BEST-IN-CLASS SOFT TISSUE REPAIR. Ortho RTi Presentation October 2017 Brent Norton, CEO

Transcription

1 BEST-IN-CLASS SOFT TISSUE REPAIR Ortho RTi Presentation October 2017 Brent Norton, CEO

2 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 forwardlooking 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,

3 WHAT IF we could heal/repair soft tissue injuries such as shoulder tears, knee meniscus, cartilage tears? What would happen to ones pain and pain management? What would happen to productivity and longevity? What would happen to joint replacement surgery and medical costs? Lets fix the injury not the complications of the injury 3

4 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 , $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

5 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

6 THE ORTHO PRODUCT A proprietary biopolymer (Sticky Scaffold) mixed with patient blood (Bioactive) in the OR Freeze-dried in a standard vial Fits seamlessly into current surgical procedures Ortho injected at repair site Takes about 5 minutes No additional equipment needed Advantages ü ü ü Biologically repairs tissue One-time, inexpensive procedure Low cost of goods (90%+ margins) ü Simple to manufacture ü Long shelf life at room temperature Rotator Cuff 6

7 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: no cell residency or recruitment Cells present after 7 days: promotes residency and cell recruitment Sticky scaffold Activity Stabilizes the blood clot in the injury Impedes clot shrinkage 7 Sticks to the lesion surfaces

8 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

9 PROOF OF CONCEPT ROTATOR CUFF MODEL ORTHO INJECTED AT REPAIRED SITE AFTER TENDON REATTACHMENT Ortho placed over and under the tendon after repair SUTURE ANCHORS 9

10 ROTATOR CUFF MODEL TISSUE HEALING THE TENDON AT 3 MONTHS POST-SURGERY Normal Tendon (not injured) Standard of Care (repaired with anchors only) Ortho + Anchors ORGANIZED IN BUNDLES DISORGANIZED ORGANIZED IN BUNDLES 250 µm 250 µm 250 µm Organized in bundles Disorganized tissue Organized in bundles Tendon mostly disorganized and high levels of GAG* are not expressed Tendon mostly organized in bundles with smaller areas of tendon-like repair tissue 10 *Glycosaminoglycans are implicated in cellular proliferation and wound repair

11 HISTOLOGY 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 11

12 TISSUE HEALING MENISCUS TEAR MODEL Standard of Care Ortho Standard of care shows no healing at 3 months Tear no longer apparent WITH ORTHO, THE TEAR CAN NO LONGER BE SEEN 12

13 CLINICAL PLANNING ROTATOR CUFF Pilot clinical trial 5+ clinical sites; patients in each arm Primary outcome will be safety (unexpected adverse events) Registration clinical trial 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,

14 REGULATORY 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,

15 KEY MILESTONES March 2017 ORS Confece, California Q3/ Pivotal Ovine sub-studies and Efficacy study Q Complete Pivotal Study and Data Read out, IND Preparation October 2017 Closing of Financing Q BusDev transaction Q Data Read Out July 2017 SMED Conference, Toronto Q Multiple Papers published, New BOD members Q IND Approval Q Last Patient Out September 2017 Trading shares on Canadian Stock Exchange Q Institutional Financing Q First Patient In 15

16 OPPORTUNITY 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,

17 STRONG 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) 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)

18 HISTORY 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 outlicensing 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,

19 LEADERSHIP PROVEN CORPORATE & SCIENTIFIC Brent Norton MD, MBA, ICD.D Executive Chairman & CEO Medical Doctor with clinical experience in sports medicine Steve Saviuk Director CA, background in finance and venture capital investing Co-founded Valeo Pharma in 2003 & served as its President and CEO since its inception Laurence Rulleau Director Scott Rodeo, MD Clinical Advisory Board Jack Farr, MD Clinical Advisory Board Martyn Snow, MD, MSc Clinical Advisory Board Tom Wright Director Michael Buschmann, PhD Scientific Advisory Board, Director Caroline Hoeman, PhD Director Principal at CTI Life Sciences, Former V.P. BD at Gestion Univalor 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 & HSS Head Team Physician, New York Giants football team & Team Physician, US Olympic Team (2004 to 2012) Expert in cartilage and knee restoration and sports medicine Indiana Orthopedic Hospital, St Vincent s Hospital; MD, Indiana Orthopedic Surgeon at The Royal Orthopedic Hospital, UK Authored 30 publications, 4 book chapters on knee and shoulder injuries Presented over 50 papers at various national and International meetings 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) Discovered and developed BST CarGel marketed by Smith & Nephew Professor, Biomaterials and Cartilage Laboratory, University of Montreal PhD, Massachusetts Institute of Technology and Harvard University Professor at EP, MSc, Applied Biology and PhD, Toxicology from MIT National career fellowships from the Fonds de la Recherche Santé du Quebec (FRQ-S) for research in biomaterial devices for articular cartilage repair 19

20 OWNERSHIP HOLDER SHARES OWNERSHIP IN (%) TOP HOLDERS Steve Saviuk/Manitex Capital Inc. 4,808, % Michael D. Bushmann 2,222, % Caroline D. Hoemann 1,666, % Polyvalor (École Polytechnique) 1,073, % TOTAL TOP HOLDERS 9,771, % Other Holders 8,690, % BASIC SHARES OUTSTANDING 18,461, % 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% 20 GENERAL MEETING MARCH 29, 2017

21 INVESTMENT 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,

22 CONTACT Brent Norton MD, MBA, ICD.D Executive Chairman and CEO Stephen Kilmer Investor Relations