O’FALLON, Mo., Oct. 12 /PRNewswire-FirstCall/ -- Synergetics USA, Inc. announced today that it has begun to ship Malis(R) Advantage(TM) units. The Malis(R) Advantage(TM) is the successor to one of the most successful neurosurgical electrosurgical cutting and coagulation devices in the marketplace... the Codman CMC-III. The CMC-III continues to be manufactured by Synergetics and sold through Codman worldwide.
“The Advantage(TM) units have been in regulatory approvals for some time. We have successfully completed electromagnetic compatibility and safety testing required to sell the Malis(R) Advantage(TM) in the United States and the European Union,” said Gregg D. Scheller, President and Chief Executive Officer of Synergetics USA, Inc. “We await formal paperwork from our safety testing agency, but the testing has been successfully completed. Upon receipt of the paperwork, we will begin to ship the first Advantage(TM) units to both domestic and international customers against existing backorders.”
“Our entire electrosurgical product launch has been awaiting this moment. I am excited to finally have this process completed. I know that our domestic and international sales networks are too. We can now begin in earnest to sell an equipment line that includes two generators, an irrigation module and a growing line of accessories and instruments.”
Although the United States and European Union requirements have been successfully achieved, the registration process continues in other countries, including a significant one in Japan. The Company remains confident these processes will be completed in a timely manner.
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. Because such forward-looking statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. For example, uncertainty exists with respect to the following risks: 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; a significant part of our sales of neurosurgical products comes from a single customer; if any of our single source suppliers were to cease providing components, we may be unable to produce our products; the medical device industry is highly competitive, and we may be unable to compete effectively with other companies; our products may not be accepted in the market; if we do introduce new, commercially successful products in a timely manner, our products may become obsolete over time, thereby decreasing our revenue and profitability; our operating results may fluctuate; changes in the health care industry may require us to decrease the selling price of our products or could result in a reduction in the size of the market for our products, each of which could have a negative impact on our financial performance; we may be unable to obtain regulatory approval to market our products under development; we may be unable to obtain electrical safety approval to market our applicable products under development; our intellectual property rights may not provide sufficient commercial protection for our products; we may have product liability claims, and our insurance may not cover all claims; the loss of key personnel could harm our business; if we are unable to hire, train and retain additional sales, marketing, operations, engineering and finance personnel, our growth could be impaired; we plan to expand our international sales and distribution operations and the success of our international expansion is subject to significant uncertainties; we have anti-takeover defenses that could delay or prevent an acquisition and could adversely affect the price of our common stock; and acts of war and terrorism incidents and the effects of operating and market competition.
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 of Synergetics USA, Inc., Chief FinancialOfficer, +1-636-939-5100
Web site: http://www.synergeticsusa.com/
