Business
Full Year Results
Full Year Results.
About this update from Ondine Biomedical, Inc.
[{"type":"text","content":"\n\n10 May 2023\n \nOndine Biomedical Inc.\n \n(\"Ondine Biomedical\", \"Ondine\" or the \"Company\")\n \n(All figures are expressed in Canadian Dollars, unless otherwise stated)\n \nFull Year Results for the Twelve Months Ended 31 December 2022\n \nOndine Biomedical Inc. (AIM:OBI), an AIM-listed, Canadian biomedical company, is pleased to announce its audited results for the year ended 31 December 2022.\n \nCarolyn Cross, CEO, said:\n\"We are pleased to report significant steps forward in our clinical development and commercialization strategy this year, as well substantially advancing preparations for our Phase 3 study of Steriwave nasal photodisinfection. Alongside the FDA process, we are making commercial inroads into the UK, Spain and Mexico where we have already gained regulatory approval. In our home market of Canada, we now have 9 hospital installations and clinical pilots. Once Steriwave nasal photodisinfection has been granted approval in the US, we look forward to commercial rollout starting with our long-term partner HCA Healthcare, one of the largest hospital groups in the US.\n \n\"While we are focusing on the FDA Phase 3 trial and key near-term commercialization opportunities, we remain excited by the broader applications of our photodisinfection platform technology. Now more than ever, as healthcare systems continue to struggle with record patient backlogs, staff shortages, and inflationary pressures alongside rising antimicrobial resistance, we have strong conviction in the long-term prospects for our business.\"\n \n \nOperational Highlights, Including Post Year-End Events\n \n· Ondine successfully completed its primary Phase 2 clinical study. Additionally, Ondine also completed a second study designed to support upcoming regulatory submissions and to inform Phase 3 trial design.\n \n· Phase 3 preparations continue to be the primary focus for the Company. Considerable progress has been made toward the necessary project management, clinical trial site identification, HCA Healthcare operational integration, and recruitment planning. CRO and regulatory consultants have also been identified and are working with the Company on the FDA strategy and final clinical trial design. Development of the cl...