Tissue Quality and Safety

Human Tissue Therapy products are prepared from a donor determined to be suitable based on the results of screening and testing. The tests for transmissible infectious diseases produced negative results. The names and addresses of the testing laboratories, the listing and interpretation of all required infectious disease tests, and a listing of the documents reviewed as part of the relevant medical records are on file and available upon request. Due to limitations in testing technology, testing and donor screening cannot totally eliminate the risk that human tissue will transmit disease. The donor has been evaluated and has been determined to be suitable for transplantation based on the donor suitability criteria current at the time of tissue recovery in accordance with United States Food and Drug Administration (FDA) regulations, local and state regulations, and tissue bank protocols.All communicable disease testing was performed on this allograft by a laboratory registered with FDA to perform donor testing and certified to perform testing on human specimens under the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. 263a and 42 CFR Part 493); or has met equivalent requirements as determined by the Centers for Medicare and Medicaid Services in accordance with those provisions. Donor blood samples taken at the time of tissue recovery were tested for the following:

1. Cytomegalovirus Antibody (CMV Total Ab).
2. Hepatitis B surface antigen (HBsAg).
3. Hepatitis B core total antibody (HBcAb).
4. Hepatitis B Virus (HBV) Nucleic Acid Test.
5. Hepatitis C antibody (HCV).
6. Hepatitis C Virus (HCV) Nucleic Acid Test.
7. Human Immunodeficiency Virus (HIV) Type 1 and Type 2 antibody.
8. Human Immunodeficiency Virus Type 1 (HIV-1) Nucleic Acid Test.
9. Human T-Lymphotrophic Virus (HTLV) Type 1 and Type 2 antibody.
10. Rapid Plasma Reagin (RPR) for Syphilis or Serologic Test for Syphilis (STS).
11. West Nile Virus Nucleic Acid-Test (during active mosquito season per FDA Guidance).

This testing is performed by a laboratory registered with FDA to perform donor testing and certified to perform such testing on human specimens under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and 42 CFR part 493, or that has met equivalent requirements as determined by the Centers for Medicare and Medicaid Services (CMS). BONE BANK ALLOGRAFTS’ Medical Director has determined this donor tissue to be suitable for transplantation. The testing and medical release records are maintained by BONE BANK ALLOGRAFTS.

Vivaderm’s processing preserves mechanical and biologic properties:

1. Sterility Assurance Level (SAL) of 10-6 compared to competitors with a SAL of 10-3.
2. Gamma irradiation proven to inactivate a broad range of viruses1.
3. Low-dose precision gamma irradiation combined with a low temperature technique protects
   the native biological and mechanical properties of the tissue.