Our Mission
Amnion is committed to providing minimally manipulated human birth tissue products for use as biological coverings at wound and surgical sites, manufactured under a certified quality management system and made available to clinicians without the cost of intermediary distribution.
Amnion processes all allografts using its proprietary AmnioCleanse™ tissue process under current good tissue practice (CGTP) requirements and the Standards of the Association for Advancing Tissue and Biologics (AATB).
Michael P. Fortkort, Esq.
Chief Executive Officer and General Counsel
Mr. Fortkort brings entrepreneurial experience to the company and a wide range of legal expertise, including intellectual property law, transactional law, and regulatory experience. While a registered patent attorney and licensed attorney in Virginia and Washington, D.C., Mr. Fortkort has also managed several successful businesses in a variety of fields. Mr. Fortkort earned a bachelor’s degree in electrical engineering from the University of Notre Dame, a master’s degree in electrical engineering from George Washington University, and a Juris Doctorate from Georgetown University Law Center.
Who We Are
Amnion LLC manufactures minimally manipulated human amniotic membrane allografts for use as biological coverings at wound and surgical sites. These products are regulated as human cells, tissues, and cellular and tissue-based products (HCT/Ps) under Section 361 of the Public Health Service Act and 21 CFR Part 1271.
Amnion operates a single processing facility in Sterling, Virginia, where donated birth tissue is received, processed, packaged, and released. All tissue is recovered with informed maternal consent following scheduled Cesarean delivery through qualified recovery partners, and every donor is screened and tested in accordance with FDA donor eligibility requirements and AATB Standards. Finished allografts are terminally sterilized by electron beam irradiation and stored at room temperature.
Amnion sells direct to clinicians, surgery centers, and hospitals in the United States, and through registered distribution partners outside the United States. There is no minimum order. The most frequently used sizes are kept in stock and custom sizes are made to order. Request a quote for a made-to-order size.
Amnion LLC is a wholly owned subsidiary of HST Global, Inc. (OTC: HSTC).
Registrations and Accreditations
U.S. Food and Drug Administration
Registered tissue establishment, FEI 3017609580
American Association of Tissue Banks
Accredited tissue bank, Accreditation No. 00377
ISO 13485:2016
Quality management system certified by Amtivo, Certificate No. 272926
Health Canada
Cells, Tissues and Organs establishment registration CTO100270
Amnion also holds tissue bank licenses or registrations in the states that require them for out-of-state distributors. See Regulatory & Quality for the full list. Certificates are available on request.
Outside the United States?
Amnion allografts are available internationally through registered distribution partners. See our international distribution page for current markets and export documentation.