among athletes. Photobiomodulation therapy offers a non-invasive solution to accelerate recovery and improve patient outcomes. This study provided critical evidence to support regulatory submissions and CE marking.

RCTs managed every aspect of the investigation, including medical writing, project management, regulatory submissions, data management, site management, and statistical analysis. Our team ensured compliance with international standards and delivered robust data for regulatory approval.

Conclusion and Perspectives

Conclusion: The study confirmed the safety and performance of the device, paving the way for CE marking and future applications in neurological disorders such as Alzheimer’s disease. This success demonstrates RCTs’ leadership in medical device clinical investigations.

Discover how RCTs can support your medical device development with expertise in pre-CE marking clinical investigations and regulatory strategy.

Recent research has highlighted brain photobiomodulation as a promising therapeutic approach for Alzheimer’s and Parkinson’s diseases. This non-invasive technique involves the application of light to stimulate brain activity, aiming to enhance cellular function and reduce neurodegeneration. While preliminary studies show encouraging results, further clinical trials are necessary to establish its efficacy and safety.

For more detailed information, you can access the full study here: https://pubmed.ncbi.nlm.nih.gov/40287365/

To learn more about the RegenLife device and its innovative photobiomodulation technology, visit RegenLife official website.

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