SARASOTA, Fla., Oct. 29 /PRNewswire-FirstCall/ -- CPC of America, Inc. (OTC Bulletin Board: CPCF), a company focused on the development of therapeutic devices for use in endovascular procedures, today announced that it is implementing a European strategy for the development and distribution of its MedClose(TM) investigational-stage medical device. In the roll out of its strategy, CPC announced an agreement with Medical Product Service GmbH (MPS) of Germany to act as authorized European representative for the Company in seeking European regulatory approval for MedClose(TM) Vascular Closure Device (VCD). MedClose(TM) is an extravascular puncture-closure device intended to be used with a biological sealant for diagnostic and interventional cardiovascular procedures.
According to published third party research, European VCD market sales for 2008 are projected to total approximately $160 million. Industry experts forecast that in Europe, the penetration of VCDs into minimally invasive cardiovascular procedures will experience a 9% compound annual growth rate and drive VCD sales and revenues.
"The European Union offers significant opportunities to broaden the MedClose(TM) market potential," said Rod Shipman, chairman and chief executive officer of CPC of America. "By aligning ourselves with MPS, we are setting a critical path to market in Europe. Our team will work closely with MPS in building key partnerships and navigating the European regulatory regime and clinical trials. We recognize the need for a safe, reliable closure system that reduces time to hemostasis and allows for faster patient ambulation and, when necessary, wound re-access. With MedClose(TM), we aim to fill that need in the U.S. and Europe."
As CPC's authorized representative in Europe, MPS will provide service under the respective CE marking requirements that apply in the European Union. MPS's role will include vigilance reporting, communicating with competent authorities in individual member states, assisting in securing international product registrations, and preparing and completing dossiers for clinical trials and CE markings.
"MPS knows that physicians operating in catheter laboratories across the EU demand precise instruments that help improve patient safety and outcomes," said Gehard Fromel, Principal Regulatory Consultant of MPS. "We are eager to collaborate with CPC to bring to market a product that may help the European medical community and their patients."
About Medical Product Service GmbH (MPS)
Headquartered near Frankfurt, Germany, MPS is a European medical device consulting agency with more than thirty years of regulatory expertise in medical devices and surgical products. MPS represents the interests of more than 50 medical device clients chiefly in the U.S. and Asia. Gerhard Fromel DIPL. Ing., is a member of several German and international standard organizations for medical equipment, including the DIN group which addresses safety and technical standards.
CPC of America develops therapeutic devices for use in endovascular procedures. CPC's current focus is the completion of development and testing of the MedClose(TM) vascular closure system, an internal puncture-closing system for use in catheter laboratories.
Forward Looking Statements
The statements contained in this press release that are not historical are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), including statements, without limitation, regarding the Company's expectations, beliefs, intentions or strategies regarding the future. Such forward-looking statements relate to, among other things: (1) the Company's continuing development of its MedClose(TM) vascular closure system, (2) the Company's expectations concerning regulatory approvals of the MedClose system and the commencement of revenue producing operations based on the sale or licensing of the MedClose, (3) the business relationship between the Company and Medical Product Service GmbH and the expected benefits to the Company from such relationship, and (4) the commencement of manufacturing of the MedClose system. These statements are qualified by important factors that could cause the Company's actual results to differ materially from those reflected by the forward-looking statements. Such factors include but are not limited to: (1) the Company's ability to finance the continued development and commencement of manufacturing of the MedClose system, (2) regulatory approvals of the MedClose system, (3) the general risks and uncertainties inherent in any new business relationship such as the one recently entered into between the Company and Medical Product Service GmbH , and (4) those other risks and factors described from time to time in the Company's reports filed 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, 2007 and subsequently filed Forms 10-Q and Forms 8-K. The Company cautions readers not to place undue reliance on any forward-looking statements. The Company does not undertake, and specifically disclaims any obligation, to update or revise such statements to reflect new circumstances or unanticipated events as they occur
|SOURCE CPC of America, Inc.|
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