4 Nov 2015 07:00
Embargoed: 0700hrs, 4 November 2015
Akers Biosciences, Inc.
Test for Heparin-Induced Thrombocytopenia Granted Approval by Chinese Food and Drug Administration
Akers Biosciences, Inc. (NASDAQ: AKER) (AIM: AKR.L), ("Akers Bio" or the "Company"), a medical device company focused on reducing the cost of healthcare through faster, easier diagnostics, announces that the China Food and Drug Administration (CFDA) has approved for medical use throughout Mainland China the Company's flagship rapid tests for allergic reactions associated with the widely used blood-thinner, heparin.
The Company's PIFA Heparin/PF4 Rapid Assay (and PIFA PLUSS PF4 version which tests whole blood) are the first and only tests for PF4 antibodies (associated with the condition known as Heparin-Induced Thrombocytopenia (HIT)) to be approved in China.
NovoTek, a Beijing‐based pharmaceutical and medical device business development company, holds the exclusive sales and marketing rights for the Company's PIFA Heparin/PF4 devices in China. NovoTek had already begun pilot sales of the tests under a temporary emergency waiver granted by the CFDA. It now expects to roll out its marketing of the tests to hospitals throughout China where NovoTek has also obtained an exclusive license for a direct thrombin inhibitor used for treating patients diagnosed with HIT.
The Company's PIFA Heparin/PF4 devices are becoming more widely used in the US, where they 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. 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.
"Unlike in the US, where Akers Bio's tests are gradually replacing a pre-existing, slow and costly laboratory testing process for HIT, China, as far as we know, has no established testing procedure whatsoever for the condition," said Raymond F. Akers, Jr. PhD, Co-founder and Executive Chairman. "We believe NovoTek's total solution for diagnosing HIT using our tests, and providing an antidote where HIT is diagnosed, has the capacity to dramatically reduce the serious complications which can arise from the use of heparin," continued Dr. Akers.
"In the US, where some 12 million people are exposed to heparin annually, 1 to 5 per cent of those patients receive a HIT diagnosis," said Dr. Akers. "In China nearly all anticoagulation is performed using heparin. China's healthcare system is rapidly westernizing and we believe the need for reliable and timely diagnosis of HIT is becoming increasingly recognized there."
"We believe China could ultimately become one of the Company's biggest markets for the PIFA Heparin/PF4 devices," 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.
Additional information on the Company and its products can be found at www.akersbio.com. Follow us on Twitter @AkersBio.
ABOUT NOVOTEK THERAPEUTICS INC.
NovoTek Therapeutics Inc. is a vital part of NovoTek Group, and is in charge of all international business. To date, NovoTek Group has grown to seven subsidiary companies focused on pharmaceutical marketing, medical and IVD products marketing, and contract research services. NovoTek has its own preclinical research facility, clinical trial and regulatory teams, and more than 600 sales representatives (500 for pharmaceuticals and 100 for medical devices) across China. NovoTek has more than 800 employees and more than 10 local branches nationwide. www.novotekchina.com
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:
Akers Biosciences, Inc.
Raymond F. Akers, Jr. PhD
Executive Chairman
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
Taglich Brothers, Inc. (Investor Relations)
Chris Schreiber
Tel. +1 917 445 6207
Vigo Communications (Public Relations)
Ben Simons / Fiona Henson
Tel. +44 (0)20 7016 9570
Email: akers@vigocomms.com