Venaxis Advances Pivotal U.S. Study and Accelerates European Market
Development for APPY1 Blood-based Appendicitis Test
Quarterly Update Conference Call and Webcast Today at 4:30 p.m. ET
CASTLE ROCK, Colo., March 26, 2013
CASTLE ROCK, Colo., March 26, 2013 /PRNewswire/ --Venaxis, Inc. (Nasdaq:
APPY), an in vitro diagnostic company focused on obtaining FDA clearance and
commercializing its rapid, protein biomarker-based appendicitis test, APPY1,
today provided an update on its clinical and commercial activities. The
Company continues to enroll patients into its ongoing pivotal U.S. clinical
study of APPY1, as well as make strong progress on its European market
Steve Lundy, Chief Executive Officer of Venaxis, commented, "We identified a
number of significant milestones for 2013 and during the recent months have
begun achieving them, including initiation of our pivotal study for APPY1,
which we anticipate, upon completion, will support filing for regulatory
clearance with the FDA. We also obtained CE Marking for APPY1, and we
commenced an initial launch of the product for market development purposes in
Europe. As we expected, 2013 has been characterized so far by continued
progress on these critical initiatives. We are encouraged by our successful
execution to date and we plan to remain focused and diligent so that we can
reach the important milestones to come."
Enrollment into the APPY1 pivotal U.S. clinical study is expected to continue
across the 28 participating hospital sites throughout much of 2013. Based on
current projections, the Company anticipates completing the study and
potentially filing with the FDA for regulatory clearance of APPY1 by year end
Following CE Marking of APPY1 in January, Venaxis successfully executed market
development agreements with MOSS S.p.A., which is based near Milan, to cover
Italy; Istanbul-based SAVAS Medikal Inc. to cover hospitals in Turkey; and
Netherlands-based EMELCA Bioscience, covering hospitals in the Benelux
countries. Pursuant to these agreements, strategic market development
activities have commenced those regions and Venaxis anticipates announcing
additional agreements in the near term that cover the additional targeted EU
The Company also strengthened its balance sheet with an underwritten public
offering in late 2012, for which Venaxis received approximately $4.7 million
in total gross proceeds, including full exercise of the underwriter's
over-allotment option. The Company ended the year with $12.1 million in cash,
cash equivalents and short-term investments, which Venaxis believes is
sufficient to complete the ongoing U.S. pivotal trial, as well as advance the
market development activities in Europe.
Mr. Lundy concluded, "We have emerged successfully from 2012 as a pure-play in
vitro diagnostics company with sufficient capital to advance our new and
innovative diagnostic product that we believe fulfills an important need in
the emergency care market. As study enrollment continues to ramp in the U.S.
and we continue to gain traction and gather market intelligence in Europe, we
look forward to providing timely updates on our key achievements."
Conference Call Information
The Company has scheduled its quarterly conference call and webcast for today,
March 26, 2013, at 4:30 p.m. ET. Interested participants and investors may
access the conference call by dialing 1-800-860-2442 (U.S.), 1-866-605-3852
(Canada) or 1-412-858-4600 (international). A live audio webcast will be
accessible via the Investor Relations section of the Venaxis web site,
A telephonic replay of the call will be available for 30 days beginning at
8:00 p.m. ET on March 26, 2013. Access numbers for this replay are
1-877-344-7529 (U.S./Canada) and 1-412-317-0088 (international); conference
ID: 10026445. The webcast replay will remain available in the Investors
Relations section of the Venaxis web site for 30 days.
About Venaxis, Inc.
Venaxis, Inc. is an in vitro diagnostic company focused on the clinical
development and commercialization of its rapid, protein biomarker-based
appendicitis test, APPY1. 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. APPY1 is CE Marked in Europe and is
being developed in the U.S. 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 APPY1 is ongoing in select European territories. 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 APPY1 required for FDA submission, obtain FDA
clearance or approval, maintain CE Marking, cost effectively manufacture and
generate revenues from APPY1 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-K for the year ended December 31, 2012, filed
on March 26, 2013.
For Investors and Media:
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Joshua Drumm, PhD
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SOURCE Venaxis, Inc.
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