Bluetail Medical Group Receives FDA IDE Approval for Pivotal Study of the Use of Cellular Therapy

Bluetail Medical Group (BMG) is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved the company's Investigational Device Exemption (IDE) application, permitting BMG to begin a feasibility study of cellular therapy in the treatment of knee osteoarthritis (OA) in the U.S.

Cellular therapy is intended for candidates who have been diagnosed with moderate osteoarthritis of the knee and whose conditions are not severe enough to require surgery. The pivotal study will evaluate the safety, protocol, and results of cellular therapy in the treatment of knee osteoarthritis.

A Milestone for Regenerative Medicine

This FDA IDE approval represents a significant milestone for both Bluetail Medical Group and the field of regenerative medicine. As one of only a handful of clinics in the country to receive this type of approval, BMG continues to demonstrate its commitment to advancing evidence-based regenerative treatments.

BMG will continue their dedication to the development of safe and effective regenerative therapies for use in orthopedic medicine, including Platelet-Rich-Plasma (PRP) and cellular therapies.

Orthobiologics and the FDA

Cellular Therapy in the field of orthobiologics is an innovative, minimally invasive treatment option that stimulates a natural healing response in the body that has the ability to help alleviate joint pain, including osteoarthritis and other degenerative conditions. This treatment has the potential to help patients avoid expensive and time-consuming surgery down the road.

Although this emerging field of medicine had been highly unregulated for years with many unscrupulous players, the FDA recently enacted a very strict, but appropriate, regulatory framework for all Regenerative Medicine Clinics. BMG has always been committed to practicing within FDA guidelines and this IDE approval further validates their approach to patient care.