This randomized study, involving 86 patients, received DSRB approval on 9th September 2010. There are plans to expand this to a multi-centre study involving other hospitals in Singapore and in the U.S. TIGR® Matrix Surgical Mesh is the World’s 1st Long-Term Resorbable Synthetic Mesh, and it received 510(k) clearance from the US Food and Drug Administration (FDA) in February 2010 for use in reinforcement of soft tissues where weakness exists. TIGR® Matrix Surgical Mesh was launched for sale in the U.S. in June 2010.
“TIGR® Matrix feels soft and conforms well to the surgical site. If the follow up results are good, this will be beneficial to many patients undergoing TRAM Flap procedures, as strong native tissue will replace the mesh over time. This was not possible with permanent synthetic meshes – we will be monitoring the patient closely during follow up” – Dr. Wei Chen Ong (Consultant) & Dr. Jane Lim (Senior Consultant), Division of Plastic, Reconstructive & Aesthetic Surgery, National University Hospital, Singapore / Study Investigators, TIGR® Matrix Clinical Trial. “We’re pleased to get our 1st randomized patient included in this study. If the results are promising, we see a number of other potential applications for TIGR® Matrix besides TRAM Flap donor sites; it will be interesting to explore these areas when our surgeons gain more clinical experience and more study data is accrued”- Associate Professor Thiam Chye Lim, Principal Investigator & Head of Division of Plastic, Reconstructive and Aesthetic Surgery, National University Hospital, Singapore.
TIGR® Matrix Surgical Mesh is knitted from two different synthetic resorbable fibers that degrade at different rates following implantation. It is designed to be mechanically strong and supportive of tissue growth for over 6 months and resorbs completely over time, leaving no foreign material behind.
“When we identified a clinical need for this product, we knew that we had the ability and development background to give birth to a product like no other” said Thomas Engström, CEO & President of Novus Scientific. ” TIGR® Matrix is designed to be strong when you need it and gone when you don’t. It is very satisfying to see the product being adopted so enthusiastically by the surgical community. These are exciting times for Novus Scientific!”
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