Breast cancer is one of the most commonly diagnosed cancers worldwide. Unfortunately, conventional mammography—currently the standard of breast care in the US—misses approximately 35% of cancers. Its detection rate further plummets in women with dense breasts. However, the five-year survival rate for stage 0 to 1 breast cancer is an encouraging 99%, underscoring the need for early detection.
Innovative solutions are emerging to overcome the limitations of existing breast cancer detection methods, and spearheading this initiative is Koning Health, a leader in medical breast imaging technology. Its mission is to redefine early disease detection, intervention, and treatment through advanced computed tomography (CT) technology to enhance survival rates for millions of patients globally.
Since it earned the Food and Drug Administration (FDA) Premarket Approval (PMA) in 2015, Koning has set a new standard in medical imaging. The PMA is a rigorous approval process that attests to the safety, efficacy, and reliability of the company's technology—the Koning Vera Breast CT (KBCT).
The KBCT is a true 3D diagnostic device that produces real isotropic images of the breast without painful compression. The technology operates on the principle of rotating a cone-shaped X-ray beam around the breast. It acquires roughly 300 images in a full 360-degree scan, which are then digitally reconstructed into a 3D model of the breast.
This advanced technology offers exceptional spatial resolution, allowing clinicians to visualize and evaluate breast tissue clearly and accurately. Besides eliminating the discomfort associated with compression, it provides a quick scan and completes the imaging process in only seven seconds per breast. It's significant to emphasize that the KBCT scan does not provide an incremental dose of radiation to the patient and is—in fact—comparable to traditional mammography. The device also allows for 3D-guided biopsy and imaging capabilities.
Traditional breast cancer detection methods require additional views to reduce the likelihood of missing lesions, especially in dense breast tissue and women with breast augmentations. The KBCT's full 3D imaging capability provides comprehensive information in a single scan, from the nipple to the chest wall, regardless of breast size. This feature translates to accurate diagnoses. Moreover, its 360° acquisition feature offers a hands-free, more dignified approach that enhances patient experience.
The KBCT has been installed in over 20 facilities globally. As of this writing, 10 can be found in the United States, particularly in Georgia, Tennessee, Arkansas, Alabama, and New York, with a research facility in Arizona. Koning, holding over 120 patents globally, has also successfully expanded its reach, with installations in the United Arab Emirates, China, and Amsterdam. Plans for further expansion across Europe are underway.
The device has earned praise from experts in the field. Dr. Etta Pisano, Adjunct Professor of Radiology at the University of Pennsylvania, lauds it as a game-changer in breast imaging. She says, "If we can find breast cancer when it's really small before it spreads from the breast, we can save a woman's life. The Koning Breast CT is a true 3-dimensional image of the breast. Cancers have nowhere to hide. There's no way for overlapping tissue to be in the way from every angle. The images are very high quality and show cancers well."
Dr. Avice O'Connell, previous Director of Women's Imaging at the University of Rochester Medical Center, describes KBCT images as "easier to look at and read than an MRI [magnetic resonance imaging]." Dr. John Cutrone of the Breast Center at St. Frances/Emory Healthcare mirrors this sentiment, highlighting the KBCT's ability to simultaneously display sagittal, axial, and coronal images in full resolution.
"Breast CT has great potential... Current CT technology is also dose-comparable to conventional mammography and compression-free, ensuring patient safety and comfort. This has the potential to increase utilization and compliance (only 40 million out of 84 million eligible women in the US obtain annual mammography)," remarks Dr. Richard Reaven, a Radiologist at Advanced Radiology in Baltimore, Maryland, and a member of Koning's Scientific Advisory Board.
These expert testimonials showcase Koning's dedication to fulfilling its mission of advancing innovation in the field. With this commitment, the company was named a finalist for the 2023 Sharecare Award for Innovative Breast Imaging Technology. It intends to continue leading the way in bringing advanced breast imaging solutions to women worldwide.
Meanwhile, Dr. Reaven shares the global health technology company's recent accomplishment: "Koning has just passed an important milestone: over 150,000 scans have been completed worldwide. Dr. David Bodne [Scientific Advisory Board member] and I have read hundreds of cases and have found the image quality to be excellent overall. Coverage back to the chest wall can be obtained in virtually every patient scan. Additionally, the compliance rate in this country is around 50 to 55%, according to MQSA [Mammography Quality Standards Act] data. Offering a compression-free alternative to traditional mammography can significantly improve compliance rates across the country, and we, as breast imagers, can fulfill our duty of detecting breast cancer at its earliest and most treatable stage."
