Ondine Biomedical Inc. Results for the Year Ended 31 December 2025: Investor Report on Clinical Progress, Commercial Traction and Key Questions Ahead

Ondine Biomedical enters 2026 at a decisive stage in its development. The company is positioning Steriwave, its light activated antimicrobial technology, as a non antibiotic approach to reducing hospital acquired infections before they start. The immediate commercial focus remains pre surgical nasal decolonisation, but the broader proposition is much larger: a platform technology that could extend into intensive care, wound care, ENT pathways and other high value clinical settings.

The 2025 financial year was not primarily about maximising near term revenue. It was a year of deliberate investment, with resources concentrated on clinical evidence generation, regulatory preparation and manufacturing readiness. That strategy materially increased research and development spending, widened the company’s hospital footprint, and moved its pivotal US Phase 3 study close to top line results.

For investors, the central issue is straightforward. If Steriwave delivers a successful Phase 3 readout and progresses through the FDA pathway, Ondine could move from a niche commercial story into a far larger US opportunity. If the data disappoints, the company will need to rely more heavily on its existing ex US commercial base and wider platform ambitions. Either way, 2026 is shaping up to be a year that may define valuation and strategic direction.

Table of Contents

• The problem Ondine is targeting
• 2025 financial performance at a glance
• Why the Phase 3 Lantern study matters so much
• What investors should understand about the FDA pathway
• ICU expansion could become a second major pillar
• Commercial progress across Canada, the UK and Europe
• Real world evidence is strengthening the case
• Manufacturing readiness and margin potential
• Cash position and the funding question
• The longer term platform opportunity
• Key investor questions for 2026
• Outlook
• FAQ

The problem Ondine is targeting

Hospital acquired infections remain a major clinical and economic burden. In surgery, one important route of infection begins in the patient’s own nose, where pathogens can be carried into theatre and later contaminate wounds or lead to other complications. In the NHS alone, the associated burden runs to billions of pounds, millions of additional bed days and further pressure on already stretched waiting lists.

Standard approaches have tended to rely on antibiotics or topical antimicrobial agents. These methods face familiar limitations. Resistance continues to erode effectiveness, coverage can be narrow, and patient compliance is not always reliable. Ondine’s argument is that infection control should not depend heavily on whether a patient correctly follows a pre operative routine at home. Instead, treatment should be delivered by clinical staff at the point of care, in minutes, using a system designed to act against bacteria, viruses and fungi without driving antimicrobial resistance.

Steriwave is presented as that alternative. The treatment is intended to be painless, rapid and broad spectrum. That positioning matters because it seeks to place the product not simply as another decolonisation option, but as a potential step change in perioperative infection prevention.

2025 financial performance at a glance

The headline figures show a business still in early commercial scale up, but with measurable momentum.

• Revenue rose 29 per cent to $2.6 million.
• Gross profit increased 22 per cent to $1.6 million.
• Gross margin was 61 per cent.
• Hospital and surgical clinic placements increased 28 per cent to 37 sites.
• R&D expenditure rose sharply to $21.2 million from $9.2 million.
• Total operating expenses reached $31.6 million.
• Net loss was $29.5 million.

On the face of it, some may question why revenue growth slowed in percentage terms compared with the prior year. Management’s explanation is that commercial activity was intentionally kept targeted while leadership attention and financial resources were redirected to the pivotal Lantern Phase 3 study and other evidence building initiatives. In absolute dollar terms, the increase in revenue was broadly consistent with the previous year, which suggests that commercial traction did not disappear, even if it was not the principal operating priority.

Margins were affected by the hardware mix. Ondine has continued to subsidise light source replacements to support adoption, which limited margin expansion. On the other hand, consumable margins improved after introducing the next generation nasal illuminator in Canada. That distinction is important. It suggests the long term economic model still depends heavily on recurring consumable use once installations are embedded.

Why the Phase 3 Lantern study matters so much

The most important asset in the Ondine story is the Lantern study. This is described as the first randomised controlled study of nasal disinfection, conducted across two countries and 18 hospitals, with almost 5,200 patients and more than 350,000 data points.

The design uses a crossover structure. Hospitals begin in either treatment or control groups, then switch after the first recruitment phase. This allows each hospital to act as its own control, which can strengthen interpretation by reducing the effect of site specific differences.

The study was run with HCA Healthcare in 14 hospitals, under the oversight of a senior epidemiology and patient safety lead. Surgical specialties included the kinds of procedures where infection prevention is clinically meaningful and commercially relevant, such as cardiac, vascular, breast and neurosurgery.

Success is defined by two primary requirements:

1. A statistically significant reduction in surgical site infections within 30 days after surgery compared with standard care.
2. A satisfactory safety profile, with only common and non serious adverse events expected.

The company has indicated that database lock is close, with data cleaning and endpoint adjudication more than 95 per cent complete. Top line results were expected before the end of spring. A positive result would not itself guarantee FDA approval, but it would represent a major advance towards a full New Drug Application submission.

