Cleo Diagnostics Raises $5M, Nears 500-Patient Trial Target for FDA Submission
Cleo Diagnostics has broadened its U.S. market opportunity to around 2 million women annually and is on track to complete its pivotal clinical trial early this year, supported by a $5 million capital raise and regulatory progress.
- Appointment of first U.S. Key Opinion Leader to drive clinical advocacy
- Total Addressable Market expanded to ~2 million women pre-surgery annually in the U.S.
- Pivotal U.S. clinical trial recruitment nearing 500-subject target
- Completion of Stage 1 MDSAP audit advancing FDA submission readiness
- Raised $5 million and received $1.7 million R&D tax refund, cash at $9.6 million
Strategic U.S. Market Engagement
Cleo Diagnostics Ltd (ASX – COV) has taken significant strides in its quest to commercialise a blood test for early ovarian cancer detection in the United States. A key development during the December 2025 quarter was the appointment of Dr Nicholas Lambrou, a respected gynaecologic oncologist, as the company’s first U.S. Key Opinion Leader. Dr Lambrou’s involvement is expected to bolster clinical advocacy and support the uptake of Cleo’s diagnostic test among specialist clinicians, a critical step for market entry.
Market Opportunity Broadens
New analysis leveraging U.S. insurance claims data has materially expanded Cleo’s Total Addressable Market (TAM). Approximately 3.4 million women annually present with suspected ovarian or adnexal masses, with around 2 million proceeding to further diagnostic investigation. This cohort now defines Cleo’s immediate pre-surgical market opportunity, significantly larger than previous estimates. The expanded TAM underscores the urgent clinical need and commercial potential for a reliable, non-invasive ovarian cancer test.
Clinical Trial and Regulatory Progress
Recruitment for Cleo’s pivotal U.S. clinical trial remains on track to meet its initial target of 500 participants by the first quarter of 2026. The trial’s completion will provide the data foundation for the company’s planned FDA 510(k) submission. Regulatory momentum was furthered by successfully completing Stage 1 of the Medical Device Single Audit Program (MDSAP), a crucial step toward ISO 13485 certification and FDA approval. Stage 2 of the audit is scheduled for the second quarter of 2026, which will assess full compliance and readiness for commercial launch.
Financial Position Supports Next Phase
Financially, Cleo is well-positioned to advance its commercialisation plans. The company raised $5 million through a strongly supported placement and received a $1.7 million R&D tax incentive refund during the quarter, bringing its cash balance to approximately $9.6 million. These funds will support market entry activities, including reimbursement strategy, commercial manufacturing of test kits, and acceleration of its screening test development.
Looking Ahead
With clinical, regulatory, and financial milestones converging, Cleo Diagnostics is poised to make a significant impact on ovarian cancer detection. The upcoming months will be critical as the company finalises clinical trial recruitment, executes manufacturing agreements, and prepares its FDA submission. Success in these areas could pave the way for earlier diagnosis and improved survival rates for women facing this challenging disease.
Bottom Line?
Cleo’s expanding market reach and regulatory progress set the stage for a pivotal year ahead in ovarian cancer diagnostics.
Questions in the middle?
- When exactly will Cleo submit its FDA 510(k) application and what is the expected approval timeline?
- How will the expanded Total Addressable Market influence reimbursement negotiations with U.S. payers?
- What are the terms and scale of the upcoming commercial manufacturing agreement?
