Izotropic Corporation has announced a significant step toward the commercialization of its IzoView Breast CT Imaging System, filing a pre-submission with the U.S. FDA. The goal is to obtain feedback on the clinical study design required for approval of IzoView with contrast-enhancement, as an adjunct to digital breast tomosynthesis (DBT) for breast cancer screening. This approach specifically targets the challenges of screening women with dense breast tissue. The company anticipates the clinical data collection phase to take 2.5 years, including a 1-year validation period, at an estimated cost of $3.5 million.
Addressing Unmet Needs in Breast Cancer Screening
Breast cancer remains a significant health challenge, accounting for 30% of all cancers diagnosed annually in the U.S. In 2024, approximately 300,000 women were diagnosed, adding to the over 4 million women living with a history of breast cancer in the U.S. Current screening modalities often fall short, particularly for women with dense breast tissue, which not only increases cancer risk but also reduces the effectiveness of standard screening methods. Studies indicate that approximately 20% of breast cancers are missed during screening, while false negatives occur in 10-12% of screenings. False positives can affect 50-60% of women over a decade of annual screening, leading to unnecessary anxiety and follow-up procedures costing an estimated $8 billion annually in the U.S.
The U.S. Preventative Services Task Force has emphasized the urgent need for improved screening methods for women with dense breasts. Izotropic's IzoView system aims to address this need by providing high-resolution, true 3D imaging.
IzoView Technology and Clinical Potential
IzoView is designed as an adjunct to DBT, offering a potentially more effective screening tool, especially for those with dense breast tissue. Unlike traditional mammography and DBT, which rely on breast compression, IzoView uses a dedicated breast CT imaging system. Compression-based imaging can be less effective in dense breasts, as the tissue's density can obscure lesions and create artifacts.
Research at UC Davis Medical Center, where the technology was founded, has demonstrated the promise of contrast-enhanced breast CT. Studies have shown that "malignant masses are more conspicuous on dedicated contrast-enhanced breast CT than both mammography and tomosynthesis." The high spatial resolution of breast CT, reportedly 100 times greater than MRI, allows for more accurate margin analysis, lesion characterization, and microcalcification visualization, potentially at a lower cost and with faster imaging times.
Patient Experience and Workflow
The IzoView system is designed to enhance patient comfort and dignity. Patients lie face down on a table, placing their breast in an imaging cup, eliminating the need for painful compression. Optical cameras guide positioning, minimizing physical contact. The imaging hardware rotates around the breast, capturing approximately 500 high-resolution images in about 10 seconds, with a radiation dose comparable to 2-view mammography. A 3D reconstructed image is available within 30 seconds, allowing radiologists to assess abnormalities in size, shape, location, and relation to other breast structures.
Clinical Study Design and Regulatory Pathway
Izotropic's pre-submission to the FDA includes a comprehensive technical description, intended patient populations, device schematics, system operation details, and a synopsis of the proposed clinical study protocol. The company plans to use IzoView as an adjunct to DBT for screening asymptomatic women with dense breast tissue. The clinical study will involve three sites and is designed to demonstrate the safety and effectiveness of IzoView. The data collection phase is expected to take 2.5 years, including a 1-year validation period to confirm negative cancer cases. Following the study, Izotropic will submit the final data to the FDA for device approval.
Robert Thast, CEO of Izotropic, stated that the company has thoroughly investigated the challenges and opportunities associated with launching IzoView. The company believes that indicating IzoView for use adjunctive to DBT increases the market size of eligible patients by over 800% compared to a diagnostic-only focus.
