Akers Biosciences Withdraws FDA 510(k) Submission for PIFA Chlamydia Rapid Assay Pending Further Evaluation
May 29 2018 - 7:00AM
Akers Biosciences, Inc. (NASDAQ: AKER) (AIM: AKR.L), (“Akers Bio”
or the "Company"), a developer of rapid health information
technologies, announces that, upon a recommendation from the US
Food and Drug Administration (FDA), the Company has decided to
withdraw its initial 510(k) application for PIFA Chlamydia in order
to re-evaluate its options with regards to this product development
opportunity.
John J. Gormally, Chief Executive
Officer of Akers Bio, commented: “The setback to the
desired commercialization timeline for this product is
disappointing, however, PIFA Chlamydia continues to be a priority
for the Company, and the board believes this course of action will
allow the board and management to better evaluate all options.
At the same time, we remain focused on driving
sales growth of our currently commercialized products and, in
particular, PIFA Heparin/PF4 Rapid Assay, through expanded
distribution and a strategic focus on clinical end-users and
integrated delivery network customers.”
About Akers Biosciences,
Inc.
Akers Bio develops, manufactures, and supplies
rapid screening and testing products designed to deliver quicker
and more cost-effective healthcare information to healthcare
providers and consumers. The Company has advanced the science of
diagnostics while responding to major shifts in healthcare through
the development of several proprietary platform technologies. The
Company's state-of-the-art rapid diagnostic assays can be performed
virtually anywhere in minutes when time is of the essence. The
Company has aligned with major healthcare companies and high volume
medical product distributors to maximize product offerings, and to
be a major worldwide competitor in diagnostics.
Additional information on the Company and its
products can be found at www.akersbio.com. Follow us on Twitter
@AkersBio.
Cautionary Statement Regarding Forward
Looking Statements
Statements contained herein that are not based
upon current or historical fact are forward-looking in nature and
constitute forward-looking statements within the meaning of Section
27A of the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934. Such forward-looking statements reflect the
Company's expectations about its future operating results,
performance and opportunities that involve substantial risks and
uncertainties. The forward-looking statements include statements or
expectations regarding research and development efforts, the effect
of regulation by the United States Food and Drug Administration
(the “FDA”) and other agencies, regulatory clearance and the timing
of FDA filings or approvals, current and planned future business
plans, clinical studies, other matters related to the Company’s
pipeline of product candidates, future financial performance, the
impact of competitive products, product development
commercialisation and technological difficulties, other risks
detailed in the Company's periodic reports filed with the
Securities and Exchange Commission and other future
events. When used herein, the words "anticipate," "believe,"
"estimate," "upcoming," "plan," "target", "intend" and "expect" and
similar expressions, as they relate to Akers Biosciences, Inc., its
subsidiaries, or its management, are intended to identify such
forward-looking statements. These forward-looking statements are
based on information currently available to the Company and are
subject to a number of risks, uncertainties, and other factors that
could cause the Company's actual results, performance, prospects,
and opportunities to differ materially from those expressed in, or
implied by, these forward-looking statements.
For more information:
Akers Biosciences, Inc.John J. Gormally, Chief
Executive OfficerTel. +1 856 848 8698
Vigo Communications (Global Public Relations)Ben
Simons / Fiona HensonTel. +44 (0)20 7830 9704Email:
akers@vigocomms.com
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