X-ray diffraction mammography study moves into data analysis

Calidar has completed enrollment in a first-in-human clinical study of its investigational 4D Mammography system at Baptist Health Hardin in Elizabethtown, KY.

The Research Triangle Park, NC-based company said the study enrolled 61 patients and will now move into data analysis. The trial is evaluating whether the system can distinguish between healthy and cancerous breast tissue.

Calidar’s 4D Mammography system uses X-ray diffraction to measure molecular-level signals in breast tissue. The company said the approach is designed to capture information not available through conventional mammography.

The study enrolled patients who had findings requiring further evaluation. Participants received a 4D mammogram, but the results were not used to guide individual patient care because the system is investigational.

Early company-reported results suggest the technology may show improved precision compared with 3D mammography, but the full analysis is still ongoing. Calidar has not yet published peer-reviewed clinical results from the trial.

“First-in-human is the gate that separates promise from evidence,” said Joshua Carpenter, PhD, Calidar’s chief technology officer.

Baptist Health Hardin began the in-human trial in August 2025, becoming the first hospital to test the technology in patients. At the time, Baptist Health said the system was designed to measure how X-rays scatter at the molecular level, producing a tissue signature that reflects internal tissue composition rather than only shape and density.

The hospital said the study was expected to enroll about 60 patients who met specific criteria after 3D screening and diagnostic imaging that would typically lead to biopsy. The goal was to determine whether the technology could help differentiate benign from malignant tissue and guide future clinical studies.

Craig Kamen, MD, the study’s principal investigator at Baptist Health Hardin, said the collaboration could contribute to development of technology that may enhance breast cancer diagnosis.

Calidar said the system could support faster and more precise diagnosis by reducing inconclusive imaging results. Baptist Health Hardin previously said more conclusive results could mean fewer unnecessary biopsies and faster treatment decisions.

The company is now planning a Series A financing round to support a multisite pivotal study in the U.S. Calidar said it expects to publish peer-reviewed results later in 2026 and plans to submit multisite findings to the U.S. Food and Drug Administration for clearance consideration.

The 4D Mammography system has not been cleared or approved by the FDA and is not available for commercial sale. Baptist Health said the technology is limited to investigational use in the U.S. under FDA abbreviated investigational device exemption requirements.