(ORTH: CSE) (ORTIF: OTCQB)

ORTHO Regenerative Technologies is a cutting-edge med tech firm that uses proprietary technology to dramatically improve the success rate of orthopedic and sports medicine surgeries.

• In layman’s terms, that means company has a wonder delivery platform that delivers biologics – drugs made from biological processes – to repair soft tissues in the human body.

The technology uses biologics derived from things like plasma and bone marrow concentrate to regenerate new tissue in various musculoskeletal conditions, helping overcome the widespread problem of failed surgeries.

• This includes Wound Healing, Cartilage Repair and Osteo-Arthritis

ORTHO-R®: A NOVEL DRUG-BIOLOGICS COMBINATION PRODUCT

BENEFITS

• Increases PRP residence time for faster & better tissue repair

• Keeps voluminous implant completely covering the surgically repaired site

• Fast and easy to use by orthopedic surgeons

• Better mechanical and biological new tissue properties and faster recovery

• Better tissue formation and integration between tendon and bone

• Safe and gradual / sustain release of growth factors and cytokines from platelets

FEATURES

• Muco-adhesive to soft tissues

• Resist platelet-mediated clot retraction

• Coagulates rapidly & remains stable

• Augments and accelerates repair in soft tissues conditions

• Increases cell recruitment and formation of new blood vessels

• Optimal biodegradability

THE MARKET OPPORTUNITY:
ORTHOPEDICS M&A TRANSACTIONS (2014-2018)

STRATEGIC VISION 2021-2025:

• Building a continuum of value creation within the Orthobiologics technology platform

• Developing the company’s lead product, ORTHO-R®

• Adding new technologies which complement the existing portfolio

• Securing regulatory approval for the firm’s ongoing and future programs

• Establishing the management structure and talent according to the company’s stage and needs

• Listing Ortho on the U.S. NASDAQ

REGULATORY & CLINICAL PLAN:

• Plan to seek regulatory approval initially in the U.S., Europe and Canada

• ORTHO-R® regulated as a drug/biologic combination product in the U.S.

• FDA - IND submitted for U.S Phase I/II study

• FDA & CANADA-EUROPE Phase III studies in parallel (starting 2023)

• CMC program in line with FDA requirements (cGMP clinical batch manufacturing ongoing)

HOW BIG IS THE SOFT TISSUE REPAIR MARKET?

$5bn USD MARKET OPPORTUNITY

ROTATOR CUFF TEAR

• Leads to shoulder dysfunction and pain
• 4m patients in the U.S. alone
• 600k annual surgeries US alone
• >$600m market opportunity

MENISCUS TEAR REPAIR 

• Painful, compromises knee function
• 1.2m surgeries annually in the U.S. alone
• >$1bn market opportunity

CARTILAGE LESIONS REPAIR

• Lesions cause friction and pain
• 1.2m detected lesions annually in the U.S. alone
• 120k surgeries (lack of options)
• >$1bn market opportunity

STANDARD OF CARE SURGERY HAS HIGH FAILURE RATE

HENCE THE STRONG NEED FOR MORE EFFECTIVE TREATMENTS

ORTHO-R® TECHNOLOGY: A NEW PARADIGM

ORTHO-R®: EASY TO USE & ADDS 8-10 MINUTES

TO STANDARD OF CARE SURGERY

ORTHO CAP-TABLE (AS OF APRIL 2021)

FULL DISCLOSURE: Ortho Regenerative Technologies is an advertising client of AGORA Internet Relations Corp.