Press Release: A former FDA compliance officer and noted legal expert has issued a review and opinion examining the compliance of multiple Regenative Labs’ products with the important FDA 361 criteria initially granted by the Centers for Medicare and Medicaid Services (CMS) in the first quarter of 2020.
The expert validates Regenative Labs’ CoreTextTM and ProTextTM structural tissue supplements – known as allografts – for cartilage and muscle tears and other soft tissue issues, voids (missing tissue) or defects.
Specific language and findings: The legal review supported CMS’s decision on 361 HCT/P Status for the Company’s Wharton’s Jelly Allograft products.
The initiative examined the compliance of multiple Regenative Labs products besides ProTextTM and AmnioTextTM patches with FDA regulation on 361 HCT/Ps [21 CFR 1271.10(a)] concluding the products meet all 361 criteria.
This confirms CMS’s First Quarter 2020 opinion which granted Level II HCPCS codes Q4247 and Q4246 for Regenative Labs’ AmnioTextTM and two new-at-the-time innovations, CoreTextTM and ProTextTM . These were identified in that quarter coding cycle for Drug and Biological Products Publication. (Note pages 63 and 64 to see that CMS expressly acknowledges the 361 status of these Wharton’s jelly and amniotic membrane products.)
Next steps: Regenative Labs will soon publish the white paper which generated the focus of the legal review and analysis on the structural composition of the original tissue as it compares to Regenative Labs’ human tissue allograft products.
Study program involves physicians and patients: “Our study program engages with physicians all over the United States to follow patients and assess their outcomes with our products,” said CEO Tyler Barrett. “We have built an incredible amount of data from patients who have missing or damaged connective tissue.”
He added, “We think of the individual patient each and every day, and we believe the data we compile will transform the treatment of these painful and debilitating conditions so that some conventional treatments are discarded as obsolete. And our hope is that this occurs in the near future.”
The history of patient treatment: Historically, patients with cartilage and muscle tears and other soft tissue issues (voids) and defects have been treated with invasive surgery as a last resort following steroids or pain treatments like opioids.
It is well known that pain treatments only mask a problem and do not provide a long-term solution. In fact, new studies show that cortisol steroids actually make the issue worse because patients feel a false confidence and develop further injuries.
The impact of the ongoing opioid crisis has been well documented, but the fact remains that numerous people begin relieving pain from these injuries with addictive drugs.
A new gold standard: Traditional methods of treatment do not offer the non-addictive, minimally-invasive choice that Regenative Labs’ products provide to improve quality of life. In many cases, a patient’s discomfort is actually a symptom of missing or damaged tissue that isn’t functioning properly.
ProTextTM is applied via syringe in a doctor’s office directly to the exact site to replace or supplement it with tissue that the patient’s own body deems structurally similar. As noted, the procedure is minimally invasive and takes only a few minutes. There are no substances to risk addiction.
In scientific language, these Wharton’s jelly allografts are the first and only product of its type to be recognized as 361 HCT/P by any governmental regulatory body.
Physicians and patients can participate now: To participate in a Regenative Labs study or for more information, visit www.regenativelabs.com