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 System in Europe for the treatment of dry AMD. A companion post-marketing study (LIGHTSITE II) is being readied for Europe.

“Dry AMD is one of the largest unmet medical needs in medicine and its prevalence is increasing as we live longer,” commented Quan Dong Nguyen, M.D., M.Sc. and Diana V. Do, M.D., both professors of ophthalmology at the Byers Eye Institute, Stanford University School of Medicine. “In ophthalmology, currently, we have no therapies that can be offered to these patients. Both of us and many of our colleagues at Stanford, in the US, and throughout the world recognize the potential that PBM could provide as an early treatment for dry AMD, and if so, can bring significant benefits to millions of patients globally.”

“The LIGHTSITE II and III trials are part of LumiThera’s global efforts to bring forward a treatment for a debilitating eye disease that results in central loss of vision,” stated David Boyer, MD., Retina-Vitreous Associates Medical Group, Los Angeles, CA. “The planned European and US trials would create a novel treatment option for dry AMD patients, who currently have limited choices.”

“The NIH clinical grant is substantial in providing over $2.5M in funding to develop a PBM therapy for dry AMD patients in the U.S.,” stated Clark Tedford, Ph.D., President and CEO. “We are excited to have the NIH/NEI partially support the further development endeavors of LumiThera, and the grant is a significant step in the validation of the PBM technology and its potential in treating chronic eye disease.”

“We are very excited to be part of the LIGHTSITE U.S. multicenter trial.” remarked Richard Rosen, M.D., New York Eye and Ear Infirmary of Mount Sinai. “Several major U.S. centers are participating in this trial, which should help substantiate the clinical benefits of this therapy, reported to date. This trial will measure a variety of clinical and pathological outcomes and establish the long-term benefits of PBM for dry AMD patients.”

View the press release on Lumithera website at www.lumithera.com

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.

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.”

“Optos is pleased to add the Valeda™ Light Delivery System to our product range and to further support eye care professionals to diagnose and manage retinal diseases. This arrangement allows our customers to visualize AMD in the far periphery with color and autofluorescence ultra-widefield retinal imaging and provide a PBM treatment for dry AMD. This is very important for the patients who have this complicated, degenerative disease,” stated Robert Kennedy, Chief Executive Officer, Optos.

LumiThera recently sponsored a symposium on PBM in ocular disease and presented final data from the LIGHTSITE I study at the Euretina conference in September 2018 and has a multi-center trial in Europe planned to begin in the near term to further support clinical, anatomical, and patient benefits with the Valeda™ Light Delivery System. The therapy consists of a series of light-based treatments to the retinal cells, resulting in improved energy production and addressing inflammation, ischemia and metabolic dysfunction that contribute to the disease.

View the press release on Lumithera website at www.lumithera.com

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.

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 Light Delivery System at the 18th Congress of the EURETINA

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.

“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.