Annonce • Jul 13
Ondine Biomedical Provides Update On Lantern Phase 3 Pivotal Study Evaluating Non-Antibiotic Nasal Photodisinfection Technology Ondine Biomedical Inc. provided an update on its LANTERN Phase 3 pivotal study evaluating the Company's non-antibiotic nasal photodisinfection technology (branded as Steriwave® outside the US) to reduce the incidence of surgical site infections. The Company has updated the expected timeline for release of topline results from the LANTERN Phase 3 study. Results are now expected within approximately six weeks, reflecting recent guidancefrom the Company's independent data management and statistical advisersregarding the time required to complete final data management, reconciliation and database lock activities. The revised timeline reflects thescale of the study and the normal process of finalising a high-quality analysis dataset and associated documentation in preparation for regulatory submission. The primary endpoint and success criteria remain unchanged. The LANTERN (Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections) study is designed to evaluate the safety and efficacy of Ondine's nasal photodisinfection technology in reducing the rate of surgical site infections (SSIs). Conducted in collaboration with HCA Healthcare and select Canadian hospitals, the study enrolled 5,188 patients across 14 HCA Healthcare hospitals in the United States and four sites in Canada. Annonce • Jul 01
Ondine Biomedical Publishes Leeds Study Showing Steriwave Reduces Surgical Site Infections By 78% Versus Mupirocin In High Risk Endoscopic Endonasal Skull-Base Surgery Ondine Biomedical Inc. announced that full results from Leeds Teaching Hospitals' evaluation of Steriwave nasal photodisinfection versus mupirocin in endoscopic anterior skull-base surgery have been published in The Journal of Laryngology & Otology. The Leeds researchers state that given its broad-spectrum rapid action, excellent compliance and lack of resistance potential, Steriwave represents a compelling alternative to mupirocin-based decolonisation and should be considered for routine adoption. The Leeds researchers, Dr Paul Nix (Dept. of Otolaryngology) and Drs. Atul Tyagi, Nick Phillips and Asim Sheikh (Dept. of Neurosurgery) conclude that Steriwave significantly reduces SSI, antibiotic usage and ENT outpatient burden following endoscopic anterior skull base surgery. With a relative risk reduction of 78%, the number needed to treat would be 9 patients (95% CI: 5 to 27). The study finds an approximate cost of £774 per SSI prevented which compares (at only 12.3%) favourable to the published estimates of £6,300 average cost to treat a (non-meningitis) neurosurgery SSI and less than 2% of a meningitis related SSI. The publication entitled, 'Steriwave a Non-Antibiotic Nasal Photodisinfection Strategy Reduces Infection Burden in Endoscopic Skull Base Surgery', reports findings from a single-centre, before-and-after service evaluation conducted at Leeds General Infirmary, of the Leeds Teaching Hospitals NHS Trust. The evaluation compared outcomes between 105 patients (52.5%) managed with mupirocin (the standard 5-day pre-operative home-based topical antibiotic nasal decolonisation regimen) against 95 patients (47.5%) who received a single clinician-delivered Steriwave 5-minute nasal photodisinfection treatment immediately before EESB surgery. Full study results demonstrated that Steriwave nasal photodisinfection was associated with a statistically significant reduction in 30-day surgical site infections (SSIs) over mupirocin, with a relative risk reduction of 78% and an absolute risk reduction of 11.4% (95% CI 3.7%-19.1%, p=0.0059). The SSI rate was 3.2% in the Steriwave nasal photodisinfection arm compared with 14.6% in the standard-of-care arm using mupirocin topical nasal antibiotic. Compliance with Steriwave was 100%, compared with literature-reported compliance rates of about 39% for home-based mupirocin use. There were no adverse events related to Steriwave. Most importantly, no cases of meningitis were recorded in the Steriwave arm (0%), compared with 5 cases (4.8%) in the standard of care arm. Endoscopic anterior skull base surgery is classed as clean contaminated, with meningitis risk heightened by dural opening and CSF leak. Postoperative meningitis is a severe, potentially life-threatening infection and inflammation of the meninges. Meningitis poses a significant risk to the patient and results in prolonged hospital stays. With severe meningitis cases potentially exceeding $60,000 (~£47,000), the study generated a positive net Return on Investment (ROI), from the avoidance of these serious post-surgical infections alone. The study authors noted that Steriwave's rapid action, clinician-delivered administration, high compliance profile and non-antibiotic mechanism represents a compelling alternative to mupirocin-based decolonisation. The interim study findings from the Leeds researchers were previously presented on 18 June 2026 at ENDOAthens, the 10th World Congress for Endoscopic Surgery of Sinuses, Skull Base, Brain, Spine & Orbit. Steriwave is a five-minute, clinician-administered treatment designed to rapidly eliminate a broad spectrum of pathogens in the nasal vestibule using a light-activated antimicrobial process, without contributing to antimicrobial resistance. Because the treatment is delivered at the point of care immediately before surgery, it also helps address a practical challenge associated with multi-day, home-based decolonisation regimens: ensuring that the intended protocol has been completed before the patient enters the operating theatre. Annonce • Jun 22
