Osteoarthritis (OA) is the most common form of arthritis due to the increasing number of U.S. adults 65 and older developing the disease and the increase of injuries to athletes of all ages.
The chronic disease, typically diagnosed by the destruction of articular cartilage and structural changes in underlying bone, affects 27 million Americans. Cells that make up diseased tissue are unable to achieve full regulation of the healing process due to insufficient numbers or impaired functionality. This interruption of the body’s natural healing response contributes to pain and loss of joint function.
With no surgical or pharmaceutical treatment existing to cure the disease, industry experts say patients annually endure more than 700,000 total knee replacement surgeries, millions of hyaluronic and corticosteroid injections and take millions of pain medications, placing a $200 billion burden on the U.S. healthcare system. This figure does not factor in the cost to U.S. employers for short- and long-term disability claims related to OA that are almost $219,000 a year for every 1,000 employees.
GID BIO aims to lessen the burden by developing a cost-effective device and point-of-care therapy. The GID technology isolates and concentrates stromal cells from a patient’s adipose tissue. The cells are then formed into an implant and reimplanted into the knee under ultrasound image guidance, instigating the body’s natural healing response, which is a complex and highly coordinated interplay among different types of cells and the soluble factors they produce. This healing process is different than a drug, which is a synthetic chemical compound with no dynamic or reactive ability to participate in the healing process.
“Our own progenitor cells know what to do and and in some cases do it better than medication when appropriately delivered into tissues. We call it healing intelligently,” said Dr. Ricardo Rodriguez, a plastic surgeon in Baltimore.
After completing a randomized controlled Phase IIb clinical trial using an FDA-approved study design, GID BIO successfully met all safety and efficacy endpoints, with 88% of subjects responding greater than placebo and reporting a median 87% improvement in pain, stiffness and function after one year, and no serious or device-related adverse events after two years. With conditional approval from the Food and Drug Administration for a pivotal study, GID BIO’s 120-minute outpatient procedure allows patients to heal with only one month of recovery time.
GID’s tissue-based technology is part of precision medicine widely recognized as the future of U.S. healthcare. Innovative treatment approaches can lead to affordable, minimally invasive therapies to transform a patient’s recovery from chronic conditions and help reduce a national burden.