Orthogen AG announced FDA approval of an Investigational Device Exemption (IDE) for the company's proprietary technology, Orthogen® Device (OD). This approval allows the company to start a pivotal trial in the U.S., using OD for treatment of patients with knee osteoarthritis, stages II-IV.
The pivotal trial will compare improvements in pain and function using standalone glucocorticoid injections (the current standard of care) with Orthogen's patented therapy of concomitant autologous conditioned serum (ACS) and glucocorticoids in patients with knee osteoarthritis, stages II-IV.
ACS is obtained using each patient's own blood, drawn at 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 intended as add-on therapy for long-term pain reduction and functional improvement in knee osteoarthritis patients, stage II-IV, receiving an intra-articular injection of FDA-approved glucocorticoids in accordance with FDA's approved labeling.
More than 32.5 million Americans suffer from osteoarthritis, according to the Centers for Disease Control and Prevention (CDC). The burden on the US economy is an estimated $150 billion annually in lost wages and medical bills. By 2050, the number of US patients diagnosed with osteoarthritis is projected to double.
Peter Wehling, MD, PhD, Chief Executive Officer of Orthogen AG, said "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."
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