Ondine Biomedical targets US regulatory milestone after £10m raise and positive Phase 3 results

Ondine Biomedical Inc (AIM:OBI, OTC:OBIMF) President and Chief Technology Officer Nicolas Loebel spoke with Proactive's Stephen Gunnion about the company’s £10 million fundraising, positive top-line Phase 3 results and plans to bring its nasal photodisinfection technology to the US market. Loebel discussed the timing of the raise, completed at 10p per share, following the LANTERN Phase 3 trial involving 5,188 patients across 18 hospitals in the US and Canada. “Our top line results have just come through. They're very good,” he says. The company is now completing detailed analysis of the clinical data ahead of its next regulatory steps. Ondine is targeting a pre-New Drug Application (NDA) meeting with the US Food and Drug Administration (FDA) in the first quarter of 2027, followed by a potential NDA submission around the middle of the year. The work includes analysis of more than 350,000 pieces of clinical data, patient outcomes and microbiological findings. Loebel also outlined the company’s commercial priorities in markets where Steriwave® is already available. Canada remains its leading sales market, while Ondine is working to expand adoption across UK hospitals and NHS trusts and pursue opportunities in the European Union. With around 35% of the fundraising earmarked for commercial expansion and business development, the company aims to grow sales while advancing its US regulatory programme. Loebel also discusses the real-world experience gained from more than 250,000 patient treatments outside the US. Watch the full interview for Loebel’s update on Phase 3 analysis, the FDA timeline and Steriwave’s next stage of commercial growth. Visit Proactive's YouTube channel for more biotechnology company interviews, healthcare investment updates and clinical trial developments. Don't forget to give this video a like, subscribe to the channel and enable notifications for future content. Read Proactive's Editorial Policy here: https://www.proactiveinvestors.co.uk/pages/editorialPolicy #OndineBiomedical #Steriwave #Phase3ClinicalTrial #Biotechnology #Proactive #NicolasLoebel #OndineBiomedicalPLC #ClinicalTrials #Phase3Results #FDAApproval #FDAFastTrack #FDARegulatory #NewDrugApplication #HealthcareInnovation #MedicalTechnology #InfectionPrevention #HospitalInfections #PatientSafety #HealthcareInvestment #BiotechStocks #BiotechInvesting #LifeSciences #CommercialExpansion #UKHealthcare #CanadianHealthcare #ClinicalResearch #HealthcareStocks #OndineBiomedical #Steriwave #Phase3Results #FDARegulatory #Biotechnology