MOUNT PLEASANT, S.C., May 10 /PRNewswire-FirstCall/ -- Maxxon, Inc. (OTC Pink Sheets: MXON) ("Maxxon"), a growing medical products designer, manufacturer, and distributor concentrating on innovative Safety-engineered medical devices (SEMDs) that will have a price advantage over many competitors in the SEMDs arena, announces that Globe Med Tech has been working on a user/lab study to determine the optimum retraction activation force for its Maxxon 3 cc Vacuum Operated Retractable Safety Syringe ("ReVac") plunger. The purpose of this study, conducted by joint venture partner Globe Med Tech, is to simulate the actual clinical testing required by FDA and to ensure the activation force is comfortable for various healthcare professionals, including nurses, paramedics, emergency medical technicians, etc.
"Because of the added complexity and costs associated with clinical testing, it is important to optimize the design and manufacturing process before beginning the true clinical testing. Other than human testing, we have developed a tooling fixture to test the activation force of our syringe samples. Over the past few months, most critical modifications of the components and molds have been completed to adjust the activation force of the plunger. We believe it is better done now to avoid any future possible corrections, even if it has resulted in postponing the 5000 pieces sample timeframe. We want to ensure that our ReVac safety syringe design is based on a solid foundation of engineering that meets FDA regulatory compliance and our end user's expectations," stated Andy Hu, CTO of Maxxon.
"After final adjustment is approved, we will start manufacturing 5,000 samples for FDA performance testing and also for customers' evaluation," stated Ron Wheet, President and CEO of Maxxon.
About Maxxon
Maxxon operates in the Safety-engineered medical devices (SEMDs) arena. Its products include the ReVac Safety Syringe, Auto Retractable Safety Scalpel with Permanent Lock and the Auto Retractable Safety IV Catheter. The world market for SEMDs was projected to exceed $1.6 billion last year and is forecast to maintain, near term, a 20% annual growth rate. In the U.S., the safety needles and syringes market is expected to generate approximately $693 million in revenues in 2006, representing 66% of the total needles and syringes market a compound annual growth rate of 21.7%. The Theta Report estimated the number of needles and syringes sold in the U.S. and international market, combined, should exceed 20 billion units in 2006.
The company feels that it will be able to market itself as a growing SEMDs designer, manufacturer and distributor that creates innovative SEMDs, which it believes will have a price advantage over its competitors. Currently, Johnson & Johnson, Becton Dickinson and Kendall Healthcare, a Tyco International Company, are among the market leaders, but a quick product demonstration on our website will show that Maxxon is a strong alternative. Maxxon is prepared to distribute the product directly, or would consider a strategic alliance with a major distributor, upon US FDA 510K Application acceptance.
The Needlestick Safety and Prevention Act became law on November 6, 2000, Public Law 106-430. To meet the requirements of this act, OSHA revised the Bloodborne Pathogen Standard 1910.1030 effective April 18, 2001. The revised Standard requires that Employers use effective engineering controls, including safer medical devices in order to reduce the risk of injury from needlesticks and other sharp medical instruments.
OSHA estimates that 8 million workers in the health care industry and related occupations are at risk of occupational exposure to bloodborne pathogens, including HIV, Hepatitis (Carried by at least 4 million Americans) and others. In fact, a typical needle can harbor more than 20 diseases. According to the American Hospital Association, one case of serious infection by bloodborne pathogens can soon add up to $1 million or more in expenditures for testing follow-up, lost time, and disability payments.
Maxxon's 3cc safety syringe is designed as a single-handed, vacuum- operated safety syringe that retracts the used needle into the syringe after use.
For more information on Maxxon, please go to http://www.maxxoninc.com/ .
About Globe Medical Tech
Globe Medical Tech, Inc. is a high-tech medical safety and drug delivery products developer and manufacturer based in Houston, Texas, with a clean-room manufacturing presence in China. Globe has marketed its products in the U.S. and around the world, providing the medical industry with innovative low-cost, high-quality medical products. Globe's team has accumulated valuable integration experience for medical devices, while establishing itself as a cost effective operator in the medical device industry. Whether under the company's brand name, or under a private label, Globe has a history of effectively integrating patent development, research, and engineering design capabilities.
For more information on Globe, please go to http://www.globemedtech.com/ .
This press release contains some forward-looking statements. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this document should be evaluated together with the many uncertainties that affect our business. Those uncertainties are discussed in Maxxon's SEC filings.
Maxxon, Inc.
Brian Heckathorne
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