Venaxis Initiates Patient Enrollment for APPY1 Pivotal Study
CASTLE ROCK, Colo., Jan. 15, 2013
CASTLE ROCK, Colo., Jan. 15, 2013 /PRNewswire/ --Venaxis, Inc. (Nasdaq:
APPY), an in vitro diagnostic company focused on obtaining FDA clearance and
commercializing its blood-based appendicitis test, APPY1, today announced that
it has begun enrolling patients into its pivotal clinical study in the United
States. Based on current enrollment expectations, the Company anticipates
completing the study in six to eight months and filing with the FDA for
regulatory clearance of APPY1 in the fourth quarter 2013.
Steve Lundy, President and CEO of Venaxis, stated, "With our pivotal study now
underway, we anticipate 2013 will be a transformative year for Venaxis. The
pivotal clinical study is being conducted at 28 leading hospital sites, each
of which are enthusiastic to assist us in completing the study as
expeditiously as possible. We believe our overall success will be driven by
continued execution on clinical and regulatory milestones, and we are pleased
to commence patient enrollment in our pivotal U.S. study just days after
announcing that APPY1 is now a CE Marked product in Europe. Over the coming
months while the study is ongoing, we intend to launch APPY1 in initial EU
territories, as well as continue working across our network of more than 100
U.S. hospitals in order to develop the market for APPY1."
About Venaxis, Inc.
Venaxis, 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
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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