Glycosan Seeks Regulatory Approval for HyStem-Rx Biomaterial

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."