Clinical Data

Backed by Science.Driven by Outcomes.

Clinically Validated Technology

Celbrea® has been the subject of multiple independent and multicenter clinical studies conducted across diverse healthcare environments, at reputable centers of excellence. These studies provide robust evidence of its effectiveness, safety, cost-efficiency, and scalability. The findings demonstrate Celbrea’s ease of use as a point-of-care screening tool and its value as a practical complement to standard breast screening methods such as clinical breast examination (CBE) and mammography.

Healthcare professionals can review published results and summaries of ongoing studies that highlight Celbrea®’s utility in both screening and symptomatic populations.

Key Findings at a Glance

Celbrea’s technology is backed by rigorous clinical research demonstrating reliable detection of breast abnormalities, including cancers, across all breast densities. Our Ce Mark and FDA clearance reflects adherence to the highest safety and efficacy standards.

Continuous monitoring with Celbrea has been shown to improve early detection rates, empowering women and clinicians alike with timely insights.

  • Improved Clinical Decision Making: Enhances reliability of screening results when paired with other clinical screening methods such as clinical palpation.
  • High Efficacy: high sensitivity, specificity and excellent negative predictive value that reliably indicates the absence of breast disease.
  • Density Independent Results: Exhibits reliable efficacy for women with dense or non-dense breasts.
  • Performance across age groups: Consistent effectiveness regardless of age.
  • Cost-Efficient: Proven economic benefits in emerging healthcare markets with little access to care.
  • Adaptable and Scalable: To be used by clinicians and by women at home (self-test) with immediate results.
  • Non-Invasive: It can be used as often as recommended based on women’s risk profile. No adverse events have been reported across hundreds of thousands of women.

Celbrea® Clinical Data

Supporting Healthcare Providers

Clinical Integration and Use

Pre-Screening Tool to monitor breast health

Delivers fast, accessible assessments at point of care.

Screening in Low-Access Areas

Adds metabolic activity insight to enhance clinical judgement

Home Use Readiness

Early research supports reliability in unsupervised use (EU Only).

Suitable for all women

Screen at any interval, age or breast density.

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Celbrea® is backed by extensive clinical research across diverse populations and care settings. The data demonstrates consistent reliability, safety, and cost-effectiveness, reinforcing its value as a practical tool in modern breast health strategies.

Healthcare providers seeking further information or access to published data can connect directly with our medical affairs team.

As healthcare systems prioritise early detection and patient-centered care, Celbrea® offers a science-driven solution that enhances testing accuracy and expands access to meaningful screening—where and when it matters most.

Find us here

 2800 NW 105th Ave, Doral,

FL 33172 USA

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