RNS Number : 0034S
CustomVis plc
11 May 2009
Embargoed until 7am 11 May 2009
CUSTOMVIS PLC
('CustomVis' or 'the Group')
Moorfields Eye Hospital trials and Trading Update
CustomVis (AIM: CUS), the leading developer, manufacturer and distributor of solid state laser systems for the refractive surgical industry is pleased to announce that trials of the Pulsar Z1 laser will commence shortly at Moorfields Eye Hospital and provides an update on its trading activities.
-
Installation of three Pulzar™Z1 Lasers taking installed base to 40 lasers in 19 countries
-
Clinical Trials to commence at Moorfields Eye Hospital in London
-
European key opinion leader finds Pulzar™Z1 laser as good as, or better than excimer laser for efficacy, safety and stability of refractive surgery
-
Appointment of new CFO and Company Secretary
-
Tracey Technologies Inc signs an exclusive distributor agreement for Australian and New Zealand Distributorship for the iTrace device.
-
Appointment of Regulatory Affairs Manager
Three new lasers have been installed since the announcement of the interim results for the six months ended 31 December 2008 on 19 March 2009, taking the installed base to 40 lasers in 19 countries. The year-to-date number of lasers installed is now 12 compared with 11 for the previous full year of trading. Two lasers were installed in Saudi Arabia and one in Pakistan. Strong interest in the Pulzar™Z1 laser was shown at the Middle East African Council of Ophthalmology (MEACO) Congress 2009 meeting in Bahrain in March, 2009. Following the recent American Society of Cataract and Refractive Surgery (ASCRS) Conference held in Los Angeles in April 2009, where clinical papers were presented on the laser, sales inquires have increased further.
In another first for CustomVis, the world renowned Moorfields Eye Hospital in London has agreed to conduct clinical trials for laser vision correction using the Pulzar™Z1 laser. Refractive surgeons leading the trials anticipate commencing in June 2009. This is a major step forward by the Group demonstrating increased confidence by the ophthalmology profession in the laser.
The Group has recently appointed Mr Stuart Usher (aged 40) as Chief Financial Officer and Company Secretary to replace Mr Stephen McRae, who resigned to pursue other interests. Mr Usher brings extensive experience in management and corporate affairs of public listed companies including companies in the ophthalmic industry. Mr Usher is a Certified Practising Accountant of Australia, an Associate Member of the Institute of Chartered Secretaries and Administrators (UK) where he has attained the status of Chartered Company Secretary. He will not be joining the Board at this time.
At the ASCRS Conference, held in April 2009, Professor Pallikaris, one of Europe's key ophthalmic surgeons, submitted an abstract of his comparative study between the Pulzar™Z1 solid state laser and the Allegretto 400, an excimer laser. In his abstract, Professor Pallikaris stated that the 12 month follow-up study demonstrated the Pulzar™Z1 laser to be as good as, or superior to, the excimer laser in terms of efficacy, safety and stability of the refractive surgery results. 96% of the examined eyes treated with Pulzar™Z1, compared with 89% treated with the excimer laser, were within the target of +1.00/-1.00 D for photorefractive keratectomy (PRK) while 35% with Pulzar™Z1 and 31% with excimer gained more than 1 line of correction with LASIK. Professor Pallikaris concluded that both systems are safe for correction with PRK and LASIK.
The Company and Tracey Technologies Inc have signed an exclusive distribution agreement for Australia and New Zealand for the iTrace device. Tracey Technologies is the US manufacturer of the iTrace, a medical device using wave-front aberrometry with corneal topography used widely to measure quality of vision and visual function. CustomVis has a worldwide non-exclusive sales agreement for the iTrace allowing it to be sold with the Group's Pulzar™Z1 laser.
The Company has recently appointed Pauline Vitari as its Regulatory Affairs Manager. Ms Vitari has worked in the US for three years in the area of ophthalmic medical device clinical trials and regulatory affairs. She gained valuable experience in US FDA requirements which will be of benefit to CustomVis when it seeks FDA approval for the Pulzar™Z1 laser. More recently, she was located in Spain for two years gaining further expertise in the requirements of conformity under the CE Mark. Importantly for CustomVis, this last position also saw Ms Vitari running European clinical trials for a presbyopia procedure. In her new role she will work closely with the Board to expedite regulatory approval for the Company's own presbyopia procedure.
-ends-
For further information, please contact:
CustomVis plc
Simon Carroll, Chairman +61 419 304 906
Paul van Saarloos, CEO +61 410 497 456
John East & Partners Limited
(A subsidiary of Merchant Securities plc)
David Worlidge 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
MSCEASSFFADNEEE