GID BIO’s unique autologous cellular implant derived from adipose tissue is produced with its SVF-2 device and is injected into the knee intended to treat pain and function associated with osteoarthritis (OA). This procedure warrants two new Category III CPT® codes (Current Procedural Terminology) according to the American Medical Association.
CPT codes offer doctors and health care professionals a uniform language for coding medical services and procedures to streamline reporting, increase accuracy and efficiency… [and are used in] claims processing and developing guidelines for medical care review.
GID BIO’s cellular implant is intended to treat pain and function associated with knee OA. Adipose tissue harvest, cell isolation, and cellular implant formation are performed on the same day and in the same setting of a physician’s office. The cellular implant is produced and injected by specific steps that were used in an FDA compliant, multi-site, randomized, placebo-controlled Phase IIb clinical trial.
Cellular therapy is a major development that could bring new pain management and treatment options to an American population affected by OA that is projected to reach 41.4 million by the year 2030.
Currently there is no cure for OA. Pain relief is sought by several million patients with hyaluronic acid injections and corticosteroid injections and patients undergo 966,000 Total Knee Replacements (TKR) annually. Treating OA pain amounts to $200B annually in the US including surgery, hospital stays, recovery, and pain medications.
GID BIO developed its SVF-2 device and therapy and is proceeding with FDA compliant safety and efficacy studies. A multi-site, randomized, placebo-controlled Phase IIb clinical trial met all efficacy endpoints. Eighty-eight percent of participating patients responded greater than the placebo control and reported a median 87 percent improvement in pain, function and stiffness.
The American Medical Association granted GID two Category III CPT codes (0565T/05X3TX and 0566T/06X4TX) for: 1) harvesting tissue and creating a cellular implant using autologous cells (patient’s own cells); and 2) injecting the cellular implant under ultrasound guidance.
The granting of these CPT codes and statistically significant clinical trial results could mean a major development in the treatment of pain and function associated with knee OA.