The US Food and Drug Administration (FDA) has issued a clinical hold letter to Ortho Regenerative Technologies for its investigational new drug (IND) application to commence a Phase I/II clinical trial of ORTHO-R.
A drug/biologic implant combination product candidate, ORTHO-R is developed as an adjunct to standard of care surgical procedures to repair rotator cuff tears.
A surgeon can place the ORTHO-R implant directly into the injury site during a routine operative surgery without prolonging surgery time or requiring additional intervention.
In its letter, the FDA sought further chemistry, manufacturing and control (CMC) related data.
The company noted that it is equipped to address and offer the needed information and testing data in the next four to six weeks.
Ortho Regenerative Technologies president and CEO Claude LeDuc said: “We will work diligently to address the FDA’s questions as quickly as possible and look forward to continuing to work closely with them to secure IND approval.
“In parallel, we will continue working on our Phase I/II clinical trial preparation activities to ensure we minimise the impact on our overall timelines.”
Ortho is an orthobiologics company that develops new soft tissue repair regenerative technologies to potentially enhance the success rate of orthopaedic and sports medicine surgeries.
The company’s RESTORE technology platform is a muco-adhesive biopolymer matrix that is based on Chitosan.
It is designed to carry various biologics, including platelet-rich plasma (PRP) or bone marrow aspirate concentrate (BMAC), to improve and drive new tissue regeneration in several musculoskeletal conditions.
A Chitosan-PRP product candidate, ORTHO-R is formulated to boost the healing rates of occupational and sports-related injuries to tendons, meniscus and ligaments.
The company is currently developing other formulations for treating cartilage repair, bone void filling and osteoarthritis.