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ORTHO REGENERATIVE TECHNOLOGIESA NOVEL ORTHOBIOLOGICS DELIVERY PLATFORM FOR MUSCULOSKELETAL TISSUE REPAIR
CSE: ORTH
FORWARD LOOKING STATEMENTS
• These materials contain forward-looking statements relating to the business of Ortho Regenerative Technologies Inc. (the “Company” or “Ortho RTi”) including withrespect to the progress, timing and completion of the Company’s research, development, and clinical trials for product candidates, the Company’s ability tomanufacture, market, commercialize, partner and achieve market acceptance for product candidates, its ability to protect its intellectual property and operate itsbusiness without infringing on the intellectual property rights of others, the Company’s estimates for future performance and its estimates regarding anticipatedoperating losses, future revenues, capital requirements, and its needs for additional financing, and any M&A timelines. In addition, even if the Company’s actualresults or development are consistent with the forward-looking statements contained in this presentation, those results or developments may not be indicative ofthe Company’s results or developments in the future. In some cases, you can identify forward-looking statements by words such as “could”, “should”, “may”,“expect”, “anticipates”, “believes”, “intends”, “estimates”, or similar words. These forward-looking statements are based largely on the Company’s currentexpectations as of the date of this presentation and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actualresults, performance, or achievements to be materially different from any future results, performance or achievements express or implied by these forward-lookingstatements. In particular, the Company’s expectations could be affected by, among other things, uncertainties involved in the development and manufacture ofmedical devices, unexpected results, unexpected regulatory actions or delays, competition in general, the Company’s ability to obtain or maintain patent or otherproprietary intellectual property protection. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made duringthis presentation will, in fact, be realized, and no representation or warranty is given as to the completeness or accuracy of the forward-looking statements containin these materials.
• Ortho RTi is providing the information in these materials as of this date, and we disclaim any intention or obligation to publicly update or revise any forward-lookingstatements, whether as a result of new information, future events, or otherwise.
2ORTHO REGENERATIVE TECHNOLOGIES - CSE: ORTH2020-08-24
ORTHO REGENERATIVE TECHNOLOGIES - OVERVIEW
• Clinical Stage Company
• Incorporated in 2015
• Headquarters, R&D and Manufacturing in Montreal, Quebec
• Spin-off from Polytechnique Montreal (U of M)
PROFILE
• Canadian Stock Exchange ( CSE: ORTH )
• Total Capital raised US$6M
•∽ 55% controlled by Founders, University, Management Team, Board
CAPITAL
• Proprietary muco-adhesive Chitosan based Biopolymer Matrix, specifically designed to deliver Biologics such as Platelet-Rich Plasma (PRP) or Bone Marrow Aspirate Concentrate (BMAC), to Augment and Guide the regeneration of new tissue in various Orthopedics Musculoskeletal Conditions
• IP: 3 Families of Patents
• US$7.4M invested by Canadian Government and University in technology (Grants)
TECHNOLOGY
• ORTHO-R® BIOLOGICAL IMPLANT - Rotator Cuff, Ligament and Meniscus Tears
• Adjuvant to Orthopedic Surgery Standard of Care
• Exploring other formulabons for new Therapeubc usage (Oncology, Osteoarthribs, Drug Delivery)
PRODUCTS
3ORTHO REGENERATIVE TECHNOLOGIES - CSE: ORTH2020-08-24
SOFT TISSUE REPAIR MARKET OPPORTUNTY
• US$5B MARKET OPPORTUNITY
