We use a combination of regenerative therapies that are either autologous or allograft based on the history, physical exam, and in office diagnostic dynamic imaging.

MSK guide procedures are compliant with the FDA regulations.

For our procedures involving concentrated bone marrow for homologous use are not subject to FDA regulation as a human cell, tissue, or cellular or tissue-based product (HCT/P); 21 CFR 1271.3(d).

For our procedures involving autologous blood (such as PRP or A2M), physicians who are licensed by law to prescribe or administer drugs and who manufacture blood products solely for use in the course of their professional practice are not subject to FDA regulation; 21 CFR 607.65.

Procedures involving the removal of an HCT/P from a patient and the implantation of that same HCT/P back into the same patient during the same surgical procedure are not subject to FDA regulation; 21 CFR 1271.15(b).

Our non autologous products are regulated by the U.S. Food and Drug Administration as a Human Cells, Tissues and Cellular and Tissue-Based Product (HCT/P) under section 361 and is manufactured in accordance with FDA regulations for Good Tissue Practices (21 CFR § 1271). These products are minimally manipulated and intended to be for homologous use.