Answers to the questions clinicians, purchasing staff, and distributors ask most often about Amnion LLC and its amniotic membrane allografts. For anything not covered here, contact us at info@amnion.net or (571) 368-6966.
About Amnion
Who is Amnion LLC?
Amnion LLC is an FDA-registered, AATB-accredited human tissue establishment in Sterling, Virginia, that manufactures amniotic membrane allografts. Amnion is a wholly owned subsidiary of HST Global, Inc. (OTC: HSTC). Amnion processes tissue at its own facility and sells directly to clinicians and facilities.
What certifications and registrations does Amnion hold?
FDA HCT/P establishment registration (FEI 3017609580), AATB accreditation (No. 00377), ISO 13485:2016 certification (No. 272926), Health Canada CTO establishment registration (No. 100270), and tissue bank licenses or registrations in California, Delaware, Florida, Illinois, Maryland, New York, and Oregon. Details and verification links are on the Regulatory & Quality page.
Is Amnion a manufacturer or a distributor?
A manufacturer. Amnion processes, packages, labels, releases, and distributes its allografts from its Sterling, Virginia facility. Tissue recovery, donor testing, and terminal sterilization are performed by qualified contract partners under Amnion’s quality management system.
Products
What products does Amnion make?
Four amniotic membrane allografts: AmGraft™ (single-layer amnion), AmGraft™ Plus (dual-layer amnion), AmGraft™ Core (amnion-chorion), and AmDisc™ (a circular single-layer amnion allograft for ophthalmic use). All are dehydrated, terminally sterilized, and stored at room temperature.
What is the difference between AmGraft™, AmGraft™ Plus, and AmGraft™ Core?
Layer count and composition. AmGraft™ is a single layer of amnion. AmGraft™ Plus is two layers of amnion, for applications where a thicker covering is wanted. AmGraft™ Core combines the amnion and chorion layers of the placental membrane, giving a thicker and more substantial allograft. All three are processed with the same AmnioCleanse™ method.
What is AmDisc™?
AmDisc™ is a circular, single-layer dehydrated amniotic membrane allograft supplied in diameters from 5 mm to 15 mm for use as a covering on the ocular surface.
What sizes are available?
AmGraft™ and AmGraft™ Plus are available in any rectangular size from 5 × 5 mm up to 7 × 7 cm. AmGraft™ Core is available in the sizes listed on its product page. AmDisc™ is available in diameters from 5 mm to 15 mm. Amnion keeps its most-used sizes in stock and makes custom sizes to order; if you need a size not listed in the shop, use the Request a Quote page.
What are the products intended for?
Amnion’s allografts are intended for use as a covering at the surgical or treatment site. They are regulated as Section 361 HCT/Ps for homologous use. Clinicians should consult the instructions for use supplied with each product.
Do the products contain any additives, preservatives, or synthetic materials?
No. Each allograft is human amniotic membrane (or amnion-chorion, for AmGraft™ Core) processed with the AmnioCleanse™ method and dehydrated. No cross-linking agents, chemical preservatives, or synthetic carriers are added.
Storage, handling, and shelf life
How should the allografts be stored?
At room temperature, 15–30 °C (59–86 °F), in the original sealed packaging. No refrigeration or freezing is required.
What is the shelf life?
Five years from the date of manufacture, printed on each package label. The labeled shelf life is supported by Amnion’s validation studies.
How are the allografts packaged?
Each allograft is supplied in a sterile double peel pouch inside a labeled carton, with a tissue tracking record and instructions for use.
Are the products sterile?
Yes. Every lot is terminally sterilized by electron beam (e-beam) irradiation at an ISO 11137-compliant contract facility, validated to a sterility assurance level (SAL) of 10⁻⁶.
Donor screening and safety
Where does the tissue come from?
From placentas donated by healthy mothers following scheduled Cesarean-section delivery of a full-term, healthy infant, with the mother’s informed consent. Recovery is performed by an AATB-accredited recovery partner.
How are donors screened?
Each donor’s medical and social history is reviewed and each donor is tested for relevant communicable disease agents and diseases in accordance with 21 CFR Part 1271 Subpart C and AATB Standards for Tissue Banking. Tissue is released to processing only after donor eligibility has been determined and documented.
Is each allograft traceable?
Yes. Every allograft carries a unique identifier that links it to its lot and donor. A tissue tracking record accompanies each shipment so the receiving facility can complete the chain of traceability to the recipient, as required under 21 CFR 1271.290.
Ordering and pricing
How do I order?
In the United States, order directly through the shop on amnion.net, submit a Request a Quote form for custom sizes or volume pricing, or contact info@amnion.net or (571) 368-6966. Amnion sells direct to clinicians and facilities.
Do you sell through distributors?
In the United States, Amnion sells direct. In Canada, Amnion’s products are distributed by WhiteOp under Amnion’s Health Canada CTO registration. In other markets, Amnion works with authorized distributors; contact us to be connected with the distributor for your country.
Is there a minimum order?
No. Orders of a single graft are welcome. Volume pricing is available for orders of 20 or more grafts — use the Request a Quote page or contact us.
Are sizes stocked or made to order?
Amnion maintains stock of its most-used sizes and makes custom sizes to order. Contact us for the current lead time on a made-to-order size.
Do you offer pricing for facilities or group purchasing?
Yes. Facility and volume pricing is available on request through the Request a Quote page.
Can you help with reimbursement or coding?
Coverage, coding, and payment are determined by each payer. Amnion does not provide reimbursement guidance and makes no representation about coverage. Clinicians should consult their payers and coding resources.
Documentation
What documentation comes with each order?
A tissue tracking record and the instructions for use. A Certificate of Conformance for any lot is available on request.
Can I get copies of your certificates?
Yes. The ISO 13485 certificate, AATB accreditation certificate, FDA registration summary, Health Canada CTO registration, state licenses, and sterilization validation summary are available on request through the Contact page.
Do you have an FDA Certificate to Foreign Government?
Yes — Certificate No. CT:6XHP-KC9M, valid through May 17, 2028, covering AmDisc™, AmGraft™, and AmGraft™ Plus. AmGraft™ Core is manufactured under the same process and is a member of the AmGraft™ product family. Copies are available to international distributors and regulators.
How do I report a complaint or adverse reaction?
Email info@amnion.net, call (571) 368-6966, or use the contact form. Amnion investigates every complaint and reports adverse reactions involving communicable disease as required under 21 CFR 1271.350.