Ortho Regenerative Technologies received a clinical hold letter from the FDA related to its trial for its hybrid implant, Ortho-R, the company said June 4.
Ortho RTI submitted an investigational new drug application to begin phase 1 and 2 trials for Ortho-R. The FDA requested additional information related to chemistry, manufacturing and control. Ortho RTI plans to provide the information and testing data to the FDA within the next four to six weeks.
"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," president and CEO Claude LeDuc said.
Last year, Ortho-R was classified as a biologic drug. Ortho RTI had planned to start clinical trials later this year.