Brain Healing, Inc. Receives FDA Humanitarian Use Device (HUD) Designation for MELAS

Brain Healing, Inc. has been granted FDA Humanitarian Use Device (HUD) designation for its investigational non-invasive, photon-based platform targeting MELAS (Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like episodes)

A rare mitochondrial disease affecting fewer than 8,000 patients annually in the United States. This designation opens the door to the Humanitarian Device Exemption (HDE) regulatory pathway, a critical step toward making this technology available to patients with significant unmet medical needs. Developed in collaboration with the First Institute of All Medicines (FIAM), the investigational platform is designed to interact with biological systems at the cellular level to address mitochondrial dysfunction — with the potential for future application across a broader range of mitochondrial and neurodegenerative conditions.

Read the Press Release here: https://www.pr.com/press-release/964113