29 May 2018 07:00
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