SOFT TISSUE REPAIR BEST-IN-CLASS - Ortho RTi Presentation | October 2017 Brent Norton, CEO - October 2017 _final
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BEST-IN-CLASS SOFT TISSUE REPAIR Ortho RTi Presentation | October 2017 Brent Norton, CEO
FORWARD-LOOKING STATEMENTS
These materials contain forward-looking statements relating to the business of Ortho Regenerative Technologies Inc. (the
“Company” or “Ortho RTi”) including with respect to the progress, timing and completion of the Company’s research,
development, and clinical trials for product candidates, the Company’s ability to manufacture, market, commercialize,
partner and achieve market acceptance for product candidates, its ability to protect its intellectual property and operate its
business without infringing on the intellectual property rights of others, the Company’s estimates for future performance and
its estimates regarding anticipated operating losses, future revenues, capital requirements, and its needs for additional
financing, and any M&A timelines. In addition, even if the Company’s actual results or development are consistent with the
forward-looking statements contained in this presentation, those results or developments may not be indicative of the
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 current expectations 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 actual results,
performance, or achievements to be materially different from any future results, performance or achievements express or
implied by these forward-looking statements. In particular, the Company’s expectations could be affected by, among other
things, uncertainties involved in the development and manufacture of medical devices, unexpected results, unexpected
regulatory actions or delays, competition in general, the Company’s ability to obtain or maintain patent or other proprietary
intellectual property protection. In light of these risks and uncertainties, there can be no assurance that the forward-looking
statements made during this presentation will, in fact, be realized, and no representation or warranty is given as to the
completeness or accuracy of the forward-looking statements contain in 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-looking statements, whether as a result of new information, future events, or
otherwise.
ANNUAL GENERAL MEETING MARCH 29, 2017
2
WHAT IF…
we could heal/repair soft tissue injuries such as
shoulder tears, knee meniscus, cartilage tears?
What would happen to ones What would happen to What would happen to joint replacement
pain and pain management? productivity and longevity? surgery and medical costs?
Lets fix the injury not the
complications of the injury
3
ORTHO RTi
SNAPSHOT
Ortho RTi is developing best-in-class medical products
to heal shoulder and knee injuries using its proprietary
technology
• Founded in 2015
• Technology developed by Dr. Michael Buschmann, PhD, former
Canada Research Chair in Cartilage Tissue Engineering at
Ecole Polytechnique, now Bioengineering Chair at George
Mason University
• Headcount: 19, including 13 scientists under contract
• Earlier product validated mode of action, efficacy, and safety
• ~ $1 million non-dilutive Prima Grant for 2017-18, $12 million in
research funding to date
• Focused on developing technology for use in:
• Shoulder rotator cuff repair
• Knee meniscus and cartilage repair
• Other commonly injured joints – elbow, ankle, hip, etc.
4
SOFT TISSUE INJURIES
A LARGE UNMET NEED
4 million Americans with rotator cuff injuries and
are at risk for disability
• 25% of U.S. adults over the age of 40 develop a
rotator cuff tear, with aging ‘weekend warriors’
escalating the problem
• Only 600,000 surgeries are performed, with 50%
failing within 6-12 months
• 50% of rotator cuff tears progress in size in 3 years
2 million meniscal injuries annually; 16% of all
orthopedic surgeries
• 1.2 million meniscal surgeries annually with (partial)
removal the only option
• Increasing at an average of 8% per year as
population ages and remains active
1.7 million cartilage injuries detected annually;
125,000 treated
5
THE ORTHO PRODUCT
