EndoGlow is a Rochester-based startup that developed a medical device — the GreenEgg — that fluoresces under near-infrared imaging. This enables the surgeon to see beyond what is visible to the naked eye, clarifying anatomy and aiding in the identification of subsurface pathology.
Dr. Paula Doyle, a surgeon on the faculty at the University of Rochester and co-founder and chief medical officer of EndoGlow, needed funding to turn her prototype for the GreenEgg into a U.S. Food and Drug Administration-approved commercial product, including perfecting the recipe and conducting a clinical pilot study.
Doyle, representing both the University and EndoGlow, applied for a 2018 FuzeHub Manufacturing Grant and received $50,000. She used the money to complete proof-of-concept manufacturing for GreenEgg devices, including injection molding, safety testing, sterilization, and packaging validation necessary for FDA approval. A mold for manufacturing the devices was fabricated and a clinical trial was conducted, providing the data necessary for an application to the FDA. A second, larger clinical study is now underway.
Doyle said the FuzeHub support was “huge” in enabling EndoGlow to get the clinical data it needed to not only gain FDA approval, but to attract other vital grant funding that will help it improve and mass produce the GreenEgg. She said FuzeHub also was key in connecting EndoGlow with the Cornell Center for Materials Research (CCMR) at Cornell University, which helped the company scale up its recipe to commercial quantities without sacrificing any fluorescence.