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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


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


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


Avg failed

Avg success


Avg failed

Avg success

STRONG NEED FOR MORE EFFECTIVE TREATMENTS


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


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


ORTHO-R® TECHNOLOGY – NEW PARADIGM

• CHITOSAN + PRP BIOLOGIC IMPLANT PREPARATION FOR USE

CHITOSAN Freeze-dried product Blood components After centrifugation

PRP


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



• 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



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


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)


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


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


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


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


LEAN & EFFICIENT ORGANIZATIONAL STRUCTURE

• ORTHO RTI - WORLD CLASS PARTNERSHIPS AND COLLABORATORS


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


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


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


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


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!


CSE: ORTH

CLAUDE LEDUC

PRESIDENT & CEO

514-782-8804

[email protected]

LUC MAINVILLE

SVP & CFO

514-693-8854

[email protected]

FREDERIC DUMAIS

DIRECTOR IR & COMM.

514-782-8803

[email protected]

Thank you!

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