The FDA approved a trial of Orthogen’s proprietary treatment for knee osteoarthritis, which uses a patient’s blood to extract concomitant autologous conditioned serum.
The US Food and Drug Administration has approved an Investigational Device Exemption (IDE) for Orthogen’s proprietary technology, Orthogen Device (OD).
This approval allows the company to start a pivotal trial using OD to treat patients with knee osteoarthritis, stages II-IV.
The trial will compare improvements in pain and function using standalone glucocorticoid injections (the current standard of care) with Orthogen’s therapy of concomitant autologous conditioned serum (ACS) and glucocorticoids in patients with knee osteoarthritis, stages II-IV.
ACS is obtained using each patient’s blood drawn at the site of care. The OD’s closed system design enables standardized blood taking, extended extracorporeal coagulation, and serum separation to obtain ACS, which is then injected into the patient’s knee on the same day.
OD-obtained ACS is an add-on therapy for long-term pain reduction and functional improvement in knee osteoarthritis patients, stage II-IV who are already receiving an intra-articular injection of glucocorticoids.
More than 32.5 million Americans suffer from osteoarthritis, according to the Centers for Disease Control and Prevention.
“This IDE approval is a significant step towards bringing a much-needed solution to this urgent, worldwide problem of osteoarthritis,” said Peter Wehling, MD, PhD, chief executive officer of Orthogen. “We are now looking for a development and commercialization partner to support PMA approval and a subsequent full-fledged launch, including wide reimbursement coverage enabling access for a large patient group.”