• Rotator Cuff TEAR• Leads to shoulder dysfunction and pain
• 4M patients US alone
• 600K annual surgeries US alone
• $600M+ market opportunity
• Meniscus Tear Repair• Painful, compromises knee function
• 1.2M surgeries annually US alone
• $1B+ market opportunity
• Cartilage Lesions Repair• Lesions cause friction and pain
• 1.2M detected lesions annually US alone
• 120K surgeries (lack of options)
• $1B+ market opportunity
4ORTHO REGENERATIVE TECHNOLOGIES - CSE: ORTH2020-08-24
STANDARD OF CARE SURGERY – HIGH FAILURE RATE
Rotator cuff
• Repaired rotator cuffs re-tear
Meniscus
• Failed repair leads to Osteoarthritis
Cartilage
• Repair tissue not durable
20-95% failure rates
Avg failed
Avg success
20-40% failure rates
Avg failed
Avg success
15-35% failure rates
Avg failed
Avg success
STRONG NEED FOR MORE EFFECTIVE TREATMENTS
5ORTHO REGENERATIVE TECHNOLOGIES - CSE: ORTH2020-08-24
R. Mirzayan & Al., J Am Acad Orthop Surg 2019;27: 468-478
PLATELET-RICH PLASMA (PRP)
• Heterogeneous product derived
from patient’s own blood
• High concentration of platelets,
growth factors and cytokines
• PRP devices are available in all
clinics Ehrenfest et al 2014
PRP
Dohan et al 2008
Platelet
Leukocyte
Fibrin
6ORTHO REGENERATIVE TECHNOLOGIES - CSE: ORTH2020-08-24
A NOVEL ORTHOBIOLOGICS DELIVERY PLATFORM
• ORTHO-R® BIOLOGICAL IMPLANT TECHNOLOGY
• Proprietary Chitosan + Platelet-Rich Plasma combina@on formula@on
• Lyophilized Chitosan powder (2 + years shelf life)
• Solubilized with autologous PRP during surgery, adding about 6-8 min. to surgery @me
• Muco-adhesive to soK @ssues
• Coagulates rapidly, remains stable and resists platelet-mediated clot retrac@on
• Increases PRP residence -me for faster & be4er -ssue repair (from less than 24 hours for PRP alone to
up to 6 weeks for Ortho-R product)
• Proven mode of ac@on (19 publica@ons & conference presenta@ons in 3 years)
• Augments and accelerates healing in so2 3ssues condi3ons
• Increases cell recruitment and forma3on of new blood vessels
• Op3mal biodegradability
7ORTHO REGENERATIVE TECHNOLOGIES - CSE: ORTH2020-08-24
ORTHO-R® TECHNOLOGY – NEW PARADIGM
• CHITOSAN + PRP BIOLOGIC IMPLANT PREPARATION FOR USE
CHITOSAN Freeze-dried product Blood components After centrifugation
PRP
8ORTHO REGENERATIVE TECHNOLOGIES - CSE: ORTH2020-08-24
ORTHO-RⓇ PROOF OF CONCEPT – ROTATOR CUFF TEARS
ORTHO-R® delivered between
tendon and bone & on
repaired site surfacesORTHO-R® DELIVERED AT REPAIRED SITE
DURING TENDON REATTACHMENT
SUTURE ANCHORS
ORTHO-R EASY TO USE AND ADDS 8-10 MINUTES TO STANDARD OF CARE SURGERY
9ORTHO REGENERATIVE TECHNOLOGIES - CSE: ORTH2020-08-24
ORTHO-RⓇ PROOF OF CONCEPT – ROTATOR CUFF TEARS
• SUCCESSFUL HEALING WITH ORGANIZED REPAIR TISSUE
ORTHO-R® + AnchorsNormal Tendon (not injured)
Standard of Care
(repaired with anchors only)
Tendon mostly disorganized Tendon mostly organized in bundles with
smaller areas of tendon-like repair tissue
Organized in bundles
250 µm250 µm
250 µm
DISORGANIZED ORGANIZED IN BUNDLES
TENDON AT 3 MONTHS POST-SURGERY
ORGANIZED IN BUNDLES
250 µm
10ORTHO REGENERATIVE TECHNOLOGIES - CSE: ORTH2020-08-24
ORTHO-RⓇ PROOF OF CONCEPT – ROTATOR CUFF TEARS
2.5mm2.5mm
2.5mm
1mm 1mm 1mm
GlycosaminoglycansSCAR TISSUE FORMATION ENDOCHONDRAL OSSIFICATION
GAGs
GAGs
HISTOLOGY – TENDON ATTACHMENT SITE 3 MONTHS AFTER SURGERY
Expression of GAGs was
abundant at insertion
site, suggesting bone
remodeling through
endochondral
ossification is still
ongoing
Normal Tendon Standard of Care Ortho-R® + Standard of Care
11ORTHO REGENERATIVE TECHNOLOGIES - CSE: ORTH2020-08-24
Glycosaminoglycans
ORTHO-RTI - REGULATORY & CLINICAL PLAN
• Plan is to seek regulatory approval initially in the U.S., Europe and Canada (world’s
largest markets)
• ORTHO-R® regulated as a device/drug/biologics combination product in the U.S.
