LumiThera
LumiThera develops photobiomodulation (PBM) treatment protocols for dry age-related macular degeneration (AMD) and other ocular diseases, with its Valeda® Light Delivery System under clinical research. The company has received multiple recognitions and grants, including a Small Business Innovation Research grant and awards for innovation in medical technology.
Company Background
LumiThera is focused on developing photobiomodulation (PBM) treatment protocols for patients with dry age-related macular degeneration (AMD). The company's research and development efforts are primarily centered around the Valeda® Light Delivery System, which is being studied for the treatment of dry AMD and other ocular diseases and disorders. Despite significant advancements, the Valeda® Light Delivery System is not yet approved for sale in the United States.
Clinical Research
LumiThera is actively involved in clinical research to substantiate the use of PBM therapy for dry AMD. One of their significant studies, LIGHTSITE I, is the first prospective, sham-controlled, double-masked clinical trial aimed at evaluating PBM's effectiveness in patients with dry AMD. Results from this study indicated clinical improvements in both visual and anatomical outcomes. The ongoing EUROLIGHT Registry Study is another important initiative to assess long-term benefits of PBM treatment using the Valeda® Light Delivery System.
Valeda® Light Delivery System
The Valeda® Light Delivery System (LT-300), LumiThera's flagship product, is designed to treat dry AMD and other ocular disorders through PBM therapy. This system has received notable accolades, including the 2016 MD&M West Innovation Prize. Despite promising results and recognition, Valeda® is not approved for sale in the United States. The system aims to leverage PBM to promote cellular health by stimulating mitochondrial activity, a process vital to ocular health and disease mitigation.
Research Grants and Financial Support
LumiThera has secured multiple grants and financial support to further their research and development. The company received a Small Business Innovation Research (SBIR) grant from the National Institute of Health and the National Eye Institute. Additionally, a National Eye Institute grant was awarded to support a third year extension to the LIGHTSITE III clinical trial. In terms of financial backing, LumiThera completed a debt financing round with Leste Clearway and Serengeti Asset Management, receiving $5.5 million to support integration, growth, and commercial expansion.
Acquisitions and Expansions
In a strategic move to enhance their capabilities in early diagnosis of dry AMD, LumiThera acquired MacuLogix assets. Furthermore, their subsidiary, Diopsys, Inc., recently relocated to expanded headquarters in Cedar Knolls, New Jersey. These actions signify LumiThera's commitment to advancing their technological footprint and expanding their reach in the medtech industry.