We are thrilled to congratulate our long-time client LumiThera on receiving FDA authorization for their groundbreaking Valeda® Light Delivery System, marking a historic moment as the first-ever authorized treatment for vision loss in dry age-related macular degeneration (AMD) patients. Read their press release here.

Addressing a Critical Healthcare Need

The significance of this authorization cannot be overstated. According to recent CDC data, an estimated 19.8 million Americans aged 40 and older are living with AMD, representing 12.6% of this age group. Of these, approximately 1.5 million people suffer from vision-threatening AMD, which can lead to severe vision loss and significantly impact quality of life. The prevalence increases dramatically with age, affecting nearly 47% of Americans aged 85 and older, making this a critical healthcare challenge as our population ages.

A Journey of Innovation

Our collaboration with LumiThera dates back to their early development stages when they were funded by the Life Science Discovery Fund (LSDF) to develop a prototype medical device for treating dry AMD. Product Creation Studio partnered with LumiThera to realize the Valeda platform design, combining their revolutionary photobiomodulation (PBM) therapy with a practical, user-friendly delivery system. Our team supported the development of the platform, housing, patient interface, system electronics, and firmware for proof-of-concept prototypes.

This partnership exemplified the power of collaborative innovation, leading to LumiThera securing follow-on funding. Our collaboration on the project was recognized when we were named Most Innovative Company at the MDM West Conference.

Impact on Patient Care

The FDA authorization validates LumiThera's groundbreaking approach to treating dry AMD. Clinical trials demonstrated that Valeda treatment can improve best-corrected visual acuity by more than five letters (equivalent to a line on the eye chart) over 24 months. This is particularly significant given that the CDC projects AMD cases will increase substantially as the U.S. population ages, with state-level prevalence ranging from 6.2% to 18.3%.

A Testament to Perseverance

LumiThera's achievement in securing FDA authorization for Valeda represents years of dedicated research, development, and clinical validation. This milestone serves as a powerful reminder that transformative medical innovations often require patience, persistence, and strong partnerships.

We extend our heartfelt congratulations to the entire LumiThera team on this remarkable achievement. Their success not only validates their innovative approach to treating dry AMD but also sets a new standard for medical device development in ophthalmology.

Looking forward, we're excited to continue supporting innovators who, like LumiThera, are committed to advancing medical technology and improving patient outcomes through groundbreaking device development.

To learn more about LumiThera and the Valeda Light Delivery System, visit www.lumithera.com