Cleo Diagnostics

​June 2024 Quarterly Activities Report

Ovarian cancer diagnostics company, Cleo Diagnostics Limited (ASX:COV) (CLEO, or the Company) is pleased to provide the market with an update on activities in the June 2024 quarter as it develops its simple and accurate blood test for the early detection of ovarian cancer.


Highlights

  • U.S. regulatory process commenced with FDA following initial pre-submission meeting held where CLEO outlined its submission framework and clinical plan
  • A benchmarking study published in scientific journal “Cancers” demonstrated that CLEO’s ovarian cancer blood test outperforms current clinical benchmark
  • FDA-enabling U.S. clinical trials commencing this quarter, targeting recruitment of 500 patients to verify CLEO’s pre-surgical ovarian cancer test
  • CLEO’s U.S. market access and reimbursement program bolstered by appointment of New York- based healthcare industry consultancy HcFocus
  • A$9.373M cash at bank at 30 June 2024

Commencement of U.S. Regulatory Process

CLEO 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 allow 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:

  • Refine its clinical trial design to maximise resourcing and quality of data;
  • Reduce the possibility of rework;
  • Shorten the potential timeframe to application submission; and
  • Operate with an open and transparent approach.

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.


Click here for the full ASX Release

This article includes content from Cleo Diagnostics, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.

COV:AU
The Conversation (0)
CLEO Further Expands Ovarian Cancer Trial with Siles Health

CLEO Further Expands Ovarian Cancer Trial with Siles Health

Cleo Diagnostics (COV:AU) has announced CLEO Further Expands Ovarian Cancer Trial with Siles Health

Download the PDF here.

The Royal Women's Hospital Joins CLEO Ovarian Cancer Trial

The Royal Women's Hospital Joins CLEO Ovarian Cancer Trial

Cleo Diagnostics (COV:AU) has announced The Royal Women's Hospital Joins CLEO Ovarian Cancer Trial

Download the PDF here.

Medtronic chairman and CEO Geoff Martha to speak at Bernstein's Strategic Decisions Conference

Medtronic chairman and CEO Geoff Martha to speak at Bernstein's Strategic Decisions Conference

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced it will participate in Bernstein's 41st Strategic Decisions Conference on Thursday, May 29, 2025 .

Geoff Martha , Medtronic chairman and chief executive officer, will make a formal presentation beginning at 11:00 a.m. EDT ( 10:00 a.m. CDT ). Immediately following the presentation, Martha will be joined by Thierry Piéton, Medtronic executive vice president and chief financial officer, to answer questions about the company.

News Provided by Canada Newswire via QuoteMedia

Keep reading...Show less
Medtronic reports strong finish to its fiscal year with its fourth quarter financial results; announces dividend increase

Medtronic reports strong finish to its fiscal year with its fourth quarter financial results; announces dividend increase

Building momentum in key franchises including Pulsed Field Ablation, TAVR, Cardiac Rhythm Management, Diabetes, Spine, and Neuromodulation

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced financial results for its fourth quarter (Q4) and fiscal year 2025 (FY25), which ended April 25, 2025 .

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
Medtronic announces intent to separate Diabetes business

Medtronic announces intent to separate Diabetes business

Enables intense focus on highest margin growth drivers where Medtronic has leading core competencies

Leading, scaled, direct-to-consumer Diabetes business poised to become standalone company; only company with a complete ecosystem to address intensive insulin management

News Provided by Canada Newswire via QuoteMedia

Keep reading...Show less
Orchestra BioMed Reports First Quarter 2025 Financial Results and Highlights Recent Regulatory and Clinical Milestones

Orchestra BioMed Reports First Quarter 2025 Financial Results and Highlights Recent Regulatory and Clinical Milestones

  • FDA Breakthrough Device Designation Awarded to AVIM Therapy
  • FDA IDE Approved for Virtue SAB U.S. Pivotal Trial for Launch

Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, "Orchestra BioMed" or the "Company"), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced financial results for the first quarter ended March 31, 2025, and provided a business update highlighting continued regulatory momentum, disciplined operational execution, and a strengthening clinical development pipeline.

Q1 2025 Highlights:

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Medtronic to announce financial results for its fourth quarter and full fiscal year 2025

Medtronic to announce financial results for its fourth quarter and full fiscal year 2025

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that it will report financial results for its fourth quarter and full fiscal year 2025 on Wednesday, May 21, 2025 . A news release will be issued at approximately 5:45 a.m. Central Daylight Time (CDT) and will be available at https:news.medtronic.com . The news release will include summary financial information for the company's fourth quarter and full fiscal year 2025, which ended on Friday, April 25, 2025 .

Medtronic will host a video webcast at 7:00 a.m. CDT on May 21, 2025 , to discuss results for its fourth quarter and full fiscal year 2025. The webcast can be accessed at https://investorrelations.medtronic.com .

News Provided by Canada Newswire via QuoteMedia

Keep reading...Show less
New survey: 1 in 3 women have not talked to their doctor about heart health, the #1 killer of women

New survey: 1 in 3 women have not talked to their doctor about heart health, the #1 killer of women

Star Jones , award winning television personality & women's heart health advocate,   helps kick off heart health conversations this Mother's Day with the Medtronic 'Letter to My Mother' campaign

A new Medtronic-sponsored survey of women ages 30-50 reveals a significant gap in awareness and discussion around heart health among women and their mother-figures. Despite cardiovascular disease being the #1 killer of women in the U.S. many women are still unaware of the risk and the importance of heart health.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×