FDA Compliance


 

On June 6, 2021, the FDA published "Important Patient and Consumer Information About Regenerative Medicine Therapies". This statement was intended to caution the public about "Stem Cell" clinics that have been making false and fraudulent statements publicly and performing unapproved and potentially dangerous or life-threatening procedures without sound scientific proof for safety or efficacy.

Our centers in Missouri, Naples Florida, Wisconsin, Minnesota, and Arkansas conduct clinical research and currently have an investigational new drug (IND) application filed with the FDA for the use of bone marrow concentrate in the treatment of knee osteoarthritis (IND #27390.) Bluetail Medical Group's physicians are committed to applying for and obtaining multiple future IND's for other orthopedic conditions. We continue to compile outcome data on treatments we provide for numerous musculoskeletal conditions treated by Bluetail Medical Group Physicians. We have successfully published our outcome data related to the treatment of knee osteoarthritis as well as elbow ligament injuries in throwing athletes.

As a national leader in non-surgical orthopedic sports medicine for over a decade, you can trust that your Bluetail Medical Group physician is following all current FDA directives and is committed to furthering the ethical advancement of autologous cell treatments.

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