Author Archives: James Carroll

LumiThera Inc., a commercial stage medical device company creating a photobiomodulation (PBM) treatment for ocular disorders and disease, today announced it is a recipient of a small business innovative research (SBIR) phase II grant from the National Institute of Health (NIH) and the division of the National Eye Institute (NEI).

The phase II grant supports a prospective, randomized, multi-center human clinical trial in U.S. subjects diagnosed with dry age-related macular degeneration (dry AMD.) The LIGHTSITE III trial, which is subject to FDA Investigational Device Exemption (IDE) approval, will test vision and examine disease pathology in the eye following PBM treatments using the Company’s Valeda™ Light Delivery System. Subjects will be followed for up to two years. In 2018, LumiThera obtained a CE mark to commercialize the Valeda™ Light Delivery … Continue reading →

LumiThera Inc., a commercial-stage medical device company focused on developing photobiomodulation (PBM) therapies for ocular disorders and disease, announced a distribution agreement with Optos Plc, a division of Nikon, Inc., Japan to exclusively distribute the Valeda™ Light Delivery System for the treatment of dry age-related macular degeneration (AMD) in 12 European countries. Optos is recognized as the leading provider of ultra-widefield retinal imaging devices to eyecare professionals for improved patient eye care. The announcement follows the recent CE Mark Certification for the European Union (EU) for the treatment of dry AMD utilizing LumiThera’s Valeda™ Light Delivery System.

“The Distribution agreement with Optos allows LumiThera to begin commercialization throughout Europe and establishes a collaboration with a partner in the retinal imaging area,” stated Clark Tedford, Ph.D., LumiThera President and CEO. “Optos is a global leader in ultra-widefield retinal imaging technologies and we are honored to be working with them to open up a new age in the treatment of AMD.”

… Continue reading →

LumiThera® Inc., a commercial-stage medical device company focused on developing photobiomodulation (PBM) therapies for ocular disorders and diseases, announced that it will participate in the combined exhibition of the 18th EURETINA Annual Meeting and the 36th Congress of the European Society of Cataract and Refractive Surgeons (ESCRS), held in Vienna, Austria from the 20th to the 26th of September 2018.

EURETINA actively promotes new diagnostic developments, advances in vitreoretinal surgery, the development and application of new drugs, and changes in the treatment of macular degeneration.

LumiThera will debut the Valeda™ Light Delivery System for the treatment of dry AMD in the exhibition hall and will host a symposium on PBM technology entitled, “Photobiomodulation: An Innovative, Mitochondria-targeted Therapy for Dry AMD and Other Ocular Diseases” on September 20th.

Read the full press release:
LumiThera, Inc. to Debut Valeda … Continue reading →

“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 … Continue reading →