Elizabethtown KY, August 19, 2025 – Today marks a pivotal moment in the history of medical innovation. Calidar is thrilled to announce that the first patient has been successfully imaged using our 4D Mammography device prototype, which represents the first ever in-human measurement of X-ray diffraction spectra.

Today, breast cancer, like many other diseases, still can’t be reliably detected non-invasively with existing imaging tools. Standard methods like X-ray, ultrasound, and even MRI often lack the detailed information needed to confidently identify breast cancer. As a result, patients often endure a long, uncertain path to diagnosis, involving invasive biopsies, delayed treatment, or missed detection altogether.

Of the 1.5M annual breast biopsies in the US, as many as 80% (1.2M) are benign. In addition to the undue stress, uncertainty, and physical impacts for patients, benign biopsies cost $6B annually (US), a cost borne by both patients and payers. Meanwhile US providers are strained by a nationwide pathologist shortage, which has seen diagnostic workload per pathologist increase by 42% from 2007-2017, and are struggling to process the increasing number of benign biopsies each year. Worse still for patients than a benign biopsy is a delayed biopsy. As many as 20,000 patients each year who should have been sent for biopsy have their diagnosis and treatment delayed due to inconclusive imaging, which costs lives.

Calidar’s 4D Mammography device was built to help solve these problems. It works by measuring how X-rays scatter at the molecular level as they pass through the breast — a process called X-ray diffraction. This creates a unique “fingerprint” of the breast tissue’s internal composition and structure, which our system analyzes to classify what kind of tissue is present — and whether it may be diseased. Unlike traditional X-ray images, which show only shape and density, this approach reveals an entirely new dimension of data that reveals what the tissue is made of, not just what it looks like.

These tissue fingerprints have already demonstrated their diagnostic potential. In earlier studies on removed breast tissue, this type of imaging enabled cancerous tissue to be distinguished from health tissue with high precision, far beyond what’s possible with traditional X-ray imaging. The team at Calidar, (Stefan Stryker, CEO, Josh Carpenter, CTO, and Mitchell Greene, VP of Engineering) designed and built our 4D Mammography device to bring this powerful diagnostic potential to the clinic for the first-in-human study of the technology.

"This is more than a study milestone—it's a leap forward for humanity's fight against disease," said Stefan Stryker, CEO of Calidar. "Just as MRI revolutionized our ability to see inside the body non-invasively, X-ray diffraction imaging promises to unlock new dimensions of tissue characterization in real-time, directly in patients. Our first clinical application is in breast imaging, where the need for better tools is urgent. But this technology is not limited to breast cancer. Because it captures rich structural information at the molecular level, it holds potential for diagnosing a wide range of diseases — especially those that are currently hard to detect without surgery or biopsy. We're honored to plant this flag and excited to share the journey ahead."

The first-in-human study will assess how well the 4D Mammography device can distinguish between healthy tissue and breast cancer in patients and compare performance to existing mammogram devices. The study is being conducted in collaboration with Baptist Health Hardin, led by Principal Investigator Dr. Craig Kamen.

“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.”

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.

North Carolina Biotechnology Center supported the pilot study through their Strategic Research Loan funding program.

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.

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Calidar, Inc. has obtained an exclusive license from Duke University for all medical applications of a key issued patent, strengthening the company’s intellectual property foundation for its 4D Mammography technology. This agreement grants Calidar the exclusive rights to develop and commercialize volumetric X-ray diffraction imaging for clinical use, ensuring that the company’s research roadmap is aligned with a protected path to market.

Early lab testing on breast-simulating models has produced promising results, demonstrating the potential of 4D Mammography to deliver diagnostic information beyond what conventional imaging provides. These findings support Calidar’s mission to help clinicians distinguish benign from cancerous tissue with greater precision and confidence.

With the patent license secured, Calidar is accelerating development of a prototype system designed for patient imaging. Near-term efforts are focused on finalizing system performance metrics ahead of constructing the prototype 4D Mammography device, designed for a first-in-human study.

Calidar, Inc. was founded today, January 5th 2022, by CEO Stefan Stryker and CTO Josh Carpenter with a mission to radically improve breast cancer diagnostics. The company’s formation was inspired by a study conducted by Dr. Stryker at Duke Hospital, which demonstrated that X-ray diffraction imaging has the potential to significantly enhance breast cancer detection.

Building on this insight, Calidar is developing 4D Mammography—a next-generation imaging technology that adds volumetric X-ray diffraction as a “fourth dimension” of information. Unlike standard mammography, which often leaves doctors without enough detail to make definitive decisions, 4D Mammography will be designed to help radiologists more accurately distinguish between cancerous and benign tissue. This advance could reduce the more than 2 million unnecessary biopsies and surveillance cases in the U.S. each year, while lowering costs, easing patient anxiety, and enabling earlier interventions for those who need treatment.

From day one, Calidar is moving quickly into prototype development and preclinical studies. The company’s near-term focus includes engineering, validation, and early regulatory and reimbursement planning. These efforts lay the foundation for bringing 4D Mammography from the lab to the clinic—where precision diagnostics could transform patient care, reduce unnecessary procedures, and save lives.