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.
About CPC
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.