Ondine Biomedical Inc (AIM:OBI) revealed that it has made significant updates to its Phase 3 Clinical Trial Design for its lead product, Steriwave.
In a corporate update published late on Friday, the Canadian life sciences company said the modifications aim to cover a broader range of hospital-acquired infections (HAIs), including surgical site infections (SSIs), bloodstream infections and pneumonias.
The decision to expand the trial design was influenced by the company's study partner, HCA, and will now include higher-risk surgeries such as cardiotomies, orthopaedic procedures and spine procedures. This adjustment allows for a smaller study sample size of approximately 4,400 patients, a shorter time frame of 1-2 months and expected lower costs.
Despite the modifications, Ondine said it expects the recruitment rate into the trial to remain unaffected due to the high number of surgeries performed monthly at HCA facilities.
Regarding the company's commercialization strategy, Ondine also said it remains on track to deploy its technology in hospitals across core target markets outside the United States, including Canada, the UK & Ireland, Spain, and Mexico. These deployments are scheduled throughout 2023 and have already obtained regulatory approval.
Ondine also disclosed that it continues to prepare for the revised Phase 3 study, which aims to facilitate US Food and Drug Administration (FDA) approval for the use of Steriwave in the US market against a range of HAIs. The company said it is actively exploring available funding opportunities to support the achievement of these key value inflection points.
To concentrate its resources on strategic priorities, particularly the Phase 3 study, Ondine added, it has deferred certain elements of planned expenditures. This includes the postponement of spending on research and development costs for automation and scale-up, as well as the delay in planned headcount expansion.
The company said it has already scaled its production capacity sufficiently to meet current early adoption expectations and the first year of US demand following FDA approval.