A decision guide
Questions worth asking — of anyone, including us.
Regenerative wellness is one of the most over-marketed categories in health. The best protection is a short list of questions. Here are the ones we think matter — ask them of any provider you talk to.
A serious operator will welcome every one of these questions and answer them plainly. Hesitation, vagueness, or pressure is itself an answer.
Eight questions
What to ask before you consider anything.
Where exactly does the tissue come from?
Many operators source from anonymous resellers and won’t name their lab. You deserve to know the specific laboratory, how donors are screened, and how the material is processed.
Is there a Certificate of Analysis for the specific lot?
A Certificate of Analysis documents what a given lot was tested for and released to. If a provider can’t produce one, they can’t actually tell you what you’d be receiving.
Is the lab FDA-registered — and do you understand what that means?
“FDA-registered” is not the same as “FDA-approved.” Registration and inspection of a tissue facility do not mean the FDA has approved any product to treat a disease. A trustworthy provider will explain that distinction, not blur it.
Who oversees the clinical side — is it a licensed physician?
Education and clinical care are different jobs. The person deciding whether something is appropriate for you should be an independently licensed provider exercising their own clinical judgment — not a salesperson.
What does the published research actually show — and what doesn’t it show yet?
This is a field of active study. Some approaches have more evidence than others, and honest operators will tell you where the science is strong and where it is still early.
Are you calling any product “FDA-approved” or a “cure”?
No regenerative tissue product is FDA-approved to treat, cure, or prevent osteoarthritis or any other disease. Anyone who tells you otherwise is either misinformed or misleading you.
Am I being asked to decide today?
Same-day pressure is the most common red flag in this category. A real decision can wait for a private evaluation and, ideally, a conversation with your own doctor.
Will my own doctor be kept in the loop?
Your primary-care provider knows your full history. A trustworthy operator encourages you to involve them, not to go around them.
The honest headline
No regenerative tissue product is FDA-approved to treat, cure, or prevent osteoarthritis or any other disease. Renvi’s events exist to help you understand the science and ask better questions — not to sell you a treatment.
Renvi Health is a management services organization. Clinical care, if any, is provided by independently licensed healthcare providers. Tissue products are regulated as Section 361 HCT/Ps under 21 CFR Part 1271 and are not approved by the U.S. Food and Drug Administration to diagnose, treat, cure, or prevent any disease. Information on this page is educational and is not medical advice. Results vary and are not guaranteed. All decisions should be made with a licensed medical provider.