Quoted directly in FDA’s warning letter from the company’s own website, attributed to “trends” observed “with over 20,000 people using Tesla BioHealing technology to date.” No methodology, control group, or measurement protocol is described for how these “trends” were tracked; the evidentiary basis is self-reported and testimonial. No independent, controlled study of these outcomes has been published in the sources reviewed for this case, so the claim is classified untested rather than refuted: unlike the severe-disease claims above, FDA’s letter does not single out these specific “early signs” statements for a disconfirming finding, though it cites the same website and Intended Use Chart as part of the overall unapproved-device marketing.