Biorestorative Therapies, Inc. · NASDAQ:BRTX
Biorestorative Therapies — Investor Presentation (May 2018)
6 slides from Biorestorative Therapies's investor presentation, May 31, 2018
Slide 1: Product X is an Autologous HC-BMMSC with a Dual-Mechanism of Action
Product X is an Autologous HC-BMMSC with a Dual-Mechanism of Action ¢ Product X is an autologous, hypoxic-cultured, bone marrow-derived mesenchymal stem cell (HC-BMMSC) therapy in development for the treatment of patients with lumbar degenerative disc disease that have failed non-surgical options. *
Slide 2: Product X Preclinical Safety and Efficacy Data
Product X Preclinical Safety and Efficacy Data ® Preclinical safety and efficacy studies were conducted involving the Disc Height Index of Histopathological Evaluation of intradiscal injection of Product X using the rabbit annular puncture model Degenerating IVD Post Product X Degenerating IVD Post
Slide 3: Previous In-Human Data Supports Product X Viability
Previous In-Human Data Supports Product X Viability o In an in-human clinical safety and efficacy study, 33 patients diagnosed with degenerative disc disease who had exhausted conservative treatment options received intradiscal autologous, HC-BMMSCs No serious AEs were reported; 3 patients reported
Slide 4: P2 Study (cleared to proceed by FDA): Product X in Patients with Lumbar Disc Disease
P2 Study (cleared to proceed by FDA) : Product X in Patients with Lumbar Disc Disease Study Design and Patient Population: @ 72 patient (48 Product X, 24 control) randomized, double blinded, placebo controlled trial with a primary efficacy endpoint at 6 months and follow-ups at 12 and 24 months post
Slide 5: Recent Clinical Stage Studies Using Cell-Based Therapy in CLDD
Recent Clinical Stage Studies Using Cell-Based Therapy in CLDD Year Allogeneic vs. Placebo Published Cell Type Cell Dose Phase Location Autologous Controlled Yoshikawa, et al. 2010 2 BMMSC 2x108 cells Intradiscal Clinical Japan Autologous No Orozco, et al. 2011 10 BMMSC 10x10° cells Intradiscal 1 Sp
Slide 6: Autologous MSC Treatment have shown Safety and Feasibility, and Strong Indications of Clinical Efficacy
Autologous MSC Treatment have shown Safety and Feasibility, and Strong Indications of Clinical Efficacy in Patients with Lumbar Disc Degeneration Both lumbar pain and disability were significantly reduced at 3 months after MSC transplantation, and the improvement was MSC-treated maintained at 6 and
BioRestorative Therapies — Investor Presentation (May 2018) on 6ix