Heparin is a widely used blood-thinner given to patients after surgery to prevent the formation of clots. Out of approximately 12 million patients given heparin each year in the US, up to 5% develop a potential fatal allergic reaction. This reaction, known as heparin-induced thrombocytopenia (HIT), results in the opposite intended effect, turning heparin into a clotting agent, which may lead to heart attacks, deep vein thrombosis, or pulmonary embolisms.
Akers Biosciences' (NASDAQ: AKER) PIFA Heparin/PF4 Rapid Assay and PIFA PLUSS PF4 test remain the only US FDA-cleared rapid manual assays that quickly determine if a patient being treated with heparin is developing an allergy. Beijing-based NovoTek Therapuetics, who has helped with regulatory approval in China over the past two years, placed an initial $1 million order for Akers' allergy tests.
The order, which is expected to be delivered by year end, is part of a nine year distribution agreement, worth a minimum of $67.2 million. As Akers' distribution partner in China for PIFA Heparin/PF4 and PIFA PLUSS PF4, NovoTek has committed to a minimum of $1 million per year in each of the first three years, with annual minimums moving up to $4.8 million in years four and five, then $11.5 million in years six and seven, ultimately hitting $15.8 million in years eight and nine.
"Unlike in the U.S. where we are seeking to disrupt a pre-existing, slow, expensive, laboratory-based testing method for heparin platelet factor 4 antibodies, there is, as far as we are aware, no competing test in China," stated Dr. Raymond Akers, cofounder and executive chairman.
"China's healthcare system is improving and the need for reliable and timely diagnosis is becoming increasingly recognized," continued Dr. Akers. "With China's economy growing, we believe it to be the second biggest potential market in the world for our PIFA Heparin/PF4 Rapid Assay products. With no competing test of which are aware, Akers is poised to establish its products as the gold standard."
Akers has a growing suite of commercially available rapid, point of care screening and testing products designed to bring healthcare information both rapidly and directly to the consumer or healthcare provider. The Company's core strength is rooted in six proprietary platform technologies that merge diagnostic accuracy with maximum portability and ease of use.
The Company reported 32% year-over-year revenue growth in the third quarter, driven largely by US sales of PIFA Heparin/PF4 products, which rose 39% year-over-year. With the amount of time it takes to move new customer trials to sales decreasing, and growing interest for its products domestically and internationally, revenue growth is expected to accelerate.
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