//How We Select Our Products
How We Select Our Products2018-07-10T01:11:22+00:00

The StemSafety® Product-Selection Process

I: Allograft Safety Standards

Our products go through comprehensive clinical and laboratory testing to ensure they are safe and effective for patient use. We comply with US FDA regulations for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) identified in 21 CFR Part 1271 and Section 361 of the Public Health Service Act. Compliance with these regulations ensures the delivery of quality allograft products to healthcare providers with confidence.

II: Collection & Preparation

All donors are screened to ensure they meet the eligibility criteria established by the FDA. Blood testing is performed by an independent lab to ensure donor screening is complete for communicable diseases including, HIV I/II, HBV, HCV, Treponema pallidum, HTLV I/II, WNV/NAT, and Cytomegalovirus (CMV). Additional donor screening includes a medical history interview, physical examination, behavioral risk assessment, and information from other sources or records which may pertain to donor suitability.

III: Quality & Efficacy

Our human tissue products deliver industry-leading quality in a variety of form factors. The proprietary StemShot® extraction process is highly delicate, preserving natural elements and maximizing the density of viable cellular materials. Our proprietary cryopreservation process maximizes the viability and the concentration of our products.

I: Allograft Safety Standards

Our products go through comprehensive clinical and laboratory testing to ensure they are safe and effective for patient use. We comply with US FDA regulations for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) identified in 21 CFR Part 1271 and Section 361 of the Public Health Service Act. Compliance with these regulations ensures the delivery of quality allograft products to healthcare providers with confidence.

II: Collection & Preparation

All donors are screened to ensure they meet the eligibility criteria established by the FDA. Blood testing is performed by an independent lab to ensure donor screening is complete for communicable diseases including, HIV I/II, HBV, HCV, Treponema pallidum, HTLV I/II, WNV/NAT, and Cytomegalovirus (CMV). Additional donor screening includes a medical history interview, physical examination, behavioral risk assessment, and information from other sources or records which may pertain to donor suitability.

III: Quality & Efficacy

Our human tissue products deliver industry-leading quality in a variety of form factors. The proprietary StemShot® extraction process is highly delicate, preserving natural elements and maximizing the density of viable cellular materials. Our proprietary cryopreservation process maximizes the viability and the concentration of our products.

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