Medisys PLC - Premarket Approval Applicatn.
06 August 1997 - 12:23PM
UK Regulatory
RNS No 3791e
MEDISYS PLC
6th August 1997
MEDISYS PLC
("Medisys" or "the Company")
Submission of Premarket Approval application to
United States Food and Drug Administration ("FDA")
Medisys, the medical systems designer and manufacturer which
was admitted to AIM on 28 July 1997, announces that
it has filed a Premarket Approval ("PMA") application with the
FDA for the NiC1800, its innovative system designed for the
disposal of used hypodermic needles.
The filing was submitted yesterday by Wilson Sonsini Goodrich
& Rosati, the Company's regulatory legal counsel in the United
States, following completion of clinical trials and laboratory
testing in accordance with FDA requirements.
Medisys expects the FDA review process will be completed
before the end of the year. FDA approval will enable the
Company to introduce the NiC1800 into the United States
market.
The NiC1800, which is the subject of a number of patent
applications, is capable of instantly destroying hypodermic
needles at point of use.
The system 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.
It was estimated in 1995 that there were more than one million
needlestick injuries in the United States alone in 1994
creating a multi-billion dollar problem for healthcare
providers. On the basis of figures contained in a recent
report by the National Audit Commission on the cost of NHS
medical waste disposal, Medisys estimates the NiC1800 can save
the user more than twenty per cent of annual needle disposal
costs.
The NiC1800 is currently being sold in the United Kingdom,
Europe, Asia and Mexico.
Commenting on the submission, Michael Coy, Managing Director
of Medisys, said:
"Approximately twelve billion hypodermic needles are produced
annually. Any one of these is potentially a carrier of a
debilitating or even deadly disease. In the United States,
the FDA is charged with regulating matters affecting public
health. The FDA has agreed to a review of the PMA application
and a response is expected within 90 days. We believe
that this reflects the concern in the United States with the
growth in the incidence of blood-borne pathogens, such as HIV
and Hepatitis B."
For further information please contact:
Medisys:
Michael Coy 0171 436 3353
Binns & Company:
Peter Binns 0171 786 9600
END
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