Venaxis Obtains CE Mark for APPY1 Appendicitis Test
Prepares to Commence Initial Product Launch in Select European Territories
CASTLE ROCK, Colo., Jan. 7, 2013
CASTLE ROCK, Colo., Jan. 7, 2013 /PRNewswire/ --Venaxis, Inc. (Nasdaq: APPY),
an in vitro diagnostic company, today announced it has fulfilled the
requirements for CE Marking in Europe for APPY1, the Company's blood-based
appendicitis test. Initial commercialization in Europe is planned to commence
in the first quarter 2013 in key territories, including the UK, Italy, France,
Germany and Benelux countries. The Company expects to announce agreements
with top EU distributors beginning in the first quarter 2013.
Steve Lundy, President and CEO of Venaxis, stated, "We are pleased to report
this important accomplishment, which allows us to market APPY1 in Europe and
initiate the next critical phase of our market development effort. This
initial phase will involve finalizing agreements with selected distributors,
working with those same distributors and placing APPY1 in the hands of select
hospitals in each of our target European territories. Our strategy is to
leverage the experience of these key opinion leader hospital sites over the
first half of 2013 in order to generate meaningful, multinational data for
APPY1 that will allow us to refine our approach to the broader EU market and
prepare for full scale launch later in 2013. As we work in parallel to gain
U.S. regulatory clearance, EU market development remains a top priority for
Venaxis, and we believe this strategic approach will maximize our potential
for increased market penetration and allow us to ramp sales quickly once those
activities are completed."
About Venaxis, Inc.
Venaxis, Inc. (formerly AspenBio Pharma, Inc.) is an in vitro diagnostic
company focused on the clinical development and commercialization of its
blood-based appendicitis test, APPY1. The unique appendicitis test has
projected high sensitivity and negative predictive value and is designed to
aid in the identification of patients at low risk for acute appendicitis,
allowing for more conservative patient management. APPY1 is being developed
initially for pediatric, adolescent and young adult patients with abdominal
pain, as this population is at the highest risk for appendicitis and has the
highest risk of long-term health effects associated with CT imaging. For more
information, visit www.venaxis.com.
This press release includes "forward-looking statements" of Venaxis, Inc.
("Venaxis") (formerly AspenBio Pharma, Inc.) as defined by the Securities and
Exchange Commission ("SEC"). All statements, other than statements of
historical fact, included in this press release that address activities,
events or developments that Venaxis believes or anticipates will or may occur
in the future are forward-looking statements. These statements are based on
certain assumptions made based on experience, expected future developments and
other factors Venaxis believes are appropriate in the circumstances. Such
statements are subject to a number of assumptions, risks and uncertainties,
many of which are beyond the control of Venaxis. Investors are cautioned that
any such statements are not guarantees of future performance. Actual results
or developments may differ materially from those projected in the
forward-looking statements as a result of many factors, including our ability
to successfully complete required product development and modifications in a
timely and cost effective manner, complete clinical trial activities for APPY1
required for FDA submission, obtain FDA clearance or approval, complete and
maintain CE Marking, cost effectively manufacture and generate revenues from
APPY1, execute agreements required to successfully advance the company's
objectives, retain the management team to advance the products, overcome
adverse changes in market conditions and the regulatory environment, obtain
and enforce intellectual property rights, and realize value of intangible
assets. Furthermore, Venaxis does not intend (and is not obligated) to update
publicly any forward-looking statements. The contents of this press release
should be considered in conjunction with the risk factors contained in
Venaxis' recent filings with the SEC, including its Form 10-Q for the period
ended September 30, 2012, filed on November 7, 2012.
For Investors & Media:
Joshua Drumm, PhD / Jason Rando
Tiberend Strategic Advisors, Inc.
SOURCE Venaxis, Inc.
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