stemgel a tmj regenerative therapy
TRANSCRIPT
StemGELA TMJ Regenerative Therapy
Millie C Embree, MS DMD PhD
PI, TMJ Biology and Regenerative Medicine Lab
Mo Chen, PhD MBA
CEO, Wnt Scientific, LLC
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10 million Americans
$4 billion healthcare burden
Women of child bearing ages
Cartilage degeneration
Jaw bone defects
Symptoms
Pain and inflammation
Limited jaw movements
Dental malocclusion
Temporomandibular Joint Osteoarthritis (TMJ OA)
Chouinard et al, Oral Maxillofacial Surg Clin N Am 2018 2
Sclerostin (SOST)
• Inhibits Wnt pathway
• Regenerates TMJ
Hyaluronic acid (HA)
• FDA approved for osteoarthritis
• Lubricant
• Anti-inflammatory
• Anti-nociceptive
TMJ is critical for eating, speaking and dental occlusion
StemGEL activates local stem cells in the TMJ to regenerate cartilage
The Solution: StemGEL-TMJ
An injectable, local TMJ regenerative therapy that alleviates pain and restores function.
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B) Sclerostin Regenerates
Cartilage& Ameliorates TMJ OA
StemGEL-TMJ Regenerates Cartilage
SOST PBS0
2
4
6
8
10 p=0.0008
Macro
scopic
OA
RS
I S
core
+PBS control+Sclerostin
3 mm 3 mm
n=8
25 mm 50 mm
3 mm
H&E
ACAN/FCSCs
50 mm
50 mm
50 mm
Stem cells
4 mm
A) Fibrocartilage stem Cells
Regenerate Cartilage
Stem Cell
Sclerostin Release Curve
0 5 10 15 20 25 30 35 40 450
10
20
30
40
50
60
70
80
90
100
Scle
rostin R
ele
ase (
%)
Days
Embree et al, Nature Communications 2016
C) StemGEL Induces
Cartilage Regeneration
0
5
10
15
20
25
********
Col2a1 F
old
Change
StemGELSclerostinControl
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StemGEL-TMJ Advantage:
The First Non-Surgical Regenerative TMJ therapy
1. Administered in a dental office
chairside with no down time
2. Delivered locally to alleviate
pain and restore jaw function
3. Reduce inflammation and
stimulate regeneration
Palliative
ice packs, soft foods, OTC meds, oral appliances, steroid injections, hyaluronic acid (Euflexxa, Gel-one, Hyalgan)
Procedures/Surgery
arthroscopy, orthognathic surgery, TMJ replacement
Do not prevent disease or promote regeneration
Invasive, multiple surgeries, high failure rates
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“I’m in so much pain but I don’t want surgery.”
-Kolia, patient
“I’m 23 years old and cannot eat… feel hopeless.”
-Carol, patient
“I am 53 years old and had five jaw surgeries.”
-Diane, patient
Patients
Insurance
Companies
Providers
Non-surgical
Low CostsRegenerative
Pain ReliefSimple
Application
The StemGEL-TMJ Advantage
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Market Size
StemGEL Market
2.6 Million Patients
Surgical
0.3 MIL
Palliative
0.3 MIL
Palliative +
Procedures
2 MIL
TMD
10 Million Patients
Surgical
1.6 MIL
Palliative
1.6 MIL
Palliative +
Procedures
6.8 MIL
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StemGEL-TMJ Progress
$1.2 Million NIH Grant for target identification
Publish in Nature Communications, Osteoarthritis & Cartilage (7 in total)
2015
2016
2018
$225,000 NIH STTR Phase I Grant for product formulation
Collaboration agreement between Wnt Scientific & Columbia University
Patent filed by Columbia University
Wnt Scientific & Columbia sign exclusive option
Columbia BiomedX Award2019
Edward Puzas, PhD
Professor, University of Rochester
Past President Orthopaedic Research Society
Alia Koch, DDS MD
Program Director
Oral and Maxillofacial Surgery
Columbia University Medical Center
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Our Team
Millie Embree, MS DMD PhD
Director, TMJ Biology Lab
Dr. Edwin S Robinson Assistant Professor
Columbia University Medical Center
Mo Chen, MBA PhD
CEO, Wnt Scientific
Hanying Bai, PhD
VP for Research, Wnt Scientific
Janet S Lee, PhD
President, Subito Science
Clinical/Science Lead Business/Science Lead
Medical AdvisorScientific Advisor
Regulatory Advisor Scientific Advisor
Advisory BoardInventors
Traction & Path to Market
Phase I/II
Trial
Strategic Partnership/Venture CapitalInternal/Federal Grants
FDA
review
Market
EntrySubmit
IND
2022
IND Studies
GLP Toxicology
pK
Immunogenesis
CMC
Target Identification
& Formulation
Discovery
Cells
Fluid
Tissue
2014
Pre-Clinical
Validation
Validation
Assays
2019
Phase III Trial
Submit
NDA/BLA
2028
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