HTEC news:
Press Release Source: Hydron Technologies, Inc.
Hydron's MicrO2(TM) Officially Designated a Device
Tuesday October 26, 1:47 pm ET
POMPANO BEACH, FL--(MARKET WIRE)--Oct 26, 2004 -- Hydron Technologies, Inc. (OTC BB:HTEC.OB - News) announced today that the Food and Drug Administration, ("FDA") has completed its review of the Request for Designation, ("RFD"), for Hydron's MicrO2 Oxygenation Apparatus.
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The Office of Combination Products has concluded that the MicrO2 Oxygenation Apparatus is a device that will be reviewed and regulated by the Center for Devices and Radiological Health under the medical device provisions of the Federal Food, Drug, and Cosmetic Act.
Hydron's MicrO2 Oxygenation Apparatus is a device intended to produce oxygenated water infused with microbubbles to use in topical oxygen therapy. The device would be used at the patient bedside or doctors' office to enhance wound healing. Further, the device is intended for adjunctive therapy (rather than sole treatment) for wounds such as skin ulcerations due to diabetes, venous stumps, post surgical infections and gangrenous lesions, decubitus ulcers, infected amputation stumps, skin grafts, burns, and frostbite.
Terrence S. McGrath, Chief Operating Officer, stated, "This is a very positive step for Hydron and we look forward to a meeting with the FDA to establish a clear path for approval of our oxygenation technology as a medical device."
Hydron Technologies, Inc. conducts research and development of products and medical applications associated with its proprietary tissue oxygenation technology. The Company also markets skin care products through Hydron's direct-to-consumer catalog and the Internet at www.hydron.com. Catalogs are available by calling 1-800-4-HYDRON (1-800-449-3766).
Certain statements contained in this release that are not statements of historical facts are "forward-looking statements" within the meaning of the Private Securities litigation Reform Act of 1995. The words -- "believe," "expect," "anticipate," "intend," "will," and similar expressions are examples of words that identify forward-looking statements. Forward-looking statements include without limitation, statements regarding our future financial position, timing of future orders, business strategy and expected cost savings. These forward-looking statements are based on our current beliefs, as well assumptions we have made based upon information currently available to us. We do not assume, and expressly disclaim any obligation to update these forward-looking statements. For additional information regarding the risks associated with the Company's business, refer to Hydron Technologies, Inc. reports filed with the SEC.
Contact:
Contact:
Terrence S. McGrath
Phone: 954-861-6416
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Source: Hydron Technologies, Inc.
