PENSACOLA, FLA. (PRWEB) AUGUST 05, 2020
Regenative Labs has received approval from the Centers for Medicare & Medicaid Services (CMS) to cover two new innovations, CoreText™ and ProText™, making them the first Wharton’s jelly allografts to be assigned a Q code and be approved for application directly to a defect using a syringe. The company’s solutions are the first Wharton’s jelly allograft product to be recognized as a 361 HCT/P by CMS regulated under 21CFR 1271.10, establishing a new Level II HCPCS code Q4246 “CoreText or ProText, per cc.”
For decades, millions of Americans struggling with intense pain, discomfort, and mobility issues, have had few choices other than pain numbing drugs like opiates. CoreText™ and ProText™ are the first Wharton’s jelly tissue products approved by CMS for application directly to the defect – or injured area – “using a syringe.” With today’s announcement, CMS recognizes these two exclusive healthcare products as appropriate to regulate solely under Section 361 of the Public Health Service Act, as these products meet the following four criteria: they are minimally manipulated; they are intended for homologous use; they do not involve a combination of cells and tissues with another article (with some limited exceptions); and they do not have a systemic effect and are not dependent upon the metabolic activity of living cells for its primary function [as per the July 2020 guidelines 21CFR Part 1271.10(a)].
The tissue allograft products from Regenative Labs, derived from Wharton’s jelly, are available now and more than 500 physicians nationwide are already using the products to improve the quality of life for their patients. Now, Medicare and Medicaid patients can receive insurance reimbursement for care incorporating these products.
“We work with dermatologists, diabetic specialists, orthopedists, surgeons, sports medicine physicians, and others to address the connective tissue supplementation needs of their patients,” said Tyler Barrett, CEO of Regenative Labs. “We proudly strive to provide the highest quality of tissue allografts available and we’re excited that this level of medicine will be available now to the public more widely with the recent CMS decision regarding insurance coverage.”
According to CMS, both the products are intended to provide the extracellular matrix needed for the infiltration, attachment, and proliferation of cells required for the repair of damaged tissue. They are typically used for muscle and cartilage tears and to help repair damaged tissue. The products are used for wounds and tissue defects, and are applied directly to the defect using a syringe.
ProText™ is the most concentrated Wharton’s jelly product of the two Regenative Labs solutions. Less invasive than other treatments like PRP, bone marrow aspiration, or adipose tissue extraction, ProText™ is regulated as a human cell, tissue, or cellular tissue-based product (HCT/P under 21CFR Part 1271 and Section 361 of the Public Health Service Act.)
CoreText™ is a minimally manipulated Wharton’s jelly, rich in cytokines, growth factors, and proteins. Less invasive than adipose tissue extraction and bone marrow aspiration, CoreText™ treatments result in less time-consuming procedures and, more importantly, less pain.
Regenative Labs developed CoreText™ and ProText™ in 2018 and launched the products in 2019 which are being used in about 500 clinics nationwide. CMS covers patients in their 60s and older with the most common ailments including large joints like knees, hips, and shoulders. Health conscious persons in their 40s and 50s interested in preventing future debilitating issues and supplementing other treatments are also good candidates for these products, and Regenative Labs encourages people to act early. Regenative Labs has always been one of the lowest cost providers of homologous use tissue products in hopes that these savings will carry over to the patient.