WA-LUMITHERA
LumiThera, Inc., a medical device company commercializing a photobiomodulation (PBM) treatment for ocular damage and disease, today announced a new Category III CPT code effective January 1, 2025. The AMA’s CPT Editorial Panel considered and approved the company’s application for a code to report “Photobiomodulation therapy of retina, single session” at the May 2024 meeting.1
Support for this new Category III code came from many sources; one was LumiThera’s clinical trial. LIGHTSITE III was a prospective, double-masked, randomized, sham-controlled, parallel group, multi-center clinical trial conducted at ten leading US retinal centers. The purpose was to assess the safety and efficacy of photobiomodulation treatment in patients with dry age-related macular degeneration (AMD). The primary efficacy endpoint, best corrected visual acuity (BCVA), was evaluated at 13 months and was significantly improved (p < 0.025). The trial continued for a total 24 months. The 24-month data showed minimal safety risks and high patient compliance with over 80% of the patients completing the six rounds of Valeda PBM treatment sessions.
The analysis included 91 eyes in the PBM treatment group and 54 eyes in the sham-treatment group in the modified intent to treat population with at least 1 post-treatment visit and disease consistent with early/intermediate dry AMD. The results demonstrated statistically significant improvement in the primary endpoint in BCVA at 13 months in the PBM treatment group over the sham-treatment group (p < 0.025). A mean increase in ETDRS letter score of >5.0 letters from baseline was seen at both the 13- and 21-month timepoints in the PBM-treated subjects' BCVA (p < 0.0001). Less patients progressed to new geographic atrophy, a later stage scar that is seen with the permanent loss of retinal tissue.
“Establishing a unique CPT code for PBM use in retina is a positive step toward reimbursement,” stated Kevin J. Corcoran. Kevin is a Principal for Corcoran & Corcoran, a leading advisor on reimbursement for ophthalmic products and services. He said, “Not every application for a new CPT code is successful. Those that succeed, like this one, have support from the professional societies as well as evidence-based medicine published in the scientific literature.”
“In parallel with our De Novo submission to the FDA, this is another important step for dry AMD patients experiencing vision loss who currently have limited treatment options. LumiThera wants patients to have access to non-invasive Valeda treatments to improve vision and address the disease earlier in the process,” stated Clark Tedford, Ph.D., LumiThera President and CEO.
About AMD
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 estimated to increase 7-fold with age, from 4.2% in those aged 45–49 years, to 27.2% in those aged 80–85 years. Globally, the prevalence is estimated to increase by 20% between 2020 (195.6 million) and 2030 (243.3 million).
About LumiThera
LumiThera, Inc. is a medical device company focused on diagnosing, treating, and monitoring ocular disease and damage including dry age-related macular degeneration (AMD), a leading cause of blindness in adults over 65.
LumiThera’s flagship product, the Valeda® Light Delivery System, uses multiwavelength photobiomodulation to treat dry AMD patients. Valeda is CE Marked in the EU and is available in select countries in Latin America. Valeda is not cleared by the Food and Drug Administration (FDA).
AdaptDx Pro® dark adaptation functional testing technology enables eye care professionals to detect and monitor AMD three years before clinical presentation. AdaptDx Pro is available in the US and Canada.
Diopsys ERG and VEP systems help eye care professionals analyze the entire pathway for visual and neuro-visual disorders. VEP is available in the USA and select countries outside the USA. ERG is only available outside of the USA.
LumiThera’s AMD Excellence Program® provides customer implementation, training, best practices, and ongoing support across all brands.
For more information on the Valeda® Light Delivery System please visit www.lumithera.com. The AdaptDx Pro and Diopsys ERG and VEP systems are available separately through LumiThera Diagnostics, Inc. and Diopsys, Inc.
