Osteocel® Plus Safety and Quality Assurance

Safety Profile

Aseptic tissue processing Antimicrobial treatment of tissue Sterility cultures performed on every lot Selective immunodepletion process No evidence of ectopic tissue 
formation or inflammatory cellular response with experimental high doses of mesenchymal stem cells.1

Donor Testing

Hepatitis B Surface Antigen Hepatitis B Core Antibody Hepatitis C Virus Antibody Hepatitis C Nucleic Acid Test HIV-1 and 2 Antibody HIV-1 Nucleic Acid Test Human T-Lymphotropic Virus 
Antibody I/II Syphilis (Treponema Pallidum)

Donor Screening

Medical and social history evaluation Physical examination Medical record evaluation, including autopsy report (if performed) Licensed physician review and
release of every donor record

Quality Assurance

GTP compliant according to FDA regulations State of FL, MD, NY, CA, OR
licensure / registrations AATB Accreditation

References 1 Data on file with Osiris Therapeutics Osteocel® Plus is a federally registered trademark of NuVasive®, Inc. used by ACE Surgical under licence. Protected by U.S. Patent 5,811,094 and 6,355,239. Other patents pending.