Ortho Regenerative Technologies (CSE:ORTH) presented a poster entitled, “Freeze-dried [Ortho-R] in Platelet-rich Plasma in Sheep Model of Rotator Cuff Repair,” at the SICOT Orthopaedic World Congress in Montreal.
The presentation by Anik Chevrier, a researcher from Montreal’s École Polytechnique, highlighted results of a dose ranging study examining Ortho RTi’s Ortho-R technology in the biologic repair of rotator cuff injuries.
The study used histopathology read by two blinded experts, as well as MRI imaging, to compare results of Ortho-R versus standard of care in a non-clinical rotator cuff injury model in sheep.
“[Ortho-R] modulated some rotator cuff healing processes in this large animal model, as revealed by a significant decrease in tendon gap and trends of improved structural appearance of the tendon and enthesis at 12 weeks post-operative,” according to the poster.
“The promising MRI and histological findings of [Ortho-R] treated ISP tendons would be expected to translate into superior mechanical performance, and this will be assessed in a future animal study.”
In addition, there was no treatment-specific effect on histopathology of internal organs, hematology parameters, serum chemistry parameters, urine chemistry parameters and synovial fluid cell differential, which “suggests high safety.”
Ortho RTi’s CSO, Dr. Michael Buschmann, said the study provides evidence on the safety and efficacy of Ortho-R in a large animal model that “could potentially be translated to a clinical setting.” The company is continuing to work towards the submission of an investigational new drug application to the FDA.
