As a leader in government compliant stem cell therapy treatments, we were not surprised to learn that in February, Medicare announced that it will recoup all the money it paid physicians, going back two years, for dubious birth tissue injections. Without any evidence of efficacy, birth tissue and exosome products were marketed by orthopedic and chiropractic clinics to their patients for indications such as longevity, pain, chronic inflammation, autoimmune disease, and Lyme disease, as well as numerous other chronic degenerative diseases.
On December 6th, 2019, the FDA issued a Public Safety Notification on Exosome Products to inform the public of multiple recent reports of serious adverse events experienced by patients in Nebraska who were treated with unapproved products marketed as containing exosomes. Despite this warning, these clinics continued to deceive patients and practice administering the unapproved cell treatments.
Our commitment is to always maintain the highest standards for both patients and government regulators. At both Personalized Stem Cells and our parent company, VetStem, Inc., we take pride in our business model of providing elevated quality and safety of our stem cell products. It is important to note that our manufacturing facilities are FDA manufacturing compliant and have both FDA tissue establishment registration and a California tissue bank license. We focus on conducting FDA clinical trials and moving towards multiple approvals.
CEO and Founder, Dr. Bob Harman, stated, “We continue to build patient centric cell-based businesses around scientifically and medically validated disease indications and treatments, always in compliance with federal and state guidelines. As the industry continues to mature and more products become approved by the FDA, our strong regulatory team and patent estate builds for the continued success of both companies and supports the reputation of the cell therapy industry.”