LONDON (Alliance News) - Sphere Medical Holding PLC said Friday its Proxima blood analyser system had been granted CE marking in the EU.
CE marking indicates that the product is compliant with EU legislation, and can be freely sold within the European market. However, as four elements of the technology were required to be reviewed separately, this has made the approval process "significantly slower than anticipated", Sphere Medical said.
The medical devices company said that that it has continued to trade "satisfactorily" in its first quarter to end-March, with financial results ahead of its expectations.
The company said that since the appointment of Wolfgang Rencken as chief executive in February, it has focused its efforts on preparing for the launch of Proxima. It will initially target key strategic UK hospitals for early adoption of the technology.
During the first quarter the company's operating loss was less than budgeted, it said, as it tightly controlled operating expenses.
The company is continuing to progress is collaboration agreement with Ortho Clinical Diagnostics, Inc, working on product improvements for Proxima.
"A very considerable effort has gone into the CE marking process, and today's announcement of its successful completion represents a significant milestone for the company and is the beginning of Proxima's commercial future," Rencken said in a statement.
Shares in Sphere Medical were trading up 5.7% at 28.55 pence Friday morning.
By Hana Stewart-Smith; hanassmith@alliancenews.com; @HanaSSAllNews
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