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Contract # 36F79719D0049


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PRODUCT DESCRIPTION

Axolotl Ambient™ is an ambient temperature (25±7°C, 77±13°F) stored liquid allograft derived from the amniotic components of the placenta to advance soft tissue repair and reconstruction. It is classified as minimally manipulated under FDA regulation 21 CFR Part 1271 and section 361 of the PHS.

The two primary cell lines which reside in the amnion are human mesenchymal stromal cells (hMSC) and human amnion epithelial cells (hAEC). Both of these cells are considered to be pluripotent stem cells. Axolotl Ambient™ contains growth factors and cytokines such as epidermal growth factor (EGF),vascular endothelial growth factor (VEGF), and transforming growth factor – beta (TGF-ß), Interleukin-10 (IL-10). These proteins are essential for fetal growth and development and express significant therapeutic benefits when used as a treatment to stimulate repair and regeneration. Axolotl Ambient™ is immune-privileged, anti-inflammatory, anti-fibrotic, pro-vascular, and cytoprotective because of the cells being sourced from the amnion. These secreted factors also signal endogenous progenitor cells to promote regeneration and repair of damaged or degenerated tissue.


DONOR SCREENING

The donor tissue is recovered and processed aseptically, in accordance with all FDA and AATB guidelines and quality assurance standards in a controlled environment. Axolotl Ambient™ allograft tissue products have been subjected to microbiological studies at recovery and final packaging.


 Order Products by Product Code or Product Name

Name                      Code                  Size

Axolotl Ambient™           AA05              0.5 mL

 Axolotl Ambient™           AA10              1.0 mL

 Axolotl Ambient™           AA20              2.0 mL