Novus Scientific Presents Initial Results of the First-in-Man Study for
TIGR(TM) Matrix Surgical Mesh - The World's 1st Long-Term Resorbable
Synthetic Mesh
</pre> <p><span class="xn-location">SINGAPORE</span>, <span class="xn-chron">March 19</span> /CNW/ -- 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 <span class="xn-location">Orlando</span>, Florida by Dr. Fernando Ruiz-Jasbon, Consultant Surgeon at Kungsbacka Hospital / <span class="xn-location">Gothenburg</span> University, <span class="xn-location">Sweden</span>.</p> <p/> <p>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).</p> <p/> <p>"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."</p> <p/> <p><span class="xn-person">Thomas Engstrom</span>, 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 <span class="xn-location">Orlando</span> 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."</p> <p/> <p>"To date, all my patients in the study have followed a normal post-operative course," said <span class="xn-person">Dr. Jonny Norrby</span>, Consultant Surgeon at Kungsbacka Hospital / <span class="xn-location">Gothenburg</span> University, <span class="xn-location">Sweden</span>, 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."</p> <pre> About TIGR(TM) Matrix Surgical Mesh </pre> <p>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 <span class="xn-chron">January 25th, 2010</span>, 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.</p> <pre> About Novus Scientific </pre> <p>Novus Scientific (<a href="http://www.novusscientific.com">www.novusscientific.com</a>) is an innovator in the development and commercialization of resorbable synthetic medical devices. Global Headquarters is in <span class="xn-location">Singapore</span>, with <span class="xn-location">United States</span> Headquarters in <span class="xn-location">Boston</span>. European Headquarters and the core R&D function are in Uppsala, <span class="xn-location">Sweden</span>.</p> <pre> TIGR(TM) is a trademark of Novus Scientific Pte. Ltd </pre> <p>CONTACT: James Archetto, +1-781-577-2599, <a href="mailto:[email protected]">[email protected]</a>, or <span class="xn-person">Ben Craven</span>, +46-730-345522, <a href="mailto:[email protected]">[email protected]</a>, both of Novus Scientific. Web site: <a href="http://www.novusscientific.com/">http://www.novusscientific.com/</a></p> <pre>
For further information: 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
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