The products offered by BioStem Technologies™ include RHEO™, OROPRO™, VENDAJE™, and VENDAJE™ OPTIC are perinatal tissue-derived allografts. They are designated as Human Cell, Tissue, and Cellular and Tissue-Based Products (HCT/P) by the U.S. Food and Drug Administration (FDA), are minimally manipulated, and are produced in accordance with the FDA regulations for Good Tissue Practices (21 CFR 1270, 1271).
Quality System
We are committed to continuous improvement and have established a Quality Management System which provides a framework for measuring and improving our performance.
At BioStem Technologies, quality is essential to us because we value our customers' reputations and, above all else, their patients' safety. In our FDA registered, cGMP compliant lab, we strive to provide products and services which not only meet but exceed, Current Good Tissue Practice requirements.
Monitor
Training
Objectives
Audit
Measure
Review
Performance monitoring of selected suppliers against a set criteria
Employee training and development
Construct measurable quality objectives in line with our business
Internal processes are audited at regular intervals
Measure audits against previously constructed objectives
Regular reviews of audit results, customer feedback and complaints
Tissue Donation
BioStem Technologies procures all tissue through ethical and elective donation within the United States, from mothers who have provided full informed consent. Donor eligibility requires a healthy mother to have delivered a live birth via elective Cesarean section. Donor suitability is determined through a stringent social, physical, and medical screening process, which includes a full medical record review by a third-party medical doctor.
Live Cesarean Birth
First 12 Hours
12-24 Hours
30-32 Hours
45 Days
A healthy mother gives a planned, live cesarean birth
The donation is collected and shipped to BioStem's lab
The donation is received at BioStem's lab and processing begins immediately
Less than 36 hours from the birth, the donation has been processed and sample testing begins in our FDA/cGMP compliant lab
After 45 days if the processed tissue meets all guidelines for internal and 3rd party testing, it is released for packaging and sale
Tissue Donor Screening
Donor eligibility is based on screening and testing donors for relevant communicable diseases or disease agents (RCDADs). These tests must indicate that the donor is free from risk factors for, or clinical evidence of, infection due to RCDADs and is free from communicable disease risks.
Human immunodeficiency virus, types 1 and 2 (HIV-1/2)
Hepatitis B virus (HBV)
Hepatitis C virus (HCV)
Human transmissible spongiform encephalopathy (hTSE), including Creutzfeldt-Jakob disease (CJD)
Treponema pallidum (agent that causes syphilis)
Vaccinia
Sepsis
West Nile virus (WNV)
Zika virus (ZIKV)
Chlamydia trachomatis (CT)
Neisseria gonorrhea (NG)
Human T-lymphotropic virus, type I and type II (HTLV-I/II)
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