The "CE" mark is the abbreviation for Conformité Européenne, meaning European Conformity. CE marking is a certification that indicates conformity with health, safety, and environmental protection directives for products sold within the European Economic Area (EEA).
"The CE mark allows LumiThera to begin commercialization throughout the 28 EU member states and coincides with the initiation of the LIGHTSITE II Clinical Study in select European sites in the upcoming months," stated Clark Tedford, Ph.D., LumiThera President and CEO. "We are excited to be able to offer a safe and effective early stage clinical intervention for patients with dry AMD."
"It is very exciting to see the development of PBM treatment for dry AMD patients," stated Samuel Markowitz, M.D., Department of Ophthalmology and Vision Sciences, University of Toronto. "These patients have limited options and losing their central vision is horribly debilitating to their quality of life. The previous LIGHTSITE I Clinical Studies demonstrated that PBM therapy was most beneficial in early stage dry AMD patients. It was also determined that retreatments at scheduled intervals will be needed to maintain clinical benefits."
"PBM may change the way we think about treating dry AMD," says Dr. Robert Devenyi, Ophthalmologist-in-Chief and Director of Retinal Services, UHN, University of Toronto. "Until now we just waited and watched the patients lose vision with limited therapeutic options. Now we may have a treatment that can target improvement in visual outcomes and reduce a key component of the pathology. The next step is to confirm the early results in the multi-center LIGHTSITE II trial and work with ophthalmology medical community in establishing best treatment practices."
Visit the Company's website at http://www.lumithera.com.
About LumiThera Inc.
LumiThera is a commercial-stage medical device company focused on treating people affected by ocular disorders and diseases including dry age-related macular degeneration, a leading cause of blindness in adults over 65. The Company is a leader in the use of Photobiomodulation for treatment of acute and chronic ocular diseases and disorders. The Company is developing the office-based LT-300 Light Delivery System to be used by ophthalmologists and other eye specialists as non-invasive medical treatments.
The device has been granted authorization to use the CE Mark by a EU Notified Body as required for commercial use in the European Union only. The LT-300 is not yet approved for use by the Food & Drug Administration (FDA) in the USA.