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National University Hospital Singapore Receives DSRB Approval to Use TIGR® Matrix Surgical Mesh in a New Randomized Controlled TRAM Flap Study
Date:9/13/2010

SINGAPORE, Sept. 13 /PRNewswire/ -- Novus Scientific Pte. Ltd today announced that the National University Hospital (NUH), Singapore has received Domain Specific Review Board (DSRB i.e. IRB equivalent) provisional approval for a new study: Abdominal Wall Closure After Lipectomy, TRAM/DIEP Flap - Comparison of TIGR (100% Resorbable) vs Polypropylene (Permanent) Mesh.

This is a randomized study, involving 86 patients. There are plans to expand this to a multi-site and possibly multi-centre study involving other hospitals in Singapore and in the U.S. TIGR® Matrix is the World's 1st Long-Term Resorbable Synthetic Mesh, which was launched for sale in the U.S. in June 2010. In February 2010, the US Food and Drug Administration (FDA) cleared, TIGR® Matrix Surgical Mesh for use in reinforcement of soft tissues where weakness exists.

"TIGR® Matrix is potentially an ideal prosthesis for patients undergoing breast reconstruction via TRAM Flap, as only a temporary donor site reinforcement is needed. Unlike permanent meshes, TIGR® Matrix is a long-term, synthetic, resorbable product that can be used as prophylaxis against hernia formation, while reducing the potential risk of permanent mesh related complications," said Associate Professor Thiam Chye Lim, Principal Investigator & Head of Division of Plastic, Reconstructive and Aesthetic Surgery, National University Hospital, Singapore.

TIGR® Matrix is knitted from two different resorbable fibers that degrade at different rates following implantation. This unique patented dual-fibre design provides an initial high strength / high stability configuration, with gradually increasing compliance over time as the product is degraded and resorbed. The macroporous structure is designed to permit tissue integration for tissue repair.

"Novus Scientific is very excited to collaborate with such a renowned institution as NUH and especially with an esteemed Principal Investigator like Associate Professor TC Lim and his team. We see TIGR® Matrix filling a gap between permanent synthetic and biological meshes – the best of both worlds. This study will potentially bring significant clinical benefits to patients undergoing breast and other soft-tissue reconstruction," said Thomas Engstrom, CEO & President of Novus Scientific.

Reference Link: This study is listed in ClinicalTrials.gov a service of the U.S. National Institutes of Health under http://clinicaltrials.gov/ct2/show/NCT01136603?term=Tram&rank=2

About Novus Scientific

Novus Scientific (www.novusscientific.com) is an innovator in the development and commercialization of resorbable synthetic medical devices.  Global HQ is in Singapore while European Headquarters and the core R&D function are in Uppsala, Sweden.   The company's roots are Swedish as all the founders of Novus Scientific are previous owners / senior managers / members of the soft tissue-engineering project within Uppsala-based, Radi Medical Systems AB (now owned by St. Jude Medical Inc). The US Division, Novus Scientific, Inc. is headquartered near Boston, one of the world's foremost medical research cities. From this hub, Novus Scientific, Inc. will distribute TIGR® Matrix Surgical Mesh throughout the United States.

TIGR® is a registered trademark of Novus Scientific Pte. Ltd

CONTACT: Tac-Whei Ong, tacwhei.ong@novusscientific.com, 65-68900360


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