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Serica Technologies Receives FDA 510(k) Clearance for SeriScaffold(TM) Technology for Soft Tissue Repair
Date:2/25/2009

ructure necessary for optimal healing. A silk-based scaffold that supports immediate tissue infiltration and maintains its integrity over a longer term, as it is being bioresorbed by the body, may be significant in addressing these clinical needs."

"First and foremost, it is our sincere hope that the properties of the SeriScaffold technology could represent a significant shift in soft tissue repair, in terms of the surgical outcome and healing process, for patients," added Altman.

"We plan to leverage the well known physical properties of silk in additional surgical applications, and will be initiating new clinical studies using our novel technology. Our goal is to develop a portfolio of tailored scaffold products, to be available in a multitude of contoured shapes and sizes, for those patients undergoing breast reconstruction and/or augmentation," said Altman. "It is our intent that our product portfolio serve the unique needs of this patient population where a significant loss of tissue occurs during surgery, with the hope of better restoring the repair site to a more natural state."

The SeriScaffold(TM) platform technology provides a unique natural protein-based alternative to synthetic materials and graft products harvested from human or animal cadaver tissue. "We believe our proprietary SeriScaffold technology has applications for a wide range of necessary procedures for patients requiring reconstructive plastic surgery, as well as for patients undergoing elective and other forms of soft tissue repair surgery," said Altman.

With additional research and development planned, SeriScaffold technology-based products have the potential to be lead products in the plastic surgery market, where 860,000 aesthetic augmentation and reconstructive surgical procedures are conducted annually. This silk-based scaffold technology is also showing promise in other procedures includin
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