ORTHO Regenerative Technologies is a cutting-edge med tech firm that 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.

The firm recently appointed Patrick O’Donnell to its board of directors.

• O’Donnell comes with significant company-building experience
• He will prove crucial in putting this healthcare pioneer on-track for a NASDAQ listing

HOW BIG IS THE SOFT TISSUE REPAIR MARKET?

US$5bn MARKET OPPORTUNITY

Rotator Cuff Tear

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

Meniscus Tear Repair

• Painful, compromises knee function
• 1.2m surgeries annually US alone
• $1bn+ market opportunity

Cartilage Lesions Repair

• Lesions cause friction and pain
• 1.2m detected lesions annually in U.S. alone
• 120k surgeries (and a 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 – NEW PARADIGM

ORTHO-R EASY TO USE AND ADDS 8-10 MINUTES TO STANDARD OF CARE SURGERY

APRIL 2021:

Ortho Announces Submission of Investigational New Drug Application for ORTHO-R

• Phase I/II clinical trial initiation for rotator cuff tear repair in the U.S. anticipated in Q2 2021
  
  

Ortho RTI has submitted an Investigational New Drug ("IND") application to the U.S. Food and Drug Administration ("FDA") for the initiation of a Phase I/II clinical trial of ORTHO-R in rotator cuff tear repair.

"The IND submission for our first ORTHO-R human trial is a key milestone for the Company. It brings us one step closer to the enrollment of our first patient, a recognized value creation event in our industry", said Claude LeDuc, President and CEO of Ortho RTI.

"There is a clear need for improved rotator cuff tear repair treatments, as estimates have put the re-tear (or non-healing) rate at an average of 50%. With more than 600,000 patients undergoing rotator cuff surgery every year in the U.S., this represents an enormous commercial opportunity, and as demonstrated in 2020 by our GLP preclinical program results, we strongly believe that ORTHO-R can help address these significant unmet needs and meaningfully improve the success rate of these surgeries."

The Phase I/II clinical trial is a prospective, randomized, controlled and blinded study to evaluate the safety and efficacy of ORTHO-R + standard of care surgery vs standard of care surgery alone in rotator cuff tear repair. The clinical trial will enroll a total of 78 patients at 6 to 10 clinical sites throughout the U.S.  Enrollment is expected to begin in Q2 of 2021. 

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