RBI Granted 'Fast Track' Designation by FDA, Validating Its Direc

Regeneration Biomedical received FDA Fast Track designation for its direct-to-brain autologous stem cell therapy for Alzheimer's disease, following Phase I results showing safety and improvements in CSF biomarkers. The company is now cleared to begin a multi-centre Phase II placebo-controlled trial with repeated dosing. If you're building blood-brain barrier crossing technology, CSF biomarker assays, or neurodegenerative diagnostics for Alzheimer's, RBI has just proved the market exists—and Fast Track means their Phase II data lands in 18-24 months, not five years. That's your window to sell into their trial or position as their follow-on therapy.