Synergetics Receives CE Mark Approval on Malis® Line of Products
O'FALLON, Mo., May 16 // -- Synergetics USA, Inc. (NASDAQ:SURG) received notice from its notified body that its electronics manufacturing plant near Philadelphia successfully completed an audit to ISO standard 13485-2003. Products manufactured in the Pennsylvania facility now qualify for the CE Mark. Synergetics can directly distribute its Malis® branded products into the European Union countries and other countries that require the CE Mark registration.
"We are very pleased to be able to sell some of our most important products internationally," said Gregg D. Scheller, President and Chief Executive Officer of Synergetics. "This, combined with the Omni(TM), makes us a very attractive strategic partner for many international neurosurgical distributors. I am pleased with our progress in establishing an international dealer network. Within seven months, our international sales team has managed to attract some of the best international dealers for neurosurgery. We have done this on the strength of the Malis® and Omni(TM) brands."
Following the September 2005 merger of Synergetics with Valley Forge Scientific Corp., Synergetics has pursued direct distribution of its products worldwide. In April of 2006, the Company announced that it had successfully completed all product labeling and regulatory requirements necessary to ship its Omni(TM) into most international markets.
To date, the Company has secured distribution partners in 41 countries, including most major international markets. With this CE Mark approval, Synergetics' full line of electrosurgical generators (other than its CMC-III generator which is manufactured exclusively for Codman and Shurtleff, Inc.), an accompanying irrigation module, associated disposables and instruments are available to be marketed internationally.
The Company believes that the international markets for these products exceed $150 million annually in neurosurgery. Synergetics previously has not participated directly in this market.
About Synergetics USA, Inc.
Synergetics USA, Inc. resulted from the September 2005 combination of Valley Forge Scientific Corp. and Synergetics, Inc., bringing together their respective unique capabilities in bipolar electrosurgical generators and design, and manufacture of microsurgical hand instruments. Synergetics USA, Inc. designs, manufactures and markets medical devices for use primarily in ophthalmic surgery and neurosurgery and for other healthcare applications. Its products are designed and manufactured to support micro or minimally invasive surgical procedures. In addition to its surgical devices and equipment, it designs and manufactures disposable and non-disposable supplies and accessories for use with such devices and equipment. It also manufactures and sells bipolar electrosurgical generators and other generators, based on its DualWave(TM) technology, and complementary instrumentation and disposable products for use in neurosurgery, spine surgery, pain control and in dental applications. Synergetics sells its products primarily to hospitals, clinics and surgeons in approximately 70 countries.
SYNERGETICS USA, INC.
3845 Corporate Centre Drive
O'Fallon, Missouri 63368
(636) 939-5100
http://www.synergeticsusa.com/
Attn: Pamela G. Boone, Chief Financial Officer
Source: Synergetics USA, Inc.
CONTACT: Pamela G. Boone, Chief Financial Officer of Synergetics USA, Inc., +1-636-939-5100
Web site: http://www.synergeticsusa.com/