Ondine Biomedical Provides Update on Us Phase 3 Pivotal Study for Nasal Photodisinfection Technology Ondine Biomedical Inc. provided an update on its LANTERN Phase 3 pivotal study evaluating the Company's non-antibiotic nasal photodisinfection technology (branded as Steriwave® outside the US). Endpoint adjudication has been completed, all queries resolved, and site principal investigators are signing all case books which is a required administrative step towards database lock. This is expected to complete within the coming week, and once complete, the locked dataset will be transferred to statistical analysis in accordance with the Statistical Analysis Plan ("SAP"). The Company expects to report top-line results within one to two weeks thereafter. The LANTERN (Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections) study is designed to evaluate the safety and efficacy of Ondine's nasal photodisinfection technology in reducing the rate of surgical site infections ("SSIs"). Conducted in collaboration with HCA Healthcare and select Canadian hospitals, the study enrolled 5,188 patients across 14 HCA Healthcare hospitals in the United States and four sites in Canada. Ondine's lead product, Steriwave®, is authorized for nasal decolonisation in Canada and certain international markets. In the United States, the technology has been granted Qualified Infectious Disease Product designation and Fast Track status by the U.S. Food and Drug Administration and recently completed enrolment in its Phase 3 clinical trial. The Company has a pipeline of additional photodisinfection products in various stages of development for application in areas including chronic sinusitis, ventilator-associated pneumonia, burns and other indications. Ondine's light-activated antimicrobial technology, commercially available as Steriwave® in certain jurisdictions, is not approved, cleared, or commercially available for sale or clinical use in the United States and is limited by U.S. law to investigational use only. References to clinical outcomes in this release should be interpreted in the context of the specific studies or real-world evaluations described and do not imply regulatory approval for any particular indication. Annonce • Jun 05
Ondine Biomedical Inc., Annual General Meeting, Jun 30, 2026 Ondine Biomedical Inc., Annual General Meeting, Jun 30, 2026. Annonce • May 21
Ondine Biomedical Inc. to Report Q1, 2026 Results on Jun 04, 2026 Ondine Biomedical Inc. announced that they will report Q1, 2026 results on Jun 04, 2026 Annonce • May 02
Ondine Biomedical Inc Presents Steriwave Data At Infection Prevention And Control Conference Ondine Biomedical Inc. announced that its President and Chief Technology Officer, Dr. Nicolas Loebel, was a featured speaker at the Infection Prevention and Control Conference. The event took place 28-29 April at The National Conference Centre in Birmingham and brought together leading clinicians, infection prevention specialists, and NHS decision-makers from across the UK. The IPC Conference 2026 featured sessions addressing strategies to reduce healthcare-associated infections, improve antimicrobial stewardship, and address operational pressures within the NHS. The program included expert-led sessions on surveillance and early identification of infection risks, practical containment strategies, and scalable interventions to improve patient safety while reducing costs. The conference also highlighted the urgent need for innovation-driven solutions to address increasing surgical backlogs, workforce constraints, and the growing burden of antimicrobial resistance. In alignment with the conference's focus on evidence-based best practices and innovation adoption, Ondine Biomedical presented clinical outcomes associated with its Steriwave® nasal photodisinfection, which NHS Supply Chain recently classified as an Innovation Product. This classification reflects Steriwave's alignment with long-term NHS priorities, including reducing AMR, supporting infection prevention, and improving the efficiency and sustainability of healthcare delivery. Dr. Loebel's presentation, titled "Nasal Photodisinfection: Addressing the Hidden Costs of HAIs", focused on the clinical and economic burden of healthcare-associated infections and the role of nasal decolonisation in reducing infection risk. The presentation highlighted limitations of traditional approaches and outlined how Steriwave nasal photodisinfection offers a compelling non-antibiotic alternative aligned with evolving antimicrobial stewardship priorities. Key highlights from the presentation included: · Burden of HAIs:Healthcare-associated infections drive significant clinical and economic impact, including increased length of stay, higher