Cleo Commences U.S. Regulatory Process with FDA

Highlights

Commencement of U.S. Regulatory Process

CLEO has completed an initial pre-submission meeting with the U.S. Food and Drug Administration (FDA) where the Company outlined its submission framework and clinical plan for its ovarian cancer detection blood test. The pre-submission meeting is designed to permit CLEO to receive early guidance from FDA review teams prior to an eventual application submission.

The meeting was interactive with the FDA providing constructive and positive feedback on CLEO’s approach to obtaining regulatory approval in the U.S. for its ovarian cancer detection blood test. This outcome provides confidence that CLEO’s clinical trial designs and strategic direction are appropriately aligned with FDA requirements.

Early interaction with the FDA is important as a part of CLEO’s U.S. market access strategy for a number of reasons, as the guidance outcomes allow CLEO to:

CLEO is pursuing expedited FDA approval for its first ovarian cancer detection product – the pre-surgical Triage test – via the 510(k) application pathway. This approach provides the quickest pathway to achieve regulatory approval for devices that achieve “substantial equivalence” to an existing predicate.

Clinical Trial Activity

CLEO’s clinical trial design has now been reviewed and approved in both the U.S. and Australia. Institutional Review Board (IRB) approval is a legal requirement for any clinical trial, to ensure trial activities are ethically sound and compliant with federal regulations.

Trial sites are being formally contracted, and patient recruitment is to commence shortly. CLEO is working with U.S.-based Contract Research Organization (CRO), Lindus Health to manage the international arm of the trial.

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