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Ondine treats first patients in Phase 2 FDA trial
Ondine treats first patients in Phase 2 FDA trial.
About this update from Ondine Biomedical, Inc.
[{"type":"text","content":"\n \n \n \n RNS Number : 8124A\n Ondine Biomedical Inc.\n 07 February 2022\n \n \n \n \n 7 February 2022\n \n \n Ondine Biomedical Inc.\n \n \n (\"Ondine Biomedical\", \"Ondine\" or the \"Company\")\n \n \n \n \n \n Ondine Biomedical treats first patients in nasal photodisinfection US Phase 2 for the prevention of post-operative infections\n \n \n \n \n \n · \n Post-operative infections occur in up to 300,000 patients per year in the United States and cost the US healthcare system tens of billions of dollars a year.[i]\n \n \n \n \n \n Ondine Biomedical Inc. (LON: OBI), has treated the first patients in its nasal photodisinfection exploratory \n \n Phase 2 trial\n \n . The \n study will evaluate how effectively the treatment eradicates pathogens -\n \n Staphylococcus aureus -\n \n in the nose, and \n the occurrence of surgical site infections (SSIs) within 30 days of surgery. \n \n \n \n \n \n The single-center, BENEFIT-ADPT open-label study \n is being carried out at HCA Healthcare's Memorial Health University Medical Center in Savannah, Georgia and will involve up to 500 surgical patients. \n \n \n \n \n \n Carolyn Cross, Ondine's CEO commented \"We are delighted to be able to initiate this important study with the team at HCA Healthcare's Memorial Health University Medical Center. We are particularly pleased to start treating patients in light of the Omicron challenges, which have strained hospital resources and impacted clinical trials around the world. We appreciate HCA's support and the importance they place on reducing SSIs. This is a truly novel approach to nasal disinfection, and we believe that our technology has the potential to have a significant effect on combatting SSIs, complications, and extended hospital stays.\"\n \n \n \n \n \n SSIs are the leading cause of \n \n \n readmissions\n \n \n to hospital following surgery and a significant cause of post-surgical morbidity and mortality, with approximately 3% of patients who contract an SSI dying as a consequence. \n \n \n \n \n \n Prior to surgery, all clinical trial patients will undergo a nasal culture to determine the prevalence of Staphylococcus aureus, the main cause of surgical site infections. Each patient will then receive Ondine's nasal photodisinfection (investigational product) followed by a...