MICA AI MEDICAL

Organization and Team
MICA is an Israeli digital health and medical AI startup, founded in 2020 and headquartered in Tel Aviv. The company is led by an experienced and multidisciplinary team, including serial entrepreneurs with successful exits, AI and software engineers, and world-renowned clinicians specializing in breast imaging and oncology. The founding team includes Lior Wayn (CEO), Lilia Shwartsman, Dr. Dov Tamarkin, and Dr. Roni Weitzen, bringing together deep expertise in medical technology development, clinical practice, and commercialization.

MICA operates with a strong medical advisory board and has built a robust ecosystem of collaborators, including top-tier hospitals, research centers, and imaging professionals. The company adheres to ISO 13485 standards and is structured to support global commercialization efforts, with dedicated regulatory, R&D, clinical, and business development functions.

Market Opportunity
Breast cancer is the most common cancer among women worldwide. Early detection is key to improving survival rates, yet traditional screening methods face limitations, especially in women with dense breast tissue—estimated to affect over 40% of screening-age women. For these women, standard mammography is significantly less effective, leading to increased false negatives and delayed diagnoses.

Today, MRI is considered the gold standard for screening high-risk women with dense tissue. However, it is expensive, time-consuming, and not widely accessible, limiting its use as a population-based screening tool. This gap creates a substantial unmet need for a cost-effective, scalable, and accurate alternative. The global market for breast imaging solutions is projected to reach billions in the coming years, driven by increasing awareness, regulatory mandates for dense breast notifications, and the growing demand for AI-driven healthcare solutions.

MICA’s Solution and Technology
MICA has developed M2C (Mammo to Contrast) – an AI-powered software solution that enables accurate detection of breast cancer in women with dense breast tissue without the need for contrast-enhanced imaging. The proprietary algorithm analyzes standard digital mammograms and simulates diagnostic insights typically gained from contrast-based MRI exams.

Using a unique combination of deep learning, radiomic feature extraction, and advanced imaging analysis, M2C identifies subtle patterns and vascular changes associated with malignancy. The solution integrates seamlessly into existing PACS/RIS workflows, offering radiologists a non-invasive, efficient, and explainable tool to improve diagnostic accuracy and confidence.

M2C’s key differentiator is its ability to serve as a virtual contrast-enhanced MRI—providing advanced diagnostic capabilities at a fraction of the cost, without requiring any additional imaging sessions or contrast injection.

Achievements

• Regulatory Approvals: M2C is approved for clinical use in Israel and Argentina, with the FDA clearance process underway in the United States.
• ISO Certification: MICA is ISO 13485 certified, ensuring compliance with international standards for medical device quality management.
• Clinical Validation: M2C has undergone extensive clinical studies in collaboration with leading medical institutions, showing high sensitivity and specificity, especially in dense breast cohorts.
• Product Integration: The solution has been successfully integrated into clinical environments and radiologist workflows, demonstrating ease of adoption and usability.
• Pilot Deployments: Multiple pilot studies are in progress in major hospitals, showing strong clinical interest and positive preliminary outcomes.

Collaborations
MICA maintains strategic collaborations with:

• Sheba Medical Center – Israel’s largest hospital and a global leader in medical innovation.
• ARC (Accelerate, Redesign, Collaborate) – a health innovation ecosystem affiliated with Sheba, fostering R&D and commercialization.
• Leading radiologists and oncologists in Israel, Europe, and Latin America contribute to MICA’s clinical roadmap and validation.

These collaborations provide MICA with unparalleled access to clinical expertise, imaging datasets, and feedback loops to continuously optimize its technology and ensure real-world relevance.

Advantages

• Clinical Impact: Enables early detection in dense breast cases where mammography alone is insufficient, potentially saving lives and reducing healthcare costs.
• Disruptive Technology: Replaces the need for contrast-enhanced MRI in many cases, democratizing access to high-level diagnostics.
• Scalability: Software-only solution deployable in any imaging center with standard mammography equipment.
• Cost-Effective: Eliminates the need for additional imaging, contrast agents, and radiologist time associated with MRI, making it suitable for large-scale screening.
• Explainability: Provides interpretable outputs and visual overlays that assist radiologists in decision-making.
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