StimLabs, LLC. Announces Launch of Second Umbilical Cord Derived Product: Corplex™ P
ROSWELL, Ga., Aug. 27, 2020 /PRNewswire/ -- StimLabs, LLC, a leader in regenerative technologies and products that are revolutionizing patient care, today announced the launch of Corplex P, a unique product solution to a common clinical need.
Corplex P, a shelf-stable Wharton's Jelly allograft obtained from donated human umbilical cord tissue, is intended for homologous use for the supplementation of connective tissue voids in open wound environments. This Wharton's Jelly tissue is provided in a small-piece format, packaged into sterile glass vials, and is intended to be packed into open wound environments for protection and cushioning. Corplex P provides an ideal alternative for supplementing irregular voids, with the benefits of a collagen-rich, hydrophilic biomaterial.
StimLabs' company promise is to rapidly respond to clinical needs with unique, clinically-driven technologies. Corplex P was born out of a growing and widespread demand for a conformable placental derived product. Within a year of explored interest, StimLabs responded to this demand with proper market research, careful product considerations, and thorough safety measures.
"While the global pandemic has dramatically impacted the healthcare landscape, StimLabs has continued investing in new technologies to meet the clinical needs of patients," says Tom Dion, Executive Vice President and Chief Commercial Officer at StimLabs. "Considering the intensities that new product development entails and the current pandemic, this kind of timeline is nearly unheard of."
Corplex, StimLabs' first umbilical cord product was launched in early Q1, and Corplex P, an umbilical cord derivative, is available today. As of July 1, 2020, both products have been granted Q Codes by the Centers for Medicare and Medicaid Services (CMS) under Q4232 (Corplex) and Q4231 (Corplex P).
About Corplex P
Corplex P is donated human tissue regulated by the United States Food and Drug Administration (FDA) as a human cell, tissue, or cellular or tissue-based product (HCT/P) under Section 361 of the Public Health Service (PHS) Act. Corplex P allografts are aseptically processed and terminally sterilized according to FDA current Good Tissue Practice requirements and the American Association of Tissue Banks (AATB) Standards for Tissue Banking (14th ed.). StimLabs is registered with the FDA as a Tissue Establishment, is accredited by the AATB, and meets all state and federal requirements for processing and distributing human tissue.