BioRestorative Therapies, Inc. · NASDAQ:BRTX
BioRestorative Therapies — Investor Presentation (2017)
21 slides from BioRestorative Therapies's investor presentation, 2017
Slide 1: BioRestorative Therapies Presentation 2017
niorestordtlve therapies PRESENTATION 2017
Slide 2: Forward Looking Statements
Forward Looking Statements Statements in this presentation, including the information set forth as to the future financial or operating performance of BioRestorative Therapies, Inc. (the “Company”), that are not current or historical factual statements may constitute “forward looking” information wi
Slide 3: Company Overview
Company Overview BioRestorative Therapies, Inc. develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Our two core programs relate to the treatment of disc/spine disease and metabolic disorders. MULTIPLE CELL THERAPY PROGRAMS DISC/SPINE PROGRAM (brtxD
Slide 4: Lower Back Pain Disc Therapy Program
Lower Back Pain Disc Therapy Program Lower Back Pain is the Most Common, the Most Disabling, and the Most Costly Musculoskeletal Problem Treated Protruding / Bulging Disc Spinal Fusion Surgery INTRODUCING A NEW STANDARD OF CARE TO TREAT CHRONIC LUMBAR DISC DISEASE 4
Slide 5: Cell-Based Lumbar Disc Therapeutic
Cell-Based Lumbar Disc Therapeutic Disc Therapy to Treat Chronic Lumbar Disc Disease (Protruding and Bulging Discs) BRTX-100 - Lead Cell Therapy Candidate Product Formulated from Autologous Cultured Mesenchymal Stem Cells (or MSCs) Collected from the Patient’s Bone Marrow Treatment is Intended f
Slide 6: BRTX-100: Production Process
BRTX-100: Production Process Collection and Shipment to BRT of Patient’s Bone Marrow and Blood Production of BRTX-100 Thawing and Injection of BRTX- • Hypoxic Culturing 100 into Patient’s of MSCs Disc • Biomaterial Carrier Shipment of BRTX- Formulation and 100 to Clinical Cryopreservation of Site/Ph
Slide 7: BRTX-100: Engineered for the Disc
BRTX-100: Engineered for the Disc BRTX-100 Key Attributes: Contains Hypoxic (Low Oxygen) Cultured Mesenchymal Stem Cells Co-Administered with Biomaterial Carrier High Cell Viability for Disc Cryopreserved BRTX-100 Cell Based Therapy (2 step mechanism): Structural (Bio-Mechanical Proper
Slide 8: Human Clinical Experience
Human Clinical Experience HUMAN CLINICAL EXPERIENCE SAFETY STUDY EFFICACY 8
Slide 9: Disc Morphologic Changes
Disc Morphologic Changes Therapy May Have a Significant Impact on the Morphology of the Disc 42 yo Male needed epidural steroid Apr 2009-Sag T2 FRFSE FS 4/2009 ET-24, TR-4233, TE-105.2 injections multiple times annually PRE-TREATMENT for radiculopathy Large central, contained, broad based protru
Slide 10: BRTX-100: Clinical Trial Design
BRTX-100: Clinical Trial Design Trial Design: A Phase 2 Prospective, Double-Blinded, Placebo Controlled, Randomized Study, n=72 Evaluate Safety and Efficacy of a Single Dose of BRTX-100 5-10 Clinical Trial Sites Primary Efficacy Endpoint – 6 months Patient Follow Up – 12 Months $8M to $1
Slide 11: Treatment Options
Treatment Options Current treatment options for the BRTX-100-addressable population range from conservative methods such as medication or physical measures, to more invasive surgical procedures Discectomy: surgery to remove part of the herniated disc material that presses on a nerve root or the spin
Slide 12: Prevalence Summary
Prevalence Summary Trinity used a multi-pronged approach to determine the prevalence of the BRTX- 100-addressable patient population 12
Slide 13: Key Highlights - Value Proposition
Key Highlights - Value Proposition Unique Product Engineered to Address the Challenges of the Targeted Application Autologous hypoxic-cultured cell product BRTX-100 is formulated and co-administered with biomaterial carrier Pending Clinical Trial FDA Clearance of Phase 2 Clinical Trials
Slide 14: Key Milestones
Key Milestones Milestones Target Timeline Publish Human Retrospective Safety Study 3Q2016 FDA Clearance of Phase 2 Clinical Trial 1Q2017 Patient Enrollment 3Q2017 Primary End Point Reportable Data 3Q2018 14
Slide 15: ThermoStem Program (Brown Adipose Stem Cells)
ThermoStem® Program (Brown Adipose Stem Cells) Potential Treatments for Metabolic Diseases Pre-clinical allogeneic cell-based therapy to target obesity, diabetes and metabolic disorders using brown adipose (fat) derived stem cells (BADSC) to generate brown adipose tissue (BAT) BAT is a specializ
Slide 16: 2014 Publication in STEM CELLS Journal
2014 Publication in STEM CELLS Journal Volume 32, Number 2, February 2014 The International Journal of Cell Differentiation and Proliferation B 572. Metabolically Active Human Brown Adipose Tissue-Derived Stem Cells Francisco J Silva, Dolly J Holt, Vanessa Vargas et al. I n sI d e Th I s I ssu e See
Slide 17: Preclinical Metabolic Results: Glucose and Body Weight
Preclinical Metabolic Results Glucose and Body Weight Blood Glucose Levels Body Weight 600 40 35 500 30 Body weight (g) 400 25 Glucose (mg/dl) 20 300 15 200 10 5 100 0 1 2 3 4 5 6 7 8 9 10 11 12 13 0 Control 1 2 3 4 5 6 7 8 9 10 11 12 13 Weeks after transplantation Control BADSC Weeks after transpla
Slide 18: Preclinical Metabolic Results: Triglycerides and Cholesterol
Preclinical Metabolic Results Triglycerides and Cholesterol Levels Triglycerides Level Cholesterol Level Mice fed high chow diet throughout experiment and transplanted with brown adipose derived stem cells (BADSC)/scaffolds and controls 18
Slide 19: Brown Fat Delivery Device
Brown PreclinicalFat Delivery Metabolic Results Device Encapsulation Device Brown Adipose Cells (live) UCP1 (red) Positive Cells
Slide 20: Metabolic Key 2016/17 Targeted Milestones
Metabolic Key 2016/17 Targeted Milestones Milestones Target Timeline Identify Key Cell Line for Pre-Clinical Testing 3Q 2016 Develop Delivery System for BAT 3Q 2016 Initiate Pre-Clinical Testing in Animals 2Q 2017 Identify Target Indication 1Q 2017 Complete Pre-Clinical Testing in Animals 3Q 2017 Pr
Slide 21: Thank You
Thank You OTCQB: BRTX biorestorative.com 21
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