SINGAPORE, March 19 Novus Scientific Pte. Ltd today announced the presentation of initial results of the First-in-Man study for TIGR(TM) Matrix Surgical Mesh. The study results were presented today at the American Hernia Society Meeting in Orlando, Florida by Dr. Fernando Ruiz-Jasbon, Consultant Surgeon at Kungsbacka Hospital / Gothenburg University, Sweden.
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In the study, 40 patients with primary inguinal hernias were enrolled and TIGR(TM) Matrix was implanted for hernia repair. Clinical outcome is being assessed at 0.5, 1, 3, 6 and 12 months. In preliminary follow-up, there have been no serious adverse events and the mean pain score assessed when coughing fell from 17.4 prior to surgery to 0.3 at 6 months (on a scale of 0-100).
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"Handling this product during the procedure is no different to a standard mesh. However, I envision that the long-term resorbable characteristics of the product will be a successful new concept for treating hernia patients," said Dr. Ruiz-Jasbon. "These patients will continue to be followed long-term as part of the Swedish National Hernia Registry. This will allow us to assess the long-term safety of TIGR(TM) Matrix and also see if there is a difference in long-term complications compared with the standard implantation of permanent foreign materials."
Thomas Engstrom, CEO & President of Novus Scientific, stated, "We are extremely satisfied with the positive reaction of surgeons to this study using TIGR(TM) Matrix. The level of interest shown during the Orlando meeting has further reinforced our belief that a long-term resorbable mesh is the future of soft tissue repair. Based on the responses of the surgeons and the positive data from this study, we are currently planning further studies."
"To date, all my patients in the study have followed a normal post-operative course," said Dr. Jonny Norrby, Consultant Surgeon at Kungsbacka Hospital / Gothenburg University, Sweden, who enrolled the majority of patients in the study. "The concept of a resorbable mesh is very attractive in the eyes of the patients, something that has been reflected during patient recruitment."
About TIGR(TM) Matrix Surgical Mesh
TIGR(TM) Matrix Surgical Mesh is the world's first long-term resorbable, synthetic matrix. It is knitted from two different resorbable fibers that degrade at different rates following implantation. This unique patented dual-fiber design provides an initial high strength / high stability configuration, with gradually increasing compliance over time as the product is resorbed. TIGR(TM) Matrix Surgical Mesh is 100% synthetic and macroporous. On January 25(th), 2010, the US Food and Drug Administration (FDA) cleared the 510(k) for TIGR(TM) Matrix Surgical Mesh, for use in reinforcement of soft tissues where weakness exists.
About Novus Scientific
Novus Scientific (www.novusscientific.com) is an innovator in the development and commercialization of resorbable synthetic medical devices. Global Headquarters is in Singapore, with United States Headquarters in Boston. European Headquarters and the core R&D function are in Uppsala, Sweden.
TIGR(TM) is a trademark of Novus Scientific Pte. Ltd
CONTACT: James Archetto, +1-781-577-2599, [email protected], or Ben Craven, +46-730-345522, [email protected], both of Novus Scientific. Web site: http://www.novusscientific.com/
SOURCE Novus Scientific Pte. Ltd
