The investigational system uses X-ray diffraction to measure molecular-level signals in breast tissue, aiming to improve diagnostic precision.
Calidar, Inc has announced the completion of enrollment in its first-in-human clinical study of the investigational 4D mammography system. The study, conducted with Baptist Health Hardin in Elizabethtown, KY, enrolled 61 patients and marks a key step in the development of the imaging platform, which is designed to improve breast cancer diagnostics.
The 4D mammography system uses X-ray diffraction to measure molecular-level signals within breast tissue, a capability not present in conventional mammography. With enrollment complete, Calidar and its partners will analyze the data to evaluate the system’s ability to distinguish between healthy and cancerous tissue.
“First-in-human is the gate that separates promise from evidence,” says Dr Carpenter, chief technology officer of Calidar, in a release. “We cleared it—and the early performance data is directionally aligned with our clinical thesis, with early signals pointing to up to 4x improvement in precision over 3D mammography. Full analysis is ongoing, but we now have human evidence that suggests 4D mammography works. Everything that follows is about scale.”
Addressing a Clinical Need in Diagnostics
According to the company, breast cancer diagnostics present an ongoing clinical challenge in the US, where approximately 1.8 million breast biopsies are performed each year. Of those, 70% to 80% are ultimately diagnosed as benign, contributing to over $7.4 billion in annual healthcare costs. The company also notes that inconclusive imaging results contribute to delayed diagnoses for an estimated 60,000 breast cancer patients annually. By measuring the structure, composition, and molecular fingerprint of tissue, Calidar states its system aims to provide greater diagnostic clarity.
The first-in-human study began in August 2025. Patients who presented with findings requiring further evaluation were enrolled and received a 4D mammogram to test the system’s performance against existing devices. The results were not used to inform patient care.
Next Steps Toward FDA Submission
Data analysis is currently in progress, and performance results have not yet been disclosed. Calidar anticipates that a peer-reviewed paper on the study will be published in the second half of 2026.
To support further development, the company is initiating a Series A fundraising round to finance a multi-site pivotal study. Following the conclusion of that study, Calidar plans to submit the results to the US Food and Drug Administration (FDA) in pursuit of regulatory approval. The 4D mammography system is investigational and has not been cleared or approved by the FDA.
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