FDA Approves CytoCore's SoftPAP(TM) Cervical Cell Collector

Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 07 Feb 2008 - 3:00 PDT

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CytoCore Inc. (OTCBB:CYOE), the biopharmaceutical research and medical device company for early detection and treatment of reproductive-tract cancers, announced that the U.S. Food and Drug Administration has approved the company's 510(k) submission to sell CytoCore's SoftPAP™ cervical cell collector. The SoftPAP collects more comprehensive and complete cervical cell specimens for Pap testing.

"CytoCore's SoftPAP™ cervical cell collector is a significant advance in women's health," says Robert McCullough, Jr., CytoCore's CEO. "Each year, over 2 million American women are told that their Pap test was negative when, in fact, they have early stage cervical cancer. These false negatives are frequently caused by an inadequate or incomplete sample of cervical cells. SoftPAP collects complete specimens from the cervical canal, the cervical surface and the transition zone simultaneously. There is evidence that the use of SoftPAP significantly reduces the rate of false negative Pap tests leading to earlier treatment of cervical cancer."

"Studies also demonstrate that the most common adverse events that occur during the collection of the specimen are virtually eliminated with the SoftPAP," according to Dr. Richard Domanik, President and COO. "Studies involving more than 400 cervical cell collections show a 95% reduction in bleeding and spotting which are the most frequently reported adverse events associated with collection of specimens for Pap testing."

"FDA clearance enables us to become a truly global company," says Dan McMahon, Director of Marketing. "We have been selling SoftPAP in Europe for the past few months and are negotiating distribution agreements in Latin America as well. We are in the final stages of completing the North American distribution organization and expect to be able to launch the product in the United States by the end of the first quarter."

About CytoCore Inc.

CytoCore develops cost-effective cancer screening systems, which can be used in a laboratory or at the point-of-care, to assist in the early detection of cervical, endometrial, and other cancers. The CytoCore Solutions(tm) System is being developed to provide medical practitioners with highly accurate, cost-effective cancer screening systems that can be seamlessly integrated into existing medical models. More information is available at: http://www.CytoCoreInc.com.

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 CytoCore Solutions™ 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 for the year ended December 31, 2006. Except as expressly required by law, CytoCore undertakes no obligation to publicly update or revise any forward-looking statements contained herein.

CytoCore Inc.