Research Triangle Park, NC – April 28, 2026 – Calidar, Inc., an innovative start-up in precision diagnostic imaging, today announced the completion of enrollment in its first-in-human clinical study of the 4D Mammography system. The study, conducted in collaboration with Baptist Health Hardin in Elizabethtown, KY, enrolled 61 patients and represents a significant milestone in the development of a next-generation imaging platform designed to improve breast cancer diagnostics. The 4D Mammography system leverages X-ray diffraction to measure molecular-level signals within breast tissue — a capability not available in conventional mammography. With enrollment now complete, Calidar and its clinical partners will proceed with data analysis to evaluate the system's ability to distinguish between healthy tissue and breast cancer. "First-in-human is the gate that separates promise from evidence," said Dr. Carpenter, CTO of Calidar. "We cleared it — and the early performance data is directionally aligned with our clinical thesis, with early signals pointing to up to 4x improvement in precision over 3D mammography. Full analysis is ongoing, but we now have human evidence that suggests 4D Mammography works. Everything that follows is about scale." The first-in-human study was initiated in August 2025, when the team successfully imaged the first patient with the 4D Mammography system. The completion of enrollment is the next major step in what Calidar believes could redefine how breast cancer is detected at the point of imaging. Breast cancer diagnostics remain a significant clinical challenge. In the United States, approximately 1.8 million breast biopsies are performed each year, with 70-80% ultimately diagnosed as benign. These unnecessary procedures contribute to over $7.4 billion in annual healthcare costs and place a growing burden on radiologists and pathologists. At the same time, inconclusive imaging results contribute to delayed diagnoses for an estimated 60,000 breast cancer patients annually. By measuring the structure and composition of tissue—not just its shape or density—the 4D Mammography system aims to provide a new dimension of diagnostic clarity. Baptist Health Hardin served as the clinical research site for this study. The study enrolled patients who presented with findings requiring further evaluation. Once enrolled, participants received a 4D Mammogram to test the system’s ability to differentiate between healthy and cancerous breast tissue and benchmarks performance against existing mammography devices. Participation in the study was conducted under investigational use; results were not used to inform individual patient clinical care. Data analysis is ongoing, and performance results have not yet been disclosed. It is anticipated that a peer reviewed paper on the study will be published in the second half of 2026. To support the final phase of developing 4D Mammography, Calidar is initiating a Series A raise that will fund a multi-site pivotal study, nationally. Following the conclusion of this pivotal study, Calidar anticipates submitting these results in pursuit of FDA approval for 4D Mammography. 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.ESEARCH TRIANGLE PARK, N.C. — August 12, 2026 — 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. Pivotal Study Partnership Inquiries should be directed to Thomas Blum, VP of Clinical at Calidar. Email us

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).

Research Triangle Park, NC – April 28, 2026 – Calidar, Inc., an innovative start-up in precision diagnostic imaging, today announced the completion of enrollment in its first-in-human clinical study of the 4D Mammography system. The study, conducted in collaboration with Baptist Health Hardin in Elizabethtown, KY, enrolled 61 patients and represents a significant milestone in the development of a next-generation imaging platform designed to improve breast cancer diagnostics. The 4D Mammography system leverages X-ray diffraction to measure molecular-level signals within breast tissue — a capability not available in conventional mammography. With enrollment now complete, Calidar and its clinical partners will proceed with data analysis to evaluate the system's ability to distinguish between healthy tissue and breast cancer. "First-in-human is the gate that separates promise from evidence," said Dr. Carpenter, CTO of Calidar. "We cleared it — and the early performance data is directionally aligned with our clinical thesis, with early signals pointing to up to 4x improvement in precision over 3D mammography. Full analysis is ongoing, but we now have human evidence that suggests 4D Mammography works. Everything that follows is about scale." The first-in-human study was initiated in August 2025, when the team successfully imaged the first patient with the 4D Mammography system. The completion of enrollment is the next major step in what Calidar believes could redefine how breast cancer is detected at the point of imaging. Breast cancer diagnostics remain a significant clinical challenge. In the United States, approximately 1.8 million breast biopsies are performed each year, with 70-80% ultimately diagnosed as benign. These unnecessary procedures contribute to over $7.4 billion in annual healthcare costs and place a growing burden on radiologists and pathologists. At the same time, inconclusive imaging results contribute to delayed diagnoses for an estimated 60,000 breast cancer patients annually. By measuring the structure and composition of tissue—not just its shape or density—the 4D Mammography system aims to provide a new dimension of diagnostic clarity. Baptist Health Hardin served as the clinical research site for this study. The study enrolled patients who presented with findings requiring further evaluation. Once enrolled, participants received a 4D Mammogram to test the system’s ability to differentiate between healthy and cancerous breast tissue and benchmarks performance against existing mammography devices. Participation in the study was conducted under investigational use; results were not used to inform individual patient clinical care. Data analysis is ongoing, and performance results have not yet been disclosed. It is anticipated that a peer reviewed paper on the study will be published in the second half of 2026. To support the final phase of developing 4D Mammography, Calidar is initiating a Series A raise that will fund a multi-site pivotal study, nationally. Following the conclusion of this pivotal study, Calidar anticipates submitting these results in pursuit of FDA approval for 4D Mammography. 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.

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 high-precision diagnostic information that today's 3D imaging cannot provide. Calidar's technology is designed to reduce unnecessary biopsies, improve diagnostic accuracy, and enable earlier detection at the point of imaging. 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).

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.