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Under the direction of Co-Founder and Chief Business Officer Tara Ghazi, MALCOVA is redefining breast cancer imaging through its proprietary CT-based imaging platform. The company’s groundbreaking approach aims to overcome longstanding limitations in breast cancer detection, especially for women with dense breast tissue—a population often underserved by current imaging technologies.
MALCOVA’s journey began with a critical observation: existing breast cancer imaging technologies fell short for women with dense breast tissue, leaving a significant gap in early cancer detection. “There’s a major unmet need in breast cancer imaging,” shared Ghazi. “Our company was founded when the perfect alignment of that need met a groundbreaking innovation in imaging technology.”
Ghazi originally supported the company in a limited role while working full-time elsewhere. Seeing MALCOVA’s transformative potential, she soon committed fully, becoming a Co-Founder. “I became completely committed when I saw the potential for real clinical impact,” she recalled.
Breast cancer is alarmingly common, affecting one in eight women globally. Despite extensive screening efforts, over 40,000 women in the U.S. still die from the disease annually. Notably, nearly 50% of U.S. women have dense breast tissue, making cancer detection far more difficult.
“Mammography works well for about half of women, but for the other half—those with dense breast tissue—it’s a coin flip whether cancer will be detected,” explained Ghazi. Dense tissue and cancer appear similarly on mammograms, often causing missed diagnoses.
The FDA now mandates that women be notified if they have dense breast tissue, underscoring the urgent need for more effective imaging options. Ghazi stressed, “If you’re a woman with dense breasts, you shouldn’t be put through imaging with a technology that’s known to be ineffective for your body.”
MALCOVA’s technology harnesses advanced CT imaging in a way never done before. While CT is widely used in healthcare, it previously couldn’t deliver safe, high-quality breast imaging due to an inherent limitation called scatter contamination, which required prohibitively high radiation doses.
“We created an entirely new architecture and method of CT imaging,” Ghazi shared. “Our method delivers high-quality images with low exposure to patients, making it uniquely suitable for breast cancer detection.”
MALCOVA’s CT platform produces precise 3D images without compressing the breast, eliminating the discomfort associated with mammography. It also detects critical early signs like microcalcifications, which ultrasound and MRI can’t detect.
“Mammography creates flat, 2D images that let tissue hide,” Ghazi explained. “Our CT technology captures the entire breast in 3D from every angle, ensuring nothing is missed while keeping radiation exposure as low as standard mammography.”
Additionally, MALCOVA’s platform could potentially replace the need for multiple imaging sessions. “Women shouldn’t have to undergo repeated procedures because one technology isn’t enough,” said Ghazi. “We aim to be the first and only front-line test that patients need.”
Since its founding in 2020, MALCOVA has been funded primarily through non-dilutive grants from the National Science Foundation (NSF) and the National Institutes of Health (NIH). “We’ve been fortunate to secure grants because our solution addresses such a critical and recognized need,” Ghazi shared.
This year, MALCOVA completed its third-generation prototype, integrating all essential features needed for clinical effectiveness. The company is now preparing for its first-in-human study in collaboration with Yale University, scheduled for 2025.
Additionally, MALCOVA has entered a Seed funding round to support its clinical development and plans to pursue Breakthrough Device Designation from the FDA. “We believe our technology is solving one of the most pressing needs in breast cancer imaging,” Ghazi emphasized.
According to LSI’s Market Analysis and Projections (MAP) database, the global market for CT imaging systems is projected to reach $7.3 billion by 2025. The market for CT imaging systems will see healthy growth from 2023 to 2028, increasing at a CAGR of 4.9% to an estimated $8.4 billion by 2028.
The growth of the CT imaging systems market will outpace the growth of the wider diagnostic imaging market, which is projected to grow at a CAGR of 4.6% during the same forecast period.
Ghazi has been selected to present at LSI USA ‘25 next March 17-21 in front of hundreds of global medical technology companies. Join us in welcoming Ghazi to the event in Dana Point, CA, where she will share the latest updates on MALCOVA’s technology and development.
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