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
Bending Spoons S.p.A. announces closing of initial public offering2.7.2026 20:35:00 CEST | Press release
Bending Spoons S.p.A. (“Bending Spoons”), a leading technology company, today announces the closing of its initial public offering of an aggregate of 57,971,015 of its ordinary shares, at an initial public offering price of $29.00 per share. The offering consisted of 34,398,640 shares sold by Bending Spoons and 23,572,375 shares sold by certain selling shareholders (the “Selling Shareholders”). The gross proceeds from the offering to Bending Spoons, before deducting underwriting discounts and commissions and other offering expenses, was approximately $953,917,285.50. Bending Spoons did not receive any proceeds from the sale of shares by the Selling Shareholders. Bending Spoons’ ordinary shares began trading on the Nasdaq Global Select Market on July 1, 2026 under the ticker symbol “BSP”. Goldman Sachs International, J.P. Morgan, and Allen & Company LLC are acting as joint lead book-running managers for the offering. Wells Fargo Securities, BofA Securities, Jefferies, Evercore ISI, BNP
Strategic Partnership Between Record Asset Management and Admicasa2.7.2026 19:00:00 CEST | Press release
RAM Swiss Holding AG announces a strategic partnership with Admicasa Holding AG (Admicasa). RAM Swiss Holding AG is a subsidiary of LSE-listed Record Financial Group (Record) and part of the Record Asset Management (RAM) group of companies. The partnership is a milestone in the growth of Admicasa and marks an important step in the continued expansion of Record’s private markets platform. Subject to regulatory approval, the agreement, signed on 1st July 2026, provides RAM Swiss Holding AG with a 50% participation in the Admicasa Fondsleitung AG, part of Admicasa, and establishes a long-term partnership to develop investment opportunities in the Swiss and Global real estate market with a plan to expand into other asset classes in the medium term. RAM is the European asset management arm of Record, the LSE-listed specialist investment group managing USD 115 billion of assets on behalf of institutional clients worldwide. Record's client base comprises pension funds, foundations, sovereign
IQM Quantum Computers Becomes First European Quantum Computing Company Listed on a Major U.S. Exchange2.7.2026 16:47:00 CEST | Press release
IQM begins trading on Nasdaq Global Select Market under the ticker symbol “IQMX” Company enters next phase of growth as a publicly traded leader in full-stack superconducting quantum computing IQM maintains a strong pro forma cash position of EUR 337 million IQM Quantum Computers (Nasdaq: IQMX) (“IQM”, “IQM Quantum Computers” or the “Company”), a global leader in full-stack superconducting quantum computers, today became a publicly traded company following the completion of its business combination with Real Asset Acquisition Corp. (“RAAQ”). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260702960460/en/ IQM Quantum Computers Becomes First European Quantum Computing Company Listed on a Major U.S. Exchange The company’s American Depositary Shares begin trading today on the Nasdaq Global Select Market under the ticker symbol “IQMX”. The listing marks a major milestone for IQM establishing the company as the first European quan
GigaDevice Launches First GD24CL Series I²C EEPROM, Further Expanding Its Non-Volatile Memory Portfolio2.7.2026 16:00:00 CEST | Press release
GigaDevice, a leading semiconductor company specializing in Flash memory, 32-bit microcontrollers (MCUs), sensors, and analog products, announced today the launch of its new GD24CL series I²C EEPROM. The series delivers outstanding performance, comprehensive security protection mechanisms, and excellent reliability that addresses the stringent requirements for stable and long-term storage of critical configuration data. These offered features will benefit applications in industrial, energy, Internet-of-Things (IoT), data centers, and networking. As GigaDevice’s first EEPROM product series, the launch further enhances the company’s non-volatile memory portfolio and provides customers with more dynamic storage solutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260702394554/en/ GigaDevice Launches First GD24CL Series I²C EEPROM, Further Expanding Its Non-Volatile Memory Portfolio. The GD24CL series is designed with high
Medical University of Graz Enrolls First Patient in DEEPER CHALLENGE Trial Evaluating Spur® Peripheral Retrievable Scaffold System in a Select CLTI Cohort2.7.2026 13:00:00 CEST | Press release
Reflow Medical, Inc. announces that the Medical University of Graz has enrolled the first patient in the DEEPER CHALLENGE clinical trial. This investigator-initiated, single-center, single-arm, prospective study, supported by a grant, investigates early vessel recoil following below-the-knee treatment using the Spur® Peripheral Retrievable Scaffold System in combination with a commercially available drug-coated balloon. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260701995624/en/ The study investigates early vessel recoil following below-the-knee treatment using the Spur® Peripheral Retrievable Scaffold System in combination with a commercially available drug-coated balloon. The study plans to enroll up to 40 patients with chronic limb-threatening ischemia (CLTI) across two distinct cohorts: patients with diabetes and patients with end-stage renal disease receiving hemodialysis for at least six months, with women comprisi
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