Ortho Regenerative Technologies (Ortho RTi) initiated a six-month pivotal animal study on Ortho-R biopolymer for rotator cuff repair. A pre-Investigational New Drug meeting is scheduled with FDA to formalize requirements for the filing of an application to commence human trials on Ortho-R.
Three-month results from the animal study are expected to confirm previous findings of superior healing over standard of care, and will be used to assess whether the repair could be accelerated or improved with a higher dose of Ortho-R.
Ortho RTi's proprietary biopolymer is designed to increase healing rates of sports related injuries to tendons, meniscus, ligaments and cartilage. The company is assessing its potential for therapeutic uses outside of soft tissue repair, as well.