AmDrop™ is an amniotic liquid allograft derived from the amniotic components of the placenta to advance soft tide repair, replacement and reconstruction. It is classified as minimally manipulated under FDA Regulation 21 CFR part
1271 and section 361 of the PHS.
AmDrop™ is donated human tissue and is deemed free from risk factors for and the clinical evidence of infection due to relevant communicable diseases and other exclusionary disease conditions through the review of the donor’s medical records, including medical/behavior risk assessment and a recent physical examination.
The donor is deemed eligible for tissue donation by the tissue bank’s Medical Director and has been determined to be acceptable for transplantation use through a stringent quality assurance review process. Additionally, testing of a qualified blood samples indicates that the donor is negative or nonreactive for communicable diseases.
Ready to Use
AmDrop™ amniotic fluids are delivered in sterile vials as ready-to-use, flowable grafts; no thawing or additional preparation is required.
Stable shelf life
AmDrop™ is stored at room temperature (50-86°F/10-30°C) until ready for use. Product has a one-year shelf life.
AmDrop™ has been shown to suppress the immune response and modulate inflammation.
AmDrop™ is provided in a sterile vial in a clear peel-pouch and may be introduced to the sterile field.
Human tissue donors undergo a stringent quality assurance review process. Additionally, donor blood testing and screening verifies samples are negative or nonreactive for the following communicable disease markers:
- HUMAN IMMUNODEFICIENCY VIRUS (HIV): HIV-1/2 Antibodies, Nucleic Acid Test for HIV-1 RNA
- HEPATITIS B VIRUS (HBV): HBV Surface Antigen, HBV Core Antibody (Total), Nucleic Acid Test for HBV DNA
- HEPATITIS C VIRUS (HCV): HCV Antibody, Nucleic Acid Test for HCV RNA
- HUMAN T CELL LYMPHOTROPHIC VIRUS I/II: HTLV-I/II Antibody
- SYPHILIS: Rapid Plasma Reagin Screen, Treponemal Specific Test
- WEST NILE VIRUS: Nucleic Acid Test for WNV RNA
AmDrop™ products are primarily amniotic liquid allografts derived from the amniotic components of the placenta to advance soft tissue repair, replacement, and reconstruction. It is classified as minimally manipulated under FDA regulation 21 CFR Part 1271 and section 361 of the PHS. Amnion-derived fluid and membranes are rich in the essential components necessary for tissue regeneration and repair including:
- Growth Factors
- Hyalauronic Acid
- Mesenchymal components
We strive to help medical professionals improve their patients’ quality of life by leveraging the latest biologic therapies to provide advanced care for what would otherwise be non-treatable conditions.