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Akers Biosciences Announces Legal Settlement, Strategic Update, CEO Change

NEW YORK (360Dx) – Akers Biosciences today announced that it has reached a settlement agreement with Pulse Health, which had filed a lawsuit against it in September alleging a breach of contract under a settlement agreement entered into by the two firms in April 2011.

The firm today also announced a leadership change, an update to its business strategy, and the resignation of its nominated adviser on the London Stock Exchange's AIM market that could lead to Akers Bio's suspension from trading.

As part of the legal settlement, Akers Bio will pay $930,000 to Pulse Health, and it has agreed to a permanent injunction against making, using, selling, or offering to sell the BreathScan OxiChek product, a disposable breath test to rapidly determine levels of oxidative stress in the body. Further, Ackers Bio agree that it will not make, use, sell, or offer any product that detects aldehydes or oxidative stress in exhaled human breath or breath condensate using basic fuchsin or sodium metabisulfite or any form, analog, or equivalent thereof.

Nor will it make, use, sell, or offer the BreathScan Lync device, or any equivalent thereof, as part of a test for aldehydes or oxidative stress in human exhaled breath or breath condensate. BreathScan Lync is an optical scanning device that reads and interprets breath test data from Akers Bio's BreathScan line of rapid breath tests, including OxiChek.

Akers Bio said that it does not anticipate a material impact on revenues as a result of its withdrawal from sale of the BreathScan OxiChek product.

The firm today also said that FinnCap gave three months' notice on Saturday of its resignation as Akers Bio's nominated adviser on the AIM submarket of the London Stock Exchange. FinnCap told Akers Bio that its resignation will take immediate effect if the Akers Bio board does not attend an AIM rules briefing hosted by FinnCap on Oct. 12.

Should FinnCap cease to act as the firm's nominated adviser, Akers Bio will be immediately suspended from trading on AIM. Akers Bio would then have one month to appoint a replacement nominated adviser. If it fails to do so, the admission of its AIM securities will be cancelled.

Akers Bio CEO John Gormally, who joined the company in 2015 and was appointed to its board in 2017, has resigned from both positions. The firm appointed Howard Yeaton — who has more than 30 years of senior financial and strategic business experience and has served as a consultant to Akers Bio since April — as Gormally's replacement as CEO. In the role, Yeaton will report to the firm's board of directors.

Additionally, the New Jersey-based company announced that its board of directors — following a review of its commercial and product development strategies — has decided that the firm will focus primarily on the commercialization of its Particle Immuno-Filtration Assay (PIFA) immunoassay platform, which rapidly detects target antigens or antibodies employed in the firm's core commercialized products. Tests that run on the platform include the PIFA Heparin/PF4 and PIFA Pluss/PF4 rapid assays, which test for an allergic reaction to heparin and account for the "significant majority" of Akers Bio's revenues.

Akers Bio said that it is taking steps to improve its market presence for these products, including the use of specialized independent sales representatives and the implementation of a program to educate the marketplace by preparing and publishing clinical studies and physician seminars about the risks associated with heparin-induced thrombocytopenia.

Akers Bio said that it will continue to explore other commercial opportunities for the deployment of PIFA technology, which is also used in its PIFA Pluss chlamydia rapid assay in development. The firm said that it will continue to manufacture BreathScan Alcohol Detectors, based on its Micro Particle Catalyzed Biosensor technology platform, and Tri-Cholesterol products, based on its Rapid Enzymatic Assay technology platform.