Therics, Inc., a subsidiary of Tredegar Corporation, announced that it has received FDA clearance to market a new resorbable beta-tricalcium phosphate bone void filler device used to treat osseous defects of the skeletal system.
The TheriLink(TM), TheriWedge(TM) and TheriMatrix(TM) extensions covered by the clearance complete a new line of bone graft products offered by Therics that also includes TheriFil(TM) and TheriLok(TM).
These implants cover a broad spectrum of clinical applications in the orthopaedic and neurosurgical markets. Each is manufactured using Therics' TheriForm(R) microfabrication process.
The products feature a unique design of highly biocompatible, beta- tricalcium phosphate that creates a resorbable interlocking network within the defect site to promote healing. "The launch of this new product line completes the initial phase of our commercialization efforts. There is growing interest among physicians in our fabrication process and its potential for improved patient outcomes, and we're very encouraged as we move into the next phase of our product launch in the second half of 2004," said Thomas S. Stribling, president of Therics. Therics' TheriForm technology, originated at the Massachusetts Institute of Technology (MIT), is distinguished by its ability to spatially control, with extreme precision, the placement of multiple materials into complex three-dimensional constructs.
The process provides a high degree of flexibility in the design of product characteristics such as macro and microarchitecture, material composition, and internal and external surface textures. Therics has an exclusive license from MIT to develop this technology for FDA-regulated biostructures and implantable metal parts.
Based in Princeton, N.J., Therics is a developer of digital microfabrication process technology for medical devices and other medical applications.