Breast cancer, a leading cause of cancer-related death, poses a significant health concern for women worldwide. Despite widespread screening efforts, over 42,000 women die each year from the disease. Early and accurate detection is critical, yet current imaging technologies often fall short, especially for women with dense breast tissue, where the current imaging technologies lack sensitivity.
MALCOVA is a company dedicated to revolutionizing breast cancer screening by addressing the challenges posed by dense breast tissue. Founded in 2020 by Dr. Tara Ghazi and Dr. Peymon Ghazi, MALCOVA is a medical technology company headquartered in Newark, California.
According to co-founder and CEO Dr. Peymon Ghazi, by “bringing CT’s precision to breast cancer screening where it’s been historically lacking,” MALCOVA’s solutions seek to enable earlier diagnosis and better outcomes for women with dense breasts, ultimately contributing to the fight against breast cancer on a global scale.
Dense breast tissue, seen in 50% of women over 40, poses a significant challenge in screening for breast cancer. High breast density limits the sensitivity of traditional X-ray-based screening methods, such as mammography, due to the two-dimensional nature of these images. Insufficient images in mammography is a particular problem for people with dense breast tissue because it reduces the contrast between healthy and abnormal tissue and contributes to missed lesions, resulting in later diagnosis and poorer outcomes.
While mammography uses two-dimensional technology to create an image of the breast tissue, computed tomography (CT) scans offer the ability to obtain three-dimensional images, which allows for better detailing of breast tissue, especially in women with dense breast tissue. Conventional CT scans, however, produce high levels of radiation exposure and poor image quality due to a process known as “scatter contamination.” Poor image quality from “scatter contamination” has been shown to decrease the sensitivity of mammography to as low as 30% in women with dense breast tissue, leading to delayed or missed diagnosis of breast cancer.
MALCOVA’s proprietary “narrow beam” CT scanning technology enhances the accuracy and sensitivity of breast cancer detection by decreasing scatter contamination by 90%. In addition, the system is designed with patient comfort in mind by enabling imaging without breast compression and integrating advanced AI detection modules that support both screening and diagnostic uses. This technology delivers high-quality imaging while maintaining radiation exposure levels comparable to a standard mammogram, offering a promising solution for improving breast cancer diagnosis in both women with dense breast tissue and those without. This patient-centered, data-driven approach reflects the leadership and vision behind MALCOVA.
Dr. Tara Ghazi, co-founder of MALCOVA, brings a unique background as both a scientist and strategic entrepreneur. She holds a master’s degree in Cognitive Neuroscience and a PhD in Philosophy from Johns Hopkins University, with prior research experience at the University of Cambridge and the University of California, Berkeley. Much of her academic work has focused on how humans process visual-spatial information, which aligns closely with MALCOVA’s mission to enhance diagnostic imaging.
Dr. Ghazi also brings over a decade of experience in the service industry, where she developed the leadership and customer service skills necessary to build and lead teams, essential skills for a fast-scaling startup like MALCOVA. Dr. Ghazi’s combined backgrounds in science and service allow her to connect technical innovation with business execution, making her an exceptional leader as MALVOCA takes its technology to market.
Dr. Ghazi initially served as Director of Operations during MALCOVA’s early launch phase while simultaneously managing a full-time role elsewhere. Since 2022, she has transitioned to working full-time at MALCOVA and now serves as the company’s Chief Business Officer. Her move to full-time leadership signifies the company’s evolution from early-stage development to a venture ready for commercialization.
Since its founding in 2020, MALCOVA has developed its third-generation prototype and built a robust patent portfolio. The company is progressing towards regulatory approval via the Premarket Approval (PMA) pathway, which is the FDA’s most rigorous route for medical devices. This effort is backed by upcoming human clinical trials in partnership with Yale University, scheduled to begin in 2025. This marks a critical milestone in MALCOVA’s path toward clinical validation and market entry. Additionally, the company is seeking FDA Breakthrough Device designation, which would accelerate the regulatory process as it provides significant advancements in diagnosing a life-threatening condition.
MALVOCA received Seed funding primarily through grants from the National Science Foundation (NSF) and the National Institutes of Health (NIH), raising over US $4 Million in non-dilutive financing. The company is now growing its Series A round to support clinical studies, regulatory submission, and initial commercialization.
Positioned to fill a critical gap in breast cancer diagnostics, MALVOCA targets hospitals, imaging centers, and healthcare networks that require more effective solutions for screening dense breast tissue. With a market value of US$4.7 billion and a projected compound annual growth rate (CAGR) of 8.6%, demand for accurate and accessible breast diagnostics is rapidly increasing. MALVOCA is well-poised to capture this opportunity through a dual-revenue model that includes capital equipment sales and recurring licensing for its proprietary software and AI-driven detection modules. To support its commercialization strategy, the company will seek both FDA and CE Mark indications for dense-breast screening, positioning its technology as a next-generation diagnostic platform throughout both U.S. and global markets.
MALCOVA’s next key milestone includes completing human imaging studies, followed by pursuing FDA Breakthrough Device designation to accelerate regulatory approval. With strong preliminary results, a growing market, and significant clinical interest, MALCOVA is laying the groundwork for global expansion as it addresses the gaps in breast cancer diagnostics. As Dr. Tara Ghazi, MALCOVA’s co-founder and Chief Business Officer, states: “We’re not just improving diagnostics—we’re rewriting the rules for a population historically sidelined.”