“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.”
Read the full press release:
LumiThera LT-300 Device For Treating Dry Advanced Macular Degeneration Granted CE Mark
Disclosure: I am an investor in Lumithera a) because it successfully treats an unmet medical need, (dry AMD) b) I think it will be the first billion dollar photobiomodulation company.