LumiThera: From Prototype to Commercial Medical Device
Transforming Eye Disease Treatment with Photobiomodulation –
LumiThera, Inc. is a U.S.-based medical device company founded in 2013 by a multidisciplinary team of doctors, engineers, and business professionals. Their shared mission: to develop non-invasive treatments that slow the progression of degenerative eye diseases and help prevent vision loss.
Under the leadership of President & CEO Clark E. Tedford, Ph.D., LumiThera has been dedicated to leveraging photobiomodulation (PBM) technology to improve visual function. A key application of this work is age-related macular degeneration (AMD), a leading cause of blindness worldwide. While their early prototype showed strong promise, bringing the product to market would require solving significant regulatory, technical, and manufacturing challenges.
This is where StarFish Medical came in.
“This is the fourth startup company I’ve been associated with. Building a company and a product from scratch takes a tremendous amount of effort. Having the right partners in place makes all the difference.” — Clark E. Tedford, Ph.D., President & CEO, LumiThera
From Prototype to Scalable Medical Device
LumiThera had developed a working prototype and gathered promising early clinical data. However, their original design partner lacked the capacity to advance the product into commercial production or meet the quality and regulatory standards required for a medical device.
Key challenges LumiThera faced:
- Refining the prototype to meet commercial manufacturing standards
- Navigating complex regulatory pathways, including FDA and CE Mark
- Establishing supply chain systems compliant with ISO 13485, which is a quality management system standard and not a product compliance certification, and FDA requirements
To move forward, LumiThera needed an experienced development partner. That’s when they turned to StarFish Medical.
Partnering for Commercial Success
LumiThera chose StarFish Medical for their expertise in navigating the path from late-stage prototype to commercial launch. StarFish provided strategic support across design, manufacturing, and regulatory domains, aligning LumiThera’s scientific vision with industry requirements.
They refined the Valeda® Light Delivery System for manufacturability, addressed technical risks, and ensured all processes met ISO 13485 and FDA standards. The collaboration included close integration with LumiThera’s engineering team to troubleshoot issues, produce clear documentation, and conduct essential testing. This comprehensive effort set the stage for international regulatory approval.
Key Contributions from StarFish Medical:
- Optimized product design for scalable manufacturing
- Developed a compliant and efficient production process
- Provided regulatory submission support (CE Mark, FDA)
- Ensured quality assurance through ISO 13485 systems
- Led verification testing to validate safety and performance
“Our goal was to help LumiThera bring the right product to market—not just quickly, but with confidence in its quality and performance. We’ve supported low-volume manufacturing of commercial units since 2019, enabling their global expansion and helping ensure patients worldwide have access to this innovative treatment.” — Kathryne Young, Director of Manufacturing, StarFish Medical
Delivering a Groundbreaking Solution
The partnership resulted in a successful transformation of the Valeda® Light Delivery System into a globally available product. Since 2019, commercial units have been in production, providing patients with access to a novel treatment approach for dry AMD.
With CE Mark approval in the European Union and De Novo FDA authorization in the U.S., LumiThera is poised for global expansion. StarFish Medical’s guidance helped ensure the final product met the highest commercial and regulatory standards.
Key Outcomes
- Commercial units in production since 2019
- Approved for use in the European Union and granted De Novo authorization in the United States
- Available in global markets and expanding
- Offers a non-invasive, first-of-its-kind treatment for dry AMD
“StarFish has been instrumental in building the Valeda® Light Delivery System. We’ve won multiple awards for medical device design and have been recognized at investor and ophthalmology meetings worldwide.” — Clark E. Tedford, Ph.D., President & CEO, LumiThera
Transforming Lives Through Innovation
With Valeda® now on the market, LumiThera is delivering on its original mission—improving the lives of patients facing vision loss. Ongoing studies continue to build clinical evidence and support expanded regulatory approvals worldwide.
StarFish Medical’s role helped ensure the product’s successful development and launch. Together, the teams not only brought a new medical device to life—they brought new hope to patients.
For more information on how StarFish Medical can support your medical device journey, visit starfishmedical.com.
To learn more about LumiThera’s groundbreaking technology, visit lumithera.com.