Safety Standards

Most human tissue products are derived from cadavers and processed by third-party tissue banks. We believe the use of live, healthy donors is a superior approach to regenerative medicine. The placental-derived allografts are recovered from live, healthy donors whom undergo a pre-screening process during pregnancy and are chosen based on our stringent donor selection criteria. From aseptic recovery of the tissue at childbirth to timely processing of our allografts, our protocols and procedures have been developed to meet, or exceed, all applicable industry standards for the use of human cellular and tissue-based products. Our operating entities are registered with the FDA and accredited by the AATB, AABB, and CLIA.

Donor Testing

All potential donors are pre-screened during an examination of pre-natal medical records and test results. A comprehensive medical history and a behavior risk assessment is obtained from the donor prior to donation incorporating U.S. Public Health Service guidelines. Discussions with the physician and/or the donor mother are conducted to identify circumstances that may lead to the exclusion of the donor or donated tissue.

Our infectious disease screening requirements meet, or exceed, all FDA requirements.

Qualifications

Regulatory

Our company is registered through the FDA regulatory process. We take the appropriate steps to assure that our products follow FDA standards.

Accreditations

Our facility and products exceed standards and are accredited. These standards cover all aspects of operation from donor selection and testing to product processing, storage, clinical administration, and patient outcomes.