26 February 2014
Ellex Secures CE Mark for 2RT in Treatment of Early Stage Age-Related Macular Degeneration (AMD)
- CE Mark for 2RT for laser treatment of early stage AMD secured
- This world-first treatment now available for limited roll out to key clinical sites in Europe, Australia, New Zealand, and in several South East Asian, Middle Eastern and South American countries
Adelaide, Australia, 24 February 2014 – Ellex Medical Lasers Limited (ASX:ELX), a pioneer in medical technologies for the diagnosis and treatment of eye disease, today announced that it has secured a CE Mark (Conformité Européenne) for its proprietary Retinal Rejuvenation Therapy (2RT™) laser treatment of early Age-Related Macular Degeneration (AMD). The leading cause of blindness in the developed world, AMD is a chronic eye disease that can result in vision loss in the central field of vision, including blurred central vision or a blind spot. There are no other approved treatments for the early form of AMD. Current treatment options are restricted to targeting the late form of the disease, referred to as Wet AMD, which only accounts for approximately 10-15% of all people who suffer from AMD. This represents a significant market opportunity for 2RT™. “2RT is a laser treatment of early stage AMD. Unlike current treatments, which only target the late-stage complications associated with AMD, with 2RT we aim to treat the disease before complications set in.” commented Ellex CEO, Tom Spurling. The CE Mark will allow the Company to move forward with a commercial program for 2RT in the treatment of early AMD and facilitates product sales in Europe, Australia, New Zealand, and in several South East Asian, Middle Eastern and South American countries. “With the CE Mark now in place we will commence our commercial program with a limited roll-out of the 2RT laser to a number of key clinical sites. This is a necessary step in validating, and expanding upon, the clinical findings we so far have for 2RT, and will ultimately support a wider roll out of the product and future sales growth. ” said Mr. Spurling.
ABOUT AMD Age-Related Macular Degeneration (AMD) affects one in seven Australians over the age of 50 (Source: report prepared for Macular Disease Foundation, Access Economics). The economic impact and cost of AMD is high, and is estimated to directly cost the Australian community more than AU$2.6 billion annually (Source: CERA). Current treatment options for AMD only address advanced or end-stage complications associated with the disease. In contrast, 2RT™ offers the potential to apply treatment earlier in the disease process, with the aim of slowing or reversing the process of degeneration, and hence delaying, or preventing, late stage disease. ABOUT 2RT Retinal Rejuvenation Therapy (2RT™) delivers nanosecond pulses of laser energy to stimulate a natural, biological healing response in the eye to stimulate a process of cellular rejuvenation to preserve and/or improve functional vision, reducing disease progression. These nanosecond pulses create micro-bubbles around retinal pigment epithelium (RPE) melanosomes, without causing heat to escape beyond the RPE cell walls. These micro-bubbles cause damage to the internal cell structure only: they do not break the cell’s outer membrane. This process of regeneration rejuvenates the entire transport mechanism of the retina, improving visual function and 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. ABOUT ELLEX Ellex Medical Lasers Limited (ASX:ELX) is a pioneer in the development of medical technologies for the diagnosis and treatment of eye disease. Since 1985, Ellex has evolved 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. Today, more than 20,000 Ellex laser and imaging systems are used worldwide in the fight against blindness. Ellex also leverages its sales network by distributing a number of complementary third-party ophthalmic products. Recently Ellex acquired the canaloplasty micro catheter glaucoma treatment, a recurring revenue stream, which Ellex manufactures at a plant in Menlo Park, California
Tom Spurling, CEO Ellex Medical Lasers Limited 82 Gilbert Street, Adelaide, SA, 5000 W +61 8 8104 5293 | M +61 417 818 658 firstname.lastname@example.org Victor Previn, Chairman Ellex Medical Lasers Limited 82 Gilbert Street, Adelaide, SA, 5000 W +61 8 8104 5200 | M +61 414 661 994 email@example.com Maria Maieli, Company Secretary Ellex Medical Lasers Limited 82 Gilbert Street, Adelaide, SA, 5000 W +61 8 8104 5200 firstname.lastname@example.org