Non-invasive biophoton platform advances toward HDE pathway for rare mitochondrial disease
New Castle, DE April 01, 2026 –(PR.com)– Brain Healing, Inc., a medical technology company focused on developing non-invasive therapeutic platforms for neurological and mitochondrial disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Humanitarian Use Device (HUD) designation for its investigational device intended for patients with MELAS (Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like episodes), a rare and serious mitochondrial disease affecting fewer than 8,000 individuals annually in the United States.
The HUD designation enables Brain Healing, Inc. to pursue a Humanitarian Device Exemption (HDE), a regulatory pathway designed to facilitate the development and availability of medical devices for rare diseases and conditions with significant unmet needs.
Advancing a Novel Approach to Mitochondrial Dysfunction
Brain Healing, Inc., in collaboration with the First Institute of All Medicines (FIAM), is advancing a non-invasive, photon-based investigational platform originally developed by Tesla BioHealing, LLC. The technology is designed to interact with biological systems at the cellular level and is being evaluated for its potential role in addressing mitochondrial dysfunction, a central feature of MELAS and related neurological disorders.
“Receiving FDA HUD designation for MELAS represents an important milestone in our development program,” said James Z. Liu, MD, PhD, founder and chairman of Brain Healing, Inc. “We are committed to advancing innovative, non-invasive approaches that may expand therapeutic options for patients living with rare and underserved conditions.”
Pathway Toward Clinical Development
With HUD designation secured, Brain Healing, Inc. plans to advance its program toward submission of an HDE application. Under this pathway, the FDA evaluates whether the device demonstrates probable benefit and does not pose an unreasonable or significant risk.
MELAS remains a condition with limited therapeutic options and significant clinical burden. Brain Healing, Inc. aims to contribute to this field through continued research, clinical evaluation, and regulatory engagement.
Platform Potential Beyond MELAS
While MELAS represents the company’s initial focus, Brain Healing, Inc. believes its investigational platform may have broader applicability across mitochondrial and neurodegenerative disorders. Future development efforts will explore additional indications, subject to regulatory review and clinical validation.
About Brain Healing, Inc.
Brain Healing, Inc. is a medical technology company dedicated to developing non-invasive therapeutic platforms targeting mitochondrial and neurological disorders. The company is advancing its investigational technologies through established regulatory pathways, including the FDA Humanitarian Device Exemption (HDE) program, with the goal of addressing unmet medical needs in rare and serious diseases.
Brain Healing, Inc. is funded by Tesla BioHealing, a wellness-focused organization that develops consumer-oriented technologies. Brain Healing, Inc. operates independently in pursuing regulated medical applications.
About First Institute of All Medicines (FIAM)
The First Institute of All Medicines (FIAM) focuses on clinical research, education, and certification in emerging therapeutic approaches, including biophoton-based technologies.
About Tesla BioHealing, LLC
Tesla BioHealing, LLC develops consumer-oriented wellness technologies and originated the underlying platform being evaluated by Brain Healing, Inc. for regulated medical applications.
Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding the development, regulatory pathway, and potential applications of Brain Healing, Inc.’s investigational technology. These statements are based on current expectations and are subject to risks and uncertainties, including regulatory review processes, clinical outcomes, and other factors that may affect future results. Actual results may differ materially from those expressed or implied.
The investigational device described herein has not been approved or cleared by the FDA. HUD designation does not constitute marketing approval or a determination of safety or effectiveness.
Contact Information:
Tesla BioHealing, Inc.
Suzanne Street
302-202-9350
Contact via Email
www.teslabiohealing.com
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