Presbyopia Approval

 

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               |                       [phone] | 
| Paul van Saarloos, CEO                |                       [phone] | 
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|                                       |                                       | 
+---------------------------------------+---------------------------------------+ 
| Merchant John East Securities PLC                                             | 
+-------------------------------------------------------------------------------+ 
| David Worlidge / Simon Clements       |                         020 7628 2200 | 
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|                                       |                                       | 
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| Leander PR                            |                                       | 
+---------------------------------------+---------------------------------------+ 
| Christian Taylor-Wilkinson            |                         07795 168 157 | 
+---------------------------------------+---------------------------------------+ 
 
 
 
 
 
This information is provided by RNS 
            The company news service from the London Stock Exchange 
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