Ortho Regenerative Technologies (CSE:ORTH) reported positive outcomes data from a study examining its Ortho-R technology in the biologic repair of rotator cuff injuries.
Conducted by researchers from Montreal’s École Polytechnique, the dose ranging study used histopathology, the microscopic examination of biological tissues in very fine detail, read by two blinded experts, to compare the results of Ortho-R versus standard of care in a non-clinical rotator cuff injury model in sheep.
In the study, treatment with Ortho-R was shown to improve healing versus standard of care, with the highest Ortho-R dose having the greatest effect. Treatment with Ortho-R showed improvements in the structural organization of the tendon and the structural appearance of the tendon insertion site. In addition, clinical signs and histopathology showed no treatment-specific adverse effects, suggesting high safety of Ortho-R.
“The improved histological appearance and the previously observed reduced tendon gap size by MRI at the repair site are expected to translate into superior biomechanical performance,” Dr. Michael Buschmann, CSO of Ortho RTi, said in a statement.
In addition, he said principal findings of three independent parameters showing improvement – tendon organization, structure of the insertion site and tendon gap – are very strong indicators of a beneficial effect of treatment by Ortho-R, compared with the standard of care.
Dr. Brent Norton, executive chairman, said histopathology is considered the “gold standard” in this type of analysis, as the structure of a tissue reveals its function.
“With more than 500,000 rotator cuff surgeries being performed in the U.S. each year, our goal is to take this potentially game-changing technology into the clinic as soon as possible,” he added. “To that end, we are continuing to work towards submission of an Investigational New Drug Application to the FDA.”