treatment costs, and reduced surgical capacity. With an average of 9.7 additional hospital days per major SSI, each infection can displace two to three subsequent surgical procedures. · Limitations of antibiotic decolonisation:The presentation outlined challenges associated with antibiotic-based nasal decolonisation, including resistance development, multi-day treatment protocols, and disruption of the nasal microbiome. · Photodisinfection mechanism and profile:Steriwave nasal photodisinfection was presented as a rapid, single-dose, broad-spectrum antimicrobial approach designed to eliminate nasal pathogens without contributing to antimicrobial resistance. The nurse-led application supports consistent, high compliance. · Clinical and real-world data:Data from Steriwave use across multiple clinical and real-world settings in Canada and the UK were presented, including reductions in surgical site infections and ICU-acquired pneumonia. These findings were associated with shorter lengths of stay, faster recovery, and improved patient flow, supporting hospitals in reclaiming bed capacity and increasing procedural throughput. · Health economic impact:Health economic analysis of Steriwave was highlighted, demonstrating substantial reductions in infection-related costs and improved hospital efficiency, supporting more sustainable NHS operations. Annonce • Apr 09
Ondine Biomedical and Royal Columbian Hospital Foundation Announce Major Research Milestone First-Of-Its-Kind ICU Study Accepted by 'Journal of Critical Care' Ondine Biomedical Inc. and Royal Columbian Hospital Foundation announced that the pilot study evaluating nasal photodisinfection in an intensive care unit ("ICU") setting has been accepted for publication in the Journal of Critical Care, a leading peer-reviewed journal in intensive care medicine. This study represents an early clinical evaluation of nasal photodisinfection in the ICU, extending its application beyond surgical settings. The findings contribute to a growing body of evidence supporting this non-antibiotic approach to reducing microbial burden in high-risk patient populations. Hospitals today are confronted by a dual challenge: the diminishing effectiveness of standard antibiotic treatments due to rising resistance among common pathogens, and ongoing capacity constraints driven in part by healthcare-associated infections ("HAIs"), which contribute to prolonged ICU stays and increased resource utilisation. By evaluating a non-antibiotic approach to reducing microbial burden, the AIM team is exploring a strategy to address a root cause of these infections before they develop, with the potential to support improved patient flow and more efficient use of critical care resources. The full findings of the study, including additional clinical and economic analyses, are expected to be available following online publication in the Journal of Critical Care. Annonce • Mar 12
Ondine Biomedical Inc Provides Update On US Phase 3 Pivotal Study Ondine Biomedical Inc. announced an operational update on its LANTERN Phase 3 pivotal study. The study, evaluating the Company's non-antibiotic nasal photodisinfection technology (branded as Steriwave® outside the US) remains on schedule to report top-line results in Spring 2026 in line with prior guidance. With 93% of patients enrolled across 14 HCA Healthcare hospitals and four major Canadian centres, the LANTERN study is entering its final stages of recruitment, data collection and verification, and continues to meet projected data quality and monitoring benchmarks: · Data integrity:Over 92% of clinical report forms are complete with 92% of all database queries successfully resolved. · Monitoring progress:80% of monitoring visits are now complete. · Endpoint adjudication:Nearly 80% of all primary endpoint adjudications are complete. · Participant retention:Follow-up completion currently exceeds 98%. Topline analysis will commence immediately following completion of endpoint adjudication and database lock. Reporting will include the estimated treatment effect of surgical site infection rate reduction (derived from a generalized linear mixed-effects model comparing treatment to control arm), as well as primary safety data. Annonce • Jan 13
Ondine Biomedical Inc. Highlights New Biological Evidence Supporting Its Photodisinfection Technology in A Newly Published Study in Nature Communications Ondine Biomedical Inc. highlights new biological evidence supporting its photodisinfection technology in a newly published study in Nature Communications (Aggarwal et al., 2025). The research titled " Large-scale characterisation of the nasal microbiome redefines Staphylococcus aureus colonisation status" maps the nasal microbiome in detail and helps explain why conventional screening and traditional antibiotic based nasal decolonisation treatments have important clinical limitations. The multicenter CARRIAGE study analyzed the nasal microbiomes of approximately 1,180 healthy adults and identified seven distinct Community State Types (CSTs). A primary finding of the study is that Staphylococcus auresus (S. aureus) colonization-a leading cause of hospital-acquired infections (HAIs)-is characterized by