Monterey, CA - November 17, 2011 - CerMed International (Frankfurt Stock Exchange: CRX), an international women’s medical device company, announced today that it has received CE Mark registration for CerMap its advanced Cervical Specimen Collection Device used in cervical cancer screening (Pap) procedures.
After a review of the CerMap Technical File by Emergo Europe, CerMed’s Authorized Representative, the Company received notice that it can now place the CE mark on its CerMap cervical specimen collection device indicating conformance with the “essential requirements” for a device as described in Annex IX of Directive 93/42/EEC with regards to safety and functionality. The CE registration provides validity for the product to be sold throughout the European Economic Area. In addition the Company plans to file for US FDA 510(k) clearance for CerMap in the near future leveraging on the licensed technology CerMap is based upon and which has been previously 510(k) cleared.
Drew Hofmann, Executive VP & COO of CerMed, stated: “This announcement comes at an ideal time for CerMed, as we will be launching the CerMap device to the international sales network of our Distribution partner, Audit Diagnostics, Ltd (Cork, Ireland) at the MEDICA 2011 World Forum for Medicine, International Trade Fair, being held this week in Dusseldorf, Germany.”
CerMap is the first in a series of products CerMed is developing focused on improving the sensitivity and specificity of cervical cancer screening. CerMap provides an advanced methodology for collecting cervical cells and a means for preserving the spatial relationship of the cells collected for more accurate analysis.
“We are excited about the potential impact CerMap, as well as the other products we currently have under development, will have on improving women’s health around the world”, Mr. Hofmann stated.
About CerMed International
CerMed International, Inc. is an international medical device company with several breakthrough products addressing global women’s health issues. These lower cost products will aid in reducing the risk of female reproductive diseases. They will enable women’s health initiatives to be brought to the underserved regions of the world and empower women to personally take steps to reduce the risk of HIV and other STDs.
Forward Looking Statements Related to CerMed International
This press release contains forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Some of these risks and uncertainties include, but are not limited to, (1) the economic circumstances surrounding CerMed’s business, including general economic conditions worldwide; (2) competitive pressures and developments; (3) applicable laws and regulations; (4) the success or failure of product development programs; (5) actions of regulatory authorities and the timing thereof; (6) changes in exchange rates; (7) claims or concerns regarding the safety or efficacy of marketed products or product candidates in development; and (8) integration activities with acquired companies.
The forward-looking statements contained in this press release speak only as of the date of this press release, and CerMed undertakes no obligation to revise or update any forward-looking statements to reflect new information, future events or circumstances after the date of the forward-looking statement. If CerMed does update or correct one or more of these statements, investors and others should not conclude that CerMed will make additional updates or corrections.
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