Safety & Quality
HIGHEST SAFETY STANDARDS
Skye is commited to the highest quality and safety standards. Our biologic allografts undergo strict processes and procedures to ensure tissue quality and patient safety.
Skye only sources tissue for its BioECM® products from live, healthy U.S.-based donors, who donate their placentas after successful C-section delivery.
NATURAL HUMAN TISSUE
Skye BioECM® allografts are derived from 100% natural human tissue. No additional cells, tissues or synthetic materials are added during processing.
SCREENING & TESTING
All donated tissues are determined to be suitable for transplantation by a licensed physician, Medical Director of the Tissue Bank. Prior to processing, serological and microbial testing is performed.
Communicable disease testing is performed by a laboratory that is registered with FDA and certified to perform testing on human specimens under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and 42 CFR part 493, or equivalent requirements.
• Antibody to Human Immunodeficiency Virus 1 & 2 (HIV 1 & 2)
• Nucleic Acid Test for HIV-1 RNA
• Hepatitis B Virus (HBV) Surface Antigen
• Hepatitis B Virus (HBV) Core Antibody (Total)
• Nucleic Acid Test for HBV RNA
• Antibody to Hepatitis C Virus (HCV)
• Nucleic Acid Test for HCV RNA
• Antibody to Human T Cell Lymphotrophic Virus 1 & 2 (HTLV 1 & 2)
• Rapid Plasma Reagin (RPR) Screen, or Syphilis Treponemal Specific (STS) Test
A copy of the medical records can be obtained upon request.