MedicalCV Signs Agreement with Premier for Omnicarbon Heart Valve.Business Editors/Health/Medical Writers MINNEAPOLIS--(BUSINESS WIRE)--June 9, 2003 MedicalCV, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :MDCVU), a Minnesota-based heart valve manufacturer, today announced that it signed a three-year agreement with Premier Purchasing Partners, LP, the group purchasing division of Premier, Inc., for MedicalCV's Omnicarbon(R) mechanical heart valves Heart valves Valves that regulate blood flow into and out of the heart chambers. Mentioned in: Heart Failure , effective immediately. The Omnicarbon valve will be available to Premier's nearly 1,500 member and affiliated hospitals at competitive terms and conditions. "Our agreement with Premier, the nation's leading medical purchasing group, illustrates that our Omnicarbon valve is gaining acceptance in the U.S. market," said Blair Mowery, president and chief executive officer of MedicalCV, Inc. "We believe that the Omnicarbon valve's low complication rate will provide additional economic benefits to Premier member hospitals, as well as superior outcomes for patients. We are very pleased that the Omnicarbon valve is now available to Premier member hospitals at an affordable cost." The Omnicarbon mechanical heart valve is manufactured, marketed and sold by MedicalCV. Mowery noted that the results from at least 10 clinical studies, including over 10,000 patient years of use, have consistently demonstrated one-third to one-half fewer complications with the Omnicarbon valve, such as blood clots Blood Clots Definition A blood clot is a thickened mass in the blood formed by tiny substances called platelets. Clots form to stop bleeding, such as at the site of cut. and stroke, compared to other mechanical heart valves. The Omnicarbon heart valve is unique in that it is the only monoleaflet valve-- a valve with a single hingeless pivoting pivoting said of the exercise demanded of a horse when testing a limb for weakness or lameness; the horse is forced to turn very tightly so that it actually pivots on the limb being examined. disc--to employ pyrolytic carbon Pyrolytic carbon is a material similar to graphite, but with some covalent bonding between its graphene sheets. Generally it is produced by heating a hydrocarbon nearly to its decomposition temperature, and permitting the graphite to crystallise (pyrolysis). in both its housing and disc for improved blood compatibility. Another advantage of the Omnicarbon valve's design is that it does not have the problematic fixed pivot (Mil.) the fixed point about which any line of troops wheels. See also: Fixed recesses that are characteristic of bileaflet designs and which are demonstrated to be the primary location for blood clot blood clot n. A semisolid, gelatinous mass of coagulated blood that consists of red blood cells, white blood cells, and platelets in a fibrin network. formation. About Premier Premier, Inc., is a strategic alliance in U.S. healthcare U.S. Healthcare is a now-defunct healthcare company. The logo had an apple. The merger with Aetna In 1996, the company merged with Aetna, calling it Aetna U.S. Healthcare. The U.S. Healthcare apple logo was next to the Aetna name, and U.S. Healthcare under it. U.S. , entirely owned by more than 200 of the nation's leading hospital and healthcare systems. These systems operate or are affiliated with nearly 1,500 hospital facilities and hundreds of other healthcare sites. Premier provides an array of resources supporting health services health services Managed care The benefits covered under a health contract delivery including group purchasing for more than $17 billion annually in supplies and equipment. Other resources offered by Premier are supply chain and clinical performance improvement services and insurance programs. Headquartered in San Diego San Diego (săn dēā`gō), city (1990 pop. 1,110,549), seat of San Diego co., S Calif., on San Diego Bay; inc. 1850. San Diego includes the unincorporated communities of La Jolla and Spring Valley. Coronado is across the bay. , Calif., Premier has other major facilities in Chicago, Ill.; Charlotte, N.C.; and Washington, D.C. For more information, visit www.premierinc.com. About MedicalCV MedicalCV, Inc. is a Minnesota-based heart valve manufacturer with a fully integrated manufacturing facility, where it designs, tests and manufactures all of its products. In July 2001, the U.S. Food and Drug Administration gave premarket approval premarket approval Medical devices A scientific and regulatory review by the FDA to ensure the safety and effectiveness of a Class III device, before its approval for marketing. See Advisory panel, Medical device. for the Omnicarbon valve, based on 18 years of excellent clinical results in Europe, Japan and Canada, without requiring additional U.S. clinical trials. To date, more than 35,000 Omnicarbon valves have been implanted in patients in more than 30 countries. For more information on the company, visit its Web site at www.medcvinc.com or call (651) 452-3000. This release contains certain forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. of expected future developments, as defined in the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. The forward-looking statements in this release refer to the expectations regarding the clinical performance of Omnicarbon heart valves and other matters. These forward-looking statements reflect management's expectations and are based on currently available data; however, actual results are subject to future risks and uncertainties, which could materially affect actual performance. Risks and uncertainties that could affect such performance include, but are not limited to, the following: our ability to fund our significant capital needs; market acceptance in the U.S. of our Omnicarbon 3000 heart valve; potential reductions in heart valve pricing by our competitors; the costs of licensing and acquiring new products and technologies; the time and costs involved in obtaining regulatory clearance for our Omnicarbon 4000 heart valve; competing technological and market developments; physician acceptance of our heart valves; dependence upon governmental reimbursements and third party suppliers; and the strength of the mechanical heart valve market. For more detailed information about these risks and uncertainties, please review our Annual Report on Form 10-KSB for the fiscal year ended April 30, 2002, and Form 10-QSB for the quarter ended January 31, 2003. These events and uncertainties are difficult or impossible to predict accurately and many are beyond our control. We assume no obligation to publicly release the results of any revisions that may be made to any forward-looking statements to reflect events or uncertainties after the date of such statements or to reflect the occurrence of anticipated or unanticipated events. |
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