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
Cognite Positioned as a Front Runner in LNS Research Solution Selection Matrix for Industrial AI Platforms23.4.2026 20:00:00 CEST | Press release
Cognite, the global leader in Industrial AI, has been named a Front Runner in the LNS Research Solution Selection Matrix for Industrial AI Platforms (SSM). The LNS Research SSM evaluates vendors using a rigorous methodology that leverages its “3P” framework—Product, Potential, and Presence—to assess both current capabilities and future readiness. Within the report, Cognite is recognized in three key areas: depth in user-centric industrial AI applications, its knowledge graph-based data model, and its strong partner ecosystem. Together, all three give Cognite the ability to unify and contextualize complex industrial data, enabling organizations to operationalize AI at scale. “Cognite brings a sophisticated data model built for industrial complexities, along with advanced analytics and AI-driven insights, which is crucial for industrial organizations to achieve meaningful productivity gains and enterprise-wide ROI,” said Vivek Murugesan, Research Analyst at LNS Research. “These capabilit
Venture Global Announces Closing of $750,000,000 Senior Secured Notes by Venture Global Calcasieu Pass, LLC23.4.2026 19:47:00 CEST | Press release
Venture Global, Inc. (“Venture Global”, NYSE: VG) announced today that its subsidiary, Venture Global Calcasieu Pass, LLC (“VGCP”) has closed an offering of $750,000,000 aggregate principal amount of 6.000% senior secured notes due 2036 (the “Notes”). The Notes will mature on May 1, 2036. VGCP used the net proceeds from the offering, together with cash on hand and proceeds received from certain hedge terminations, for the prepayment, in full, of VGCP’s outstanding term loans, and to pay fees and expenses in connection with the offering. The Notes are guaranteed by TransCameron Pipeline, LLC (VGCP’s affiliate). The Notes are secured on a pari passu basis by a first-priority security interest in the assets that secure VGCP’s existing senior secured first lien credit facilities and VGCP’s existing senior secured notes. The Notes were not registered under the Securities Act of 1933, as amended (the “Securities Act”) or the securities laws of any state or other jurisdictions, and the Notes
Does Muscle Composition Identify High-Risk Individuals in Chronic Kidney Disease? New AMRA Medical Study Says Yes, Reveals Strong Link to Mortality23.4.2026 17:10:00 CEST | Press release
AMRA Medical researchers recently set out to answer the question: what is the relationship between adverse muscle composition (AMC) and mortality in kidney disease? Recent findings demonstrate that AMC, characterized by low muscle volume z-score and high muscle fat infiltration, is an independent and strong predictor of all-cause mortality in individuals with chronic kidney disease (CKD). The findings, published in Clinical Journal of the American Society of Nephrology, were based on data from the UK Biobank imaging study and further reinforce the clinical relevance of MRI-derived muscle biomarkers in identifying high-risk populations across chronic diseases. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260423198497/en/ AMRA's MRI-based muscle biomarkers in clinical trials Researchers from AMRA, alongside our collaborators at Linköping University (LiU), analyzed 894 participants with CKD using AMRA’s MRI-based body composi
Diligent Unveils AI Board Member and Agentic GRC Workforce at Elevate 202623.4.2026 15:00:00 CEST | Press release
Diligent’s agentic AI strengthens board oversight and transforms how GRC teams work — reducing manual effort and outside-advisor dependency, tightening control over sensitive workflows and enabling leaders to make faster, more defensible decisions Diligent, the AI leader in governance, risk and compliance (GRC) SaaS solutions, today unveiled a new generation of autonomous AI agents, including AI Board Member — a secure AI assistant for directors — and a coordinated network of agents embedded across the Diligent One Platform. Accessible through a single command center, agents automate multi-step workflows across governance, risk, compliance and third-party management, giving organizations the impact of a “GRC manager” without adding headcount. “AI supercharges teams that embrace it, and boards are no exception,” said Brian Stafford, President and CEO of Diligent. “With AI Board Member and a network of autonomous agents woven through the Diligent One Platform, we’re giving the C-suite an
Safe Software Bolsters Leadership Team with CFO and CPO Appointments to Drive Next Phase of Growth23.4.2026 15:00:00 CEST | Press release
CFO and CPO executive hires to enhance operational and financial performance on the company’s path to $250M by 2028 Safe Software (Safe), creator of FME, the only All-Data, Any-AI enterprise integration platform, today welcomes two executives to its leadership team as it moves into the next phase of growth. Judd Lee has been appointed as the company’s Chief Financial Officer (CFO), and Vanessa Ribreau has been appointed as Chief People Officer (CPO). Having recently crossed $100M in revenue, the expanded leadership team will further enable the company to scale as it accelerates toward its goal of reaching $250M in revenue by 2028. Judd Lee is a seasoned CFO with over 15 years of experience partnering closely with CEOs to align financial strategy and accelerate sustainable growth. He is known for his strong commitment to mentorship and for building high-performing global teams rooted in trust, morale and a shared sense of purpose. With more than two decades of financial leadership acros
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