FDA Market Approval
06 Juli 2000 - 9:14AM
UK Regulatory
RNS Number:4284N
Medisys PLC
6 July 2000
MEDISYS PLC
("Medisys" or the "Group")
Futura Safety Syringe Receives FDA Market Approval
Medisys announces that it has received notice from the US Food
and Drug Administration ("FDA") that the 3ml model of its
Futura safety syringe has been approved for sale in the United
States. FDA market approval is a vital step in the Group's
plans for the launch of the Futura syringe and enables Medisys
to proceed to the next stage of its launch programme.
The Futura safety syringe is an innovative syringe with a
patented elastomer based mechanism for retracting the needle
following use. The syringe has been developed by Medisys in
response to the growing demand for medical safety products
that address the problem of needlestick injury. It has
initially been developed in a 3ml model and is also being
developed in 1ml, 5ml and 10ml models. The Group believes
that the design of the product will facilitate high volume,
low cost manufacture making it highly price competitive with
existing safety syringes.
Futura Medical Inc., the Medisys subsidiary with
responsibility for the Futura syringe, is currently
concentrating on the implementation of its manufacturing and
marketing strategies prior to the US market launch of the
product in the final quarter of 2000.
Manufacturing Strategy
Futura Medical intends to use multiple OEM suppliers to
manufacture the Futura syringe, while retaining ownership of
the moulds and other key equipment to ensure maximum
production flexibility and control over the production process
and product cost. The OEM suppliers will be strategically
located to serve key geographic markets. The manufacturing
programme is on schedule, with the first full-scale production
plants in Southern California and Singapore planned to begin
pilot production before the end of this calendar year.
Production agreements for other geographic markets are under
negotiation and Medisys plans to have high volume capacity in
place during the second half of 2001.
Sales & Marketing Strategy
Futura Medical is also developing and implementing a detailed
sales and marketing plan for the Futura syringe. The plan
envisages a two-tier approach to maximise market and customer
coverage.
A strong in-house marketing team, assembled from some of the
world's leading medical products companies, is now in place
and the sales programme will utilise Futura Medical's existing
infrastructure which already has an established customer and
distributor base throughout the US. Futura Medical will also
explore opportunities for strategic marketing alliances with
large healthcare distributors and leading suppliers of
conventional disposable syringes.
David Wong, Chief Executive Officer said: "FDA market approval
was a critical milestone in the development of the Futura
syringe. The Futura Medical team is now concentrating on
achieving production scale-up at our two initial OEM
manufacturing sites and the first multi-cavity production
moulds are currently being cut. We believe that the
capability to supply US customers in high volume will be
crucial to our future success and we have put in place a
manufacturing strategy that will make this possible.
"Our experienced in-house sales and marketing team at Futura
is well advanced in its plans for the market launch and
discussions with the large suppliers and distributors of
conventional disposable syringes are ongoing. With 15 US
states now having passed legislation mandating the use of
safety syringes, the momentum for their adoption is growing
rapidly. Medisys is committed to reducing the risk of
needlestick injury through the successful introduction of cost
effective alternatives and the Group remains well placed to
capitalise upon this very significant market opportunity."
Enquiries:
Medisys PLC 020 7663 5602
Michael Barry, Chief Financial Officer
Square Mile Communications 020 7601 1000
Kevin Smith/Becky Jewers
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