• FDA - IDE submission planned October – 2020 for U.S Phase I/II study
• FDA & CANADA-EC Phase III studies in parallel (2022)
• CMC program in line with FDA requirements (cGMP clinical batch manufacturing ongoing)
12ORTHO REGENERATIVE TECHNOLOGIES - CSE: ORTH2020-08-24
ORTHO-RⓇ PHASE I/II US CLINICAL TRIAL – ROTATOR CUFF TEARS
ORTHO-R + Standard of Care Surgery versus Standard of Care Surgery alone
• Study type: Prospective, randomized, controlled and blinded Phase I/II study
• Primary endpoint:
• Safety (unexpected adverse events)
• Secondary endpoints:
• Pain (VAS)
• Validated shoulder Function score index
• MRI healing/structural assessment
• Number of re-tears
• Assessments: Baseline – 6 weeks – 3 – 6 – 12 months
• Enrollment:
• 25 patients in control arm and 50 patients in Ortho-R arm (1:2 ration)
• Standard of care (Suture with anchors) VERSUS Standard of care + Ortho-R (proprietary CHITOSAN + autologous PRP)
• Location: 6-10 clinical sites in the US
13ORTHO REGENERATIVE TECHNOLOGIES - CSE: ORTH2020-08-24
ROTATOR CUFF TEARS - KEY VALUE CREATION MILESTONES*
Rotator Cuff
Tears
Q1 2019 Q2 2019 Q3 2019 Q4 2019 Q1 2020 Q2 2020 Q3-Q4 2020 H1 2021 H1 2022 H2 2022 2023 2024
Pre-Clinical Sheep Pivotal Trial
start
Pivotal Trial
completion
Pivotal Trial Data
analysis.
Pivotal Trial
Data analysis.
Pivotal Trial
MRI& Safety
report
Sheep Pivotal
Trial final
Report
CMC
(Manufacturing
CMO)
API /FP
Engineering
batch Process Verification
Validation of
Analytical
Methods
FP Stability study(6
months)
FP Completion
of Stability
study
API completion
of Stability
study(6 months)
CGMP Phase I/II
study clinical
batch
CGMP Phase III
study clinical
batch
Regulatory Pre-IND
meeting FDA
Pre-IND meeting
FDA Q&A
Pre-CTA
Consultation
Meeting Health Canada
Pre-RFD
Application
filling FDA
FDA Designation
IDE / IND
FDA Designation
Drug/Biologics
FDA approval for
Phase III Clinical
Study
NDA / BLA
(Biologics
License) Application
filling FDA
Phase I/II
US Clinical Trial
CRO selection
MCRA
Clinical Sites
selection
Clinical sites
Qualification,
Training & Start enrolling
Phase I/II
Clinical Trial
End enrolling
Phase I/II Clinical
Trial end of
follow-up
Phase I/II
Clinical Trial
Data Analysis & Results
Phase III
US, Canada & EU
Clinical Trials
Clinical Trial
Start enrolling
Clinical Trial
End enrolling
Clinical trial
end follow-
up
Phase III
Clinical Trial
Results
Strategic
co-development /
Licensing
Therapeu]cs co-
development
agreement
Clinical Trial
Co-development
agreement
Licensing Agreement
14ORTHO REGENERATIVE TECHNOLOGIES - CSE: ORTH2020-08-24
Value inflexion
point
*Timelines estimates may vary
ORTHO-R® PROOF OF CONCEPT – MENISCUS TEARS
2mm
250µm
No repair tissue
Tear site
2mm
250µm
Tear site
Highly cellular and
integrated repair tissue
Complete repair
Ghazi Zadeh et al 2017 Reg Med Ther
SOC + Ortho-R at 3 monthsSOC + PRP at 3 months
Sutures (SOC) + PRPOrtho-R promoted repair
15ORTHO REGENERATIVE TECHNOLOGIES - CSE: ORTH2020-08-24
ORTHO-R® PROOF OF CONCEPT – CARTILAGE LESIONS
1mm
500µm
1mm
500µm
Improved fill
Improved appearance
Dwivedi et al 2019 J Tiss Eng Reg Med
SOC + Ortho-R® at 2 monthsSOC + PRP at 2 months
Ortho-R® improved repairMicrofracture (SOC) + PRP
16ORTHO REGENERATIVE TECHNOLOGIES - CSE: ORTH2020-08-24
LEAN & EFFICIENT ORGANIZATIONAL STRUCTURE
• ORTHO RTI - WORLD CLASS PARTNERSHIPS AND COLLABORATORS
17ORTHO REGENERATIVE TECHNOLOGIES - CSE: ORTH2020-08-24
LEAN & EFFICIENT ORGANIZATIONAL STRUCTURE
ORTHO RTIBOARD OF DIRECTORS
ORTHO RTI CLAUDE LEDUC CEO
ORTHO RTI
ORTHO RTILUC MAINVILLE
SVP - CFO
ORTHO RTI FREDERIC DUMAIS
IR
ORTHO RTI NATHALIE THERRIEN REGULATORY AFFAIRS
ORTHO RTIGUY PAUL ALLARD
LEGAL COUNSEL
Polytechnique Montreal
R&D
POLYTECHNIQUE
Prof. MARC LAVERTU PHD
POLYTECHNIQUEANICK CHEVRIER MSc
R&D
POLYTECHNIQUE JULIE TREMBLAY BSC QA - PM
POLYTECHNIQUEDONG WANG MSC R&D
CLINICAL ADVISORY BOARD
18ORTHO REGENERATIVE TECHNOLOGIES - CSE: ORTH2020-08-24
BOARD & MANAGEMENT RELEVANT EXPERIENCEMichael Atkin, MBA, Chairman of the Board
30 years of experience in life sciences.
