Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 33 n° 335

REGEnLIFE presents first results of pilot clinical trial evaluating

Posted by fidest press agency su sabato, 20 marzo 2021

photobiomodulation technology in the treatment of Alzheimer’s disease

Montpellier, France, REGEnLIFE, a company specialized in the research and development of innovative photo-medical technologies for the prevention and treatment of neurodegenerative diseases, announces today the promising results of the pilot clinical trial evaluating its technology in Alzheimer’s disease (AD). The results were presented by Professor Jacques Touchon, scientific advisor on the trial, at the 15th International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD 2021), held online from March 9 to 14, 2021.REGEnLIFE’s innovative non-invasive technology, evaluated in a therapeutic trial, is based on photobiomodulation, targeting both the brain and gut via a helmet and abdominal device. This cutting-edge medical device, RGn530, stimulates cells in the brain and gut and regulates inflammation – to improve cognitive functions and behavior. It targets inflammation of the gut-brain axis, which is believed to be linked to the development of AD and other neurodegenerative diseases.
The primary efficacy endpoint was measured by the evolution of the total ADAS-Cog score, (Alzheimer’s Disease Assessment Scale), between inclusion and the end of the two-month period of treatment. The REGEnLIFE RGn530 device was shown to be safe; no major side effects were reported. Compliance with treatment sessions was very high for the vast majority of patients (92%). This level of compliance also confirms the good tolerance of the device. While the primary efficacy endpoint was not statistically met, there was a clear improvement trend in a set of cognitive functions. The results of this pilot study showed that REGEnLIFE’s technology is safe and well-tolerated by patients. These very encouraging safety and efficacy results will now be confirmed in a pivotal or phase III clinical trial.Photobiomodulation is based on photonic emissions in the near-infrared, it has already shown analgesic, anti-inflammatory and healing properties. One of the most reproducible effects is the overall reduction in inflammation, especially in the brain. REGEnLIFE’s technology could therefore be used on brain diseases and on pathologies linked to neuroinflammation. REGEnLIFE developed this device employing this scientific approach, using medical technology never before applied to neurology.According to Alzheimer’s Disease International, 35 million patients worldwide have AD. The annual cost of the disease worldwide is estimated at €850bn ($1.02tr). Currently, there are no treatments to cure Alzheimer’s.
In order to address public health issues related to a disease that affects elderly and vulnerable people, REGEnLIFE chose to develop a non-invasive technology with low constraints for patients. The cost of this device is expected to be reasonable for patients and national healthcare systems.


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