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
Fortegra Completes Acquisition by DB Insurance29.5.2026 22:30:00 CEST | Press release
The Fortegra Group, Inc. ("Fortegra"), a global specialty insurance company, today announced the completion of its acquisition by DB Insurance Co., Ltd. ("DB"), one of Korea's leading property and casualty insurers. The transaction, announced on September 26, 2025, received all required regulatory and stockholder approvals. Fortegra will operate independently, maintaining its existing leadership team, distribution relationships, and underwriting discipline. Agents, distribution partners, and customers will continue to experience the service excellence that has defined the Fortegra experience. Richard Kahlbaugh, Chairman and CEO of Fortegra, said: "Every company eventually changes ownership. That is the nature of business. The closing of this acquisition is a starting point. As part of DB Insurance, Fortegra is positioned to expand our business geographically, enhance our capabilities and deepen our market presence in the US, Europe, the United Kingdom and Asia. Together, DB Insurance a
SINOVAC Receives Nasdaq Notification Regarding Late Filing of 2025 Annual Report29.5.2026 22:01:00 CEST | Press release
Sinovac Biotech Ltd. (Nasdaq: SVA) (“SINOVAC” or the “Company”), a leading provider of biopharmaceutical products in China, today announced that it received a notification letter dated May 20, 2026 (the “Notification Letter”), from Nasdaq Listing Qualifications (“Nasdaq”) stating that as of May 8, 2026, the Company had regained compliance with the periodic filing and interim financial requirements in Nasdaq Listing Rules 5250(c)(1) (the “Periodic Filing Rule”) and 5250(c)(2), as required by the Panel’s decision dated January 21, 2026. As previously disclosed on January 22, 2026, under the Panel’s decision, SINOVAC was required to, on or before May 11, 2026, demonstrate compliance with such Nasdaq Listing Rules by completing filings of its annual report for the year ended December 31, 2024, on Form 20-F and an interim balance sheet and income statement as of the end of its second quarter of 2025 on Form 6-K. The Company timely completed such filings as required by the Panel’s decision.
From Network Automation to Agentic NetOps: NetBrain Sets the Standard for Deploying AI in Network Operations29.5.2026 15:00:00 CEST | Press release
Newest expansion of the NetBrain platform delivers Agent Skills, AI Path Doctor, MCP Server, and expanded cross-domain integrations, extending the agentic capabilities already running in production at hundreds of enterprises. NetBrain Technologies, Inc. today announced major new platform features that advance Agentic NetOps from an emerging category to operational reality. NetBrain's clients are already deploying agents that are diagnosing and remediating issues across complex multi-vendor enterprise networks. These new features further extend the platform with new agent tooling, cross-domain context, and open interfaces for the broader agentic enterprise. Early customer outcomes show the magnitude of the shift: A leading health insurer used NetBrain's Deep Diagnosis agent to diagnose and resolve a weeks old VPN connectivity issue in under five minutes. A large manufacturer resolved a critical device issue with a single prompt, isolating the root cause across the network path in under
Adtran resolves long-running patent litigation, reinforcing commitment to defend innovation29.5.2026 14:00:00 CEST | Press release
News summary: Non-practicing entity litigation continues to create costly, time-consuming pressure across the technology industry Adtran has reached a full settlement following counterclaims, with payment made to Adtran and all claims dismissed with prejudice Outcome reflects Adtran’s commitment to defend its innovations, customers and business against meritless patent assertions Adtran today announced it has resolved a patent litigation matter, resulting in a full settlement and dismissal of all claims with prejudice. The case, initiated in 2020 by a non-practicing entity asserting five patents, was transferred to the US District Court for the Northern District of Alabama in 2021 following a successful motion by Adtran. Adtran subsequently filed counterclaims, including bad-faith patent assertion under Alabama statutory law. The settlement includes payment to Adtran to resolve its counterclaims. Terms of the agreement remain confidential. “This outcome reflects a disciplined and consi
Meiji Seika Pharma Invests in GHIC’s Global Health Security Fund29.5.2026 13:00:00 CEST | Press release
Meiji Seika Pharma Co., Ltd. (Headquarters: Tokyo, Japan; President and Representative Director: Toshiaki Nagasato) today announced that it has committed to invest in the Global Health Security Fund (GHSF), which is sponsored by Global Health Investment Corporation (GHIC), a New York-based nonprofit organization. Through this investment, Meiji Seika Pharma will support the acceleration of innovations addressing critical global health challenges, including pandemic preparedness and antimicrobial resistance (AMR). GHIC is a mission‑driven nonprofit organization that deploys private investment strategies to generate both global health impact and financial returns. GHIC recently closed its second fund in GHSF. With more than a decade of experience investing in the field of infectious disease, GHIC has contributed to addressing major global health challenges. Its portfolio companies have successfully commercialized more than a dozen products, collectively reaching over 600 million people wo
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