Phoenix, February 14, 2022 (PRNewswire) – Amnio Technology is announcing the launch of two new PalinGen® coating products, PalinGen® Dual-Layer Membrane and Dual Layer PalinGen® X-Membrane, a global leader in the development and distribution of amniotic tissue allografts. The new allografts, like the entire PalinGen® membrane product family, are minimally invasive, homogenous and chorion-free. The two-dimensional nature of the allograms allows it to be applied in one direction to two external epithelial sides. The proprietary Advantek® process PalinGen® coating protects cells from cellular matrix components and regulatory proteins in amniotic tissues. Preserving the properties of natural tissue helps to control wounds.
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.
Director General of New Product Development Robert Deller“PalinGen® Dual Layer membranes have increased durability and slow response, making them ideal for use in robotics and other surgical applications,” PhD said.
“With the application of single-layer PalinGen® membrane products, patients already have improved clinical outcomes compared to standard treatment. Cytokines, growth factors and cellular matrix proteins are isolated in amnion membranes and contribute to the complex wound healing process. Dual layer membranes deliver twice as much of these components to the wound area. Sarah West.
The FDA recognizes that PalinGen® Dual-Layer Membrane and Dual Layer PalinGen® X-Membrane are small, synthetic human, tissue and cellular and tissue-based products or HCT / Ps. Letters from the Tissue Referral Group (TRG) at the Office of Tissues and Advanced Medicine (OTAT) September 30, 2021And February 8, 2022In turn, the FDA has confirmed that the PalinGen® Dual-Layer Membrane and the Dual Layer PalinGen® X-Membrane will be regulated only in accordance with the provisions of Article 361 of the PHS Act and 21 CFR 1271.
Amnio Technology has a long history of compliance with GTP practices. In recent years, the FDA has issued final guidelines on the Regulatory Products Regulatory Framework Regulation, confirming the regulation of amniotic products in the field of amniotic tissue.
William Brown“We will continue to be successful in developing and launching new products that meet the regulatory framework of the FDA and other agencies.” here we go.
Both PalinGen® Dual-Layer Membrane and Dual Layer PalinGen® X-Membrane are available in a variety of sizes to suit patient needs.
About Amnio Technology
Amnio Technology is a clinically advanced biotechnology company dedicated to advancing the science of rehabilitation. A.D. Established in 2013, Amnonio Technology has developed major capabilities in fine tissue practice and HCT / P Safety as a global leader in the development and distribution of amniotic tissue allografts. The company has strong products and liquid allografts for chronic wound treatment, PalinGen® Flow, currently in clinical trial Phase 2. For more information on Amnio technology, please visit the company’s website at www.amniotechnology.com.
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