This month marks five years since the FDA HCT/P regulations were first introduced. In that time we have (1) produced the first and currently the only Wharton’s jelly allograft to be recognized by any government body (CMS Decision Summary Q1 2020), (2) launched education modules and authored numerous letters to the industry in an effort to contextualize the guidance and the new regulatory landscape, (3) signed a strategic partnership with AAPC to provide an approved ICD-10 code list and a CME course, (4) have stood firm and exercised our voice as a leader and advocate for the industry, (5) secured IRB approval to document homologous use applications for our entire 361 product offering, (6) documented contributions in excess of 10,000 complete data sets on 180+ distinct homologous use applications for connective tissue supplementation covering specialties across the spectrum in what is to our knowledge the largest retrospective data repository for regenerative medicine in the country, (7) have begun publishing in multiple peer-reviewed publications, and (8) received international export approval for our amniotic membrane patches from the FDA.
Since the end of the discretionary enforcement period in June of last year, the regenerative medicine community has experienced a changing landscape of available options for their patients. We now know that HCT/Ps, birth tissue, or otherwise, without objective evidence of minimal manipulation or objective intent for homologous use only, are considered drugs and require premarket approval under section 351 of the PHS act. Products like amniotic fluid and exosomes have largely disappeared or have been regulated to topical use only and amniotic membrane is recognized only for its utility as a covering or a barrier (patch). That is why Regenative made clear its intent and published objective evidence of minimal manipulation for our Wharton’s jelly products to set a public example of the standard.
Regenative Labs is calling on physicians across the country to register with our IRB to seek better patient outcomes through collaboration on further observational, retrospective, and prospective research. Upon publication, many of the homologous applications that have already been recorded by our research community will represent firsts in clinical literature and the outcomes we have seen have been remarkable. While we are excited by the progress our community has made in the last five years for the advancement of this field, the more we uncover, the more the need for our community to usher in more physician leadership becomes clear. Click here or call (800) 891-3452 to learn more.
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CEO Regenative Labs