Akers Biosciences, Inc. Withdrawal of 510(k) Submission - Chlamydia Assay (4405P)
May 29 2018 - 2:01AM
UK Regulatory
TIDMAKR
RNS Number : 4405P
Akers Biosciences, Inc.
29 May 2018
May 29, 2018
Akers Biosciences, Inc.
Withdrawal of FDA 510(k) Submission for PIFA Chlamydia Rapid
Assay
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 Officer
Tel. +1 856 848 8698
finnCap (UK Nominated Adviser and Broker)
Adrian Hargrave / Scott Mathieson (Corporate Finance)
Steve Norcross (Broking)
Tel. +44 (0)20 7220 0500
Vigo Communications (Global Public Relations)
Ben Simons / Fiona Henson
Tel. +44 (0)20 7830 9704
Email: akers@vigocomms.com
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
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