The trial, LANTERN, involves over 5,000 surgical patients across 14 HCA Healthcare hospitals in American and four Canadian centres.
LANTERN is evaluating Steriwave, a nasal photodisinfection technology, as a preventative measure against surgical site infections (SSIs).
Currently, the standard of care is the antibiotic mupirocin, which requires five days of self-administration at home.
Steriwave is a non-antibiotic treatment that is administered by a nurse-assistant in five minutes, ensuring a 100% adherence rate.
Healthcare-associated infections, like SSIs, cost the American healthcare system around $35bn annually.
Carolyn Cross, CEO of Ondine Biomedical, said: “The LANTERN study represents a landmark investigation into the potential for universal nasal decolonisation to meaningfully reduce surgical site infections.
“As we approach full enrollment, we look forward to sharing our top-line results and moving forward with our FDA submission to address this multi-billion-dollar burden on the American healthcare system.”
Used preoperatively for patients undergoing surgical procedures and for infection control in Intensive Care Units (ICUs), Steriwave is currently utilised in hospitals across the UK, EU and Canada.
The Food and Drug Administration has given Steriwave Qualified Infectious Disease Product designation and Fast Track status.
Topline results from the LANTERN study are expected in Spring 2026.
Ondine is a Canadian life sciences company, focused on light-activated antimicrobial therapies, with a pipeline of investigational products based on its photodisinfection technology.
