1. Tissue Bank
HRT is an FDA registered and AATB accredited tissue bank since 2014, and is one of the nation’s leading tissue banks specializing in regenerative human tissues. Along with its quality advantages, HRT’s stringent safety standards are setting a new standard in the industry for tissue processing.
2. Tissue Source
All of HRT’s donated placental tissues are obtained from healthy mothers who are under the care of a licensed OB/ GYN physician at a partner facility. All donations are sourced from U.S.-based donors, and only after live, healthy, successful cesarean birth delivery. No maternal or fetal tissues are collected during the process.
3. Donor Screening
HRT employs stringent donor screening criteria in compliance with FDA HCT/P regulations and American Association of Tissue Banks (AATB) standards. See attached abbreviated Donor Screening Criteria.
As an integral part of donor screening, HRT screens the living donor for communicable disease (serologic and nucleic acid amplification) test markers for human immunodeficiency virus 1 & 2, hepatitis B virus, hepatitis C virus, human T cell lymphotrophic virus I/II and causative agent of syphilis in accordance to FDA regulations and AATB standards. The employed testing laboratory is FDA registered and CLIA certified to perform such tests. All test kits are FDA approved and cleared for living donor testing.
4. Tissue Recovery
HRT has an established placental donor program (PlacentaDonor.org) to connect donors with partner donation sites. All donated tissues are recovered aseptically from cesarean birth deliveries in a hospital operating room environment. Each recovered tissue is placed on wet ice and maintained at wet ice temperature range within the hour of recovery to prevent growth of microorganisms (maintain the low bioburden of the tissue) and preserve the biologic properties of the tissue.
5. Collection and Processing
Tissues are processed aseptically and subjected to minimal processing via HydraTek technology which maintains the tissues nativeproperties and integrity of the transplant. HydraTek technology is a proprietary preservation system which preserves the transplant in its natural hydrated state. Other processing methods utilize harsh chemicals, high-heat baking or lyophilization which have been shown to denature proteins, cause collagen collapse, and/or disrupt the delicate tissue matrix and protein structure of the tissues.*
6. Sterility
