Chitogenx Inc. Increases FDA Regulatory Lead For Soft Tissue Repair Trials With 8 Clinics Already Activated - $12 BILLION Market

AGORACOM Small Cap CEO Interviews

Have you ever torn a:

• Rotator cuff
• Meniscus
• Cartilage

How about someone you know? Or an athlete?

We wouldn’t blame you if you thought the care and repair of these kinds of injuries is standard and highly successful …. but you would be wrong. There is a MASSIVE problem with surgery failure rates for each of these as follows:

• ACL 30%
• Rotator Cuff 40-50% Failure Rate
• Meniscus 20-40%
• Cartilage 15-35%

Chitogenx uses its proprietary RESTORE technology platform 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.
• in the regulatory lead for regenerative products” Growing To $125B By 2030
• Signing of Material Transfer Agreement with global strategic medical company
• Clinical Trials for rotator cuff tear repair already started. Phase 1 (SEP) Phase 2 (Start OCT)
• expanded applications beyond orthopedics

Earlier this summer, the company announced enrollment of first patient in its U.S Phase I/II Rotator Cuff Tear Repair Clinical trial.

How did it go?

The first patient surgery was successfully completed at the Tucson Orthopaedic Institute in Tucson, Arizona.

What did Philippe Deschamps, CEO have to say?

"The enrollment of our first patient in the U.S. Phase I/II rotator cuff tear repair clinical trial is our most significant clinical milestone to date. With 8 centers now actively screening for patients and enrollment of additional patients already scheduled over the coming weeks, completion of the Phase I safety portion of the clinical program is now expected by the end of September should our enrolment estimates be confirmed.”

JUST HOW BIG ARE THESE MARKETS?

Rotator Cuff TEAR – $600M

• 4m patients + 600,000 annual surgeries in the U.S. alone

Meniscus Tear Repair – $1B

• There are 1.2m surgeries annually in U.S. alone

Cartilage Lesions Repair - $1B

• 120,000 surgeries and a lack of options

Tendinopathy – 8B+ market opportunity / 50% sports related injury are tendon related; 8M/Yr

Other highlights:

• 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
• $500,000 grant secured to advance the development of second technology platform indication, ORTHO-M, for meniscus repair

Now sit back, relax and listen to this powerful interview.