O’FALLON, Mo., May 16 /PRNewswire-FirstCall/ -- Synergetics USA, Inc. 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(R) 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(R) 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.
Forward-Looking Statements
Some statements in this release may be “forward-looking statements” for the purposes of the Private Securities Litigation Reform Act of 1995. In some cases, forward-looking statements can be identified by words such as “believe,” “expect,” “anticipate,” “plan,” “potential,” “continue” or similar expressions. Such forward-looking statements are based upon current expectations and beliefs and are subject to a number of factors. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements, including but not limited to: the effects of local and national economic, credit and capital market conditions on the economy in general, and on the medical device industry in particular, and the effects of foreign exchange rates and interest rates; the ability to timely and cost-effectively integrate the operations and management of Valley Forge and Synergetics following their merger transaction; the ability to realize the synergies and other perceived advantages resulting from the merger; the ability to retain and attract key personnel; the ability of Synergetics to successfully execute its business strategy; the extent and timing of market acceptance of new products or product indications; the ability of Synergetics to procure, maintain, enforce and defend its patents and proprietary know how; changes in laws, including increased tax rates, regulations or accounting standards, third-party relations and approvals, and decisions of courts, regulators and governmental bodies; the ability of Synergetics to continue to increase customer loyalty; the ability to recoup costs of capital investments through higher revenues; environmental restrictions, soil and water conditions, weather and other hazards, site access matters and building permit issues; the effects of environmental and structural building conditions relating to Synergetics’ properties; acts of war or terrorism incidents; the effects of operating and market competition; and other important factors disclosed previously and from time to time in Synergetics’ filings with the SEC. Synergetics undertakes no obligation to update these forward-looking statements.
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
Synergetics USA, Inc.
CONTACT: Pamela G. Boone, Chief Financial Officer of Synergetics USA,Inc., +1-636-939-5100
Web site: http://www.synergeticsusa.com/
