GID BIO’s results in FDA compliant, multi-site, randomized, placebo-controlled Phase IIb clinical trial support an evidence-based, data-driven approach to treat pain-management caused by osteoarthritis of the knee
While minimally invasive treatments transformed cardiology decades ago, advancements in orthopedic medicine are introducing potential alternatives to traditional surgery by applying cellular medicine therapies.
GID BIO is focused on using a data-driven approach when introducing cellular medicine therapies. Our team has worked with the FDA to make sure the design and development of controlled clinical studies is compliant with their regulations. In an FDA compliant, multi-site, randomized, placebo-controlled Phase IIb clinical trial measuring the safety and efficacy of our SVF-2 device and point-of-care (POC) therapy to treat knee osteoarthritis (OA), results at one year showed that 88 percent of subjects responded greater than placebo with a median 87 percent improvement in pain, stiffness and function. At two years, no serious or device-related adverse events occurred.
The SVF-2, a single-use device, could become the first to be used with minimally invasive cellular implant therapy to treat pain and function associated with osteoarthritis of the knee, a leading cause of disability in the United States, affecting 14 million US adults.
- A physician extracts a small amount of fat tissue from the patient’s abdominal or gluteal region under local anesthetic.
- Using the SVF-2 and GID BIO’s proprietary methods a patient’s own healing cells are extracted and refined into a cellular implant.
- The cellular implant is injected into the patient’s knee under ultrasound image guidance for precise placement.
The minimally invasive, 120-minute procedure requires no joint surgery, no general anesthetic, no post-procedure physical therapy, and no drugs for osteoarthritic pain or potentially addictive opioid-based pain medications.
The American Medical Association (AMA) granted GID two new Category III CPT codes for the SVF-2 device and therapy, setting the stage for a national reimbursement strategy. The cost of a cellular implant procedure is expected to be a fraction of the cost of total knee replacement surgery.
GID BIO is focused on adhering to FDA guidelines to help patients make informed decisions to treat pain and function associated with knee osteoarthritis.
While promising advances in regenerative cellular therapy that are evaluated for safety and efficacy could help patients navigate this vast and varied landscape with scientific options and innovative technology, it remains critical that patients are presented with all viable options and enabled to make informed decisions about their healthcare and lifestyle.