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LumiThera Announces Creation of a Light-Based Theranostic Approach to Treat Ocular Disease with Acquisition of Diopsys

The transaction is expected to close in the next few months.

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(PRESS RELEASE) SEATTLE — LumiThera Inc., a commercial stage medical device company offering photobiomodulation (PBM) treatment for ocular damage and disease, announced its entry into a definitive merger agreement with Diopsys, Inc., a leader in modern visual electrophysiology medical devices that help eye care professionals analyze the entire visual pathway for visual and neuro-visual disorders. Under the terms of the agreement, which has been approved by both the stockholders of LumiThera and Diopsys, Diopsys stockholders will receive stock in LumiThera, and Diopsys will become a wholly owned subsidiary of LumiThera. The transaction is expected to close in the next few months.

The acquisition should provide a complementary diagnosis and monitoring platform to LumiThera’s leading treatment platform using Photobiomodulation (PBM) for ocular disease and damage. Electroretinography (ERG) is an established diagnostic test that measures the electrical activity of the retina of the eye in response to a light stimulus. Diopsys brings an established commercial U.S. sales force, and when combined with LumiThera creates a larger global footprint with a significant ophthalmology/optometry customer base as LumiThera approaches the U.S. market. Previously, LumiThera reported the U.S. LIGHTSITE III dry Age-related Macular Degeneration (AMD) trial fully enrolled 100 subjects in 1Q of 2021. The LIGHTSITE III trial is continuing to move forward with the 13-month efficacy timepoint for all patients anticipated in 1Q of 2022.

Earlier this year, LumiThera and Diospys announced final positive topline data from the ELECTROLIGHT pilot study in intermediate dry AMD patients. A total of 23 eyes from 15 subjects with Dry AMD were enrolled into the prospective clinical study and treated with PBM using the Valeda Light Delivery System (3 times per week for 3 weeks) and ERG function was evaluated with the Diospys NOVA ERG system. Multi-luminance ERG improved by 14.4% from baseline (BL) after completion of the Month 1 treatment and showed a 9% improvement at 6 months in the intent to treat (ITT) population. A positive correlation between multi-luminance ERG and best corrected visual acuity (BCVA) was seen (p

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