Orthogen Gets IDE Approval for Knee Osteoarthritis Study

The FDA has approved an investigational device exemption (IDE) for Orthogen to evaluate its Orthogen Device in patients with knee osteoarthritis at stages II to IV.

The investigational device is a patented therapy of autologous conditioned serum (ACS) obtained from the patient’s blood, used with glucocorticoid injections. The device performs extracorporeal coagulation and serum separation to obtain ACS, which is then injected into the patient's knee on the same day.

The study will compare the Orthogen Device to the standard of care, glucocorticoid injections alone.

With the IDE in hand, the company is now seeking a development and commercialization partner to pursue a premarket approval.