Regeneration Biomedical

06/19/2026

Regeneration Biomedical has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for its investigational direct-to-brain autologous stem cell therapy for Alzheimer's disease.

This designation is intended to facilitate the development and review of therapies that address serious conditions and unmet medical needs.

Designation Follows Encouraging Phase I Results and FDA Clearance of a Multi-Center, Double-Blind, Placebo-Controlled Phase II Trial

06/19/2026

Regeneration Biomedical was proud to be represented at the 2026 ISCT Annual Meeting, where Dr. Duma delivered a podium presentation to an international audience of scientists, physicians, and industry leaders.

Thank you to ISCT for bringing together the global cell and gene therapy community to advance innovation and scientific collaboration.

05/29/2026

New findings from RBI's completed Phase 1 Alzheimer's study demonstrated improvements in cognitive measures and cerebrospinal fluid (CSF) proteomic biomarkers following treatment with direct-to-brain autologous stem cells.

Read the full press release here:
https://apnews.com/press-release/ein-presswire-newsmatics/rbis-phase-1-first-in-mankind-direct-to-brain-stem-cells-show-improved-csf-proteomics-cognition-in-alzheimers-2c79968fa04ea27960c401e2d8819725

Presented at ISCT 2026 in Dublin May 6-9: intracerebroventricular injections showed sustained CSF, amyloid PET, cognitive improvements in Alzheimer’s disease.

04/24/2026

Regeneration Biomedical will be delivering a podium presentation at the 2026 ISCT Annual Meeting, presenting to an international audience of scientists and physicians on advancements in regenerative neurotherapeutics.