CardioComm Solutions' HeartCheck(tm) ECG PEN and GEMS (tm) Home Receive China Food and Drug Administration Clearance
14 Mai 2014 - 3:02PM
Access Wire
Clearance opens the way for
HeartCheck(TM) Device Sales and SMART Monitoring ECG Services in
China
TORONTO, ONTARIO / ACCESSWIRE / May 14 2014 /
CardioComm Solutions, Inc. (TSX VENTURE:EKG)
("CardioComm Solutions" or the "Company"), a global medical provider of
electrocardiogram ("ECG") acquisition and management software
solutions, confirms that China's Food and Drug Administration
("CFDA") has cleared the HeartCheck(TM) PEN ECG device and GEMS(TM)
Home software for sale in China.
CardioComm Solutions had
already secured clearances for the sale of the HeartCheck(TM) PEN
through the US FDA, Health Canada and by European CE marking.
GEMS(TM) Home, the associated Windows-based software that provides
a personal electronic ECG health record management solution, also
enables access to the Company's global SMART Monitoring ECG reading
service. The CFDA clearance was secured by Beijing Choice
Electronic Technology Co., Ltd. ("BCET"), which manufactures the
HeartCheck(TM) PEN exclusively for CardioComm Solutions under the
BCET original equipment manufacturer's code MD100P. The CFDA
clearance also specifically names GEMS(TM) Home. With CFDA
clearance, registration of the HeartCheck(TM) brand can be
completed in preparation for the sale of the devices and the start
of ECG reading services through GEMSTM
Home in China.
The CFDA clearance of the
HeartCheck(TM) PEN and SMART Monitoring ECG service provide
CardioComm Solutions with access to another significant market. The
CFDA applications were managed by BCET with assistance from
CardioComm Solutions for preparation of the GEMS(TM) Home
components. The Company's next step is registration of the
HeartCheck(TM) brand name fusing the MD100P clearance, similar to
what has been completed in Europe and North America. In order to
sell the devices and offer ECG reading services, CardioComm
Solutions will release a Mandarin language version of GEMS(TM) Home
and SMART Monitoring ECG interpretation reports.
"We are pleased to have the
access to sell our devices and ECG services into China. In
anticipation of this CFDA clearance, BCET and CardioComm Solutions
have been planning the launch of a national HeartCheck(TM) and
SMART Monitoring ECG screening service that would utilize the many
community clinics for private as well as government reimbursed
SMART Monitoring ECG reading referrals," said Etienne Grima, CEO of
CardioComm Solutions. "A high level of control by the Company is
important for appropriate access and use of our SMART Monitoring
ECG service. By implementing a pre-authorized, unique serial number
registration procedure through GEMSTM
Home, the gate keeper for accessing SMART Monitoring, we can
ensure that only HeartCheck(TM) devices manufactured for us will
work with both GEMS(TM) Home and the SMART Monitoring
service."
"CardioComm Solutions already
utilizes a SunGard availability service for the SMART Monitoring
infrastructure which can be scaled to support SMART Monitoring in
any of 16 locations internationally. We intend to expand into China
through our trusted partners where the sheer size of the potential
market will allow us to realize new revenue streams from activation
of HeartCheck(TM) devices on the SMART Monitoring ECG service, as
well as from a share of per ECG fees that will be charged for use
of the ECG service," said Simi Grosman, member of the Board of
Directors for CardioComm Solutions.
About CardioComm
Solutions
CardioComm Solutions' patented
and proprietary technology is used in products for recording,
viewing, analyzing and storing electrocardiograms (ECGs) for
diagnosis and management of cardiac patients. Products are sold
worldwide through a combination of an external distribution network
and a North American-based sales team. The Company has earned the
ISO 13485 certification, is HPB approved, HIPAA compliant, and has
received FDA market clearance for its software devices. CardioComm
Solutions is headquartered in Toronto, Ontario, Canada, with
offices in Victoria, B.C.
FOR FURTHER INFORMATION PLEASE CONTACT:
Etienne Grima, Chief Executive Officer
1-877-977-9425
investorrelations@cardiocommsolutions.com
www.cardiocommsolutions.com
Forward-looking statements
This release may contain
certain forward-looking statements and forward looking information
with respect to the financial condition, results of
operations and business of CardioComm Solutions and certain of the
plans and objectives of CardioComm Solutions with respect to these
items. Such statements and information reflect
management's current beliefs and are based on information currently
available to management. By their nature,
forward-looking statements and forward-looking information involve
risk and uncertainty because they relate to events and depend on
circumstances that will occur in the future and there are many
factors that could cause actual results and developments to differ
materially from those expressed or implied by these forward-looking
statements and forward-looking information.
In evaluating these
statements, readers should: specifically consider risks discussed
under the heading "Risk
Factors" in the Company's Annual Information Form,
available at www.sedar.com; not to place
undue reliance on forward-looking statements and forward-looking
information; be aware the Company does not assume any obligation to
update the forward-looking statements and forward-looking
information contained in this Annual Information Form other than as
required by applicable laws (including without limitation Section
5.8(2) of National Instrument 51-102 (Continuous Disclosure
Obligations).
Neither TSX Venture Exchange
nor its Regulation Services Provider (as that term is defined in
policies of the TSX Venture Exchange) accepts responsibility for
the adequacy or accuracy of this release.
SOURCE: CardioComm Solutions, Inc.
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