Product Update
30 März 2005 - 12:11PM
UK Regulatory
RNS Number:3185K
Medisys PLC
30 March 2005
For Immediate Release 30 March 2005
Medisys PLC
("Medisys" or "the Group")
Hypoguard Receives FDA Clearance for Alternate Test Site Claim for Advance
Micro-draw
Medisys announces that Hypoguard has received notification from the US Food and
Drug Administration (the "FDA") that the Advance Micro-draw blood glucose
monitoring system has been cleared for marketing with a claim that it can be
used with blood samples drawn from alternate sites. This allows the Group to
market the product with an Alternate Test Site ("AST") claim, for testing of
blood samples drawn from the palm in addition to the finger tips.
The Advance Micro-draw blood glucose monitoring system utilises the Group's
proprietary bio-sensor. It incorporates a capillary-fill feature which draws the
blood into the strip's testing cell and enables it to function with a small
sample size. Testing of blood samples drawn from parts of the body, other than
the finger, is perceived as involving less pain for the patient.
David Wong, Chairman, commented: "US market clearance for the AST claim for our
Advance Micro-draw product is an important milestone in the development of our
portfolio of blood glucose monitoring products. Being able to make an AST claim
for Advance Micro-draw is important from a marketing perspective and our product
labelling will incorporate the claim as soon as possible."
- Ends -
Enquiries:
Medisys PLC 020 7563 5200
Michael Barry, Chief Financial Officer
Weber Shandwick Square Mile 020 7067 0700
Kevin Smith
This information is provided by RNS
The company news service from the London Stock Exchange
END
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