Section 361 portfolio · For licensed physicians
Structural tissue allografts from Wharton's jelly
Alongside our investigational program, TriCelX supplies human tissue allografts made from the Wharton's jelly of donated umbilical cords, with VelaMatriX™ in development. Each is regulated solely under Section 361 of the Public Health Service Act and 21 CFR Part 1271, and is intended for homologous use only.
What Section 361 means
Four criteria, met by design
Under 21 CFR 1271.10(a), a human tissue product is regulated solely under Section 361, without premarket approval, when it meets all four of these criteria.
01
Minimally manipulated
Processing does not alter the original relevant characteristics of the tissue that relate to its use for reconstruction, repair or replacement.
02
Homologous use only
The tissue performs the same basic function in the recipient as in the donor, as stated in its labeling and advertising.
03
Not combined with another article
Except water, crystalloids, or a sterilizing, preserving or storage agent.
04
No systemic effect
Its primary function does not depend on a systemic effect or on the metabolic activity of living cells.
The tissue
Cushion, support and protection
Wharton's jelly is the gelatinous connective tissue of the umbilical cord. Its natural job is structural: it cushions, supports and protects the umbilical vessels from compression and twisting.
Minimal manipulation. Our processing is designed to preserve those structural characteristics, so the tissue can provide the same cushioning, support and protection in the recipient.
Homologous use. Each allograft is intended only for uses where that same structural function is needed.
The portfolio
One tissue. Three structural uses.
LuMatriX™
Supplied to physicians
Aesthetic practice
A Wharton's jelly allograft for aesthetic practice, supplied cryopreserved in defined tissue concentrations.
Homologous use: replacement tissue where volume is needed to cushion or support the affected soft tissue.
OrthoMatriX™
Supplied to physicians
Orthopedic practice
A Wharton's jelly structural connective-tissue allograft for orthopedic practice, supplied cryopreserved in saline in defined tissue concentrations.
Homologous use: to replace or supplement missing or damaged connective tissue at the site of a structural defect, where cushioning and support are needed.
VelaMatriX™
In development
Wound & surgical cover
A Wharton's jelly structural tissue membrane, prepared as a sheet.
Homologous use: as a cover, wrap or barrier over wounds and over exposed tendon, nerve, bone and soft tissue during surgery, through its physical properties of covering, cushioning and protection.
Featured · Aesthetic practice
LuMatriX™
The natural era of bio-aesthetics
A Wharton's jelly allograft for aesthetic practice, intended for homologous use as replacement tissue where volume is needed to cushion or support the affected soft tissue. Supplied cryopreserved to licensed physicians.
Aesthetic application
With age, the skin's support proteins, collagen and elastin, decline. Tissue becomes lax and the face can lose volume. LuMatriX™ is used as replacement tissue where volume is needed to cushion or support the affected area.
What is Wharton's jelly?
The gelatinous connective tissue of the umbilical cord, which cushions, supports and protects the umbilical vessels. The Wharton's jelly in LuMatriX™ is minimally manipulated to preserve those structural characteristics. Cords are donated with consent after full-term, healthy deliveries; no embryonic or fetal material is used.
Made in Frisco
Processed in TriCelX's cGMP, FDA-registered, AABB-accredited facility at the Baylor Scott & White Sports Therapy & Research Center at The Star, under current good tissue practice (21 CFR Part 1271). Shipped frozen to physician offices with lot documentation.
Common standards
- Umbilical cords donated with consent by screened, healthy mothers after full-term deliveries. No embryonic or fetal material.
- Donor eligibility and current good tissue practice under 21 CFR Part 1271, in our cGMP, FDA-registered, AABB-accredited facility in Frisco, Texas.
- Shipped frozen to physician offices, with lot documentation in the physician portal.
Section 361 allografts are not drugs and do not undergo FDA premarket review. They are separate from XytriX™, our investigational biotherapeutic. Information on this page is for licensed healthcare professionals; the treating physician decides whether a use is appropriate for each patient.
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