Ortho Regenerative Technologies (CSE:ORTH) Inc, a clinical stage orthobiologics company developing novel soft tissue repair regenerative technologies, has reported financial results and highlights for the fourth quarter and fiscal year ended January 31, 2022.
During the fiscal fourth quarter, the company was cleared by the US Food and Drug Administration (FDA) to proceed with a Phase 1/2 clinical trial evaluating the safety and efficacy of its Ortho-R soft tissue repair platform. The trial will evaluate Ortho-R in combination with platelet-rich plasma as an adjunct treatment to standard of care surgery in rotator cuff tear repair.
"Securing the IND clearance for initiating our Phase 1/2 rotator cuff tear repair clinical trial, was truly our biggest accomplishment in fiscal year 2022" CEO Philippe Deschamps said in a statement. "Following FDA's new requirement to obtain a biologics license for regenerative treatments, we are now leading the way with our proprietary Ortho-R biopolymer PRP combination, being tested in humans for improving standard of care surgeries.”
READ: Ortho Regenerative Technologies secures US patent for its ORTHO-R soft tissue repair platform
Currently, six US trial sites are fully contracted and three sites are actively screening patients, Dechamps said, meaning the first patient is expected to be enrolled soon.
Also in the quarter, Ortho closed a non-brokered $1.05 million private placement offering of unsecured convertible note units, with $380,250 of insiders' subscriptions, and issued 1,075 note units at a price of $975 each, the company said.
Last month, the company closed an oversubscribed non-brokered private placement of units for gross proceeds of $3.2 million, with approximately $560,000 of insiders' subscriptions.
“With the recent closing of our oversubscribed $3.2 million private placement, Ortho is now well positioned to accelerate Phase 1/2 clinical trial activities and solidify its position as the leading player in the dynamic regenerative medicine market,” CFO Luc Mainville said.
Ortho Regenerative is a clinical-stage orthobiologics company dedicated to the development of novel therapeutic soft tissue repair technologies to dramatically improve the success rate of orthopedic and sports medicine surgeries.
Contact Andrew Kessel at andrew.kessel@proactiveinvestors.com
Follow him on Twitter @andrew_kessel