Regenative Labs, the established leader in the connective tissue allograft space, today launched AmnioText™ Dual-Layer Patch for wounds. AmnioText is the company’s first product to offer private practices, hospitals and wound care centers a sterile, dehydrated amniotic membrane allograft to cover and protect a patient’s wounded tissues. The Regenative Labs current suite of products are regulated by the FDA under 21 CFR part 1271 section 361, are minimally manipulated and for homologous use only.
“As we continue our pioneering innovation at Regenative Labs, we’re proud to open yet another new market to serve patients with the introduction of AmnioText, a wound covering technology,” said Tyler C. Barrett, CEO of Regenative Labs. “Amniotic tissue has been used clinically for more than 100 years and we are excited to continue to expand our 361 product offerings. Our new AmnioText patch helps fill the gap in the national shortage of options in this space and meet high demand for these types of products.”
AmnioText features include:
- dual layering with the ability to place the patch on either side facing the wound
- stores at room temperature (no cryopreservation required)
- readily adheres to the wound surface and stays put when placed
- maintains shape when placed on a moist wound bed
- terminally sterilized
- 5-year shelf life
The non-embryonic tissues undergo extensive medical, social screening and blood testing prior to Regenative Labs use. Only tissue cleared after this stringent screening regimen is processed and re-tested under standards established by the FDA’s requirements. AmnioText is listed on RedBook and Medispan and holds a HCPCS code (Q4247) from the Centers for Medicare & Medicaid Services (CMS) as a 361 HCT/P.
AmnioText is available in sizes ranging from 1cm x 1cm to 10cm x 10cm for immediate ordering, shipping and delivery. Visit https://regenativelabs.com/ for details, call 800-891-3452 or email info@RegenativeLabs.com.
Regenative Labs launched a national research program in spring of 2020 to study connective tissue allografts and, in August 2020, announced it had received approval from CMS to cover a new innovation, ProText™, making it the first connective tissue allograft to be assigned a Q code (Q4246) approved for application directly to a defect using a syringe.
About Regenative Labs
Located in Pensacola Fla., Regenative Labs is an FDA registered and inspected tissue bank that has become the leader in human cell and tissue allograft space. Regenative Labs has launched several research initiatives in order to collect data from scientists, physicians, hospitals and surgery centers in order to improve patient outcomes. Formed by veteran industry professionals familiar with the daily challenges of innovations in healthcare, the company provides effective, non-addictive, non-invasive options for patients. Regenative Labs has a laser-focused, expert product research and development team which follows FDA guidelines for minimal manipulation and homologous use. Learn more at http://regenativelabs.com.
This article was originally published here