Orthogen’s IDE Trial for Knee OA Gets FDA Nod

Orthogen has received U.S. Food and Drug Administration (FDA) approval for an Investigational Device Exemption (IDE) trial of its Orthogen Device (OD) to treat patients with knee osteoarthritis (OA), stages II-IV.
 
The pivotal trial will compare pain and function improvements using standalone glucocorticoid injections with Orthogen’s concomitant autologous conditioned serum (ACS) and glucocorticoids for knee OA.
 
ACS is obtained using the patient’s own blood. OD’s closed system design allows standardized blood taking, extended extracorporeal coagulation, and serum separation to obtain ACS, which is then injected into the knee on the same day. OD-obtained ACS aims to be an add-on therapy for long-term pain reduction and functional improvement in stage II-IV knee OA patients receiving the intra-articular injection of FDA-approved glucocorticoids.
 
Peter Wehling, MD, Ph.D., CEO of Orthogen AG, told the press, “This IDE approval is a significant step towards bringing a much-needed solution to this urgent, worldwide problem of osteoarthritis. 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.”