Advanced Biomaterial Systems receives U.S. patent for mixing and dispensing apparatus

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Advanced Biomaterial Systems, Inc. (ABS) has received U.S. patent 6,984,063 for an Apparatus for Mixing and Dispensing Components. This patent is a continuation of several patents which incorporate twistOR and Plexis technology.

The mixing and dispensing capability of this device provides unequalled control in minimally invasive techniques such as vertebroplasty and kyphoplasty. The next generation technology encompasses the delivery of unique medical polymers for soft tissue intervention. Additional United States and International patents are pending.

Additionally, ABS received CE Mark approval of its Plexis Bone Void Filling System and Concert Spine VR Bone Cement Products. "The CE Mark demonstrates that the company is in compliance with the regulatory requirements of Medical Devices Directive (93/42/EEC) and allows the company to market the device in any European Union member country and in other selected international markets," said Forrest Rudnick, ABS Vice President Quality Assurance. "The certification of a quality management system, specifically for the manufacture of products covered by the new Approach EC Directives, is essential for ABS to export products to the global market."

The Plexis Bone Void Filling System in conjunction with Concert Spine VR Bone Cement provides physicians the ability to treat vertebral compression fractures with precise control of radiopaque bone cement. "In addition to allowing for extended working time Concert Spine VR Bone Cement provides the consistency of a smooth, silky paste, deliverable through a 15 gauge cannula, from initial dispensing to depletion," states Roy Bogert, ABS Vice President of R&D. "Unlike other bone cements altered from orthopaedic indications, Concert Spine VR Bone Cement was specifically developed to address the concerns and requirements pertaining to the minimally invasive treatment of vertebral compression fractures. The design and future modifications of the Plexis device provide a delivery means that is minimally invasive while maintaining polymers or other materials in controlled suspension for precise qualitative and quantitative placement."

Finally, ABS received ISO 13485:2003 Certification for medical device design and manufacturing. "The achievement of ISO certification designates a corporate commitment to quality in the design and manufacture of medical devices that involves all levels of an organization," states Forrest Rudnick, ABS Vice President Quality Assurance. "This certification demonstrates the on-going commitment at ABS to providing the highest quality products and services to our clients.

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