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Generic Medical Devices Receives CE Mark for the GMD Universal Circumcision Clamp

Posted on: Tuesday, 6 February 2007, 09:01 CST

Generic Medical Devices, Inc.™ (GMD™), the first company to design, develop, manufacture and supply quality surgical products marketed at generic prices, today announced CE Marking and a EC-Declaration of Conformity (EC-DoC) indicating compliance with essential health and safety requirements set out in applicable European Directives that will allow the company to place the GMD Universal Circumcision Clamp on the market in all European Union countries, as well as other countries that accept this certification. In January, GMD announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the circumcision clamp domestically. Today's announcement opens the door for worldwide sales of the company's first product and the first generic alternatives to standard-of-care surgical implementation devices.

"At GMD, we are pioneering an entirely new marketplace in the medical device industry," said Richard Kuntz, president and CEO of Generic Medical Devices. "Our goal is to make a significant impact on healthcare costs by bringing down the price on standard-of-care devices. The GMD Universal Circumcision Clamp is the first example of our ability to develop a generic version of a widely used and trusted product that meets the strictest regulatory guidelines and then deliver it at about two-thirds the cost of brand name counterparts. Over the coming year, we expect to pursue regulatory clearance in the United States and abroad for several new devices as we develop our portfolio of high quality generic product lines."

The GMD Universal Circumcision Clamp is a medical device intended for use in circumcision procedures generally performed on newborns and less frequently on older males.

GMD is the first company to implement the generic model, made successful by the pharmaceuticals industry, within the medical device market. Leveraging expired patents on standard-of-care surgical devices that have undergone few, if any, changes since first being introduced to the market, GMD is bringing high quality, substantially equivalent alternatives to market at lower prices. Devices chosen by GMD all have existing 510(k) classification, reimbursement by Medicare and third-party payors, established product safety, efficacy and outcomes, and a trained surgeon/physician base.

About Generic Medical Devices

Generic Medical Devices, Inc.™ is the world's first designer, developer, manufacturer and supplier of quality medical products marketed at generic prices that allow healthcare providers to meet the standard of care for patients. Recognizing the need for healthcare reform and the ever-increasing burden that America's aging population is placing on the healthcare system, GMD™ set out to develop lower-priced products with proven outcomes and "better-than" product features. These generic devices, based on products that are becoming a commodity in the marketplace, allow the healthcare system to provide more patients access to innovative and often expensive treatments while helping to stem the tide of rising healthcare costs. The company's quality system has been certified to meet the requirements of ISO 13485:2003, providing a framework for global regulatory compliance of its products. For general information, please visit www.genericmedicaldevices.com. For investor relations, please contact Adam Fountain at Broadmark Capital at (206) 623-1200 or afountain@broadmark.com.

Safe Harbor Statement

The Private Securities Litigation Reform Act of 1995 provides a safe harbor for certain forward-looking statements. This press release contains forward-looking statements, which reflect our views regarding future events and financial performance. These forward-looking statements are subject to certain risks and uncertainties, including those identified below, which could cause actual results to differ materially from historical results or those anticipated. The words aim, believe, expect, anticipate, intend, estimate and other expressions, which indicate future events and trends, identify forward-looking statements. Actual future results and trends may differ materially from historical results or those anticipated depending upon a variety of factors, including, but not limited to: the effect of government regulation, including when and if we receive approval for marketing products in the United States; the impact of international currency fluctuations on our cash flows and operating results; the impact of technological innovation and competition; acceptance of our products by physicians and patients, our historical reliance on a single product for most of our current sales; our ability to commercialize our recently licensed product lines; our intellectual property and the ability to prevent competitors from infringing our rights; the ability to receive third party reimbursement for our products; the results of clinical trials; our continued losses and the possible need to raise additional capital in the future; our ability to manage our international operations; our ability to hire and retain key technical and sales personnel; our dependence on key suppliers; future changes in applicable accounting rules; and volatility in our stock price. We cannot assure that we can continue our business through new and innovative product introductions.

Source: Business Wire

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