Presbyopia Approval
06 November 2009 - 8:34PM
UK Regulatory
TIDMCUS
RNS Number : 1047C
CustomVis plc
06 November 2009
6 November 2009
CUSTOMVIS PLC
("CustomVis" or "the Group")
Presbyopia Approval
CustomVis (AIM: CUS), the leading developer, manufacturer and distributor of
solid state laser systems for the refractive surgical industry is pleased to
announce it has been granted approval for its presbyopia treatment by the
Therapeutic Goods Administration ("TGA"), Australia's regulatory agency for
medical drugs and devices.
The approval is a major achievement for the Group, becoming one of the first
refractive laser developers in the world to be granted regulatory approval for
the treatment of presbyopia. As well as Australian approval, the treatment has
been granted European CE approval, allowing the procedure to be carried out
within the European Union. The Directors believe this is the first presbyopia
treatment of this method of laser surgery to receive CE approval.
Presbyopia is an age-associated progressive loss of the focusing power of the
eye's lens, making it difficult to see objects close-up. Most people over the
age of 40 will suffer from it to some degree and current treatment options are
limited, generally meaning the use of reading glasses, bifocal glasses or the
invasive insertion of intraocular lenses, none of which offer a true solution.
CustomVis, over the past few years, has pioneered a technique which will restore
close-up vision while the patient retains good long distance sight.
The Group's installed base of Pulzar Z1 lasers will be capable of conducting the
PresBvis(TM) presbyopia treatment through this regulatory approval. The Group
expects to conduct simple software upgrades over the next two months, thereby
allowing surgeons operating the Pulzar Z1 lasers to begin offering this
treatment to their patients shortly.
PresBvis(TM) users will be charged on a per-patient basis, bringing a new cash
flow stream into the business, with fees paid in advance to CustomVis for each
treatment performed.
Dr. Paul van Saarloos, Chief Executive of CustomVis, commented, "Being one of
the first laser developers in the world to offer this highly specialised
treatment for a very common problem will give us a big competitive advantage. As
well as being a new and additional source of revenue for the Group we anticipate
it will lead to expanded sales of the Pulzar Z1."
-ends-
For further information, please contact:
+---------------------------------------+---------------------------------------+
| CustomVis plc | |
+---------------------------------------+---------------------------------------+
| Simon Carroll, Chairman | +61 419 304 906 |
| Paul van Saarloos, CEO | +61 410 497 456 |
+---------------------------------------+---------------------------------------+
| | |
+---------------------------------------+---------------------------------------+
| Merchant John East Securities PLC |
+-------------------------------------------------------------------------------+
| David Worlidge / Simon Clements | 020 7628 2200 |
+---------------------------------------+---------------------------------------+
| | |
+---------------------------------------+---------------------------------------+
| Leander PR | |
+---------------------------------------+---------------------------------------+
| Christian Taylor-Wilkinson | 07795 168 157 |
+---------------------------------------+---------------------------------------+
This information is provided by RNS
The company news service from the London Stock Exchange
END
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