Healthcare Industry News: intended use
News Release - January 22, 2007
Generic Medical Devices Receives 510(k) Clearance for the GMD Universal Circumcision ClampDevice Marks First 510(k) Clearance for a Significantly Equivalent Surgical Product to be Marketed at Generic Price
GIG HARBOR, Wash.--(HSMN NewsFeed)--Generic Medical Devices, Inc.(TM) (GMD(TM)), the first company to design, develop, manufacture and supply quality surgical products marketed at generic prices, today announced that the U.S. Food and Drug Administration (FDA) has cleared the GMD Universal Circumcision Clamp for market. This marks the company's first 510(k) clearance by the FDA for a medical device that will be sold as a generic alternative to existing, standard-of-care surgical products. GMD will now deliver the benefits of branded devices at costs that help reduce strains on the healthcare system.
"Generic Medical Devices commends the FDA for their continued dedication to ensuring patient safety," said Richard Kuntz, president and CEO of Generic Medical Devices. "The FDA's review and clearance of the GMD Universal Circumcision Clamp is evidence that generic devices are as safe and effective as the original, brand name products. As a company, we are now able to go to market with widely-used and clinically-proven alternatives to high-priced medical products at costs that are attractive to healthcare organizations and third-party payors alike. The Circumcision Clamp is the first of what we hope will be many generic medical devices brought to market over the next few months."
The GMD Circumcision Clamp is a Class II medical device intended for use in circumcision procedures generally performed on newborns and less frequently on older males. Clearance of the GMD Universal Circumcision Clamp is based on the device being substantially equivalent -- having the same or equivalent materials, design specifications, technological characteristics, operation, intended use and performance -- to pre-amendment devices and a product currently on the market. Additionally, because this type of technology and procedure have a long history of efficacy and clinical use, no additional clinical research was required to establish equivalence.
"This 510(k) clearance demonstrates GMD's commitment to meeting the FDA's requirements for high-quality surgical medical devices as we begin to introduce our products under the FDA's heightened oversight," added Dr. William Duffell, Jr. Ph.D., chief regulatory officer at Generic Medical Devices. "We look forward to continuing to work with the FDA to introduce new, generic medical devices that meet the highest standards for patient safety and efficacy."
"In addition to opening the door for GMD to market low-cost generic devices for healthcare organizations in the United States, clearance also gives us the chance to begin exploring opportunities with organizations in Third World nations where there is an immediate need for proven and affordable devices that could help stem infection rates for such diseases as HIV," continued Kuntz. "The potential humanitarian benefits could be enormous and far reaching."
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.(TM) 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(TM) 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. For more information, please visit www.genericmedicaldevices.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: Generic Medical Devices Inc.
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