WA-LUMITHERA
7.8.2024 12:43:27 CEST | Business Wire | Press release
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
58% of Consumers Say They Don't Care Whether a Product is a National Brand or Private Label. They Just Buy What They Need21.8.2026 12:00:00 CEST | Press release
New NIQ & World Data Lab report reveals how consumer polarization is redefining value, accelerating private label adoption, and reshaping competition on the shelf As fast-moving consumer goods (FMCG) prices rose 26% globally between 2021 and 2025, consumers have become more deliberate about where they save and where they spend. NielsenIQ (NYSE: NIQ) has released new findings showing that private label is no longer viewed simply as a lower-cost substitute, but as a credible competitor across value, mainstream, and premium segments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260819950224/en/ Private label is no longer just a value play. The findings, published in NIQ’s latest report, A Tale of Two Consumers: The Polarized Mindsets Reshaping Global Consumption, created in collaboration with World Data Lab, show how consumer polarization is redefining value and reshaping competition on the shelf. The report also draws on ins
Tanium Reappoints Co-Founder Orion Hindawi as CEO to Drive Next Chapter of Growth20.8.2026 21:10:00 CEST | Press release
Company to focus on deepening its Autonomous IT capabilities, further expanding AI offerings across its portfolio, and strengthening customer and partner engagement Tanium, a leader in Autonomous IT, today announced that Co-Founder and Executive Chairman Orion Hindawi has been appointed Chief Executive Officer, effective immediately. Dan Streetman is stepping down as CEO and as a member of the Board after leading Tanium for the last three years, during which time Tanium scaled its go-to-market operations and secured strong industry analyst recognition for innovation within the Tanium platform. Streetman will continue to advise Tanium as part of the transition and co-founder David Hindawi will return to the role of Chairman of the Board. With this foundation in place, this transition positions Tanium to deepen its Autonomous IT capabilities and further expand AI offerings across its portfolio and strengthen customer and partner engagement. The Hindawis co-founded Tanium in 2007 to build
PCI Energy Solutions to Join Mitsubishi Electric, Reinforcing Long-Term Commitment to Customers, Employees, and the Energy Industry20.8.2026 19:46:00 CEST | Press release
Mitsubishi Electric to retain PCI’s core management team and support continuity of operations, customer service, and product innovation PCI Energy Solutions ("PCI"), a leading U.S.-based provider of enterprise software for energy management and optimization, announced today that it has entered into a definitive agreement to be acquired by Mitsubishi Electric Corporation. The agreement was executed on August 20, 2026 (Japan Standard Time). The Transaction represents a strong endorsement of PCI's business, technology, employees, customer relationships and position in the energy industry. Mitsubishi Electric intends to retain PCI's core management team following completion of the Transaction, enabling PCI to preserve leadership continuity, industry expertise and its customer-focused operating model while benefiting from Mitsubishi Electric's global scale, complementary capabilities and long-term investment capacity. The agreement has been signed, but the Transaction has not yet closed. PC
Perma-Pipe Secures More Than $67 Million in New Orders in the Second Quarter of 202620.8.2026 19:02:00 CEST | Press release
Awards include significant Oil & Gas projects in MENA and Canada, as well as the Company's largest single leak detection project to date and continued growth at its new Ohio facility. Perma-Pipe International Holdings, Inc. (Nasdaq: PPIH), a global leader in engineered piping and corrosion protection solutions, today announced that the Company secured more than $67 million in new orders during the second quarter of fiscal 2026, representing strong demand across its strategically important end-markets and geographies. The orders further strengthen Perma-Pipe's backlog and provide increased visibility into future revenue growth. The Company's backlog remains well diversified across geographies, customers and end-markets. The Company continued to see strong demand across its core Oil & Gas and infrastructure markets, while also securing important new business in emerging applications, including advanced leak detection and monitoring solutions. During the quarter, Perma-Pipe secured sizabl
Impartner Launches the First CPQ Built for Partners20.8.2026 15:00:00 CEST | Press release
New quote management capability brings configure, price, and quote (CPQ) into Impartner’s PRM platform, connecting product configuration, pricing, segmentation, and approvals. Impartner, the leading partner revenue orchestration platform, today announced the launch ofImpartner CPQ, giving partners a direct path to create and advance quotes within the Impartner PRM platform. The new capability enables faster movement from opportunity to submission while giving vendors control over the rules, products, pricing, and approvals that govern each transaction. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260820479441/en/ Give partners a faster path from opportunity to quote with Impartner's CPQ. For many partnership programs, quoting remains a largely manual process. Partners often depend on vendor sales teams to prepare quotes because traditional CPQ systems are designed primarily for direct sellers or require additional licensin
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