A proprietary biopolymer (Sticky Scaffold)
mixed with patient blood (Bioactive) in the OR
• Freeze-dried in a standard vial Ortho injected
at repair site
• Fits seamlessly into current surgical procedures
• Takes about 5 minutes
• No additional equipment needed
Advantages
ü Biologically repairs tissue
ü One-time, inexpensive procedure
ü Low cost of goods (90%+ margins)
ü Simple to manufacture
ü Long shelf life at room temperature Rotator Cuff
6
ORTHO’S BIOPOLYMER
STICKY SCAFFOLD
Without Ortho Treatment With Ortho Treatment
ORTHO TREATMENT
(GREEN)
RECRUITED CELLS
(BLUE)
2 mm 2 mm
Cells gone after 7 days: Cells present after 7 days:
no cell residency or recruitment promotes residency and cell recruitment
“Sticky scaffold” Activity
• Stabilizes the blood clot in the injury
• Impedes clot shrinkage
• Sticks to the lesion surfaces
7
ORTHO TREATMENT
A BIOACTIVE SCAFFOLD
BLOOD VESSELS
(PINK)
5 mm 50 µm
Ortho subcutaneous treatment
at 14 days
“BioActivity”
• Increases vascularization of tissues
• Promotes tissue repair and regeneration
8
PROOF OF CONCEPT
ROTATOR CUFF MODEL
ORTHO INJECTED AT REPAIRED SITE
AFTER TENDON REATTACHMENT
Ortho placed over
and under the SUTURE ANCHORS
tendon after repair
9
ROTATOR CUFF MODEL
TISSUE HEALING
THE TENDON AT 3 MONTHS POST-SURGERY
Standard of Care
Normal Tendon (not injured) (repaired with anchors only) Ortho + Anchors
ORGANIZED IN BUNDLES DISORGANIZED ORGANIZED IN BUNDLES
250
250µm
µmOrganized in bundles 250 µmDisorganized tissue Organized in bundles
250 µm
Tendon mostly disorganized and Tendon mostly organized in
high levels of GAG* are not bundles with smaller areas of
expressed tendon-like repair tissue
10 *Glycosaminoglycans are implicated in cellular proliferation and wound repairHISTOLOGY SUPPORTS
ROTATOR CUFF HEALING
Normal Tendon Standard of Care Ortho + Anchors
SCAR TISSUE FORMATION ENDOCHONDRAL OSSIFICATION
GAG
GAG
2.5mm 2.5mm 2.5mm
GAG
GAG
1mm 1mm 1mm
The tendon attachment site at 3 months post-surgery Expression of GAG was abundant at insertion
site, suggesting bone remodeling through
endochondral ossification is still ongoing
11TISSUE HEALING
MENISCUS TEAR MODEL
Standard of Care Ortho
Standard of care shows Tear no longer
no healing at 3 months apparent
WITH ORTHO, THE TEAR CAN NO LONGER BE SEEN
12CLINICAL PLANNING
ROTATOR CUFF
Pilot clinical trial
• 5+ clinical sites; 20-25 patients in each arm
• Primary outcome will be safety (unexpected adverse
events)
Registration clinical trial
• 15-25 sites in the U.S. and Canada, ~200 patients
• 6 month enrollment
• Primary outcomes will be pain and function at 6 months
post operation
• Health economic outcomes for payers will be included
ANNUAL GENERAL MEETING MARCH 29, 2017
13REGULATORY PROGRESS
Plan is to seek regulatory approval initially in the
U.S. (world’s largest market)
U.S. regulatory agent
• M Squared Associates, Washington, DC and
New York, NY
• Experience with biopolymers and similar
products
Completed a pre-IND meeting with the U.S. FDA
• Ortho will be regulated as a biologic
• Obtained FDA feedback on development plan
ANNUAL GENERAL MEETING MARCH 29, 2017
14KEY MILESTONES
Q2-3 2018
March 2017 Q3/4 2017 Complete Pivotal
ORS Confece, Pivotal Ovine sub-studies Study and Data Read
California and Efficacy study out, IND Preparation
October 2017 Q2 2018 Q3 2019
Closing of Financing BusDev transaction Data Read Out
July 2017 Q4 2017 Q4 2018 Q2 2019
SMED Conference, Multiple Papers IND Approval Last Patient Out
Toronto published, New
BOD members
September 2017 Q4 2017 Q4 2018
Trading shares on Institutional Financing First Patient In
Canadian Stock
Exchange
15OPPORTUNITY
WELL PROTECTED
Issued United States patent (August 2016)
• U.S. 9,427,469. “Soluble physiological formulations combined with platelet rich plasma (PRP) for
tissue repair”
Patent applications
• PCT ‘780; Composition of matter: polymer and blood component
• PCT ‘129; Composition of matter: freeze dried and lyoprotectant for use with PRP, blood and
combinations
• PCT ‘130; Composition and use: Lyophilized scaffold comprising at least one polysaccharide, to
have a variety of beneficial effects e.g. tissue regeneration, angiogenesis, etc.
Legal opinion affirming freedom to operate
ANNUAL GENERAL MEETING MARCH 29, 2017
16STRONG PARTNERS
AND STRATEGIC INTEREST
2017
• Novadaq acquired by Stryker for $900M (June)
2016
• Cayenne Medical acquired by Zimmer Biomet (April)
• BST Cargel acquired by Smith and Nephew (January)
• Ellipse Technologies acquired by NuVasive for $410 million (January)
2015
• X-Spine acquired by Bacterin for $107 million (July)
• TEI Biosciences acquired by Integra Life Sciences for $312 million (June)
• Spinal Modulation acquired by St. Jude for $215 million (April)
2014
• Symmetry Surgical acquired by Tecomet for $450 million (August)
• Small Bone Innovations (SBI) acquired by Stryker for $375 million (June)
• ArthoCare acquired by Smith and Nephew for $1.7 billion (February)
17HISTORY OF SUCCESS
IN MEDICAL TECHNOLOGY
Brent Norton, MD, MBA, ICD.D
• Founded PreMD, completing IPOs on both TSX and AMEX
• A founding Director of Novadaq Technologies (TSX:NDQ, NASDAQ:NVDQ),
one of Canada’s most valuable medical companies, recently sold to Stryker
for $900M
• Has led transactions with AstraZeneca, Atherogenics, Eli Lilly, L’Oreal,
Parke Davis/Pfizer, etc., and taken products through the FDA to global out-
licensing with Johnson & Johnson
• Has been an active member of several Boards, public and private, in both
Canada and the US
• Currently: Venture Partner at Lumira Capital, member of the Research
Committee for CAMH, and Advisory Board member for the Ivey
International Centre for Health Innovation
• His contributions to six companies have allowed early investors the
opportunity to crystalize investment gains of over $2.5 billion
ANNUAL GENERAL MEETING MARCH 29, 2017
18LEADERSHIP
PROVEN CORPORATE & SCIENTIFIC
Brent Norton MD, MBA, ICD.D • Medical Doctor with clinical experience in sports medicine
Executive Chairman & CEO
Steve Saviuk • CA, background in finance and venture capital investing
Director • Co-founded Valeo Pharma in 2003 & served as its President and CEO since its inception
Laurence Rulleau • Principal at CTI Life Sciences, Former V.P. BD at Gestion Univalor
Director • MSc in Biology from UQAM & PhD in molecular biology from Université de Montréal
• Professor, Orthopedic Surgery at Cornell University & Attending Surgeon at New York Presbyterian
Scott Rodeo, MD & HSS
Clinical Advisory Board • Head Team Physician, New York Giants football team & Team Physician, US Olympic Team (2004
to 2012)
Jack Farr, MD • Expert in cartilage and knee restoration and sports medicine
Clinical Advisory Board • Indiana Orthopedic Hospital, St Vincent’s Hospital; MD, Indiana
• Orthopedic Surgeon at The Royal Orthopedic Hospital, UK
Martyn Snow, MD, MSc • Authored 30 publications, 4 book chapters on knee and shoulder injuries
Clinical Advisory Board • Presented over 50 papers at various national and International meetings
• Accomplished history in global sports and entertainment industry
Tom Wright • 11th commissioner of the Canadian Football League (CFL)
Director • Ultimate Fighting Championship (UFC) Exec VP and GM (Canada, Australia & New Zealand)
• Discovered and developed BST CarGel marketed by Smith & Nephew
Michael Buschmann, PhD • Professor, Biomaterials and Cartilage Laboratory, University of Montreal
Scientific Advisory Board, Director • PhD, Massachusetts Institute of Technology and Harvard University
• Professor at EP, MSc, Applied Biology and PhD, Toxicology from MIT
Caroline Hoeman, PhD • National career fellowships from the Fonds de la Recherche Santé du Quebec (FRQ-S) for research
Director in biomaterial devices for articular cartilage repair
19OWNERSHIP
HOLDER SHARES OWNERSHIP IN (%)
TOP HOLDERS
Steve Saviuk/Manitex Capital Inc. 4,808,858 26.05%
Michael D. Bushmann 2,222,222 12.04%
Caroline D. Hoemann 1,666,667 9.03%
Polyvalor (École Polytechnique) 1,073,334 5.81%
TOTAL TOP HOLDERS 9,771,081 52.93%
Other Holders 8,690,419 47.07%
BASIC SHARES OUTSTANDING 18,461,500 100.00%
Options 1,400,000
Warrants 2,913,250
FD SHARES OUTSTANDING 22,774,750
Shares in Escrow 11,508,858
Shares in Hold period 1,195,000
FLOAT 5,757,642 31%
GENERAL MEETING MARCH 29, 2017
20INVESTMENT SUMMARY
• Significant, unmet medical needs in a global US$5 billion
market, growing 8%+ / year
• First product to market timeline is short, with clear,
manageable end-points
• Active financing and M&A space in tissue repair, with
multiple transactions / exits
• Product sales and royalty revenue potential from multiple
product pipeline
• Opportunity protected by broad global patent estate
• Proven leadership team
ANNUAL GENERAL MEETING MARCH 29, 2017
21CONTACT
Brent Norton MD, MBA, ICD.D Stephen Kilmer
Executive Chairman and CEO Investor Relations
514-782-0951 647-872-4849
norton@orthorti.com kilmer@orthorti.com
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