Targeting the $5 BILLION Soft Tissue Repair Market
Chitogenx is in the regulatory lead for regenerative products + signs MOU with major Medical Institute
HOW BIG IS THE SOFT TISSUE REPAIR MARKET?
US$5bn 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
700k surgeries annually US alone
$1B+ market opporunity
Cartilage Lesions Repair
Lesions cause friction and pain
1.2M detected lesions annually US alone
120K surgeries (lack of options)
$1B+ market opportunity
- The first patient surgery was successfully completed at the Tucson Orthopaedic Institute in Tucson, Arizona.
- The ORTHO-R Phase I/II clinical study is a prospective, randomized, controlled, and blinded clinical trial, to evaluate the safety and efficacy of ORTHO-R as an adjunct to standard of care surgery vs. standard of care surgery alone for rotator cuff tear repair.
- The clinical trial will enroll a total of 78 patients at 10 clinical sites throughout the U.S.
ORTHO REGENERATIVE TECHNOLOGIES REPORTS ITS FIRST QUARTER 2023 RESULTS
● Patients recruitment initiated for U.S. Phase I/II rotator cuff tear repair clinical trial in June 2023
● Phase I/II clinical trial IND application cleared by FDA for testing ORTHO-R in combination with PRP for rotator cuff tear repair
● ORTHO-R / PRP combination becomes the first drug/biologic implant combination product cleared by the FDA for clinical trial testing
● Key U.S., Canadian and European composition and method patent secured for ORTHO-R / PRP soft tissue repair platform, protecting core IP until 2035
● $3.2 Million over-subscribed private placement secured in Q1-2022
● $500,000 grant secured to advance the development of second technology platform indication, ORTHO-M, for meniscus repair
CHITOGENX INC. INITIATES PATIENTS RECRUITMENT FOR ITS U.S. PHASE I/II ROTATOR CUFF TEAR REPAIR CLINICAL TRIAL
- Contracting procedures completed for 6 of the 10 clinical trial sites
- 5 sites fully activated, with ongoing patients' screening and recruitment
CHITOGENX INC. RECEIVES $500,000 AXELYS GRANT TO ADVANCE ORTHO-M DEVELOPMENT FOR MENISCUS REPAIR
- Meniscus indication confirms proprietary technology platform multi-indications potential
- Grant to accelerate development of second clinical indication
STANDARD OF CARE SURGERY HAS HIGH FAILURE RATE
HENCE THE STRONG NEED FOR MORE EFFECTIVE TREATMENTS
ORTHO-R® TECHNOLOGY – NEW PARADIGM
ORTHO-R EASY TO USE AND ADDS 8-10 MINUTES TO STANDARD OF CARE SURGERY
BENEFITS
- Increases PRP residence time for faster & better tissue repair (from less than 24 hours for PRP alone to up to 6 weeks for Ortho-R product)
- Keeps voluminous implant completely covering the surgically repaired site
- 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 and sustain release of growth factors and cytokines from platelets
PRODUCT DEVELOPMENT PORTFOLIO
KEY VALUE MILESTONES
HANUMAN PRP SYSTEM GLOBAL LICENSING DEAL
- Exclusive Global License to use, manufacture, sublicense and sell Product in combination with ORTHO-R
- Fields: Tendons, Ligaments, Meniscus, Cartilage and Wound Healing (non-exclusive)
- Royalty to Hanuman on net sales (on Product)
- New product addition to ORTHO RTI portfolio
- Generates significant revenues to ORTHO RTI in surplus of ORTHO R product
- Perfect complementarity / integration to ORTHO-R
WORLD CLASS PARTNERSHIPS AND COLLABORATORS
Chitogenx Signs Memorandum Of Understanding With California Medical Innovations Institute
- This Memorandum, between CALMI2 and ChitogenX will identify collaborative projects and pursue proof of concept research programs utilizing ChitogenX's proprietary regenerative medicine solutions to improve patient outcomes.
- Dr. Kassab's group has obtained nearly $100M worth of extramural research grants to fund scientific medical developments