Ondine Biomedical reports first-quarter progress
By Josh White
Date: Monday 17 Apr 2023
(Sharecast News) - Life sciences company Ondine Biomedical reported a number of operational highlights in a first-quarter update on Monday, including clinical developments for US market approval, additional clinical data and endorsements, and commercial progress.
The AIM-traded firm said it made considerable progress on the preparation of its phase three clinical study for the commercialisation of Steriwave in the US.
That followed a primary phase two clinical study in 2022,m and a smaller study designed to support upcoming regulatory submissions and inform phase three trial design.
Ondine said phase three preparations were the primary focus, with progress made towards project management, clinical trial site identification, and recruitment planning.
In addition, it said it had invested considerable resources into the next generation of efficient, injection-moulded, disposable light activator units, which would significantly reduce the cost of goods and enhance performance.
Clinical pilot outcomes of a six-month study at the Ottawa Hospital in Ontario meanwhile confirmed "substantial reductions" in patient readmission rates and length of hospital stays in spine surgery patients.
Ondine said clinical trial results demonstrating a significant decrease in viral infectivity in predominantly vaccinated Covid-19 patients were published, paving the way for a future role in pandemic preparedness planning.
A physician-sponsored press conference in Toronto was also held, during which "prominent Canadians" discussed their experiences with Steriwave nasal decolonization in enterprise settings, and the manager of rock band KISS presented on the band's extensive use of Steriwave nasal decolonization in international touring locations.
Commercial progress was reported in Canada, the UK, Spain, and Mexico, with further pilot installations and commercialisation underway.
Ondine had also established a network of local distributors in target markets, and was working with "leading key opinion leaders" to foster broad adoption of Steriwave and generate additional data for other key market initiatives.
Finally, Ondine said it was able to serve the needs of a large meat processing plant in Manitoba, Canada during the Covid-19 pandemic, protecting essential workers and substantially reducing outbreaks in the plant.
Safety data collected during the large-scale and multi-use deployment were expected to support regulatory filings, with outcomes submitted for peer review and publication.
"I am very pleased to be able to report that Ondine has taken significant steps forward in our clinical development and commercialisation strategy over the past year," said chief executive officer Carolyn Cross.
"We have also made substantial progress towards initiating the US phase three trial of our Steriwave nasal photodisinfection technology.
"We look forward to providing further updates on our clinical and commercial activity in due course as Ondine enters this exciting stage in its growth."
At 1009 BST, shares in Ondine Biomedical were down 2.36% at 16.11p.
Reporting by Josh White for Sharecast.com.
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