This diagram below demonstrates a very important differentiator between our products and every other manufacturer on the market. We are looking at the cross-section of the amniotic membrane, the placenta, which comprises two very distinct layers that are separated by the red line, the amnion and the chorion.
The amnion layer is the layer facing the baby and amniotic fluid, and then the thick chorion layer is the layer facing the mom and the abdominal cavity.
The thick chorion layer contains a lot of growth factors, but unfortunately, it also contains a lot of the Type 2 HLA antigens (human leukocyte antigen (HLA) stimulates antibody generation) that are responsible for a graft versus host autoimmune reaction.
Amnio Technology manufactures high-quality, chorion-free products to reduce the potential for graft-versus-host autoimmune response.
Our products are derived from amniotic tissues recovered under strict guidelines and policies without harming the mother or child.
PalinGen© products are manufactured using our proprietary Advantec© process, that excludes the chorion layer.
Every product is processed and packaged according to cGTP (current good tissue practices) regulations.
Quick delivery to clinicians nationwide to improve quality of life for patients in need.
Committed to a culture of Quality and continuous improvement, Amnio Technology has substantially invested in Processing/Manufacturing Operations. Employing state of the art manufacturing clean rooms, as well as closed aseptic isolator technology, ensures Products are processed in a manner that meets and exceeds Quality Standards as well as Regulatory expectations. By way of implementing semi-automated equipment and processes, Amnio Technology has developed a fully validated process which ensures Product Quality and consistency.
Amniotic tissue and membrane are known to contain collagen substrates, growth factors and extracellular matrix proteins all recognized as part of the complex wound healing process. Amnio Technology products are derived exclusively from the amnion and are chorion-free. Key natural elements found in placental tissues:
Amnio Technology is an industry leader in the development and manufacture of amnion-derived technologies. As an organization, it is our mission to serve unmet and underserved clinical needs through continuous development and improvement of innovative products that provide regenerative therapies. Through that process, Amnio Technology regularly engages with the Food and Drug Administration (FDA) to bring quality, compliant products to the market. While Amnio Technology has several products in the pipeline that will engage varying regulatory paths through the development process, currently, the PalinGen® Flow product has been identified as an investigational new drug (IND).
Amnio Technology is in the late stages of a Phase II Clinical Trial for PalinGen® Flow, an injectable, amnion-based, liquid allograft with an indication for wound healing in diabetic foot ulcers (DFU) and venous leg ulcers (VLU). PalinGen® Flow contains multiple growth factors, varying types of collagen, Hyaluronic Acid, and Tissue Inhibitors of Metalloproteinases (TIMPs), all of which are naturally occurring and intrinsic to the complex wound healing process. PalinGen® Flow is cryo-preserved and can be stored for up to 2 years from the date of manufacture in that state. The product, however, is thawed at room temperature prior to injection and can be injected through a needle as small as a 22 gauge. More information about the clinical trial is available on the FDA’s website. Information on Amnio Technology’s Expanded Access Program can be found here.
Amnio Technology is committed to Compliance, Quality and fosters a culture of Continuous Improvement. Amnio Technology has a core competency in Current Good Tissue Practices (cGTP). Our products meet or exceed the Quality and donor testing expectations set by the FDA in 21 CFR 1271. All Amnio Technology Products are manufactured in an FDA Registered and American Association of Tissue Banks (AATB) accredited facility.
An industry leader in the development and manufacture of amnion-derived technologies
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