Photobiomodulation (PBM) involves the use of visible or near infrared light (NIR) produced by a laser or a non-coherent light source applied to the tissue of the body to provide beneficial effects in a wide range of disease states. It is widely used in physiotherapy, chiropractic and sports medicine, and increasingly, recognized as a potential therapy for the treatment of severe and life-threatening disease states.
LumiThera, Inc. was created in 2013 to develop and commercialize an early treatment for ocular damage or disease using Photobiomodulation (PBM). Two of the founders were doctors, two were engineers, and the fifth founder was company President and CEO, Clark E. Tedford, a Ph.D. in neuropharmacology.
“We brought StarFish a device that was prototyped and had gone through some of the early clinical data. It still needed additional work to get it to the point of a commercial instrument.”
StarFish identified technical risks associated with manufacturing the design “as is,” addressed unknown issues that are typical of all new products, and ensured the product was developed, documented and built in a 13485 certified QMS system and FDA registered facility.
While working on the transfer, StarFish completed the specification documentation and assisted with regulatory submissions (BSI for CE Mark).
LumiThera is in the process of seeking regulatory approvals and globally expanding the treatment around the world.
Client: LumiThera, Inc