Regulatory Approval in Canada
May 20 2004 - 2:44AM
UK Regulatory
RNS Number:8770Y
Maelor PLC
20 May 2004
Maelor plc Granted Regulatory Approval for ContiSol(TM) in Canada
Wrexham, UK, 20 May 2004: Maelor plc, the AIM-listed specialist healthcare
products company, today announced that ContiSol, its own brand of urethral
catheter maintenance solutions, has been approved for use as a medical device in
Canada. This regulatory approval marks a major milestone for the Company, being
the first time that a Maelor product will be available in North America.
ContiSol is a series of products designed to prolong the life of indwelling
urological catheters and to prevent blockages. The range offers an appropriate
choice of agents for the management of catheter problems, such as blockages,
encrustation, and the formation of sediment, all of which may lead to infection.
The container has been designed to enable either medical staff or the patient,
through gentle agitation of the solution in the catheter, to achieve optimal
dissolution and flushing. ContiSol is designed to reduce the need for frequent
catheter change.
Maelor is actively seeking a distribution partner in Canada, and the launch of
ContiSol will take place as soon as possible following this appointment. In the
meantime, Maelor is collaborating in a multicentre clinical trial co-ordinated
by Dr Katherine Moore of the University of Alberta. In this study the use of
ContiSol is to be compared with current clinical practice, which is to replace
urethral catheters when a blockage occurs.
Maelor Chief Executive Stephen Appelbee said: "Prior to this approval, products
such as ContiSol were always considered to be drugs, rather than devices, in
North America. Our team's achievement in persuading Health Canada to reverse
this ruling is not only important locally, but it may have significant
implications elsewhere in the world, particularly in the USA."
ENDS
For further information:
Maelor plc
Stephen Appelbee, Chief Executive Officer 01978 810 153
Financial Dynamics
Ben Atwell/Lucy Briggs 020 7831 3113
Notes to Editors:
Maelor plc
Maelor is an AIM listed specialist healthcare products company. Maelor operates
on a virtual basis, outsourcing both product development and manufacturing, and
outlicensing the sale of its products to distribution partners.
The company has several products on the market including OptiFlo(R), ContiSol
and Volplex(R). OptiFlo, a urethral catheter maintenance range, launched in the
UK in June 1999 and distributed through Bard Limited, has gained a 42% share of
the UK community prescription market, which is estimated to have a value of
around #5 million per annum.
ContiSol, Maelor's own brand urethral catheter maintenance range, has already
been launched in Spain and Greece. The product has also gained approval in
Argentina where launch is expected shortly.
Volplex, the company's blood plasma substitute, is used for patients suffering
from the effects of trauma, surgery or certain medical conditions which result
in hypovolaemia (lower than normal blood volume).
Maelor has various products in its pipeline including micelle propofol, a
reformulation of the world's biggest selling general anaesthetic.
Volplex(R) and ContiSol(TM) are trademarks of Maelor Pharmaceuticals Limited.
OptiFlo(R) is a Trademark of Bard Limited.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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