United States — Food and Drug Administration & United States — Medicare

United States — Food and Drug Administration: The United States — Food and Drug Administration has granted Orphan Drug Designation to G2B-002 for DIPG and pGBM, which is a positive regulatory status for the drug's development.

United States — Medicare: United States — Medicare, through its subsidiary Shilpa Biocare Private Limited, has entered a strategic equity partnership with Gate2Brain, becoming a strategic shareholder and a key partner for manufacturing and regulatory aspects of G2B-002. This reinforces its commitment to innovation and long-term value creation.

United States — Food and Drug Administration: The United States — Food and Drug Administration has cleared the CareMiBrain system for use and has approved new monoclonal antibody treatments for Alzheimer's Disease, creating a market for the PET scans.

United States — Medicare: United States — Medicare covers brain PET scans for beta-amyloid plaque detection and new monoclonal antibody treatments for Alzheimer's Disease, which is crucial for patient access to Grey Matters Health Inc.'s services.