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™ 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™ 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."
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For further information, please contact:
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CustomVis plc
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Simon Carroll, Chairman
Paul van Saarloos, CEO
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+61 419 304 906
+61 410 497 456
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Merchant John East Securities PLC
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David Worlidge / Simon Clements
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020 7628 2200
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Leander PR
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Christian Taylor-Wilkinson
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07795 168 157
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