Venaxis Nears Completion of Pivotal Clinical Trial of APPY1™ Test
Advances Market Development and Commercialization Activities in Europe and
Quarterly Update Call and Webcast Today at 8:30 a.m. Eastern Time
CASTLE ROCK, Colo., Nov. 7, 2013
CASTLE ROCK, Colo., Nov. 7, 2013 /PRNewswire/ --Venaxis, Inc. (Nasdaq: APPY),
an in vitro diagnostic company focused on obtaining FDA clearance for and
commercializing its CE Marked APPY1 Test, a rapid, multiple biomarker-based
assay for identifying patients that are at low risk for appendicitis, today
provided a corporate update for the third quarter 2013. The Company remains
on track to complete patient enrollment for its pivotal clinical study of the
APPY1 Test in the United States at or around the end of the year. In
parallel, Venaxis continues to accelerate market development activities in
Europe and the U.S.
Steve Lundy, President and CEO of Venaxis™, stated, "Advancing the APPY1 Test
toward potential FDA clearance continues to be our top priority. We look
forward to reporting top-line data from the pivotal study toward the end of Q1
2014, and dependent on the study results, to submitting our final data package
to the FDA shortly thereafter. In parallel, we continue to have very positive
dialogue with emergency room physicians and administrators at leading
hospitals in the U.S. and Europe as part of our market development
activities. Based on the enthusiasm and feedback we are receiving from
thought leaders regarding the potential economic and clinical benefit of using
the APPY1 Test, we believe Venaxis will be well positioned to gain significant
traction in Europe upon full commercial launch, as well as when we enter the
U.S. market upon potential FDA clearance in 2014."
During the third quarter, the APPY1 Test successfully passed two interim
futility analyses performed by an external Data and Safety Monitoring Board
(DSMB). In September, the DSMB recommended the study continue to completion
following an analysis of the first approximately 1,100 patients to complete
the study. To date, Venaxis has enrolled more than 1,700 patients and aims to
complete the study with 2,000 net evaluable patients.
As an important component of its European market development activities,
Venaxis is working with leading hospitals in Belgium, the Netherlands, Italy
and Spain on completing clinical studies designed to demonstrate the benefits
that could be achieved by using the APPY1 Test. Venaxis is also completing
development of a modeling tool designed to help individual hospitals
quantify their potential cost savings from possible implementation of the
APPY1 Test. The modeling tool is currently undergoing beta testing and the
initial feedback has been positive. Venaxis believes the studies and modeling
tool will be valuable in advancing the commercial adoption of the APPY1 Test.
In addition, Dr. Damien Gruson of University Saint Luc hospital in Brussels,
Belgium, will present positive results from a recently completed hospital
laboratory validation study at the Journées International de Biologie in Paris
later this month. The results confirm that the APPY1 Test performs accurately
and reliably in the hands of hospital laboratory personnel performing the test
and reporting the results to the emergency room doctor.
Venaxis reported initial APPY1 Test revenue in its Quarterly Report on Form
10-Q for the period ended September 30, 2013, which represents revenue arising
from the initial stocking orders by the European companies engaged to assist
Venaxis with European market development activities.
Venaxis ended the third quarter 2013 with cash, cash equivalents and
short-term investments of approximately $17 million.
Conference Call and Webcast Information:
Interested participants and investors may access the conference call by
dialing 1 (877) 870-4263 (U.S.), 1 (855) 669-9657 (Canada) or 1 (412) 317-0790
(international). A live audio webcast will be accessible via the Investor
Relations section of the Venaxis web site, ir.venaxis.com.
A telephonic replay of the call will be available for 90 days beginning
approximately on hour after the end of the conference call through February 7,
2014. Access numbers for this replay are 1 (877) 344-7529 (U.S./Canada) and 1
(412) 317-0088 (international); conference ID: 10036520. The webcast replay
will remain available in the Investors Relations section of the Venaxis web
site for 90 days.
About Venaxis, Inc.
Venaxis, Inc. is an in vitro diagnostic company focused on the clinical
development and commercialization of its CE Marked APPY1 Test, the Company's
rapid, protein biomarker-based assay for appendicitis. This unique
appendicitis test has projected high sensitivity and negative predictive value
and is being developed to aid in the identification of patients at low risk
for acute appendicitis, allowing for more conservative patient management.
The APPY1 Test 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. While FDA clearance is being sought, an initial
launch for the APPY1 Test is ongoing in select European countries. For more
information, visit www.venaxis.com.
This press release includes "forward-looking statements" of Venaxis, Inc.
("Venaxis") 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 the APPY1 Test required for FDA submission,
obtain FDA clearance or approval, maintain CE Marking, cost effectively
manufacture and generate revenues from the APPY1 Test at a profitable price
point, 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 quarter
ended June 30, 2013.
Venaxis and APPY1 are trademarks of Venaxis, Inc.
For Investors and Media:
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Joshua Drumm, PhD
email@example.com; (212) 375-2664
firstname.lastname@example.org; (212) 375-2686
SOURCE Venaxis, Inc.
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