LAKE OSWEGO, Ore., July 9 /PRNewswire-FirstCall/ -- Calypte Biomedical Corporation , medical diagnostic tests manufacturer for the rapid detection of antibodies to the human immunodeficiency virus (HIV) announced today that it has leased an 11,000+ square foot site located in Portland, Oregon. The site permits the consolidation of its research laboratory and administrative functions under one roof and will become the Company's new headquarters location. The site also provides manufacturing space which the Company plans to utilize to build pilot lots for clinical trials in the U.S. The Company expects these studies to be a prelude for submitting a formal application for approval with the U.S. Food and Drug Administration ("FDA").
"This facility is our first step in reestablishing our presence in the U.S. diagnostic test market and moving toward approval of our Aware(TM) HIV- 1/2 oral test in the U.S. We plan to start by commencing the process of filing for FDA approval of an oral fluid test for professional use," stated Roger Gale, Calypte's Chairman and Chief Executive Officer. "One of the uses of funds from the recently-completed PIPE is to advance our efforts to market our oral fluid tests in the U.S. market. Calypte has invested over $3 million to acquire technology and equipment to take advantage of this opportunity."
"While multiple outcomes are possible, our objective for beginning the FDA regulatory process is to ultimately receive approval for manufacturing and distribution of an over-the-counter ("OTC") oral fluid HIV diagnostic test in the U.S.", Mr. Gale concluded.
Calypte plans to occupy its new facility in September 2007.
About U.S. HIV/Aids:
The U.S. is the largest market for HIV diagnostic tests in the world, with 2005 revenues for screening tests estimated at $165 million. An FDA advisory panel has recently announced its support for having an OTC test available in the U.S. In September 2006, the CDC updated its HIV testing guidelines, specifically recognizing the benefits of rapid tests in timely communicating HIV status to patients. The CDC's revised recommendations include routine HIV testing for patients in all health-care settings after the patient is notified that testing will be performed unless the patient declines (opt-out screening); at least annual testing for persons at high risk for HIV infections; and routine opt-out screening for all pregnant women.
About Calypte Biomedical:
Calypte Biomedical Corporation (www.calypte.com) is a U.S.-based healthcare company focused on the development and commercialization of rapid testing products for sexually transmitted diseases such as the Aware(TM) HIV-1/2 OMT test that are suitable for use at the point of care and at home. Calypte believes there is a significant need for rapid detection of such diseases globally to control their proliferation, particularly in developing countries, which lack the medical infrastructure to support laboratory-based testing. Calypte believes that testing for HIV and other sexually transmitted infectious diseases may make important contributions to public health, and could increase the likelihood of treating those with undetected HIV and other sexually transmitted diseases.
Statements in this press release that are not historical facts are forward-looking statements within the meaning of the Securities Act of 1933, as amended. Those statements include statements regarding the intent, belief or current expectations of the Company and its management. Such statements reflect management's current views, are based on certain assumptions and involve risks and uncertainties. Actual results, events, or performance may differ materially from the above forward-looking statements due to a number of important factors, and will be dependent upon a variety of factors, including, but not limited to, the Company's ability to obtain additional financing, if and as needed, and access funds from its existing financing arrangements that will allow it to continue its current and future operations and whether demand for its test products in domestic and international markets will generate sufficient revenues to achieve positive cash flow and profitability. The Company undertakes no obligation to publicly update these forward-looking statements to reflect events or circumstances that occur after the date hereof or to reflect any change in the Company's expectations with regard to these forward-looking statements or the occurrence of unanticipated events. Factors that may impact the Company's success are more fully disclosed in the Company's most recent public filings with the U.S. Securities and Exchange Commission ("SEC"), including its annual report on Form 10-KSB for the year ended December 31, 2006 and its subsequent filings with the SEC.
Company Contact: Investor Relations Contact: Richard Brounstein, Tim Clemensen, Executive Vice President Rubenstein Investor Relations (971) 204-0282 Phone: (212) 843-9337 email: rbrounstein@calypte.com email: tclemensen@rubensteinir.com
Calypte Biomedical CorporationCONTACT: Richard Brounstein, Executive Vice President of CalypteBiomedical Corporation, +1-971-204-0282, rbrounstein@calypte.com; orInvestor Relations, Tim Clemensen of Rubenstein Investor Relations,+1-212-843-9337, tclemensen@rubensteinir.com, for Calypte BiomedicalCorporation
Web site: http://www.calypte.com//
