Digirad Receives CE Mark Approval for Advanced, Solid-State Cardius(R) X-ACT Imaging System
January 25 2012 - 7:30AM
Marketwired
Digirad Corporation (NASDAQ: DRAD) today announced that it has
received Conformitee Europeene (CE) Mark approval for its Cardius®
X-ACT imaging system, enabling Digirad to market and manufacture
its advanced, solid-state camera system in the European Union. The
Cardius X-ACT imaging system was designed to increase diagnostic
accuracy and make earlier detection of disease possible.
Digirad also announced that it had begun to strategically build
out a targeted international selling network by signing a
distribution agreement with Epsilon Elektronik in Turkey, a part of
the Istanbul-based Bozlu Group. Last year, Digirad signed a similar
agreement with UK-based Southern Scientific, which has already
placed an ergo™ portable solid-state camera at the Manchester Royal
Infirmary where it is being used in a number of general and
surgical imaging settings.
"One of the legs of our transition to growth in the product
category is to build a targeted network of top distributors in key
international markets that have a growing demand for flexible,
high-quality imaging products such as the X-ACT. Our experience and
the data indicate that price point, flexibility and potential for
better clinical outcomes at lower overall costs are key elements to
healthcare buying decisions, and our growing line of camera
products uniquely fits those requirements," said Digirad CEO Todd
P. Clyde. "It is our intention, as one of several new initiatives
in 2012, to more aggressively build a distribution network to tap
the developing markets for dedicated cardiac and portable nuclear
imaging in a more meaningful way. To that end, gaining of CE Mark
and additional distribution agreements are key initial elements of
that process."
The Cardius X-ACT imaging system features a low-dose
volume-computed tomography attenuation correction system that
significantly reduces artifacts in the images caused by overlying
tissues.
"We believe our Cardius X-ACT imaging system, our ergo flexible
imaging camera and future camera models will be well-received
internationally because of their accuracy, diagnostic benefits and
economic models that fit well with healthcare spending. They all
provide new clinical information that increases the benefit of
nuclear cardiology procedures. That increase in diagnostic
confidence can improve outcomes and raise the standard in the
industry internationally for SPECT system performance at a price
point that is accessible in many countries," added Clyde.
Digirad has previously received clearance from the FDA to market
the Cardius X-ACT imaging system in the U.S. and has garnered both
CE Mark and FDA clearance to market its ergo portable solid-state
camera.
About Digirad Corporation Digirad is a
leading provider of diagnostic imaging products, and personnel and
equipment leasing services. For more information, please visit
www.digirad.com. Digirad® and Cardius® are registered trademarks of
Digirad Corporation.
Forward-Looking Statements This press
release contains statements that are forward-looking statements as
defined within the Private Securities Litigation Reform Act of
1995. These include statements regarding our ability to deliver
value to customers and our expanded product and service offerings.
These forward-looking statements are subject to risks and
uncertainties that could cause actual results to differ materially
from the statements made, including the risks associated with
changes in business conditions, technology, customers' business
conditions, reimbursement, radiopharmaceutical shortages, economic
outlook, operational policy or structure, acceptance and use of
Digirad's camera systems and services, reliability, recalls, and
other risks detailed in Digirad's filings with the U.S. Securities
and Exchange Commission, including Annual Report on Form 10-K,
Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and
other reports. Readers are cautioned to not place undue reliance on
these forward-looking statements, which speak only as of the date
hereof. All forward-looking statements are qualified in their
entirety by this cautionary statement, and Digirad undertakes no
obligation to revise or update the forward-looking statements
contained herein.
Investor Contact: Matt Clawson Allen & Caron
949-474-4300 Email Contact Company Contact: Richard Slansky
CFO 858-726-1600 Email Contact
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