Ortho Regenerative Technologies Inc. “Ortho RTi“, is an emerging Orthopaedic and Sports Medicine Technology company. Today the company announced that following a formal meeting with the FDA, its development program to date has exceeded expectations. As a result, the Company is in the position to submit its IND (Investigational New Drug) while completing its pivotal study and confirms the timeline to initiate the human clinical program by year-end.
“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 favorably as we progress towards the clinic. Furthermore, streamlined testing of our product around safety, toxicology, and characterization “CMC” (Chemistry Manufacturing and Controls) was deemed to be acceptable for our IND and eventual final submissions “BLA” (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”.
“2019 is shaping up to be a transformational year for Ortho RTi. With the confirmation of our development program and the recent completion of the surgeries in our pivotal study on Ortho-R, we are rapidly progressing towards demonstrating the clinical merits of using our lead biologic Ortho-R for rotator cuff repair”, said Dr. Brent Norton, Ortho RTi’s Chief Executive Officer.