Cleo Commences Health Economic Study to Support U.S. Market Entry
Highlights
Partnership with EntityRisk to provide evidence-based insight into the economic value of Cleo’s Ovarian Cancer Pre-Surgical Test in the U.S.
Partnership with Norstella to examine detailed physician and claims data to identify high-value launch markets and maximise early adoption potential
Refined Total Addressable Market estimate to accelerate payor reimbursement negotiations, and drive investor confidence ahead of commercialisation.
MELBOURNE, AUSTRALIA, 18th August 2025: Ovarian cancer diagnostics company, Cleo Diagnostics Limited (ASX:COV) (CLEO or the Company) is pleased to announce it has engaged and commenced work with EntityRisk and Norstella to deliver a United States (U.S.) focused health economic analysis and market assessment for its first commercial product, the Ovarian Cancer Pre-Surgical Test.
U.S Market Access and Reimbursement Support
EntityRisk, a specialist in health economics and value modelling, will lead the development of a model to quantify the economic benefits of adopting Cleo’s Pre-Surgical Test for Ovarian Cancer. The project will also leverage the expertise of Managed Markets Insight & Technology, LLC (MMIT), a Norstella company, whose market access and payer intelligence capabilities will ensure the modelling is informed by comprehensive U.S. reimbursement data. Together, these outputs will provide robust, evidence-based justification to support payor engagement, identify optimal reimbursement arrangements, and underpin Cleo’s commercialisation pathway in the U.S. healthcare market.
Ken Browe, Senior Vice President at Norstella, commented:
“Our collaboration with Cleo represents exactly the kind of partnership we are passionate about — EntityRisk’s rigorous health economic modelling, combined with MMIT’s payer and market access intelligence, to demonstrate clear value to the U.S. healthcare system. By integrating these insights, we aim to support a compelling reimbursement case that accelerates adoption of Cleo’s Ovarian Cancer Pre-Surgical Test and delivers meaningful benefits for patients and providers alike.”
Targeted Market Entry
Cleo will also leverage Norstella’s extensive health system and claims databases to refine its launch markets in the U.S., focusing on those regions with the highest clinical need and greatest commercial potential. This targeted approach is aimed at maximizing early adoption and accelerating early revenue generation, which is forecast for next year directly following FDA submission.
Strengthened Investor Confidence with Accurate Market Data
Norstella’s comprehensive analysis of physician procedural trends, payer policies, and claims data will deliver a refined, evidence-based Total Addressable Market (TAM) estimate for Cleo’s Ovarian Cancer Pre-Surgical Test. This granular market sizing will not only guide manufacturing scale-up and operational planning but also provide a credible foundation for discussions with potential U.S. commercial partners, payors, and investors. By quantifying the true scope of the market opportunity with precision, Cleo will be equipped to negotiate from a position of strength, accelerate strategic decision-making, and instil confidence across its stakeholder base.
Commenting on the Agreement, CLEO Chief Executive Officer, Dr Richard Allman, said:
“Cleo is very pleased to partner with Norstella and EntityRisk to progress these important strategic initiatives. Their expertise will ensure our market entry is focused, data-driven, and positioned for success in the competitive and complex U.S. healthcare environment.
This integrated approach will equip payors with a clear, evidence-based understanding of the clinical and economic value of our Ovarian Cancer test, helping to facilitate reimbursement decisions and support successful entry into the U.S. market. We expect completion of the health economic analysis before year end, with the results to be published shortly thereafter.”