Paradigm Medical Receives Canadian Regulatory Approval for Its P60 Ultrasound BioMicroscope.SALT LAKE CITY -- Paradigm Medical Industries, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). : PMED PMED Primary and Mass Education Division .OB/PMEDW.OB) today disclosed it has received a Canadian Device License for its new-generation P60 Ultrasound BioMicroscope (UBM UBM United Business Media Plc (London) UBM Under-Bump Metallization UBM UniCredit Banca Mobiliare S.p.A. (Italy) UBM United Bikers of Maine UBM Unbalanced Magnetron UBM Ultimate Building Machine ). "The approval will allow the Company to begin selling the P60 in Canada immediately," said Paradigm Medical's President and Chief Executive Officer, Raymond P.L. Cannefax. During the last ten months, Paradigm Medical has received regulatory approval for use of the P60 UBM in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. and in Western European countries and some parts of the Pacific Rim Pacific Rim, term used to describe the nations bordering the Pacific Ocean and the island countries situated in it. In the post–World War II era, the Pacific Rim has become an increasingly important and interconnected economic region. . "Approval from Canada's Health Canada, Therapeutic Products Directorate Therapeutic Products Directorate (TPD) is a Canadian federal authority that regulates pharmaceutical drugs and medical devices for human use, a role performed by the Food and Drug Administration in the United States. is equivalent to our receiving U.S. Food and Drug Administration approval and the European CE Mark for the P60," Mr. Cannefax noted. The P60 UBM is a fourth-generation device that is a sophisticated microprocessor-based, multi-frequency Ultrasound BioMicroscope that allows practitioners to acquire and view high-resolution images of the anterior segment of the eye. High-resolution images are also obtained of the iris, the lens and other surrounding structures, retina, and vitreous body vitreous body n. A transparent jellylike substance enclosing the vitreous humor and filling the interior of the eyeball behind the lens. Also called hyaloid body, vitreum. . The P60 is used for imaging of vital structures of the eye, primarily the front half of the eye. Imaging of the anterior chamber angle is one of the principal areas studied in the detection and management of glaucoma glaucoma (glôkō`mə), ocular disorder characterized by pressure within the eyeball caused by an excessive amount of aqueous humor (the fluid substance filling the eyeball). pathologies and related surgical filtering. Glaucoma is the leading cause of blindness, affects one out of every five people over age 50. Some 75% of glaucoma goes undiagnosed because of the lack of sophisticated equipment. The UBM line is Paradigm Medical's largest generator of revenues, accounting for more than 25% of sales, and providing high gross margins. "Our marketing strategy is to aggressively enter the international marketplace for the P60, providing this new technology to the current users of our earlier-approved versions, in addition to new eye-care specialists. We believe demand will be significant for the P60 and have adequate finished product inventory to meet the immediate market need," Mr. Cannefax said. "We will also continue to market our other UBM devices--the P40 and P45--in regions where P60 has not yet received regulatory approval." Paradigm Medical Industries, Inc., currently develops, manufactures and markets high-tech, proprietary diagnostic equipment and consumable products for the medical industry. The Company's corporate officers are located at 2355 South 1070 West, Salt Lake City, Utah For ships of the United States Navy of the same name, see . Salt Lake City is the capital and the most populous city of the U.S. state of Utah. The name of the city is often shortened to Salt Lake, or its initials, S.L.C. 84119. Call (801) 977-8970 or visit us at www.paradigm-medical.com. This press release contains statements that, if not verifiable historic fact, may be viewed as forward-looking statements that could predict future events or outcomes with respect to Paradigm and its business. The predictions embodied in these statements will involve risk and uncertainties and, accordingly, actual results may differ significantly from the results discussed or implied in such forward-looking statements. |
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