Ondine Biomedical Inc (AIM:OBI) said its focus for the coming year will be the phase III clinical trial of its pioneering Steriwave photodisinfection technology in the US.
It also emphasised the "near-term commercialisation opportunities" for its product, which aims to prevent surgical site infections.
This announcement was accompanied by a review of the notable progress made in 2022, as detailed in the company's full-year results.
Ondine has successfully completed its primary phase II clinical study in the US, as well as a supplemental evaluation, both instrumental in preparing for regulatory submissions and the crucial final-stage trial design.
It also has made substantial strides in preparing for the phase III trial, with advancements in project management, site identification, recruitment planning and strategy development.
The manufacturing of the trial product is also nearing completion, with ongoing efforts in site contracting, training and operational planning.
On the commercial front, Ondine has expanded its presence in the Canadian hospital market and has made its debut in three additional countries - the UK, Spain and Mexico.
Ondine's CEO, Carolyn Cross, said: "While our focus is on the FDA phase III trial and key near-term commercialization opportunities, we're enthusiastic about the broader applications of our photodisinfection platform technology.
"Given the current challenges facing healthcare systems, such as patient backlogs, staff shortages, and inflationary pressures, combined with increasing antimicrobial resistance, our conviction in the long-term prospects for our business remains strong."
Turning to the financials, Ondine closed 2022 with a healthy US$13.1mln on its balance sheet. The company posted a loss of US$19.5mln for the year ending 31 December 2022, reflecting the significant investments made in the commercial scale-up of Steriwave and, importantly, the clinical work conducted.