SEATTLE , July 26, 2022 /PRNewswire/ — LumiThera Inc., a commercial stage medical device company offering photobiomodulation (PBM) treatment for ocular damage and disease, today announced the purchase of MacuLogix assets by its wholly owned subsidiary. MacuLogix, Inc., is the leader in early diagnosis of dry Age-related Macular Degeneration (AMD) patients and developer of the particular wearable AdaptDX Pro ® dark adaptometer. The device allows eye care professionals to measure darkish adaptation, which is used to diagnose dry AMD in individuals earlier than any other technology. The particular AdaptDx Pro, launched within 2020, is available for sale in the US, Canada , EU and other countries.
“The core technology measures the inability to visually adapt to low levels of light, a key clinical marker seen in sufferers with early AMD. Dark adaptation technologies has been validated in 42 peer-reviewed papers, ” stated Greg Jackson , Ph. D., former MacuLogix Chief Technology Officer plus Co-Founder. “Over 1 million AdaptDX tests have been performed and about 200, 000 patients have been newly diagnosed. inch
LumiThera’s announcement follows the release of its positive 13-month U. S. LIGHTSITE III treatment data in intermediate dry Age-related Macular Deterioration (AMD) patients with the particular Valeda ® Light Delivery System. The LIGHTSITE 3 trial enrolled 100 subjects, who are receiving Valeda treatments every 4 months. A 13-month efficacy timepoint with regard to all individuals met the predesignated primary best corrected visual acuity endpoint with a statistically significant improvement over the sham group (p = 0. 02). The study showed improvements in best corrected visual acuity within intermediate dry AMD topics with over 50% showing a line or better improvement on the eyechart with the mean associated with 9. 7 letters gained for the responders. The pivotal U. H. study and previous medical studies will support FDA submission regarding potential ALL OF US approval. Valeda will be currently approved in Europe and several countries in Latin America .
In March, LumiThera announced the particular acquisition of the Diopsys ® Visual Evoked Potential (VEP) plus Electroretinogram (ERG) vision testing technology. The Diopsys product line, is usually an established diagnostic and monitoring system that steps the electrical activity of the particular retina of the eye in response to a light stimulus, providing a quantitative vision measure to assist in diagnosis and monitoring of vision disease.
“AdaptDx Pro can identify dried out AMD sufferers at the earliest timepoint, in advance of pathology, and before vision loss, ” stated Clark E. Tedford , Ph. Deb., President plus CEO, LumiThera, Inc. “The AdaptDx wearable, light-based earlier diagnostic intended for dry ADVANCED MICRO DEVICES adds a complementary assessment of retinal health in order to the LumiThera product line, further expanding LumiThera’s synergistic platform associated with products to get eye treatment professionals. We are excited to combine analysis, treatment, and monitoring platforms to provide a complete solution pertaining to dry AMD patients. ”
AMD is a leading cause of vision loss for people aged 65 and older. Losing central vision can make it harder to see faces, drive, or do close-up work like cooking or fixing things around the house. The overall prevalence of AMD is definitely estimated to increase 7-fold with age, from 4. 2% in those aged 45–49 years, to 27. 2% in all those aged 80–85 years. Globally, the prevalence is estimated to increase by 20% between 2020 (195. 6 million) plus 2030 (243. 3 million).
MacuLogix, Inc. equips eye care professionals along with the instrument, tools and education needed to effectively manage patients with age-related macular degeneration (AMD) by leveraging the science of dark adaptation through its AdaptDx ® and AdaptDx Pro ® guided by Theia™. Dark adaptation functional screening technology through MacuLogix enables eye treatment professionals in order to detect, monitor and treat AMD three years before it can be seen clinically. MacuLogix’s ADVANCED MICRO DEVICES Excellence Program ® provides each customer along with in-practice training and treatment best practices to support the particular implementation plus optimization associated with dark version testing. Visit www.maculogix.com for additional information.
Diopsys, Incorporation. is a leader in modern visual electrophysiology medical devices that help eye care professionals analyze the entire visible pathway meant for visual and neuro-visual disorders. The company provides Visual Evoked Potential (VEP) vision tests technology.
LumiThera is really a commercial-stage medical gadget company focused on treating people affected by ocular harm and illness including dry age-related macular degeneration, a leading cause of blindness within adults more than 65. The company is a leader in the use of PBM for therapy of visual disorders. The organization is commercializing the particular office-based Valeda ® Light Delivery System to be used by eyecare providers as medical treatments.
The particular Valeda Gentle Delivery Program has been granted authorization in order to use the CE Mark by an EU Notified Body because required designed for commercial use in the European Union only. Valeda is available in select countries in Latin The united states . Valeda is not approved just for use by the Food & Drug Administration (FDA) in the USA .
Visit the particular Company’s website at www.lumithera.com .
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SOURCE LumiThera Incorporation.