Author Archives: James Carroll
LumiThera Enrolls First Patient in the U.S. Multi-Center, LIGHTSITE III Clinical Study to Treat Dry Age-Related Macular Degeneration
SEATTLE, Oct. 1, 2019 /PRNewswire/ — LumiThera Inc., a commercial stage medical device company delivering photobiomodulation (PBM) treatment for ocular disorders and disease, today announced it has begun enrolling patients in a multi-center United States clinical study in dry Age-Related Macular Degeneration (AMD) patients.
The randomized, multi-center study called LIGHTSITE III enrolled and treated the first patient at Cumberland Valley Retina in Hagerstown, Maryland. The United States study is being conducted in leading retinal centers throughout the United States. The study will enroll approximately 100 patients suffering from dry AMD and treat them over the course of two years. In addition to demonstrating safety, key efficacy endpoints include visual acuity, contrast sensitivity and reduction of drusen deposits.
In February, the company announced that the National Institute of Health and the division of the National Eye Institute was providing a $2.5M grant to partially support the U.S. study.
“This is an … Continue reading
SEATTLE, June 12, 2019 /PRNewswire/ — LumiThera, Inc. and Product Creation Studio today announced that LumiThera’s Valeda Light Delivery System has been honored with a silver award in the 21st Annual Medical Design Excellence Awards competition. The 2019 winners were announced at the MDEA Ceremony on Tuesday, June 11, 2019 in conjunction with the MD&M East event in New York, New York.
LumiThera, Inc. is a leader in the use of photobiomodulation for the treatment of acute and chronic ocular diseases and disorders. Age-related macular degeneration (AMD) is the leading cause of blindness in adults over 65. Product Creation Studio worked with LumiThera from product concept through transfer to manufacturing to design and engineer a medical device that would accurately, safely, and effectively treat patients suffering from dry AMD. The resulting Valeda Light Delivery System is currently the only approved treatment using 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 … Continue reading
Those suffering from America’s opioid crisis recently received two major messages of hope.
On Oct. 24, President Donald Trump signed the Opioid Crisis Response Act (OCRA) into law. Dozens of bills designed to address the diverse aspects of the opioid crisis were consolidated into one strategic and integrated approach.
OCRA received overwhelming bi-partisan support in both Chambers.
HR6, which is now Public Law 115-2716, broke new ground in being the first legislation to mandate aggressive development and adoption of alternative pain treatments that include “innovative medical technologies for pain management.”
On Oct. 11, Congress held its first ever briefing on ending opioid use through “innovative medical technologies for pain management.”
Photobiomodulation (PBM) was the featured technology.
Read the full news story on newsmax.com
LumiThera and Optos Announce Collaboration to Commercialize the Valeda™ Light Delivery System for Treating Dry Age-Related Macular Degeneration in Europe
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 … 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.
36 Photobiomodulation therapy papers published in February 2018. Highlights include:
- DNA repair mechanisms, modulation of telomere maintenance
- Improved motor response in patients with spinal cord injury
- Prevention of < grade 2 radiodermatitis in breast cancer patients (RCT)
- No adverse effects on SCC primary cancer, recurrence or survival
- Improved physiological and performance parameters in runners
- Improved depth of anaesthesia during endodontic treatment