The strategic significance is hard to overstate. Approval would place Ondine in a potentially first in class position for formal nasal decolonisation use in the United States. Management believes the total addressable market is in the multibillion dollar range, and that exclusivity benefits linked to the regulatory pathway could create a favourable competitive position.

What investors should understand about the FDA pathway

Even with positive Lantern data, there is no instant move to commercial scale in the US. The likely next step is a pre NDA meeting with the FDA, expected in the autumn if the timeline holds. That process requires a full briefing package and specific questions for the agency.

After that, the FDA may request additional actions, clarifications or supporting material before the formal NDA is submitted. Because Steriwave is a combination product involving both device and drug elements, the review is broader than for a simple single modality product. Manufacturing, preclinical work, clinical data and label claims all form part of the assessment.

Ondine noted that it has fast track and QIDP status and would seek priority review. In favourable circumstances, this could compress the review period after NDA submission to around six months. However, this is still dependent on the scope of questions raised by the regulator and how quickly the company can address them.

For investors, the key takeaway is that positive top line data is a major catalyst, but not the end of the process. There remains regulatory execution risk, timing risk and the practical challenge of preparing for launch while regulatory questions are still being resolved.

ICU expansion could become a second major pillar

While surgery remains the immediate lead indication, Ondine also advanced into critical care in 2025. The company supported what it described as the first study of Steriwave in the intensive care unit at Royal Columbian Hospital.

This setting matters because ICU patients are often among the most vulnerable to severe infections, including pneumonia. These complications can lead to sepsis, shock, respiratory distress and multiple organ failure. Any intervention that can safely reduce pathogen burden in this environment has obvious medical and economic relevance.

The pilot reported that treatment in instrumented patients was feasible and safe, with no device related serious adverse events. It also showed a marked reduction in nasal pathogen burden and a near 40 per cent reduction in ICU acquired pneumonia. The results were published in a peer reviewed critical care journal.

This remains an early signal rather than definitive proof. A larger, multicentre study would be needed to validate the findings across broader endpoints and more varied patient populations. Still, the direction of travel is encouraging. If replicated, the ICU opportunity could materially broaden Steriwave’s use case beyond pre operative care.

Commercial progress across Canada, the UK and Europe

Although clinical work dominated 2025, the company continued to add sites and deepen usage in existing accounts.

Canada

Adoption expanded in several meaningful institutions. The University of Ottawa Heart Institute moved to use Steriwave as standard care in cardiac surgery. Interior Health became the second health authority in British Columbia to standardise Steriwave in hip and knee replacements. Deployments also continued across Fraser Health and other leading cardiac and surgical centres.

United Kingdom

In the UK, Ondine launched a pilot at Royal Papworth Hospital, a prominent cardiothoracic centre, while also expanding NHS supply chain access across England and Wales. This is an important operational step because access frameworks can influence the ease with which NHS hospitals adopt new technologies.

Europe and other territories

The company also reported clinical collaborations and pilot activity in Switzerland, Germany and Spain, including work in pre operative decolonisation and ENT surgery pathways. In Mexico, Steriwave entered ABC Medical Center, and in Australia the technology is being assessed in cancer patient settings.

The pattern here is clear. Ondine is building a patchwork of real world footholds rather than pursuing an expensive broad commercial rollout. That approach can be sensible for an emerging medtech and therapeutics business, particularly when formal US approval remains pending.

Real world evidence is strengthening the case

Beyond formal trials, Ondine highlighted several real world data sets that support the practical value of Steriwave.

• At Sherbrooke University Hospital in Quebec, a retrospective quality of care analysis associated Steriwave with a 78 per cent reduction in spine surgical site infections and a 30 per cent reduction in average length of stay.
• At Mid Yorkshire Teaching NHS Trust, use of Steriwave was linked to a 71 per cent reduction in knee and hip arthroplasty infections compared with another topical nasal antimicrobial approach.
• A York health economic analysis estimated savings of £1.49 to £2.38 for every pound spent on Steriwave across major surgeries.

That economic point deserves emphasis. These savings were described as immediate rather than dependent on long term system transformation. If the intervention lowers infection rates directly, hospitals may realise the return quickly through reduced complications and shorter stays.

Real world evidence does not replace pivotal trial data, but it can strengthen procurement discussions, support guideline conversations and reinforce payer interest. In the current regulatory and reimbursement environment, that combination of clinical and pharmacoeconomic evidence is increasingly valuable.

Manufacturing readiness and margin potential

One practical issue often overlooked in smaller healthcare companies is whether supply chains can support a commercial inflection point. Ondine appears to be addressing this in advance.

