Friday, September 22, 2023
Realeve has recently announced a substantial grant to support a groundbreaking study in partnership with the Cleveland Clinic, aimed at revolutionizing post-stroke recovery. The study will leverage Realeve's Pulsante® micro-neuromodulation system, an externally powered implantable neuromodulation device, for stimulating the sphenopalatine ganglion (SPG). This approach, combined with hyperbaric oxygen therapy, holds the potential to enhance blood circulation in stroke patients, reducing brain damage, and improving neurological recovery. Notably, Realeve's technology has already demonstrated its effectiveness in treating brain-related disorders, with over 700 patients benefiting from it.
Additionally, Realeve has earned Breakthrough Device designation from the FDA, with plans to seek FDA approval and a CE Mark for treating cluster headaches in 2024. This designation expedites the review process for technologies that can significantly improve the quality of life for individuals facing life-threatening or debilitating conditions.
Realeve's overarching mission is to address a critical barrier in brain health, namely the brain's natural barrier that hinders the effective delivery of drugs for conditions such as stroke and cancer treatment. Currently, Realeve is evaluating the potential impact of its patented SPG therapy on the Blood Brain Barrier (BBB) using its clinically validated Pulsante System. This technology holds great promise for addressing conditions like Alzheimer's, tumors, and various central nervous system disorders, representing a significant advancement in the field of neurological disease treatment and an attractive opportunity for biotech investors.
The Pulsante system consists of a tiny bioactive implant that is minimally invasively inserted, leaving no visible scarring. This implant works in conjunction with an external handheld controller that stimulates the SPG, which plays a key role in the autonomic nervous system and can impact multiple neurological conditions. This targeted therapy not only offers pain relief but also has the potential to enhance blood flow and improve medication delivery to the central nervous system.