Ortho RTi posts positive Ortho-R data in rotator cuff repair
Ortho Regenerative Technologies (CSE:ORTH) reported positive preliminary MRI 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 pilot dose escalation study used MRI outcomes, read by two blinded experts at three intervals, to compare results of Ortho-R versus standard of care in a non-clinical rotator cuff injury model in sheep.
Treatment with Ortho-R was shown to significantly improve healing, as measured by gap reduction between the tendon and bone, versus standard of care, with the highest Ortho-R dose having the greatest effect.
Detailed results from the study will be submitted to a future medical conference and for publication.
"We are very encouraged by this data, as Ortho-R demonstrated an ability to induce healing in as little as three months," Ortho RTi's executive chairman and CEO, Dr. Brent Norton, said in a statement.
"With a small study size, getting meaningful data is challenging, yet the relative gap reduction induced by Ortho-R was statistically significant (p=0.01),” he added.
With more than 500,000 rotator cuff surgeries being performed in the United States each year, and with that number continuing to grow, Dr. Norton said the company is looking forward to taking its technology into the clinic as soon as possible. “To that end, we are beginning to make preparations to submit an Investigational New Drug Application to the FDA for this, our lead indication.”