Baptist Health Hardin first in the world to begin in-human trials of new 4D Mammography technology
ELIZABETHTOWN, KY (August 19, 2025) – Baptist Health Hardin has become the first hospital in the world to begin in-human clinical trials of a revolutionary breast imaging technology that could transform the way breast cancer is detected and diagnosed.
Calidar Inc., a pioneer in precision diagnostic imaging, has developed the world’s first clinical system for X-ray diffraction imaging of breast cancer. The investigational 4D Mammography device reads molecular level “fingerprints” in tissue offering information that is not available using currently approved imaging technology.
Breast cancer remains difficult to diagnose without invasive procedures leading to millions of unnecessary biopsies and delayed care each year. In this first-in-human study at Baptist Health Hardin, researchers will test the technology’s potential ability to identify cancer earlier and more accurately with the goal of giving doctors and patients better answers faster.
The trial launched today with the successful imaging of the first patient using the 4D Mammography system designed by Stefan Stryker, Josh Carpenter and Mitchell Greene of Calidar, Inc. The device uses X-ray diffraction to measure how X-rays scatter at the molecular level, producing a unique “signature” that reflects the internal composition of breast tissue. Unlike traditional X-ray images which rely on shape and density, this technology reveals what the tissue is made of — not just what it looks like — offering a new dimension of diagnostic data. This first clinical trial is expected to enroll approximately 60 patients over the next several months.
“This is more than a study milestone — this is the start of a new era of medical imaging,” said Dr. Stryker, CEO of Calidar. “X-ray diffraction has unlocked some of the most iconic achievements in science — from discovering the structure of DNA to revealing the composition of another world on the Mars rover — and now we are bringing its power into the clinic to look inside the human body in a completely new way. Our 4D Mammography system brings this capability to the challenge of breast cancer diagnostics where high-precision noninvasive imaging tools are urgently needed.”
In this first-in-human trial, researchers will assess the technology’s ability to identify cancer earlier and more accurately. The study is being conducted in collaboration with Baptist Health Hardin (BaptistHealth.com/Hardin) in Elizabethtown, Kentucky, led by Principal Investigator Craig Kamen, MD.
The 4D Mammography technology is designed to improve the speed and precision of diagnoses by reducing the number of inconclusive imaging results. More conclusive results can mean fewer unnecessary biopsies, a faster path to treatment and a better chance for positive outcomes.
“We are excited to collaborate on this next-generation research and contribute to the development of technology that could meaningfully enhance our capabilities for diagnosing breast cancer,” said Dr. Kamen.
“We are honored to be participating in this first-in-human clinical trial focusing on advancing care for mammography patients,” said Bert Jones, the hospital’s director of Medical Imaging. “This groundbreaking research has the potential to change the course of treatment for countless people. Being part of this pivotal moment in medical innovation represents more than just scientific process — it’s a step forward in improving the lives of women everywhere.”
“Baptist Health Hardin is committed to ensuring our patients have access to the most advanced technologies available,” said hospital President Robert Ramey. “Being chosen as the first hospital in the world to conduct in-human trials of 4D Mammography reflects the dedication of our physicians and staff to setting a new standard in patient care.”
The study will involve approximately 60 patients who meet specific criteria following 3D screening and diagnostic imaging that would typically lead to a biopsy. Data from the trial will help determine the system’s effectiveness and guide future studies including potential use in routine breast cancer screening.
Baptist Health Foundation Hardin supported the project by funding a portion of the necessary renovations to house the new 4D Mammography equipment and services.
The 4D Mammography system is investigational and has not been cleared or approved by the U.S. Food and Drug Administration. It is not available for commercial sale and is limited to investigational use in the United States under FDA’s abbreviated IDE requirements.