a low-diversity microbial state (CST-1) that actively inhibits "Good Neighbor" commensal bacteria. The research redefined the biological understanding of "intermittent" carriers. Previously considered a distinct group, these individuals were shown to be persistent carriers with fluctuating bacterial loads. Separate clinical evaluations and health economic modeling presented at the 2025 International Conference on Prevention & Infection Control (ICPIC) have reported up to a 70% reduction in surgical site infections (SSIs) in facilities utilizing universal photodisinfection protocols. These evaluations suggest that the approach can lead to significant cost savings per procedure by reducing hospital readmissions and length of stay. Photodisinfection technology is currently deployed in hospitals across Canada and within the UK's National Health Service (NHS). In the United States, the technology is advancing through a Phase 3 clinical trial as part of the FDA regulatory process. Ondine Biomedical remains focused on expanding the application of photodisinfection into intensive care units, dialysis centers, oncology, and long-term care facilities to support global antimicrobial stewardship goals. Annonce • Oct 28
Ondine Biomedical Inc. Announces Preliminary Results from the Steriwave ICU Pilot Study At Royal Columbian Hospital Ondine Biomedical Inc. announced that preliminary results from the Steriwave ICU Pilot Study at Royal Columbian Hospital (RCH) demonstrate that Steriwave® nasal photodisinfection, a non-antibiotic, topical and fast acting broad spectrum antimicrobial, significantly reduces harmful pathogens in critically ill Intensive Care Unit (ICU) patients. There was a significant reduction in nasal bacterial load over the course of the study (p < 0.05) in the Steriwave group, but not in the control group. This 4-fold colonisation reduction compared to controls is an impressively strong result in the ICU setting. Reducing airway pathogens in vulnerable ICU patients can help lower high ICU infection and mortality rates. This report found that a concerning one in six lab-confirmed bacterial infections worldwide was resistant to antibiotic treatment. Study results are particularly important given that mupirocin-an antibiotic derived from Pseudomonas bacteria-is often used for nasal decolonisation, causing rising levels of resistance (up to 63% of MRSA in some settings). By contrast, Steriwave photodisinfection kills microbes via a free-radical process, with no known resistance development. Its vital support has been instrumental in enabling to undertake this significant study within the Intensive Care Unit (IC U). Their collective work sets a new standard for translational infection-control, conclusively demonstrating the utility of a rapid, point-of-care decolonisation method which eliminates all pathogens, not just Gram-positive species like MRSA. Reducing bioburden has been proven to reduce the rate of ICU infections, which in turn reduces mortality rates, antibiotic use and length of stay, thereby freeing up more capacity in overcrowded ICUs. 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 even across repeated applications. Steriwave is already being successfully used in hospitals across Canada and in the UK to decolonise the nose - a major pathogen reservoir - prior to surgery to reduce surgical site infections. Advancing Innovation in Medicine (AIM) is the research and innovation division of the Royal Columbian Hospital Foundation. AIM is dedicated to pioneering innovative clinical solutions that enhance patient outcomes, improve healthcare productivity, and create global impact through strategic partnerships. Annonce • Sep 19
Ondine Biomedical Inc. to Report First Half, 2025 Results on Sep 26, 2025 Ondine Biomedical Inc. announced that they will report first half, 2025 results on Sep 26, 2025 Annonce • Sep 04
Ondine Biomedical Inc. to Present Health Economic Data at ICPIC 2025 Ondine Biomedical Inc. announced that it was invited to make an oral presentation about health and economic benefits of Steriwave nasal photodisinfection at the 12th International Conference on Prevention & Infection Control (ICPIC) in Geneva, Switzerland. ICPIC is recognized as the leading conference for infection prevention and control, attracting global experts and healthcare innovators. The Company's abstract detailing a health economic analysis by the York Health Economics Consortium (YHEC) has been accepted and upgraded to an oral presentation (session O06). The annual global conference will be held 16-19 September 2025, in Geneva, Switzerland. This presentation will highlight how Steriwave nasal photod isinfection significantly reduces costs associated with surgical site infections (SSIs), demonstrated in both a patient series of elective hip and knee replacements at Mid Yorkshire Teaching NHS Trust (MYTT) and more extensively in two separate health economic models using literature-derived data across multiple surgical specialties. YHEC's research shows that Steriwave not only improves patient outcomes but also delivers substantial net savings by preventing SSIs in major surgeries. Steriwave is a non-invasive and pain-free nasal decolonisation treatment that uses a proprietary light-activated antimicrobial agent to destroy harmful pathogens - including bacteria, viruses, and fungi - in the nose. Steriwave treatment involves applying a proprietary photosensitive agent to each nostril with a nasal swab, followed by illumination with a specific wavelength of red light for five minutes. The treatment is effective immediately, takes less than five minutes, and preserves the natural microbiome while offering immediate microbial reduction without the development of resistance. It is widely used in hospitals across Canada and increasingly in the UK. Annonce • Jul 21
