Medisys PLC - US FDA Approval
17 Oktober 1997 - 9:30AM
UK Regulatory
RNS No 3119k
MEDISYS PLC
17th October 1997
MEDISYS PLC
UNITED STATES FDA APPROVAL
Premarket approval ("PMA") for NiC 1800 obtained from
United States Food and Drug Administration
Medisys PLC ("Medisys" or "the Company"), the medical
systems designer and manufacturer which was admitted to AIM
on 28 July 1997, announces that it has obtained United
States marketing approval from the United States Food
and Drug Administration ("FDA") for the NiC1800, its
innovative system designed to instantly destroy
hypodermic needles at the point of use.
The approval is by way of a PMA for a class 3 device.
The requirement to file for a PMA and the designation of the
device as class 3 represents the most rigorous form of
examination and testing undertaken by the FDA.
Approval has been obtained ahead of schedule and will
enable Medisys to commence distribution of the NiC 1800 in
the United States. The Company is currently in discussions
with nationwide distributors to launch the product in the
United States in early 1998.
Commenting on the FDA's approval, Michael Coy, Managing
Director of Medisys said:
"This is a major breakthrough for the Company. The NiC
1800 is the only needle incinerator device to be approved
for clinical use by the FDA. The United States, which is
estimated to use at least 5 billion needles each year,
is the most significant potential market for the NiC
1800. In 1994, the latest year for which figures are
available, the annual cost of the needlestick injury
problem to the United States healthcare system was
approximately US$3 billion.
Needlestick injuries are a major source of occupational
exposures to HIV and Hepatitis B. We believe that the speed
with which the FDA has granted approval for the NiC 1800
reflects the system's potential for combating this problem."
Enquiries:
Medisys PLC:
Brian Timmons, Finance Director 0171 436 3353
Gary Hawes, Director, Regulatory Affairs 0171 436 3353
Binns & Company:
Peter Binns or Paul Vann 0171 786 9600
Editors' Notes:
The NiC 1800 system - the first product to be launched by
the biohazardous medical waste division of Medisys - is
marketed to healthcare institutions and private
practitioners as a cost effective way of disposing of
used needles and reducing the incidence of needlestick
injuries among healthcare workers. The system is
currently being sold in the United Kingdom, Europe, Asia
and Mexico.
END
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