Calypte Only Company with Full Menu of Tests.
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Monday May 14, 8:30 am ET
LAKE OSWEGO, Ore., May 14 /PRNewswire-FirstCall/ -- Calypte Biomedical Corporation (OTC Bulletin Board: CBMC - News), medical diagnostic tests manufacturer for the rapid detection of antibodies to the human immunodeficiency virus (HIV), announced that its Board of Directors appointed Mr. Adel Karas as an independent member of the Company's Board of Directors effective May 8, 2007.
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Mr. Karas has over 35 years of experience, primarily on the international front, much of it in the market regions in which Calypte is targeting sales for its Aware(TM) HIV-1/2 Oral Fluid diagnostic tests. Since December 2005 Mr. Karas has worked as the Regional Director (Asia, Africa & Middle East) for the World Agency of Planetary Monitoring & Earthquake Risk Reduction (WAPMERR) based in Dubai, United Arab Emirates (UAE). WAPMERR is involved with disaster management and risk assessments.
Prior to his involvement with WAPMERR, in 2003 Mr. Karas co-founded and served as Managing Director of Strategic Energy Investment Group in Dubai. He started this group following his retirement from Petroleum Geo-Services (PGS) in Houston, Texas where he served as Senior Vice President of Business Development for two years before moving to Dubai where he set up and, for the next eight years, served as President of PGS for the Middle East Region. Mr. Karas served, as well, as the executive vice president for Grant Tensor Geophysical in Houston-Texas and as the president of Tensor Geophysical in Egypt. Mr. Karas attended AinShams University, University of Texas and University of Houston. He holds degrees in Geophysics and Operations Research as well as a Masters Degree in electrical engineering and an MBA.
Roger I. Gale, President and CEO of Calypte stated, "We are pleased to welcome Mr. Karas to our Board and look forward to his knowledge and guidance as we expand, with his help, into regions where our non-invasive HIV/AIDS rapid test is much needed, including the Middle East and Asia. Further, we expect his knowledge of and contacts in Thailand, where we have outsourced manufacturing, and Switzerland, where many key humanitarian agencies are headquartered, will help us facilitate our business opportunities as well. As Calypte focuses on the emerging HIV epidemic countries, I expect that Mr. Karas will play a vital role in Calypte's growth in those areas of the world. We intend to use his strong technical training - he is, quite simply, a quick study - and his many years of varied international experience, including establishing cross border entities and mergers and acquisitions. He has strong relationships with key business and governmental leaders in this area as well."
Mr. Karas commented, "I am honored to be a part of Calypte at this critical juncture - the start of its "journey" to quote management. I expect to be effective in assisting the Company from my own base of operations in Dubai. I consider Calypte a lean, point of care diagnostic testing company, today focused on HIV, but with the capability to do much more. My experience supports the Company's newly articulated strategy - that physical presence is essential; being on the ground regionally to aggressively get close to the customer and understand the uniqueness of the many regions in which Calypte operates."
"I personally took a company that was headquartered in Houston to Dubai, set up a regional center and then used the in-country advantage to capture a 50% market share. I believe Calypte's simple, accurate, non-invasive products will be well received in this part of the world. I have personally accompanied management and visited key business contacts in UAE and have seen for myself the strong interest Calypte's products generate," Mr. Karas continued.
About Calypte Biomedical:
Calypte Biomedical Corporation (http://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
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Source: Calypte Biomedical Corporation
Since December 2005 Mr. Karas has worked as the Regional Director (Asia, Africa & Middle East) for the World Agency of Planetary Monitoring & Earthquake Risk Reduction (WAPMERR) based in Dubai, United Arab Emirates (UAE). WAPMERR is involved with disaster management and risk assessments.
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Calypte Begins U.S. Initiative
Monday July 9, 8:30 am ET
Company Secures Manufacturing/Headquarters Facility in Portland Oregon
LAKE OSWEGO, Ore., July 9 /PRNewswire-FirstCall/ -- Calypte Biomedical Corporation (OTC Bulletin Board: CBMC - News), 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.
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
DCAI Regulatory Approval Received for the Aware(TM) HIV-1/2 Oral Fluid Rapid Test
LAKE OSWEGO, Ore., July 11, 2007 /PRNewswire-FirstCall via COMTEX News Network/ -- Calypte Biomedical Corporation (OTC Bulletin Board: CBMC), medical diagnostic tests manufacturer for the rapid detection of antibodies to the human immunodeficiency virus (HIV) announced today that it has received registration and marketing approval for its Aware(TM) HIV-1/2 OMT (oral fluid) rapid test in India from the Central Drugs Standard Control Organisation, commonly referred to as the Drug Control Authority of India ("DCAI").
Roger Gale, Calypte's Chairman and Chief Executive Officer, stated, "As has been highlighted in recent news reports, India is at the forefront in the fight against HIV/AIDS and we have seen strong interest in our oral fluid tests from both the Government and private sectors. A Calypte team has just returned from India where we have begun putting in place the infrastructure to access and build on this important business opportunity. We expect the market for HIV diagnostic testing in India to grow significantly in the next few years."
Mr. Gale continued, "This DCAI approval is a significant milestone in the advancement of our business; a very exciting time for all of us at the Company. Once our non-invasive HIV diagnostic tests gain market acceptance, we anticipate significant growth in market share of such tests. In addition to creating a distribution network, we expect to establish both research and manufacturing operations in India. While we will initially enter the Indian market with our HIV-1/2 oral fluid rapid test, we are also considering introducing our Aware(TM) HIV-1/2 rapid tests using both blood and urine samples to complement the current oral fluid test. India is also a logical center for development of Calypte's new products."
About India:
India has a population of over 1.1 billion, second only to China. According to recently published 2006 estimates by the National AIDS Control Organization or NACO, supported by both UNAIDS and WHO, India has an estimated 2.5 million HIV infections, ranking third behind South Africa and Nigeria for the highest number of HIV/AIDS infected people. Mr. Naresh Dayal, Secretary Health and Chair of the National AIDS Control Board said, " ... we cannot be complacent. The steady and slow spread of the HIV infection is a worrying factor."
The announcement of these new HIV estimates coincides with the launch of a 5-year, $2.8 billion AIDS campaign by the Government of India to prevent the spread of the virus among the country's large under-25 population. Calypte believes that a simple and cost effective non-invasive rapid test is an ideal solution to safely and quickly identify HIV/AIDS patients for treatment and care in large-scale programs such at this.
About Calypte Biomedical:
Calypte Biomedical Corporation (http://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:
Richard Brounstein, Executive Vice President
(971) 204-0282
email: rbrounstein@calypte.com
Investor Relations Contact:
Tim Clemensen,
Rubenstein Investor Relations
(212) 843-9337
email: tclemensen@rubensteinir.com
SOURCE Calypte Biomedical Corporation
Richard Brounstein, Executive Vice President, of Calypte Biomedical Corporation,
+1-971-204-0282, or rbrounstein@calypte.com; Investor Relations, Tim Clemensen,
+1-212-843-9337, or tclemensen@rubensteinir.com, for Calypte Biomedical Corporation
http://www.calypte.com
