Precision medicine — commonly referred to as personalized medicine — is widely recognized as the future of U.S. healthcare. Innovative treatment approaches can lead to affordable, minimally invasive therapies that lead to patients’ recovery from chronic conditions such as knee osteoarthritis, which affects 14 million US adults and is the main factor in more than 700,000 total knee replacements annually.
For a chronic degenerative disease like osteoarthritis, reparative cells found in the diseased tissue are unable to achieve full regulation of the healing process due to insufficient numbers or impaired functionality. There is currently no cure on the market.
GID BIO developed a single-use device and cellular point-of-care (POC) therapy. The personalized approach works by physicians removing a small amount of adipose (fat) tissue from a patient’s abdominal or gluteal area and using the SVF-2 to isolate and refine the cells into a cellular implant that then gets reimplanted into the knee under ultrasound image guidance.
“If your therapy is trying to stop degeneration and help restore balance to the unhealthy environment causing cartilage degeneration, than adipose is the way to go,” says Dr. Diego Correa, an assistant professor at the University of Miami’s Miller School of Medicine and researcher of adult stem cell biology. “The SVF-2 device stops the vicious cycle of degeneration.“
GID BIO’s SVF-2 device and point-of-care therapy met all endpoints in an FDA-approved, multi-site, randomized, placebo-controlled Phase IIb clinical trial. At one year 88% of treated patients responded greater than placebo and reported an 87% improvement in pain, stiffness and function. At two years no serious or device-related adverse events were reported. The FDA has granted conditional approval for a larger pivotal study.
The trend toward precision medicine in the U.S. is driven by the promise that personalized approaches to healthcare – along with the appropriate balance between technology development, exploratory research and clinical innovation – result in improved diagnoses, treatments and disease prevention, according to the McKinsey & Company report “Precision Medicine: Opening the aperture.”
“The goal is to get safe and effective treatments to as many people as possible,” says Doug Oliver, the founder of Regenerative Outcomes. “GID BIO’s SVF-2 device and therapy, because it is point-of-care, could help achieve that goal.”
“We believe the results from using the SVF-2 device for isolating the right type, amount and quality of stromal progenitor cells and our point-of-care therapy represent a major development for cellular medicine treatments and the progression toward a U.S. model of precision medicine,” says GID BIO CEO, William Cimino.