Amnio Technology, a global leader in the development of and distribution of amniotic tissue allografts is announcing the launch of two new PalinGen® membrane products, PalinGen® Dual-Layer Membrane and Dual Layer PalinGen® X-Membrane. The new allografts, like the entire family of PalinGen® membrane products, are minimally manipulated, homologous use and chorion-free. The dual-layered nature of the allografts allow for unidirectional application with two outward facing epithelial sides. The proprietary Advantek® process used to manufacture PalinGen® membranes preserves the extracellular matrix components and regulatory proteins present in amniotic tissues. Preserving the characteristics of the natural tissue aids in wound management.
PalinGen® Dual-Layer Membrane and Dual Layer PalinGen® X-Membrane are indicated for patients suffering from non-healing acute and chronic wounds as well as complex and/or open surgical wounds and burns.
Senior Director of New Product Development, Robert Diller, PhD, shared his insight into the motivation for developing a multilayered amniotic product, “The PalinGen® Dual layer membranes have increased durability and slower resorption, which makes them ideal for use in robotic and other surgical applications”
“With the application of single-layer PalinGen® membrane products, patients already experience improved clinical outcomes compared to treatment with standard of care. Cytokines, growth factors, and extracellular matrix proteins have been identified in amnion membranes and contribute to the complex wound healing process. Compared to single layer allografts, PalinGen® Dual Layer membranes deliver twice as many of these components to the wound area,” said lead Research Scientist on the development project, Sarah West.
The FDA recognized PalinGen® Dual-Layer Membrane and Dual Layer PalinGen® X-Membrane as being minimally manipulated, homologous use human cell, tissue, and cellular and tissue-based products or HCT/Ps. In letters received from the Tissue Reference Group (TRG) within the Office of Tissues and Advanced Therapies (OTAT) on September 30, 2021, and February 8, 2022, respectively, FDA confirmed that PalinGen® Dual-Layer Membrane and Dual Layer PalinGen® X-Membrane would be regulated solely under section 361 of the PHS Act and the regulations in 21 CFR 1271.
Amnio Technology has a long history of Good Tissue Practices (GTP) experience and compliance. In recent years, the FDA has issued final guidance on its Framework for the Regulation of Regenerative Medicine Products, making the confirmation of the regulatory status of amniotic products critical for business continuity in the amniotic tissue space.
William Brown, Managing Director of Operations at Amnio Technology, recognized the efforts of the entire Amnio Technology Team, “We continue to be successful in the development and launch of new Products in our pipeline, which meet the Regulatory framework of the FDA and other Agencies. With a Team dedicated to compliance from the first step, we continue to expedite new product availability to clinicians for implementation into their practice and, ultimately, the ability to improve quality of life for the patient.”
Both PalinGen® Dual-Layer Membrane and Dual Layer PalinGen® X-Membrane are available in a variety of sizes suited for the patient’s needs.
About Amnio Technology
Amnio Technology is a clinical stage biotechnology company dedicated to advancing the science of regenerative medicine. Established in 2013, Amnio Technology has developed core competencies in Good Tissue Practice and HCT/P Safety becoming a global leader in the development and distribution of amniotic tissue allografts. The Company has a robust pipeline of products and its liquid allograft for the treatment of chronic ulcers, PalinGen® Flow, is currently in a Phase 2 clinical trial. For more information about Amnio Technology, please visit the Company website at www.amniotechnology.com.
