25 May 2012

EKF wins FDA approval

29/11/2011 Miles Nolan

Fast growing EKF Diagnostics (EKF) has secured FDA approval to launch its Hemopoint measurement system in the key US market.

The product has had a slight name change in order to satisfy the authorities, and will now be launched by US giant Alere - the exclusive distributor of the product. AIM listed EKF has now rebranded the device as the: Alere Hemopoint H2 Hemoglobin Measurement System.

Hemoglobin is the most clinically ordered blood test in the US (400 million tests a year). The Hemopoint product is a point of care device which measures hemoglobin levels from a fingerstick in just 25 seconds, it also measures hemocrit - the percentage of red blood cells in blood. Low hemocrit may be a sign of anemia or malnutrition, so the device has a potentially significant application in developing markets. Indeed, the World Health Organisation estimates there are 2 million sufferers of anemia in the world.

In addition to gaining approval, EKF has also secured a notice of allowance from the US patent and trademark office in relation to patent rights for the cuvettes (the consumables) that will be used in the system. Following the payment of certain fees, the AIM counter expects to receive a 'Grant of Patent Rights' shortly after.

EKF enjoyed like for like sales growth of 23 per cent in the first half of 2011, so the latest news is a welcome shot in the arm for the company. Recently appoined broker Collins Stewart expects the launch of the Hemopoint to boost revenues, moreover it argues EKF is currently valued on its mature business and not the potential of new products.

We highlighted the attractions of EKF late last year, tipping the shares as a recommendation for 2011 at 22p. The price is up 5 per cent to 24.5p today, which is a reasonable achievement given the markets. However, the board still have ambitions to build EKF into a much larger player. Buy.

Tags: AIM market, Alere, FDA approval, Growth company

Sector: Health Care Equipment & Services

Companies: EKF Diagnostics

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