President of Syzent Partners Ltd. ("Syzent")
Mr. Atkin held senior executive and Board positions at Ulysses
Pharmaceuticals, Aegera Therapeutics, Sopharmia Inc., Affinité Instruments, Bristol-Myers Squibb, Lederle International.
He holds an MBA from Columbia University's graduate school of business (New York, USA) and a BA from the University of Kent at
Canterbury (Great Britain).
Steve Saviuk, C.A., Founder Ortho RTI, Director
Founder & CEO Valeo Pharma
Extensive experience in finance & Venture Capital financing
Brent Norton, MD, MBA ,Director
Founder PreMD, IPO, TSX & AMEX
Founding Director of Novadaq Technologies, TSX, NASDAQ NVQD,
multiple licensing transactions
Venture partner LUMIRA Capital
Michael Buschmann, PhD., CSO, Director
Professor, Chair Department of Bioengineering, George Masson
University
PhD, MIT & Harvard University
Discovered & Developed BST-CarGel (Smith & Nephew)
Tom Wright, MBA, ICD.D, Director
Accomplished history in global sports and entertainment industry. 11th commissioner of the Canadian Football League (CFL). Ultimate
Fighting Championship (UFC) Exec VP and GM (Canada, Australia &
New Zealand)
Claude LeDuc, President & CEO, Director
34 years BioPharma & Medical Device industry
MRM Proteomics, Genzyme Biosurgery, Biomatrix, BioSyntech, Serono Labs, Syntex Labs
$55M+ Private & Public Financings TSX,
Pierre Laurin, MSc. Director
Founder Prometic Life Sciences
Raised $1B+ Private & Public Financings
multiple licensing & partnering agreements
35 Years Biopharma experience
Caroline Hoemann, PhD., Director
Professor, George Masson University, MSc Applied Biology, PhD Toxicology at MIT
Discovered & Developed BST-CarGel (Smith & Nephew
Luc Mainville, MBA, Senior VP & CFO
Valeo Pharma, Acerus Pharma, Cardiome, NeoPharm, LAB Research, RTP Pharma, Enobia Waratah
Raised $1B+, 30+ M&A transactions, 4 IPOs
Previous Partner KPMG
19ORTHO REGENERATIVE TECHNOLOGIES - CSE: ORTH2020-08-24
KOL CLINICAL ADVISORY BOARD
Jack Farr, MD
Expert in cartilage, meniscus and knee restoration and sports medicine.
Subspecialty practice in knee and cartilage restoration.
Voluntary clinical professor in orthopaedic surgery, Indiana University Medical Center Indiana Orthopaedic Hospital, St Vincent’s
Hospital; MD, Indiana
Scott Rodeo, MD
Expert in cartilage, meniscus, rotator cuff and knee/shoulder restoration and sports medicine.
Professor, Orthopaedic Surgery, Cornell University. Attending Surgeon, New York Presbyterian, and The Hospital for Special Surgery.
Head Team Physician, New York Giants football team. Team Physician, US Olympic Team (2004-2012). Co-Chief Emeritus, Sports
Medicine and Shoulder Service.
Co-Director, Tissue Engineering, Regeneration, and Repair Program
Martyn Snow, MD, MSc
Expert in cartilage, rotator cuff and knee/shoulder restoration and sports medicine.
Orthopaedic Surgeon, The Royal Orthopaedic Hospital, UK. Authored 30 publications, 4 book chapters on knee and shoulder injuries. Presented over 50 papers at various national and international meetings.
