Calidar Completes First-in-Human Study of Eidos Prism™ and Advances Toward 2027 Pivotal Study

The company targets five to seven sites for its pivotal study spanning rural/community health systems, large academic medical centers, and independent imaging centers across the country.

RESEARCH TRIANGLE PARK, N.C., Aug. 12, 2026 /PRNewswire/ -- Calidar, Inc. today announced the successful close-out of its first-in-human (FIH) clinical study evaluating the Eidos Prism™, a modular add-on device that brings Volumetric X-Ray Diffraction (VXD) — also known as 4D Mammography — to existing 3D mammography systems. As previously announced, the study enrolled 61 patients at Baptist Health Hardin in Elizabethtown, Kentucky.

With the study now closed out, clinical investigators have submitted two manuscripts for peer review: one detailing the technology's performance in the FIH cohort, and a second covering results of an accompanying reader study. Both manuscripts are currently under review, with publications anticipated later this year.

Closing out the FIH study and submitting both manuscripts marks the transition from first-in-human evidence gathering to preparation for a multi-site pivotal study.

Building on the Baptist Health Hardin Partnership

Calidar's first clinical site relationship, with Baptist Health Hardin, supported the FIH study from first patient imaged through study close-out.

"As lead investigator for the first clinical application of Volumetric X-Ray Diffraction, the team at Calidar was a pleasure to work with. They made it easy for me to bridge the needs of my clinical practice with the expectations of our local institutional review board in addressing the potential complexities that can arise with any patient research. " - Dr. Craig Kamen, PI

From Calidar's perspective, this relationship was the best possible scenario in a first-in-human partnership and an opportunity to learn from each other to inform future studies like the pivotal kicking off in 2027.

"Dr. Kamen and the entire team at Baptist Health treated this study as a true collaboration, built upon a shared commitment to providing clearer information to patients earlier in the diagnostic process. This is exactly the kind of partnership we aim to build with each site joining us for the pivotal study." - Thomas Blum, VP Clinical, Calidar

Forward Momentum: The Pivotal Study

The company is also beginning active conversations with sites for its planned 2027 pivotal study, which will expand testing across a broader and more diverse patient population. Calidar is evaluating pivotal trial sites across four U.S. regions — Northeast, Southeast, Southwest, and Northwest — spanning rural/community health systems, large academic medical centers, and independent imaging centers.

Calidar is inviting health systems and imaging centers interested in learning more about the upcoming pivotal study and potential site partnership to reach out.

About Calidar
Calidar, Inc. is a medtech company developing the world's first clinical application of volumetric X-ray diffraction imaging for breast cancer diagnostics. Its 4D Mammography system reads the molecular fingerprint of breast tissue — delivering new diagnostic information that today's 3D imaging cannot provide. The company is headquartered in Research Triangle Park, NC.

About Baptist Health Hardin
Baptist Health Hardin serves approximately 400,000 residents in 10 central Kentucky counties — Hardin, LaRue, Meade, Breckinridge, Grayson, Nelson, Hart, Bullitt, Green and Taylor. The Elizabethtown hospital operates 300 acute care beds.

Baptist Health Hardin includes 74 points of care across the service area, including a Cancer Care Center, Outpatient Surgical Center, and three Urgent Care locations. The hospital's network includes nearly 500 physicians and advanced practice clinicians representing more than 40 specialties plus primary care. Baptist Health Hardin has also been twice awarded the Pathway to Excellence® designation for excellence in nursing services by the American Nurses Credentialing Center (ANCC).

SOURCE Calidar, Inc.