Distribution, Quality & Clinical Support
A distribution partner built on strategic tissue bank alliances — quality oversight, logistics, and turnkey custom solutions.
Premier services, end to end
Strategic Alliances
Built on partnerships with leading U.S. tissue banks advancing safer, more effective allograft processing.
Turnkey & Custom Solutions
Turnkey solutions and custom-designed products to your exact specifications, sourced through our partner network.
Storage
Controlled, compliant storage through our tissue bank partners keeps allografts ready when you need them.
Hard-to-Find Specialty Grafts
Our U.S. partnerships let us source specialty grafts on request.
Why the paperwork matters
21 CFR Part 1271
Every allograft we distribute is a human cell, tissue, or cellular/tissue-based product (HCT/P) regulated under FDA 21 CFR Part 1271. To qualify for distribution as an HCT/P rather than a licensed biologic, tissue must be minimally manipulated and intended for homologous use — performing the same basic function in the recipient as it did in the donor.
AATB-standard partners
We work with tissue banks held to the American Association of Tissue Banks’ Standards for Tissue Banking — first published in 1984 and the most comprehensive private tissue banking standards in the world, serving as a model for federal regulation and international directives alike.
Built to your specifications
Our partnerships across the United States allow us to develop and supply potentially hard-to-find specialty grafts, as well as producing turnkey solutions and products for customers desiring custom-designed products to their exact specifications.
Discuss a custom project →