Ramat Gan, Israel, August 9th, 2009- IOptima of the Israeli Based Bio-Light group (TASE: BOLT) announces that it has received CE approval for its OT-134 Laser based system, known also as IOPtiMateTM , for the non invasive filtration treatment of Glaucoma.
IOPtima, a leading Israeli based company focused in the development and commercialization of advanced technologies for Glaucoma treatment, developed a novel CO2 laser based system (IOPtiMate TM) which enables the performance of a swift simplified, efficient and cost effective filtration procedure for the alleviation of Intra Ocular Pressure. The IOPtiMate TM is a breakthrough technology which enables practitioners to provide a safe and efficient solution to relieve excessive intra ocular pressure which is the primary cause of damage to the optic nerve in glaucoma patients, and is expected to compete as the preferred first line of glaucoma treatment.
Dr. Joshua Degani, IOPtima CEO stated: “Upon the achievement of CE regulatory approval of our first product we have graduated the R&D phase of the company and we are gearing ourselves towards commercializing the product. The Company has an agreement with a US based producer for an initial supply of the IOPtiMate TM and is preparing for the distribution phase of the product.”
IOPtima is continuing in parallel its process in the US towards achieving FDA approval of the IOPtiMateTM in the US and hopes to be granted such approval during 2010.
Dr. Degani added that the CE regulatory approval was achieved in a relatively short period due to the compelling safety and efficacy data achieved by the Company in its multi center clinical trials conducted across three continents. The outcome of the CE regulatory approval is that the IOPtiMateTM can now be clinically and commercially implemented in all European and other jurisdictions which accept the CE as a binding regulatory guideline.
IOptima is currently setting the foundations for distributing and implementation of the IOPtiMate TM in Europe, where the Company intends to implement a Pay Per Procedure model through cooperation with a strategic partner. The Company has already begun implementation of its Pay Per Procedure model in conjunction with a strategic partner in India.
About the Glaucoma Market:
It is estimated the approximately 57.5 million people worldwide suffer from Glaucoma, which is a chronic disease requiring constant treatment. The cost of medication treatment of Glaucoma, the currently most common form of treatment, is estimated to be above $3 Billion every year. Such medications, though initially effective, are challenged by very poor patient compliance and, at times, limited long term efficacy.
In the US, Glaucoma is said to be the second most common cause for blindness and it is estimated that over 3 million people in the US over the age of 40 suffer from Glaucoma and worldwide’ there are over 15 million people at risk of eyesight loss due to the sickness. There are currently over 500,000 procedures performed annually for various treatments of Glaucoma in the US alone and this number is expected to increase substantially with the introduction of a safe and efficient procedure, such a the IOPtiMate TM.
In parallel, IOPtima is in advanced stages of completion of the OT-135, the next generation of the IOPtiMate TM.
Dr. Ami Eyal, CEO of Bio-Light, IOptima’s parent company, currently in India as part of implementation process of the IOPtiMate TM in central clinical sites in India added: “IOPtima is a success story from our perspective, after achieving CE mark for its lead product within budget and accordance with the workplan set out. The foundations of IOptoima’s initial pay per procedure set up in India, together with our strategic partner have been put in place and so far all the centers participating in the clinical demonstrations have been very enthusiastic of the IOPtiMate TM system and its potential impact on Glaucoma treatment.”
IOptima is a subsidiary of Bio-Light, Israeli Life Sciences Investments Ltd., a management and holding company specializing in developing Life Sciences developments. Bio-Light is traded on the Israeli Stock Exchange under the symbol TASE:BOLT.