Ondine Biomedical Inc. Announces Completion of First Icu Clinical Study Evaluating Nasal Photodisinfection in Critical-Ill Patients Ondine Biomedical Inc. announced completion of the world's first ICU clinical study evaluating nasal photodisinfection in critically-ill patients. The study was conducted at Royal Columbian Hospital (RCH), a leading tertiary care and trauma centre, marking a significant step forward in the fight against hospital-acquired infections (HAIs). The study evaluated the use of Steriwave®? as a non-antibiotic nasal decolonization therapy in the ICU setting. The company believe that size of the ICU market is at least as large as the pre-surgical decolonization market. Steriwave offers a resistance-free, rapid approach to reducing infections and improving patient outcomes. Steriwave currently stands as the only antimicrobial proven to eliminate a broad range of multidrug-resistant pathogens from the nose within minutes, without fostering antimicrobial resistance. Rising antibiotic resistance increases the urgency and the opportunity for non-antibiotic solutions in hospital infection prevention. Current guidelines from the CDC and IDSA already recommend nasal decolonization for ICU patients, particularly targeting Staphylococcus aureus. However, resistance to standard decolonization agents such as mupirocin is rising sharply, with resistance rates reaching as high as 80% in some settings. Steriwave's non-resistance-forming photodisinfection platform directly addresses this unmet need and offers an innovative solution for healthcare systems facing mounting antimicrobial resistance and infection control pressures. Annonce • Jul 16
Ondine Biomedical Inc. Reports Increasing Clinical Adoption of its Light-Invasive Anticrobial Therapy, Steriwave® Ondine Biomedical Inc. reported increasing clinical adoption of its light-activated antimicrobial therapy, Steriwave®, across a broad range of surgical specialities in hospitals throughout the UK and Canada to reduce surgical site infections (SSIs). Hospitals are now routinely implementing Steriwave nasal decolonisation prior to major surgeries - including cardiac, orthopaedic, neurosurgical, ENT, spinal, and cosmetic procedures - as awareness grows of its effectiveness in reducing SSIs. SSIs remain a significant concern in surgical care, contributing to approximately 3% mortality, extended hospital stays averaging nearly 10 additional days. A comprehensive study in Alberta, Canada, found that complex SSIs following hip and knee replacements can cost hospitals up to CAD 95,000 per case and pose serious health risks for patients. The patient's nasal passages are a significant source of post-surgical infections, with studies indicating that up to 69% of SSIs originate from pathogens that can colonise the nose. Leading health authorities, including the CDC, WHO, and SHEA, strongly recommend pre-operative nasal decolonisation as an effective strategy to lower the risk of infection. In contrast to mupirocin - the current standard for nasal decolonisation despite its limited bacterial spectrum and rising resistance - Steriwave offers a fast-acting, resistance-free alternative that is effective across nasal pathogens, including bacteria, viruses and fungi. In some hospitals, mupirocin resistance exceeds 70%, underscoring the urgent need for more versatile and reliable infection prevention tools like Steriwave. Steriwave is a non-invasive, painless nasal treatment that uses a proprietary photosensitive agent activated by red light to destroy harmful bacteria, viruses, and fungi. The procedure takes five minutes, is effective immediately, and allows the normal nasal microbiome to recover quickly, without fostering antimicrobial resistance. Steriwave is actively utilized in hospitals across Canada, including more than half of the country's ten largest hospitals, as well as several prominent NHS Trusts in the UK. In the United States, the technology is currently undergoing a Phase 3 clinical trial in collaboration with HCA Healthcare, the nation's largest private healthcare group. This study aims to secure FDA marketing approval, further expanding Steriwave's reach and impact. Annonce • Jun 25
