FAQ's

Frequently Asked Questions

We are striving towards educating clinicians and patients on the contents and benefits of amniotic fluid.

Work Process

What processes and practices does Amnyo currently have in place to guarantee the safety and efficacy of its products?

Amnyo's tissue processing follows Standard Operating Procedures that have been established to ensure that the safety and efficacy of the tissues are maintained during processing. Our manufacturing, quality assurance, and final product specifications have been approved by our medical director, who is a board-certified clinical pathologist. Our tissues are tested for sterility per United States Pharmacopoeia USP <71> standards and donors are screened for relevant communicable diseases.

What data does Amnyo have to support product safety and efficacy?

We have not performed any controlled clinical trials that produce specific safety and efficacy data; however, there have been no reported adverse events attributed to our products to date.

What quality controls does Amnyo have in place to address variable collection and processing techniques by its suppliers?

Amniotic fluid is qualitatively assessed before it is accepted (i.e. for color, turbidity, fluid consistency etc.) in addition to review of the serology and social history screening results. Amnyo has partnerships with multiple amniotic fluid suppliers nationwide. Our recovery partners procure the tissues with protocols that adhere to the American Association of Tissue Banks (AATB) standards. Additionally, we have reviewed their collection protocols and have found them acceptable.

Who processes Amnyo's products and how is quality controlled within the facility?

Amnyo processes their amniotic fluid products in-house at their laboratory in Flagstaff, Arizona. The lab team is led by a PhD scientist with many years of scientific experience. Amnyo has a Quality Management System established to ensure that the safety and efficacy of tissues are maintained during processing.

Products

What is the source of Amnyo's amniotic fluid?

All human tissues used to manufacture our products are sourced from donors who have undergone delivery via scheduled cesarean section and who have been rigorously screened for both medical conditions and social histories. Our tissue recovery partner procures tissues with protocols that follow American Association of Tissue Banks (AATB) standards. Additionally, we have reviewed their recovery, screening, labeling, and shipping protocols and have found them acceptable.

What serology testing is conducted on donors?

Donor blood is tested for the following communicable diseases:

-Syphilis (STS)

-Hepatitis B Virus (Surface Ag, Core Ab, NAT)

-Hepatitis C Virus (Ab, NAT)

-Human T-lymphotropic virus, type I (Ab)

-Human T-lymphotropic virus, type II (Ab)

-Human immunodeficiency virus, type O (Ab, NAT)

-Human immunodeficiency virus, type 1 (NAT)

-Human immunodeficiency virus, type 2 (Ab)

-Cytomegalovirus (Ab)

-West Nile Virus (NAT)

Donors are also screened for social histories and high-risk behaviors that may make them a more at-risk demographic for communicable diseases.