Steriwave ICU Study Shows 39.5% Pneumonia Drop

Pioneering research from Royal Columbian Hospital Foundation shows a significant decrease in pneumonia rates and establishes a new benchmark for ICU infection prevention.

Ondine Biomedical Inc. (AIM: OBI) is pleased to announce that Royal Columbian Hospital Foundation ("RCHF")'s Advancing Innovation in Medicine ("AIM") Research Team, at one of Canada's leading critical care centres, has achieved a major milestone in patient safety and clinical innovation with the peer-reviewed publication of a landmark intensive care unit ("ICU") study in Critical Care.

The RCHF study, "Suppression of Microbial Burden to Reduce Pneumonia in Critical Illness: the SMURF Feasibility Pilot Study", delivers compelling new evidence on preventing life-threatening infections in critically ill patients with a nasal photodisinfection protocol. This study marks the first nasal photodisinfection deployment in an ICU setting. AIM researchers observed that Ondine's Steriwave® nasal photodisinfection therapy, already utilised in Canadian and UK hospitals to reduce surgical site infection rates, proved safe and highly effective in treated ICU patients when compared to a control group.

Top-line results showed a 39.5% reduction in pneumonia rates, decreasing from 14.9 to 9.0 cases per 1000 ICU patient-days. Although this pilot study was not powered for statistical significance on this clinical outcome measure, the nearly 40% reduction in pneumonia rate was associated with a statistically significant reduction in early cumulative nasal pathogen burden (p<0.01). No intervention-related adverse events were detected. The study lays a strong foundation for larger follow-on trials expected to dramatically change standard of care in ICU pneumonia prevention.

• Elizabeth Rohrs, PhD, RRT, RCH principal investigator and RCH Foundation Research Director, commented:

"Every case of pneumonia prevented in ICUs translates to days of ventilation avoided, earlier discharges, and beds freed for the next critically ill patient. The preliminary results from SMURF suggest that a simple, five-minute nasal treatment could make a real difference at scale. Our next step is a multicenter randomised trial to confirm these findings, and we're excited to build on what this pilot has shown."

• Steven Reynolds, MD, FRCPC, Executive Lead of the AIM Institute, TB Vets Professor in Critical Care at Simon Fraser University, stated:

"The initial findings from the SMURF study are encouraging, providing a clear trajectory for validating an approach that could represent a paradigm shift in pneumonia prevention. Ventilator-associated pneumonia remains a significant burden, contributing to patient mortality, prolonged suffering, and considerable increased costs within ICUs. By preventing a meaningful proportion of these infections, we can fundamentally improve clinical outcomes and better support a healthcare system managing increasingly strained resources."

The study highlights a crucial insight: reducing the microbial load in the nose significantly lowers the risk of respiratory infections, including ventilator-associated pneumonia ("VAP") and hospital-acquired pneumonia (together "nosocomial pneumonia"). As healthcare systems face escalating antimicrobial resistance, traditional topical antibiotics are increasingly ineffective.

In contrast, photodisinfection provides a broad-spectrum advantage, remaining effective against multidrug-resistant Gram-negative bacteria, which now account for approximately 67% of culture-positive ICU infections [1]. Notably, Pseudomonas aeruginosa and Klebsiella pneumoniae are identified as the primary pathogens driving these VAP occurrences, highlighting the significance of Gram-negative bacteria in ICU infection epidemiology.

The burden of these infections is profound. While ICU-acquired infections occur in approximately 13-15% of admissions [2],[3], research indicates nosocomial pneumonia is associated with an average of 13-21 additional ICU days in hospital,11-42% mortality, and an average additional cost per case of $56,000 to $102,000 [4]. Reducing these infections directly addresses hospital capacity constraints and improves system-wide efficiency.

The SMURF Feasibility Pilot Study was supported in part by the Royal Columbian Hospital Foundation, whose investment in AIM research continues to drive frontline innovation in Canada.

As BC's most comprehensive critical care hospital, one in three British Columbians rely on Royal Columbian Hospital (RCH). It is the only hospital in BC with trauma, cardiac, neurosciences, high-risk obstetrics and neonatal intensive care on one site. RCH looks after some of the most seriously ill and injured patients in B.C.

Since 1978, donors to Royal Columbian Hospital Foundation have helped fund priority equipment needs, facility enhancements, research, education and innovation at Royal Columbian Hospital.

As part of Royal Columbian Hospital Foundation, the AIM Institute is a social enterprise that partners with innovative health-tech companies, providing clinical insights grounded in deep expertise, alongside clinical trial design and execution. Find out more: https://rchfoundation.com/aiminstitute/

About Steriwave® and its Mode of Action

The two-step process involves applying the Steriwave formulation in the nostrils where it electrostatically binds to microbes rather than human cells. The area is then illuminated with safe red light to activate the formulation, triggering an oxidative burst that physically destroys all manner of pathogens within minutes. This rapid and overwhelming oxidative stress makes it extremely difficult for pathogens to develop resistance, and the process stops immediately once the light is turned off. Steriwave has been used in a growing number of hospitals since 2011.

About Ondine Biomedical Inc.

References:

[1]. Vincent JL, Sakr Y, Singer M, et al. Prevalence and Outcomes of Infection Among Patients in Intensive Care Units in 2017. JAMA. 2020;323(15):1478-1487. doi:10.1001/jama.2020.2717

[2]. European Centre for Disease Prevention and Control. Healthcare-associated infections acquired in intensive care units: annual epidemiological report for 2020. Stockholm, Sweden: ECDC; 2024.

[3]. European Centre for Disease Prevention and Control. Healthcare-associated infections acquired in intensive care units: annual epidemiological report for 2021. Stockholm, Sweden: ECDC; 2024.

[4]. Zilberberg MD, Nathanson BH, Puzniak LA, Shorr AF. Descriptive epidemiology and outcomes of nonventilated hospital-acquired, ventilated hospital-acquired, and ventilator-associated bacterial pneumonia in the United States, 2012-2019. Crit Care Med. 2022;50(3):460-468.