Ondine Biomedical Inc. Announces the Implementation At Vernon Jubilee Hospital, British Columbia's Interior Health Authority Has Completed the Rollout of Steriwave®? Nasal Decolonization Therapy for All Total Hip and Knee Replacement Surgeries Ondine Biomedical Inc. announced that, with the implementation at Vernon Jubilee Hospital, British Columbia's Interior Health Authority (IHA) has completed the rollout of Steriwave®? nasal decolonization therapy for all total hip and knee replacement surgeries. With this implementation, IHA becomes the second provincial health authority in Canada to adopt Steriwave as standard of care for these procedures. Steriwave is now in use at 17 hospitals across all five health authorities in British Columbia (BC), which collectively serve most of the province's 5.7 million residents. Steriwave is also standard of care in six of Canada's top ten largest hospitals and in several UK private sector and NHS trust hospitals. Elizabeth Bryce, Titus Wong, Diane Roscoe, and Bas Masri, these institutions became the first in the world to implement universal pre-surgical nasal photodisinfection for major surgeries. Their work demonstrated sustained infection rate reductions exceeding 50% over more than a decade without generating antimicrobial resistance. The VGH/UBC team was recognized with several awards including the 2013 International Consortium for Prevention and Infection Control Innovation Excellence Award in Geneva, becoming the first Canadians to receive this global award. Subsequent data from VGH's spine team, led by Dr. John Street, showed that the use of Steriwave in spine surgery patients reduced post-surgical infection rates by 66.5% and delivered nearly CAD 2,600 in cost savings per patient amounting to CAD 2.5 million in annual savings for the hospital's spine program. These VCH results laid the groundwork for broader adoption across BC and abroad, including Mid Yorkshire Teaching NHS Trust in the UK, which reported a 71% surgical site infection (SSI) reduction for hips and knees and recently won the President's Award at the 2025 IPA World Congress (Shanghai) and has been shortlisted for the prestigious HSJ Patient Safety Awards for these results. Annonce • Jun 10
Ondine Biomedical Inc. Presents Major Advancements in the Fight Against Multidrug-Resistant Pathogens Ondine Biomedical Inc. is presenting major advancements in the fight against multidrug-resistant pathogens at the 19th World Congress of the International Photodynamic Association (IPA) being held this week in Shanghai. The Company has developed an intelligent robotic tool that leverages advanced AI-driven algorithms to identify the most effective combinations of antimicrobial therapies for eliminating a wide range of pathogens. This tool highlights the powerful synergy between Ondine's light-activated photodisinfection technology and existing antibiotics and antiseptics-a market valued at $80-100 billion globally in 2024. The presentation, given by Ondine research scientist Micah Chavez, introduces a novel methodology that uses a high-throughput robotic assay to characterize interactions between legacy antimicrobials and potent photodisinfection. The assay, designed specifically by the Company for this purpose, utilizes a new optical checkerboard approach to conducting dozens of simultaneous microbiological experiments with lethal pathogens in a safe and reproducible manner, conforming to reporting requirements of the Clinical and Laboratory Standards Institute (CLSI) and American Society for Microbiology (ASM) guidelines. AI-driven algorithms are used to select the most promising combination of agents to team with photodisinfection for combined topical and systemic attack against any given multi-drug-resistant pathogen. Ondine's photodisinfection platform technology underpins Steriwave®?, the Company's lead product, developed to prevent healthcare-associated infections by targeting pathogens in the nasal cavity. Steriwave is in use at leading healthcare institutions in Canada and the UK, including hospitals within the CanHealth Network and the NHS, and a pivotal clinical trial is currently underway to support FDA regulatory submission in the United States. Annonce • Jun 09
Ondine Biomedical Inc. Announces New Data from University College London Demonstrating the Potent Efficacy of Ondine's Steriwave® Photodisinfection Technology Against the Often-Lethal Fungus Mucor Ondine Biomedical Inc. announced new data from University College London (UCL), demonstrating the potent efficacy of Ondine's Steriwave®? photodisinfection technology against the often-lethal fungus Mucor. The findings were presented in an abstract at the 19th World Congress of the International Photodynamic Association (IPA) in Shanghai, China. Dr. Colin Hopper and Dr. Aashvi Joshi of University College London, Eastman Dental Institute, Oral and Maxillofacial Surgery, London, stated: "Fungal infections, especially mucormycosis, are a serious threat in hospitals, with alarmingly high mortality rates and very few effective treatment options. The ability of Steriwave to rapidly and safely decolonize the nose of fungal pathogens represents a major advance in infection prevention, helping to protect patients from these life-threatening infections with affordable therapy." Mucor fungal infections, particularly mucormycosis, pose a serious risk to immunocompromised patients, such as those undergoing bone marrow transplants, with mortality rates often exceeding 50%. Current therapies for mucormycosis are limited by high toxicity, incomplete efficacy, the