Honorary Professor, Birmingham and Aston University
Jacques Toueg, MD
Practising Orthopaedic Surgeon and Director of Montreal Institute for Special Surgery.
Chief Physician, National Training Center of Tennis Canada, and the Tennis Roger’s Cup.
Physician treating team members of professional sports organizations including NHL, the Major Junior Hockey League of Quebec, CFL,
Boxing Canada
20ORTHO REGENERATIVE TECHNOLOGIES - CSE: ORTH2020-08-24
FINANCING NEEDS SOURCES – 3 YEARS PROJECTION US$8Millions
EQUITY, $5,000,000GRANTS, $1,050,000
DEBENTURE, $1,250,000
R&D TAX CREDITS, $700,000
2020-08-24 ORTHO REGENERATIVE TECHNOLOGIES - CSE: ORTH 21
USE OF PROCEEDS - 3 YEAR PROJECTION
RCT GLP SHEEP PIVOTAL, $612,000
RCT CLINICAL PHASE I/II, $3,700,000
MENISCUS GLP SHEEP PIVOTAL, $570,000
PAYROLL & STAFF CONSUL., $575,000
WORKING CAPITAL, $250,000
CMC, $480,000
REGULATORY, $170,000
PROF. FEES (CONSULTANTS), $345,000
CSE - IR, $120,000
IP, $100,000
R&D POLYTECHNIQUE, $1,035,000
US$ 8MILLIONS USE OF PROCEEDS
2020-08-24 ORTHO REGENERATIVE TECHNOLOGIES - CSE: ORTH 22
ORTHOPEDICS M&A TRANSACTIONS 2014 - 2018
$0
$500
$1,000
$1,500
$2,000
ARTHROCARE /
SM
ITH &
NEPHEW
2014
SMALL
BO
NE IN
NO
VATION
/ S
TRYKER 2014
SYM
ETRY SU
RGIC
AL /
TECOM
ET 2014
SPIN
AL M
ODU
LATIO
N /
ST-JU
DE 2015
TEI BIO
SCIE
NCES
/ IN
TEGRA L
IFE S
CIEN
CE 2015
X- SPIN
E / B
ACTERIN 2
015
BST-C
ARGEL
/ SM
ITH &
NEPHEW
2016
CAYENN
E MEDIC
AL / Z
IMM
ER BIO
MET 2
016
ELLIP
SE T
ECHNO
LOGIE
S /
NIV
ASIVE 2
016
ROTATIO
N M
EDICAL
/ SM
ITH &
NEPHEW
2017
NO
VADAQ /
STRYKER 2
017
CARTIVA /
WRIG
HT MEDIC
AL 2018
K2M /
STRYKER 2
018
EMERG
ING IM
PLAN
T TECHN
OLO
GIE
S / D
EPUY S
UN
THES …
$1,700
$375 $450$215 $312
$107 NA NA$410
$210
$900
$435
$1,400
NA
US
D$
M
M&A USD$M
23ORTHO REGENERATIVE TECHNOLOGIES - CSE: ORTH2020-08-24
ORTHO REGENERATIVE TECHNOLOGIES – VALUE PROPOSAL
1. Fill a significant Market Need
• Need for improving standard of care surgery outcomes
• First solution to address the lack of residence time of Orthobiologics use in musculoskeletal conditions
• USD$5B soft tissue repair global market
2. Novel Technology
• Increases very significantly the residence time and impedes blood clot retraction of Orthobiologics use in the Treatment of Soft Tissue Injuries in Various Musculoskeletal Conditions
• Validated mode of action, safe and easy to use solution, adjunct to standard of care surgery
• New unique drug/biologics/device combination therapeutic status (first in a new category)
3. Smart Business Model
• CLINICAL STAGE COMPANY
• Focus on developing Orthobiologics applications in US Market first
• High volume, low cost products
• Reduces healthcare stakeholders’ costs by improving standard of care surgery outcomes
4. Great Exit Potential
• CSE listed and OTCQB target listing during 2020
• Exploring NASDAQ listing for 2021
• Substantial orthopaedics M&A transactions comparable history
• Highly Experienced leadership, Board, R&D and Clinical Team
5. COMPANY WELL UNDERVALUED TO COMPARABLES!
24ORTHO REGENERATIVE TECHNOLOGIES - CSE: ORTH2020-08-24
CSE: ORTH
CLAUDE LEDUC
PRESIDENT & CEO
514-782-8804
LUC MAINVILLE
SVP & CFO
514-693-8854
FREDERIC DUMAIS
DIRECTOR IR & COMM.
514-782-8803
Thank you!