From the bark of the willow tree 3,500 years ago that Egyptians and Sumerians popularized for pain relief, medicine is one industry that can be counted on for constant innovation over the centuries.
Today, cellular therapy is the pillar of modern medicine, building on drugs and devices/surgery that have dominated medical care for the last 200 years. Cellular therapy is precision medicine and propels forward numerous paths to potentially treat degenerative diseases.
With a commitment to advancing modern medicine, our team set out to create a cost-effective cellular medicine procedure that could be accessible to millions.
CEO William Cimino, Ph.D., with three engineering degrees and experience designing more than 50 medical products, worked with his team to reduce an entire tissue processing facility to a disposable, single-use device that can be used at point-of-care. This device, called the SVF-2, uniquely isolates stromal vascular fraction cells from 30 cc’s of a patient’s own adipose tissue to create a cellular implant in less than 60 minutes.
The first application of the SVF-2 device and cellular therapy is targeted to treat pain and function associated with knee osteoarthritis. We engaged with the FDA from the start in a randomized, placebo-controlled clinical trial and became the first regenerative cell therapy for osteoarthritis to meet study endpoints using autologous stromal cells from adipose tissue.
Now, with initial evidence of safety and efficacy and a working regulatory pathway with the FDA, our team is working to complete pivotal clinical studies. We are also evaluating application to other degenerative diseases including:
“The Phase IIb clinical trial showed significant results. We know that the response we observed is the result of isolating and concentrating the right types and number of cells in the cellular implant. We continue clinical research and development for our therapy for other degenerative diseases. We are also continuing research and development efforts to simultaneously achieve a smaller tissue harvest and an increased cell yield,” noted Cimino.