need for aggressive surgery, frequent treatment failures, and persistently high mortality rates. These issues highlight the urgent need for new and more effective treatment strategies for the growing problem of drug-resistant fungal infections. The research, conducted at UCL-where photodisinfection was invented by Emeritus Professor Michael Wilson in the late 1980s-showed that Ondine's Steriwav technology was able to completely inhibit the growth of all cells of Mucor in vitro, with very short treatment times. By providing effective nasal decolonization of Mucor and other fungal pathogens, Steriwave photodisinfection offers a new approach to reduce patient risk and improve outcomes for those most vulnerable to invasive fungal disease. The ability to rapidly and safely eliminate these pathogens from the nasal passages is especially significant in hospital settings, where nasal pathogens are a major source of surgical site infections (SSIs) and healthcare-associated infections (HAIs), and where antimicrobial resistance is an escalating threat. Ondine's patented Steriwave technology is already in use in hospitals across Canada and the UK for nasal decolonization to prevent SSIs and HAIs. The new findings from University College London provide further evidence of Steriwave's broad-spectrum efficacy and potential to significantly reduce the burden of healthcare-associated infections worldwide. Annonce • May 16
Ondine Biomedical Inc., Annual General Meeting, Jun 26, 2025 Ondine Biomedical Inc., Annual General Meeting, Jun 26, 2025. Annonce • May 08
Ondine Biomedical Inc. to Report Fiscal Year 2024 Final Results on May 15, 2025 Ondine Biomedical Inc. announced that they will report fiscal year 2024 final results at 8:00 AM, GMT Standard Time on May 15, 2025 Annonce • Mar 28
Mike Farrar Resigns as Non-Executive Director of Ondine Biomedical Inc Ondine Biomedical Inc. announced that Mike Farrar has resigned from his position as Non-Executive Director of the Company, effective immediately, following his appointment by the Health Minister for Northern Ireland, Mike Nesbitt, as the Interim Permanent Secretary of the Northern Ireland Executive Department of Health. Annonce • Jan 31
Ondine Biomedical Inc. has completed a Follow-on Equity Offering in the amount of $3.999974 million. Ondine Biomedical Inc. has completed a Follow-on Equity Offering in the amount of $3.999974 million.
Security Name: Common Shares
Security Type: Common Stock
Securities Offered: 38,033,412
Price\Range: $0.10517
Transaction Features: Subsequent Direct Listing Annonce • Dec 30
Ondine Biomedical Inc. Recruits First Patient for US Phase 3 Trial Ondine Biomedical Inc. has enrolled and treated the first patient in the Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections ('LANTERN') Phase 3 clinical trial. The trial, involving approximately 5,000 patients in 14 hospitals, is evaluating Ondine's non-antibiotic nasal photodisinfection technology, branded as Steriwave®? outside the US. The first patient was enrolled at Centennial Medical Center in Nashville, Tennessee, on Friday December 27th, 2024. The Phase 3 trial is being conducted in collaboration with HCA Healthcare, a leading healthcare provider in the United States. This group-randomized crossover study will enroll approximately 5,000 surgical patients undergoing cardiac, orthopaedic, vascular, neurosurgical or radical mastectomy procedures. The study will compare standard infection prevention practices with, and without, Ondine's nasal photodisinfections technology in order to reduce the incidence of surgical site infections. The final patient is expected to enroll in mid-2025, and preliminary trial results are projected for release in Autumn 2025. Ondine's nasal photODisinfection is a 5-minute, non-invasive procedure that rapidly decolonizes the nose of infection-causing pathogens without the use of antibiotics. This innovative approach avoids contributing to antimicrobial resistance (AMR). The process involves applying a proprietary photosensitive agent to each nostril with a nasal swab, followed by illumination with a specific wavelength of red light. The light activates the agent, producing an oxidative burst that destroys bacteria, viruses and fungi in a single treatment. Nasal decolonization is recommended in the 2016 WHO Global guidelines for the prevention of surgical site infections, and the Society for Healthcare Epidemiology of America (SHEA) guidelines, published in May 2023, recommend nasal decolonization for major surgical procedures. Annonce • Nov 02
Ondine Biomedical Inc. has completed a Follow-on Equity Offering in the amount of £9 million. Ondine Biomedical Inc. has completed a Follow-on Equity Offering in the amount of £9 million.
Security Name: Common Shares
Security Type: Common Stock
Securities Offered: 103,403,318
Price\Range: £0.085
Security Name: Common Shares
Security Type: Common Stock
Securities Offered: 2,479,035
Price\Range: £0.085
Transaction Features: Subsequent Direct Listing Annonce • Nov 01
Ondine Biomedical Inc. has filed a Follow-on Equity Offering in the amount of £8.5 million. Ondine Biomedical Inc. has filed a Follow-on Equity Offering in the amount of £8.5 million.
