CytoCore Launches Clinical Trials for the e2 Collector.Testing Expected to Confirm Performance of New Cervical Cancer Cervical Cancer Definition Cervical cancer is a disease in which the cells of the cervix become abnormal and start to grow uncontrollably, forming tumors. Collection Device CHICAGO -- CytoCore, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :CYCR) today announced that it has begun three "marketing confirmation" trials for the e2 Collector[TM] cervical cell collection device. These trials will compare the performance between the e2 Collector and the standard spatula/brush combination for 650 women with moderate to high-grade cervical lesions, and will determine patient and physician satisfaction. These trials are intended to demonstrate the manufacturability, ease of use, and potential performance advantages of the e2 Collector. The Collector previously has received 510K approval from the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. for "essential equivalency equivalency the combining power of an electrolyte. See also equivalent. " to the spatula/brush. As the first step in the Pap test Pap test, Pap smear, or Papanicolaou test (păp'ənē`kəlou), medical procedure used to detect cancer of the uterine cervix. , the e2 Collector is designed to provide more thorough and accurate collection of cervical cells from the entire cervix cervix /cer·vix/ (ser´viks) pl. cer´vices [L.] 1. neck. 2. the front portion of the neck. 3. cervix uteri. in a single step. Due to its shape and design characteristics, the e2 Collector is intended to offer greater ease of use for physicians and establishes consistency in cell collection thereby potentially reducing the number of false positive and false negative test results. The first site for the confirmation trial is University Hospitals Case Medical Center (UHCMC UHCMC University Hospitals Case Medical Center (Cleveland, OH) ) in Cleveland. Up to seven additional sites are expected to join the trial over the next four to six weeks. CytoCore expects to complete this trial within 90 days and submit the subsequent trial data to the FDA for clearance during the second quarter. "The trials should show the Collector's ability to provide a more thorough and accurate cell sampling to the labs for analysis, and to improve the patient and physician experience during the examination," said Dr. George Gorodeski, head of CytoCore's Medical Advisory Board and Chief Scientist. "The Collector should be more comfortable for the patient and easier to use for the physician. With the conclusion of these trials, the e2 Collector could become a useful upgrade for the first phase of the Pap test and represent a significant improvement in its accuracy and quality." Much as the arrival of the Pap smear Pap smear or Papanicolaou smear Sample of cells from the vagina and cervix of the uterus for laboratory staining and examination to detect genital herpes and early-stage cancer, especially of the cervix. Developed by the Greek-born U.S. back in the 1960's launched routine screenings that have profoundly reduced the number of cervical cancer deaths, CytoCore expects that the e2 Collector will similarly help women at risk in the detection of cervical pre-cancers in their earliest stages. "The e2 is the only procedure that is designed to collect a representative sample of cells from the entire cervix," said Dr. Floyd Taub, founder of the company that developed the HPV HPV human papillomavirus. HPV abbr. human papilloma virus Human papilloma virus (HPV) virus test and a CytoCore Scientific Advisory Board member. "Its patented design automatically collects cells from the endocervix (inside) and ectocervix (outside) in one quick step. Its automatic action is intended to provide a consistent method of collecting the cervical cells that relies less of the technique of the individual performing the test. This simple but elegant device will replace the current weak link in the cervical cancer screening process." CytoCore hopes to have the e2 Collector recognized and adopted as a "best standard of care" for the patient cell collection procedure as the first step of the Pap test. "We expect to sign distributors for the e2 Collector within the next quarter, both domestically and internationally" stated CytoCore's CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , Dr. Augusto Ocana. "My conversations with potential distribution partners indicate high levels of interest for this device and for CytoCore's other products. With a successful conclusion of this trial and subject to FDA clearance, we anticipate sales of the e2 Collector to start in early to mid third quarter. Cytocore will soon be transitioning into a company with products in the market generating revenue. These are exciting times for our Company." For further information, please visit www.CytoCoreInc.com About CytoCore Inc. CytoCore develops cost-effective cancer screening systems, which can be utilized in a laboratory or at the point-of-care, to assist in the early detection of cervical, endometrial endometrial /en·do·me·tri·al/ (en?do-me´tre-il) pertaining to the endometrium. endometrial, n relating to the end-ometrium or cavity of the uterus. , and other cancers. The InPath[TM] System is being developed to provide medical practitioners with a highly accurate, low-cost, cervical cancer screening and treatment system that can be integrated into existing medical models or at the point-of-care. Dr. Gorodeski has a significant financial interest in this research, consisting of equity and salary as consultant and director of the Scientific Advisory Board of CytoCore. Dr. Gorodeski's invention licensed to CytoCore could generate royalty income for Dr. Gorodeski, for University Hospitals of Cleveland University Hospitals is a major not-for-profit medical center in Cleveland, Ohio, United States. With 150 locations throughout northeast Ohio, it encompasses a network of hospitals, outpatient centers and primary care physicians. and for CASE University. Certain statements in this release are forward-looking. These statements are based on CytoCore's current expectations and involve many risks and uncertainties, such as the company's inability to obtain sufficient financing, the possibility that clinical trials will not substantiate CytoCore's expectations with respect to the InPath[TM] System, and other factors set forth in reports and documents filed by CytoCore with the Securities and Exchange Commission. Actual results may differ materially from CytoCore's current expectation depending upon a number of factors affecting the Company's business. These factors include, among others, risks and uncertainties detailed in the Company's periodic public filings with the Securities and Exchange Commission, including but not limited to the Company's Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the year ended December 31, 2005. Except as expressly required by law, CytoCore undertakes no obligation to publicly update or revise any 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. contained herein. |
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