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Sphere Medical: CE mark paves the way for full commercial launch of blood monitor

Sphere Medical has received the final approval that paves the way for the commercial launch of its breakthrough blood monitor later this year.


Shares in Sphere Medical (LON:SPHR) spiked 5% after it said it had received the final approval that paves the way for the commercial launch of its breakthrough blood monitor later this year.  

The group has attained its CE mark under the EU Medical Devices Directive, which means its Proxima system complies with European product legislation. In all it has four CE marks.

The company in a statement said it will go ahead with what it called a post market clinical follow-up study, which will be carried out at the Queen Elizabeth Hospital in Birmingham, as well as heading into the full commercial launch of Proxima.

Sphere will initially target “key strategic UK hospitals in specific clinical application areas suitable for early adoption of the Proxima system”, investors were told.

The CE mark news was given alongside a broader update on the company in which it was revealed Sphere’s losses in the first quarter were smaller than anticipated. It has £7.8mln on the balance sheet.  

Since the appointment of Wolfgang Rencken as chief executive in February, the company said the focus has been on “bringing about a commercial and customer-centred culture at Sphere Medical”. 

Rencken added: "Within the past three months, since my appointment as CEO, I have been impressed by the potential of the Proxima technology.  

“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.  

“This is an exciting time for the company, its partners, investors and staff and I am delighted to have joined at such a pivotal time."

A 3.20pm the shares were up 1.44p at 28.44p. 

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