Security Name: Common Shares
Security Type: Common Stock
Securities Offered: 97,520,965
Price\Range: £0.085
Security Name: Common Shares
Security Type: Common Stock
Securities Offered: 2,479,035
Price\Range: £0.085
Transaction Features: Subsequent Direct Listing Annonce • Oct 18
Ondine Biomedical Inc. Receives Regulatory Approval to Market Steriwave Nasal Decolonization to Reduce Healthcare-Associated Infections in Patients Undergoing Surgery in the United Arab Emirates Ondine Biomedical Inc. announced that it has received regulatory approval to market Steriwave nasal decolonization to reduce healthcare-associated infections (HAIs) in patients undergoing surgery in the United Arab Emirates (UAE). HAIs remain a critical challenge across the world, resulting in significant costs, avoidable deaths, and human suffering. HAIs rank as the fifth most frequent cause of mortality in acute-care hospitals in the United States. Post-surgical infections, in particular, extend recovery times and often require prolonged antibiotic treatment, which governments, such as in the UK, are actively seeking to reduce. In the U.S., the average hospital cost per surgical site infection (SSI) is approximately $20,000. Nasal decolonization is recommended in the 2016 WHO Global guidelines for the prevention of surgical site infections, and the Society for Healthcare Epidemiology of America (SHEA) guidelines, published in May 2023, recommend nasal decolonization for major surgical procedures. Steriwave uses a patented light-activated agent to rapidly eliminate infection-causing pathogens in a single, 5-minute treatment. The process works so rapidly that pathogens do not have the opportunity to develop resistance, making it an effective alternative to antibiotics. Hospitals using Steriwave have reported high levels of staff and patient compliance. Steriwave has also been proven to be highly effective against drug-resistant pathogens. A 2023 study showed that Steriwave is highly effective (>99.99% kills in 20 seconds) against both moderately drug-resistant (MDR) and extensively drug-resistant (XDR) pathogens. Annonce • Sep 24
Ondine Biomedical Inc. announced that it expects to receive CAD 5 million in funding Ondine Biomedical Inc. announced a private placement to issue 22,222,222 common shares at an issue price of CAD 0.225 for gross proceeds of CAD 5,000,000 on September 24, 2024. The closing of the transaction is expected to be on or before 8 November 2024. Annonce • Sep 16
Ondine Biomedical Inc. Announces Board and Committee Changes Ondine Biomedical Inc. announced changes to its Board of Directors with the reappointment of Margaret Shaw and the resignation of Mr. Craig Tooman. Mr. Tooman steps down from the Board and as Audit Committee Chair having served a commendable three-year term to focus on his increasing duties as CEO of NASDAQ listed Silence Therapeutics Inc. Ms. Shaw, a seasoned finance professional with extensive experience in investment management and capital markets, will Chair the Audit & Risk Oversight Committee and join the Nominating & Governance Committee. Margaret Shaw's appointment strengthens Ondine's Board in several key areas: Financial Expertise:As a former Chartered Financial Analyst (CFA) and former institutional portfolio manager, Ms. Shaw brings critical financial management skills to the Board, enhancing its ability to navigate current and future financing challenges. Diversity and Inclusion:Ms. Shaw's reappointment contributes to Ondine's goals of achieving gender diversity on its Board, enabling the company to meet its target of a minimum of 33 % female representation. Strategic Insight:With a proven track record in strategic planning and risk management, Ms. Shaw will play a pivotal role in shaping the company's direction as it progresses through the FDA approval process and continues to expand its market presence. Margaret Shaw previously served on Ondine's Board of Directors from April 2009 to September 2011, during which time she contributed to the company's growth and strategic initiatives. Her return to the Board reflects her deep commitment to Ondine's mission and her confidence in the company's future. Annonce • May 29
Ondine Biomedical Inc. to Report Fiscal Year 2023 Final Results on Jun 07, 2024 Ondine Biomedical Inc. announced that they will report fiscal year 2023 final results on Jun 07, 2024 Annonce • May 04
Ondine Biomedical Inc. has completed a Follow-on Equity Offering in the amount of £3.037487 million. Ondine Biomedical Inc. has completed a Follow-on Equity Offering in the amount of £3.037487 million.
Security Name: Common Shares
Security Type: Common Stock
Securities Offered: 39,209,992
Price\Range: £0.07
Security Features: Attached Warrants
Security Name: Common Shares
Security Type: Common Stock
Securities Offered: 4,182,673
Price\Range: £0.07
Security Features: Attached Warrants
Transaction Features: Rights Offering; Subsequent Direct Listing 
