Akers Biosciences Announces $2.5M Order To Supply PIFA Heparin/PF4 Products To China
THOROFARE, NJ--(Marketwired - March 02, 2016) -
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The China Food and Drug Administration ("China FDA") recently approved the Company's rapid tests for allergic reactions associated with the widely used blood-thinner, heparin, for medical use throughout China. NovoTek, a Beijing-based pharmaceutical and medical device company, holds the exclusive sales and marketing rights for the Company's PIFA Heparin/PF4 Rapid Assay products in China.
The Company's PIFA Heparin/PF4 Rapid Assay and PIFA PLUSS PF4 version (which tests whole blood) are the first and only tests of any kind for PF4 antibodies (associated with the condition known as heparin-induced thrombocytopenia ("HIT")) to be available in China.
PIFA Heparin/PF4 Rapid Assay and PIFA PLUSS PF4 remain the only US FDA-cleared rapid manual assays that quickly determine if a patient being treated with the blood thinner heparin may be developing HIT. This clinical syndrome reverses the heparin's intended therapeutic effect and transforms it into a clotting agent. Patients suffering HIT are at risk of developing limb- and life-threatening complications, so the timely test result provided by the Company's Heparin/PF4 devices is paramount to effective, clinical decision making.
"The China FDA's approval of our test paves the way for Akers Bio and NovoTek to establish the PIFA Heparin/PF4 Rapid Assay devices as the gold standard for HIT testing throughout China," said Raymond F. Akers, Jr. PhD, Co-founder and Executive Chairman.
"Our partner, NovoTek, is developing a complete solution to manage HIT in the Chinese healthcare system by having the exclusive licenses both for our test as well as for a treatment for those patients who have been diagnosed with HIT."
"We look forward to fulfilling this order and to working with NovoTek to build what we believe will be an increasing flow of business for the Company over the coming years," added Dr. Akers.
About Akers Biosciences, Inc.
Akers Biosciences 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.
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. These statements include but are not limited to statements regarding the intended terms of the offering, closing of the offering and use of any proceeds from the offering. 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:
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