During 2025, the company decided to bring production of a key high margin twist top photosensitiser delivery device in house. Final assembly is primarily being done in Bothell, Washington, while a major Canadian initiative near Toronto is intended to support larger future demand. The company also explained that in house production is not only about scaling volume, but also about reducing exposure to external supply chain disruption and improving gross margin over time.

If the US opportunity opens, manufacturing execution will become critical. Management has expressed confidence that it is preparing well before approval, which is encouraging. Still, investors should continue to ask for evidence that quality systems, capacity planning and distribution logistics are developing at the same pace as clinical ambition.

Cash position and the funding question

Ondine raised approximately $24 million during 2025 and completed a further financing of more than $9 million in April 2026. Management indicated this should extend cash runway into early Q4 2026.

That provides room to support top line Phase 3 results, FDA engagement and commercial readiness. Beyond that horizon, funding decisions are likely to depend heavily on the Lantern outcome.

This is one of the most important investor questions. If the data are positive, the company may be able to raise capital on more favourable terms or explore strategic partnerships from a position of greater strength. If not, financing could become more challenging. As with many growth stage healthcare businesses, dilution risk has not disappeared. It has merely shifted further down the timeline.

The longer term platform opportunity

Ondine is keen to frame itself as more than a single indication company. Management argues that much of the core R&D investment has already been made over the last decade, including multiple generations of hardware development and expertise in delivering light to a range of anatomical targets.

The implication is that Steriwave is the lead product from a wider photo disinfection platform. Potential future areas mentioned include:

• Wound care
• Sinus disease
• Intrathoracic applications
• ENT and intraoral use
• Critical care applications such as ventilator associated pneumonia prevention
• Longer term consumer or clinic based applications in dermatology and fungal conditions

This broader vision may be attractive, but investors should be disciplined. Platform stories can be powerful, yet value is usually unlocked one indication at a time. For now, the principal determinant of near to medium term upside remains US surgical decolonisation.

Key investor questions for 2026

Ondine has made undeniable progress, but several questions still deserve close scrutiny.

• Will Lantern produce a clear and statistically persuasive efficacy result? The company’s confidence is notable, but the market will focus on the data rather than the narrative.
• How quickly can the FDA process move after top line results? Even an accelerated route can still involve unexpected requests and delays.
• What will US launch economics look like? Total addressable market estimates are useful, but investors will ultimately want pricing, gross margin and adoption assumptions.
• How fast could HCA or similar systems roll out Steriwave? Large network adoption could transform revenue, but implementation in complex hospital systems still requires operational discipline.
• How much additional capital will be required before sustainable scale is reached? The majority of development costs may be behind the company, but commercial expansion is rarely cheap.
• Can ex US growth continue while the business remains heavily focused on the US catalyst? The balance between focus and distraction will matter.

Outlook

Ondine Biomedical’s 2025 results reflect a company that chose evidence over short term optics. Revenue growth continued, but the real story was the transfer of resources into pivotal clinical work, ICU expansion, manufacturing readiness and the accumulation of real world data.

The business now sits near an inflection point. If the Lantern trial succeeds, Ondine may be able to convert years of development spending into a more credible US regulatory and commercial path, supported by a first in class positioning and an increasingly substantial evidence package. If the result is mixed or negative, the investment case will need to be reassessed through the lens of existing international operations and longer term platform optionality.

Either way, the company has moved beyond being a pure concept story. It now has active commercial placements, published ICU data, health economic support and a late stage regulatory asset nearing a crucial readout. For investors, this is no longer a question of whether the opportunity sounds compelling. It is a question of whether the next set of data can validate the scale of the ambition.

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FAQ

What does Ondine Biomedical’s Steriwave technology do?

Steriwave is a light activated antimicrobial treatment designed to reduce pathogens in the nose and potentially other anatomical sites. Its current lead use case is pre surgical nasal decolonisation to help reduce surgical site infections without relying on antibiotics.

Why is the Lantern Phase 3 study so important?

The Lantern study is central to the US regulatory pathway. A positive outcome would support the company’s move towards an FDA New Drug Application and could open access to a much larger commercial opportunity in the United States.

Did Ondine grow commercially in 2025?

Yes. Revenue rose 29 per cent to $2.6 million and the number of hospitals and surgical clinics using the product increased 28 per cent to 37. However, 2025 was primarily an investment year focused on clinical evidence rather than aggressive sales expansion.

What were the main financial pressures in 2025?

The biggest factor was increased R&D spending, which rose to $21.2 million as the company advanced its Phase 3 programme. This was the main driver of the year’s $29.5 million net loss.

Is Ondine only focused on surgery?

No. Surgery is the lead commercial indication, but the company is also exploring intensive care and sees broader platform potential in wound care, ENT, sinus disease and other applications.

How secure is the company’s funding position?

Following fundraising in 2025 and an additional financing in April 2026, management expects cash runway into early Q4 2026. Future capital needs are likely to depend heavily on the outcome of the Lantern study and the pace of regulatory and commercial execution.