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

MSCBCBBGGBBCCRL


MDY Healthcare (LSE:MDY)
Historical Stock Chart
Von Jun 2024 bis Jul 2024 Click Here for more MDY Healthcare Charts.
MDY Healthcare (LSE:MDY)
Historical Stock Chart
Von Jul 2023 bis Jul 2024 Click Here for more MDY Healthcare Charts.