#None #Research Triangle Park #Calidar #4D Mammography #Eidos Prism™

Calidar's Groundbreaking Journey in Breast Cancer Diagnostics

Calidar, Inc., a pioneering medtech firm, recently marked a significant milestone by successfully completing its first-in-human (FIH) clinical study of the Eidos Prism™. This innovative modular device introduces Volumetric X-Ray Diffraction (VXD), commonly known as 4D Mammography, to enhance existing 3D mammography systems. Conducted at Baptist Health Hardin in Elizabethtown, Kentucky, this clinical study included 61 patients and provided valuable insights into the device's efficacy.

As the study comes to a close, the clinical team has submitted two manuscripts for peer review. One document highlights the device's performance in the first human cohort, while the other presents findings from a supplemental reader study. With both papers currently under review, Calidar anticipates publication later this year, transitioning from evidence gathering to preparation for a pivotal multi-site study set to begin in 2027.

Building Strong Collaborations

The partnership with Baptist Health Hardin proved to be instrumental for Calidar's first clinical site. Dr. Craig Kamen, the principal investigator (PI) involved with the project, praised the collaborative spirit of the Calidar team. He reflected on how their cooperation allowed seamless integration between the clinical requirements and the protocols mandated by the local review board, addressing potential complexities within patient research.

In highlighting the partnership's success, Thomas Blum, VP of Clinical at Calidar described it as a mutually beneficial learning opportunity. He emphasized the importance of such collaborations in ensuring clearer communication to patients earlier in the diagnostic journey. This approach will also set the stage for future partnerships as Calidar expands its pivotal study.

Looking Ahead: The Pivotal Study

As Calidar prepares for its next critical phase, active discussions with potential clinical trial sites are underway. The pivotal study will include a more extensive and diverse patient demographic, extending its reach across four distinct regions in the U.S.: Northeast, Southeast, Southwest, and Northwest. The goal is to collaborate with rural/community health systems, major academic medical institutions, and independent imaging centers, solidifying Calidar's commitment to advancing breast cancer diagnostics.

The company is actively seeking health systems and imaging centers interested in participating in the pivotal study. These partnerships are crucial for expanding the reach and impact of the Eidos Prism™, thereby improving breast cancer detection methodologies.

About Calidar, Inc.

Calidar, Inc. is at the forefront of medtech innovation, focusing on the clinical application of volumetric X-ray diffraction imaging for breast cancer diagnosis. Their 4D Mammography system offers a revolutionary way to analyze the molecular signatures of breast tissue, generating diagnostic information not readily available through conventional 3D imaging.

About Baptist Health Hardin

Baptist Health Hardin serves a significant population in central Kentucky, covering ten counties and providing a comprehensive healthcare network. With 300 acute care beds and numerous facilities offering specialized services such as cancer care and urgent care, Baptist Health is well-equipped to deliver quality medical services.

The successful FIH study and upcoming pivotal study play an essential role in transforming breast cancer diagnostics, and Calidar continues to strive towards making significant advancements in the field.