18 July 2012
Ellex Secures CE Mark for Breakthrough Retinal Rejuvenation Therapy
Adelaide, Australia, 18 July 2012 – Ellex Medical Lasers Limited (ASX:ELX), a global leader in ophthalmic laser and imaging technology, today announced that it has secured a CE Mark (European Conformity) for its breakthrough Retinal Rejuvenation Therapy (Ellex 2RT™).
According to Ellex CEO, Mr. Tom Spurling: “This CE Mark has a global significance. The 2RT therapy materially changes the decision making process of patients and ophthalmologists faced with the prospect of retinal treatment with a laser. We call it a “cool” laser to emphasise the pain-free and damage-free outcomes for the patient. We expect that 2RT therapy will radically alter the risk/benefit assessment of patients by ophthalmologists.”
“Ellex is proud to begin the roll-out of this patented technology, particularly in light of strong interest from the European market.”
“The CE Mark specifically facilitates product sales in Europe, Australia, New Zealand, several SE Asian, Middle East and South American countries. Furthermore, it forms a foundation for registration of the product in Japan and China,” added Mr Spurling.
Following successful clinical studies, European ophthalmologists will now be able to use Ellex 2RT™ to treat Diabetic Macular Edema (DME), a common symptom of Diabetic Retinopathy that causes a decrease in visual acuity. Diabetic Retinopathy is a common complication of diabetes and affects more than 2.5 million people worldwide. Ellex 2RT™ is also undergoing clinical trials for the treatment of Early Age-Related Macular Degeneration (AMD), the leading cause of blindness in the developed world.
Ellex 2RT™ delivers nanosecond pulses of laser energy to stimulate a natural, biological healing response in the eye to treat retinal disease. Importantly, this technique allows therapeutic benefit to be achieved without the collateral thermal damage and pain associated with conventional retinal laser treatment.
Ellex Medical Lasers Limited (ASX:ELX) is a global leader in the design and manufacture of ophthalmic laser and ultrasound systems used by ophthalmologists to diagnose and treat eye disease. With more than 16,000 systems delivered to the market, Ellex has evolved since 1985 from a manufacturing company of primarily OEM products, to direct marketing of its own branded products through subsidiaries in the United States, Japan, Germany and Australia, and a network of distribution partners in more than 100 countries. In recent years, Ellex has diversified its product range beyond lasers and ultrasound equipment to include distribution of a number of complementary third-party ophthalmic products.
ABOUT ELLEX 2RT
Over 10 years in the making, Retinal Rejuvenation Therapy (Ellex 2RT™) is a non-thermal laser therapy that stimulates a natural, biological healing response in the eye. Unlike conventional laser treatment, Ellex 2RT does not cause permanent collateral damage to the sensitive structures of the eye.
The Ellex 2RT™ laser applies short nanosecond pulses of low-energy light to stimulate a process of cellular rejuvenation to preserve and/or improve functional vision, reducing disease progression. This breakthrough approach retains the therapeutic effect of laser therapy whilst eliminating the thermal tissue damage inherent in conventional retinal photocoagulation laser treatment.
Ellex 2RT™ is performed using a novel laser device designed and manufactured by Ellex.
ABOUT DIABETIC RETINOPATHY
Diabetic Retinopathy is a common complication of diabetes. A progressive eye disease, it causes damage to the light sensitive film at the back of the eye, known as the retina. If left untreated, this can result in visual impairment and blindness. So acute is the problem that Diabetic Retinopathy is now included on the World Health Organization’s (WHO) priority list of diseases. The most common form of the disease, known as Diabetic Macular Edema (DME), occurs when fluid from this abnormal blood vessel growth leaks into the centre of the retina.