"Looks like"?? Read, and re-read if you must, ALL the press releases. The lab and facilities have been inspected, by the FDA and has met the QAAAA for The American Association for Accreditation of Ambulatory Surgery Facilities' inspection.
Nowhere, NOWHERE, do the press releases say that the process is approved by the FDA, and NOWHERE on the FDA website, and/or by calling the FDA (I did), do they tell you that.
But this other company, Irvine Stem Cell, just got a definitive answer on an svf process:
“Your SVF product is intended to treat a variety of diseases and conditions, including, but not limited to, autism, Parkinson’s disease, pulmonary fibrosis, chronic obstructive pulmonary disease (COPD), multiple sclerosis (MS), cerebral palsy, and amyotrophic lateral sclerosis (ALS), and is therefore a drug under section 201(g) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. 321(g)] and a biological product as defined in section 351(i) of the Public Health Service Act (PHS Act) [42 U.S.C. 262(i)]. It is also a human cell, tissue, or cellular and tissuebased product (HCT/P) as defined in 21 CFR 1271.3(d).”
“In addition, your SVF product fails to meet 21 CFR 1271.10(a)(2)’s criterion that the HCT/P be “intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer’s objective intent.”
