West Perth company Eastland Medical Systems Ltd has obtained European regulatory approval for its ClipOn hypodermic needle, clearing the way for commercial sales in European markets.
West Perth company Eastland Medical Systems Ltd has obtained European regulatory approval for its ClipOn hypodermic needle, clearing the way for commercial sales in European markets.
The news of the regulatory approval comes after a constructive year for the company, which received its first substantial order for ClipOn ‘safe’ needle device of five million units in June.
The export order was placed by UK-based Response Medical Equipment Ltd, a subsidiary of International Medical Devices PLC, in which Eastland has 32 per cent shareholding.
Last week, Response indicated that it had been awarded CE mark approval by SGS, Europe’s leading quality certification group.
The CE mark is the European regulatory approval for medical devices and will provide access to the 28 European countries with a total population of 445 million.
Eastland believes the award of the CE mark is a key component for future approvals in the Asia-Pacific and South America.
Eastland chief executive officer Dermot Patterson said that, with the award of the CE mark, the commercial roll-out of ClipOn would start in Europe where there were significant commercial opportunities for the ‘safe’ needle.
“Response is well advanced in the UK with discussions with the National Health Service and this should facilitate ClipOn moving to market acceptance,” he said.
Eastland has acquired several medical product distributors in the UK through International Medical Devices, while in South Africa, its Eastland Medical Systems SA is a substantial shareholder in a medical products distributor.
Earlier this year, the company acquired Westcoast Surgical and Medical Supplies, which is forecast to add at least $4 million per annum of revenue to Eastland, and a 50 per cent shareholding in Ampack Medical Pty Ltd, a WA-based sterile products manufacturer.
In his CEO report last month, Mr Patterson said the company was looking for new business opportunities globally to continue its strategy of developing a business portfolio that would offer further diversity in revenue streams.
The company recently appointed Peter Jooste QC to the position of chairman, replacing Don O’Sullivan, while Mr Patterson has also joined the board after his appointment to CEO in September 2006.
Eastland reported its first net profit with an NPAT of $26,079 for 2005-06 and revenue from its Australian operations of about $6.9 million.
