A dehydrated Wharton's Jelly tissue allograft designed to supplement connective tissue voids
StimLabs, 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).
Corplex P is a Wharton’s Jelly allograft obtained from donated human umbilical cord tissue. The allograft is processed using the Clearify™ process to retain key extracellular matrix components in Wharton’s Jelly including collagens and glycosaminoglycans, such as hyaluronic acid. Corplex P is dehydrated, cut into small pieces, and presented in a graft form. The allografts are then packaged as individual units to fill volumes of 1 cc, 2 cc and 4 cc in sterile glass vials and terminally sterilized. The final product is intended for homologous use for the supplementation of connective tissue voids in open wound environments to protect and cushion the surrounding tissue.
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.
Source: Company Press Release