Ortho Regenerative Technologies (Ortho RTi) announced that following a formal meeting with FDA, the company can submit its Investigational New Drug (IND) for Ortho-R biopolymer for rotator cuff repair while completing its pivotal study, and will initiate a human clinical program by year-end.
The proprietary biopolymer has been designed to increase the healing rates of sports related injuries to tendons, meniscus, ligaments and cartilage. It can be placed directly into the injury site during a routine surgical procedure without significantly extending the length of the surgery and without further intervention.
“The review of our scientific and preclinical package and the meeting with the FDA went very well. Consequently, we are in a position to address whether we can adjust our timelines favourably as we progress towards the clinic. Furthermore, a streamlined testing of our product around safety, toxicology, and characterization Chemistry Manufacturing and Controls was deemed to be acceptable for our IND and eventual final submissions Biologics License Applications, saving Ortho RTi millions of dollars in additional expenses,” said Dr. Michael Buschmann, Ortho RTi’s Chief Scientific Officer. “As we reported recently, we can confirm that the results of the recently initiated pivotal study on Ortho-R will be used to augment the IND package with more information on the ideal dosage to take forward into patients.”
Ortho Regenerative Technologies (Ortho RTi) announced that following a formal meeting with FDA, the company can submit its Investigational New Drug (IND) for Ortho-R biopolymer for rotator cuff repair while completing its pivotal study, and will initiate a human clinical program by year-end.
The proprietary biopolymer has been designed to...
Ortho Regenerative Technologies (Ortho RTi) announced that following a formal meeting with FDA, the company can submit its Investigational New Drug (IND) for Ortho-R biopolymer for rotator cuff repair while completing its pivotal study, and will initiate a human clinical program by year-end.
The proprietary biopolymer has been designed to increase the healing rates of sports related injuries to tendons, meniscus, ligaments and cartilage. It can be placed directly into the injury site during a routine surgical procedure without significantly extending the length of the surgery and without further intervention.
“The review of our scientific and preclinical package and the meeting with the FDA went very well. Consequently, we are in a position to address whether we can adjust our timelines favourably as we progress towards the clinic. Furthermore, a streamlined testing of our product around safety, toxicology, and characterization Chemistry Manufacturing and Controls was deemed to be acceptable for our IND and eventual final submissions Biologics License Applications, saving Ortho RTi millions of dollars in additional expenses,” said Dr. Michael Buschmann, Ortho RTi’s Chief Scientific Officer. “As we reported recently, we can confirm that the results of the recently initiated pivotal study on Ortho-R will be used to augment the IND package with more information on the ideal dosage to take forward into patients.”
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