Glycosan BioSystems Seeks CE Mark in the European Union for HyStem-Rx, a Unique, Implantable Scaffold for Tissue Engineering
SALT LAKE CITY, June 1 Glycosan BioSystems announced today that the Company has begun the process for gaining regulatory approval within the European Union for the use of HyStem-Rx as a resorbable scaffold for implanting autologous adipose derived cells in reconstruction and aesthetic plastic surgery procedures. Upon approval, HyStem-Rx will receive a CE Mark as an implantable medical device. HyStem-Rx will be indicated for use to correct subcutaneous contour defects arising from traumatic injury, oncologic resections, and other conditions that result in the loss of adipose tissue.
Spokesman for the Company said, "There is increasing recognition that development of successful cell-based therapies will require implanting cells within a matrix to protect them from natural inflammatory processes and to provide a three dimensional scaffold on which cells can attach and proliferate. HyStem-Rx is a unique biomaterial that was designed as a biocompatible, resorbable mimic of the extra-cellular matrix to be used as a delivery matrix in cell-based therapies. Pre-clinical studies have shown HyStem-Rx to support the growth of a wide variety of cell types and the proliferation and differentiation of embryonic stem cells as well as neural, hepatic, and adipose derived progenitor cells."
Glycosan BioSystems, Inc. is a privately held Salt Lake City biotechnology company that develops, manufactures, and sells unique biocompatible hydrogels that mimic the extracellular matrix, the complex mixture of macromolecules that holds cells together in tissues and organs. The Company's products are used in cell culture and stem cell research and have applications as implantable, resorbable scaffolds for tissue engineering, regenerative medicine, and cell-based therapies. Glycosan is the licensee of the University of Utah Research Foundation for certain intellectual property based on unique chemical cross-linking strategy to prepare hyaluronan based hydrogels from chemically modified hyaluronan and other extracellular matrix constituents. More information on the Company and its products can be found at www.glycosan.com.
SOURCE Glycosan BioSystems, Inc.
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