Ondine Biomed Regulatory News (OBI)

7 July 2023

ONDINE BIOMEDICAL INC.

("Ondine Biomedical", "Ondine" or the "Company")

CORPORATE UPDATE

Ondine Biomedical Inc. (LON:OBI) a Canadian life sciences company, provides the following update.

Updated Phase 3 clinical trial

Ondine has modified its Phase 3 Clinical Trial Design for lead product Steriwave®, to cover a broader range of hospital-acquired infections (HAIs), including surgical site infections (SSIs), bloodstream infections and pneumonias. The expanded design was suggested by the Company's study partner, HCA. The increased number of infection classes, as well as selection of higher-risk surgeries such as cardiotomies, orthopaedic, and spine procedures, permits a smaller study sample size (approx. 4,400 patients), 1-2-month shorter time frame, and expected lower costs. Given the high number of surgeries being carried out monthly at HCA, the broadening of the design is not expected to have any impact on the recruitment rate into the trial. 

Commercialisation Strategy

The Company's commercialisation strategy remains on track. Several clinical deployments of the technology are planned in hospitals across core target markets outside the US with existing regulatory approval throughout 2023. These include Canada, UK & Ireland, Spain, and Mexico.

Ondine continues to prepare for its revised Phase 3 study, now designed to facilitate FDA approval for the use of Steriwave in the US market against a range of HAIs, and is exploring available funding opportunities to support the attainment of these key value inflexion points.

Operating Budgets

To focus its resources on strategic priorities, including the Phase 3 study, the Company has deferred certain elements of planned expenditures. Spending on R&D costs for automation and scale-up will be deferred until after conclusion of the study, as will planned headcount expansion. Ondine has already sufficiently scaled current production capacity for current early adoption expectations and the first year of US demand post FDA-approval.

**ENDS**

This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) 596/2014 as it forms part of UK domestic law by virtue of the European Union (Withdrawal) Act 2018. Upon the publication of this announcement via the Regulatory Information Service, this inside information is now considered to be in the public domain.