a clinical stage orthobiologics company dedicated to the development
of novel therapeutic soft tissue repair technologies to dramatically
improve the success rate of orthopedic and sports medicine surgeries

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Message: VIDEO – Ortho Regenerative Technologies $ORTH $ORTIF Marks Massive Milestone With FDA Clinical Trial Approval

VIDEO – Ortho Regenerative Technologies $ORTH $ORTIF Marks Massive Milestone With FDA Clinical Trial Approval

posted on Dec 15, 2021 09:15AM

Ortho Regenerative Technologies (CSE: ORTH) (OTCQB: ORTIF) is a cutting-edge, clinical stage orthobiologics company dedicated to the development of novel therapeutic soft tissue repair technologies, which are used to dramatically improve the success rate of orthopedic and sports medicine surgeries.  

The MedTech firm 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

One of the firm’s key offerings is ORTHO-R, a hybrid drug/biologic implant combination product, formulated and designed to increase the healing rates of occupational- and sports-related injuries to tendons, meniscus and ligaments.

On December 13, the company announced that the clinical hold on its U.S. Investigational New Drug application has been lifted by the U.S. Food and Drug Administration and that the Company is now cleared to proceed with its Phase I/II U.S clinical trial to evaluate the safety and efficacy of ORTHO-R as an adjunct treatment to standard of care surgery in rotator cuff tear repair.  

By lifting the clinical hold, the FDA confirmed that Ortho has satisfactorily addressed all issues related to its August 16 clinical hold letter.

This is a major development, marking the biggest milestone of Ortho’s history so far.

"We are delighted to have reached this critical regulatory milestone, and we are grateful for the FDA's productive guidance and collaboration," said Claude LeDuc, Ortho’s President and CEO.

"Achieving this green-light to begin our clinical study is the result of committed efforts from the ORTHO team, which includes Polytechnique Montreal's Biomaterial and Cartilage Laboratory scientific team, MCRA's regulatory and clinical team, and our manufacturing and analytical partners."

We can now proceed with our Phase I/II U.S. clinical trial. There is a clear and significant unmet medical need to improve the success rate of orthopedic and sports medicine soft-tissue surgeries.”

We sat down with LeDuc for a deeper dive into what this news will mean for the company...

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