Ondine Biomedical (OBI) Study result summary

Study Design and Methodology

• LANTERN was a large, pivotal, cluster-randomized, crossover Phase 3 study in 18 hospitals (14 US, 4 Canada) with 5,188 patients, comparing standard of care to nasal photodisinfection plus standard of care.

• The intervention is a patented, light-activated, non-antibiotic antimicrobial administered pre-surgically to reduce microbial burden.

• The study targeted high-risk, major surgical procedures and included a diverse patient cohort with significant comorbidities and varied procedure lengths.

• Standard of care included mupirocin use, with compliance and workflow designed to mirror real-world hospital practice.

• Bayesian analysis was pre-specified, incorporating real-world evidence from over 250,000 prior patient treatments, and aligned with evolving FDA guidance.

Key Results and Statistical Outcomes

• The primary endpoint was met, with a 98.2% probability of benefit for nasal photodisinfection over standard of care.

• A 40.5% reduction in 30-day surgical site infection risk was observed versus standard of care alone.

• Frequentist analyses confirmed statistical significance, with p-values between 0.016 and 0.022.

• Safety profile was favorable, with only mild, transient adverse events and no serious safety concerns.

• The product demonstrated broad-spectrum efficacy, including against MRSA, fungi, and emerging pathogens.

Commercial and Clinical Implications

• A 40% reduction in SSI is considered highly material and clinically relevant, with significant potential for hospital adoption.

• The technology is positioned as a universal solution for surgical and ICU settings, with potential expansion to other infection-prone environments.

• The addressable market is estimated in the tens of billions globally, with hundreds of millions in potential annual revenue.

• The product is already commercialized outside the US and is being prepared for broader deployment.

• Payback for hospitals is expected to be rapid, with each avoided infection saving up to $100,000 in downstream costs.