With no surgical or pharmaceutical treatment existing to cure the disease, industry experts say patients undergo 966,000 total knee replacement surgeries (TKR) annually, millions of hyaluronic and corticosteroid injections, and take millions of pain medications.
The average cost of a TKR with included basic inpatient fees is around $57,000. This figure does not include pre- and post-surgery visits, outpatient fees, readmissions or the cost to U.S. employers for short- and long-term disability claims related to OA that in some cases add almost $219,000 a year for every 1,000 employees.
“Many of my patients who have previously had total knee replacement surgery didn’t fully understand what they were signing up for,” says Dr. Gerard Malanga, founder of New Jersey Sports Medicine, LLC, and an invited expert at a recent collaborative industry roundtable discussion aimed at advancing cellular medicine. “If they had been aware of the risks, they would have loved to have had an alternative treatment and delay knee replacement surgery as long as possible.”
GID BIO aims to make treatment for pain and function associated with knee osteoarthritis accessible to millions with a single-use device and point-of-care therapy. Though not yet confirmed, the cost of GID BIO’s treatment is expected to be a fraction of TKR surgery. A pathway toward reimbursement is being made with two Category III CPT codes (0565T/05X3TX and 0566T/06X4TX) granted by the American Medical Association for:
1) harvesting tissue and creating a cellular implant using autologous cells (patient’s own cells)
2) injecting the cellular implant under ultrasound guidance
The 120-minute outpatient procedure, which works by harvesting, isolating and reimplanting stromal cells at point-of-care into a patient’s knee under ultrasound guidance, saw statistically significant results in a multi-site, randomized, placebo-controlled, Phase IIb clinical trial. Eighty-eight percent of treated subjects responded greater than placebo and reported a median 87% improvement in pain, stiffness and function after one year, and no serious or device-related adverse events were reported after two years.
“At GID BIO, we want to advance the course of osteoarthritis treatment in the United States,” says Dale Tomrdle, GID BIO’s SVP of Finance and Operations. “Statistically significant results in a randomized controlled Phase IIb trial studying the safety and efficacy of our SVF-2 device and cellular therapy could mean a major development. And we want to make it available to as many people as possible.”