___________________ |
1 AMA. Summary of action of CPT Editorial Panel. https://www.ama-assn.org/system/files/may-2024-summary-of-panel-actions.pdf Accessed 8/6/24 |
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240807248314/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Klarna Launches Tap to Pay for In-Store Purchases Across 14 Markets2.12.2025 09:00:00 CET | Press release
Klarna, the global digital bank and flexible payments provider, today launches the brand new feature Tap to Pay across 14 European markets, bringing flexible payments into physical retail at scale and transforming the Klarna app into an everyday contactless wallet. With more than 80% of European shopping still happening in physical stores, Tap to Pay brings consumers the ease of online shopping into the bricks and mortar stores. Instead of hunting for cards or juggling apps, everything sits in one place — the Klarna app — making every purchase smoother from start to finish. Utilising NFC technology, Tap to Pay turns the Klarna app into a contactless wallet, letting consumers set up a flexible payment plan and pay with a tap, all in one place – without adding their card to another wallet or switching apps at checkout. Tap to Pay builds on the rapid global uptake of the new debit-first Klarna Card, now used by more than 4 million consumers. The card is debit by default, with the option t
SkillOnNet Redefines RNG Gaming with World-First Launch of AI-Powered GAIA Roulette2.12.2025 09:00:00 CET | Press release
GAIA is the world’s first AI-driven roulette host now in commercial use. Global entertainment brand SkillOnNet has announced the launch of GAIA Roulette, a groundbreaking new roulette experience powered by artificial intelligence. The game – which is now live on PlayUZU Mexico, with plans to expand to additional markets across the SkillOnNet network in the coming months – blends the thrill of RNG gameplay with the 3D realism of a live dealer. It’s the world’s first AI-driven roulette host now in commercial use. Unlike traditional RNG tables, GAIA Roulette features an intelligent, interactive digital dealer that is personalized to each player. GAIA learns player preferences, adapts its communication style, and provides real-time assistance, helping users understand bets, game flow, and strategies. Players can discuss game events – asking questions about game results, previous numbers, their wins and losses, and review gameplay history – but they can also talk about everyday topics like
Expedition Growth Capital Raises $375 Million Fund III in First and Final Close2.12.2025 09:00:00 CET | Press release
Fund III is Expedition’s third consecutive fund closed at the hard cap The London and Boston-based firm specialises in minority growth equity investments in domain-expert software & AI companies with a use but not a need for capital Expedition Growth Capital (“Expedition”), a software-specialist growth equity firm, today announced that it has raised its third fund of $375 million, continuing its focus on partnering with rapidly growing companies from across Europe that have built high-quality products and customer bases, without venture capital. The oversubscribed raise was completed in four months, with more than half of commitments from US investors, including leading endowments and foundations. Since its founding in late 2020, Expedition has built a portfolio of 17 bootstrapped software leaders from nine European countries, the majority already operating in North America. Portfolio companies include Dougs, a Lyon-based AI-powered accounting solution used by over 30,000 businesses, e
Payments Modernisation: Gap Between Confidence and Readiness Among Industry Leaders Widens, ACI Worldwide Study Finds2.12.2025 08:00:00 CET | Press release
69% of payments executives see their organisations as leaders, yet fewer than half prioritise innovation as legacy systems and internal resistance slow progress Payments leaders remain confident about the pace of industry innovation, but many risk falling behind as expectations accelerate. New global research from ACI Worldwide (NASDAQ: ACIW) and Globant reveals a widening gap between confidence and readiness that could define industry leadership in 2026 and beyond. The report Payments in Transition: Leadership in an era of transformation, based on a survey of 500 industry leaders across North America, Europe, Latin America, Middle East & Africa, and Asia Pacific, shows that while 69% of executives consider their organisations to be payments leaders, fewer than half (44%) say payments innovation is a C-suite priority. This disconnect is driven by barriers that will become increasingly costly in the year ahead. More than half (55%) of executives admit they are not fully using the techno
Oulu Launches Its European Capital of Culture Year with a Three-day Opening Festival2.12.2025 07:00:00 CET | Press release
The Oulu2026 Opening Festival on 16–18 January 2026 transforms the city centre into a vibrant celebration of culture, community and northern creativity. It marks the beginning of a historic year and invites residents, visitors and partners from Finland, Europe and beyond to take part in a unique moment for Oulu and its 39 partner municipalities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251201071170/en/ In January, Oulu’s city centre will transform into the Oulu2026 Opening Festival area. Photo: Harri Tarvainen / City of Oulu image bank. “After years of preparation, Oulu2026 is finally here. The Opening Festival gives everyone a chance to be part of something that will only happen once, and it all begins in the heart of Oulu,” says Piia Rantala-Korhonen, CEO of Oulu2026. Almost 200 events, over 20 venues The Opening Festival presents a wide range of art and cultural experiences all over the city centre. From exhibitions
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom