Steriwave Expands into ENT Surgery in Spain

22 January 2026

ONDINE BIOMEDICAL INC.

("Ondine Biomedical", "Ondine" or the "Company")

Steriwave Expands into ENT Surgery in Spain

Ondine Biomedical Inc. (AIM: OBI), a leader in light-activated antimicrobial therapies, is pleased to announce the deployment of its Steriwave® nasal photodisinfection technology into a leading ear, nose and throat (ENT) specialist group operating surgical centres in Madrid and Málaga.

Many ENT procedures involve operating in, or passing through, the nasal cavity. Sinonasal procedures (septoplasty, sinuplasty and functional endoscopic sinus surgery (FESS) and cytoreductive surgery for cancer) represent an important growth area for Steriwave with about 600,000 procedures performed in the USA annually. Of this number, Chronic Rhinosinusitis (CRS) alone represents over 300,000 procedures annually. CRS is a disease with strong infectious and inflammatory components and is a major health burden.1 Infection risk is further elevated in patients with Chronic Rhinosinusitis (CRS).

CRS is the second more common chronic disease condition affecting about 12%-15% of adults in western countries1. CRS patients, due to repeated antibiotic and steroid treatments, have nasal microbiomes that are often dominated by multidrug resistant pathogens. Frequent administration of broad-spectrum antibiotics may further deplete the resident microbiome, permitting overgrowth of pathogenic species such as Staph aureus.2 CRS is a common disease linked to a disrupted nasal microbiome, which antibiotics may worsen1. Up to 70% of complex cases with nasal polyps (CRSwNP) involve Staph. aureus colonization3,5,6 and about 30% of CRS patients are colonized with multidrug resistant bacteria like MRSA and Pseudomonas3. These "superbugs" can form persistent biofilms, significantly increase post-surgical risk and further disrupt the nasal microbiome4.

Steriwave has already demonstrated meaningful clinical impact in ENT surgery, as reported by Professor Claire Hopkins, Professor of Rhinology at King's College London and Consultant ENT Surgeon at Guy's & St Thomas' NHS Foundation Trust. In her practice, applying Steriwave prior to sinonasal surgery led to a 77% reduction in post-operative antibiotic use, with prescription rates falling from 22.5% to 5% (P=0.02).7

Steriwave is a five-minute, non-invasive treatment that uses a proprietary light-activated photosensitive agent to destroy bacteria, viruses and fungi, including antibiotic-resistant strains, without generating antimicrobial resistance. Unlike topical antibiotics, which require multiple days of application and face compliance challenges and growing resistance, Steriwave is effective immediately-including against superbugs-while enabling beneficial microbes to repopulate quickly, a key benefit in light of recent microbiome research.8

The landmark CARRIAGE study, published in Nature Communications in 2025, represents the most comprehensive analysis to date of the nasal microbiome.9 The findings reveal that Staphylococcus aureus can become dominant within the nasal environment, effectively suppressing beneficial commensal bacteria that ordinarily help guard against infection. The study specifically observed that individuals who persistently carry Staph. aureus exhibit markedly higher levels of this pathogen and reduced levels of protective commensals compared to non-carriers, resulting in a stable yet elevated risk of infection.9

Carolyn Cross, CEO of Ondine Biomedical, commented:

"For patients with chronic sinusitis, whose microbiomes are already fragile, Steriwave rapidly destroys dangerous pathogens while allowing for the rapid recovery of the natural flora that supports long-term well-being. It is rewarding to see leading Spanish ENT specialists embracing this non-antibiotic approach to deliver healthier nasal decolonisation and help to protect patients from surgical site infections as well as the risk of translocation of pathogens from the nares into the sinuses during instrumentation."

Steriwave is redefining surgical care by reducing infection risk and promoting rapid restoration of a healthy nasal microbiome. Its swift, non-antibiotic decontamination approach is gaining traction among ENT specialists in Spain and beyond, reflecting strong clinician confidence in its effectiveness and safety. This expansion aligns with Ondine's commitment to advancing patient protection and improving outcomes across diverse surgical fields and geographies. Real-world data demonstrate that Steriwave not only lowers post-surgical infection rates and antibiotic use, but also shortens hospital stays, reduces readmissions, and delivers cost savings per patient-enhancing patient care while supporting robust antibiotic stewardship and greater healthcare system efficiency.

Enquiries:

About Ondine Biomedical Inc.

Ondine Biomedical Inc. is a Canadian life sciences company and leader in light-activated antimicrobial therapies ('photodisinfection') for the prevention and treatment of infections, including those caused by multidrug-resistant organisms. Ondine has a pipeline of investigational products, based on its proprietary photodisinfection technology, in various stages of development.

Ondine's nasal photodisinfection system is CE-marked in Europe and is approved for nasal decolonisation in Canada, Australia, Mexico and several other countries under the name Steriwave®. In the US, it has been granted Qualified Infectious Disease Product designation and Fast Track status by the FDA and is currently undergoing clinical trials for regulatory approval. Products beyond nasal photodisinfection include therapies for a variety of medical indications such as chronic sinusitis, ventilator-associated pneumonia, burns and other indications.

References

1. Mahdavinia, M., et al. (2015). A comprehensive review of the nasal microbiome in chronic rhinosinusitis (CRS). Clinical & Experimental Allergy, 46(1), 21-41.

2. Foreman A, Boase S, Psaltis A, Wormald PJ. (2012) Role of bacterial and fungal biofilms in chronic rhinosinusitis. Curr Allergy Asthma Rep. 2012 Apr;12(2):127-35. doi: 10.1007/s11882-012-0246-7. PMID: 22322439.

3. Abreu NA., et al. (2012). Sinus microbiome diversity depletion and Corynebacterium tuberculostearicum enrichment mediates rhinosinusitis. Sci Transl Med. 2012 Sep 12;4(151):151ra124. doi: 10.1126/scitranslmed.3003783. PMID: 22972842; PMCID: PMC4786373.

4. Bhattacharyya, N., & Kepnes, L. J. (2001). The microbiology of recurrent rhinosinusitis after endoscopic sinus surgery. Archives of Otolaryngology-Head & Neck Surgery.

5. Shaghayegh, G., et al. (2022). Chronic Rhinosinusitis, S. aureus Biofilm and Secreted Products, Inflammatory Responses, and Disease Severity. Biomedicines, 10(6), 1362.

6. Vickery, T. W., Ramakrishnan, V. R., & Suh, J. D. (2019). The Role of Staphylococcus aureus in Patients with Chronic Sinusitis and Nasal Polyposis. Current Allergy and Asthma Reports, 19(4).

7. Hopkins, C. (2024). Photodisinfection in Sinonasal Surgery. Clinical outcomes report, Guy's & St Thomas' NHS Foundation Trust.

8. Ondine Biomedical Inc. (2023). Impact of photodisinfection on the nasal microbiome. Technical White Paper.

9. Aggarwal, D., Bellis, K. L., et al. (2025). Large-scale characterization of the nasal microbiome redefines Staphylococcus aureus colonization status. Nature Communications, 16(1), 10415.