Technology Description
Lord's Mark Industries Limited, in collaboration with the Centre for Materials for Electronic Technology (C-MET), has developed an AI-powered, radiation-free wearable breast cancer screening technology. The technology uses high-precision thermal sensors and AI-driven temperature mapping to identify abnormalities associated with breast cancer in a non-invasive manner. The wearable device is battery-operated, painless, portable, and infrastructure-light, enabling deployment even in areas with limited or no access to electricity.
Clinical Trial Status
- Completed Trials: Clinical trials in India have been completed with results demonstrating accurate identification of cases evaluated during the trials
- Current Stage: Technical Committee has approved the conduct of final clinical trials across USA, Great Britain, and Europe
- Phase 2 Trials: Scheduled to commence from January 2027 in India, USA, Europe, and Great Britain, targeting 98% accuracy for detection of cancer at cell level
- Data Utilization: Data from completed India trials will contribute to ongoing clinical and regulatory evaluation
Regulatory Progress
- India: CDSCO approval in process
- International: Working towards regulatory requirements for Europe, Great Britain, and USA, including European conformity requirements and US FDA regulatory pathways
Commercialization Timeline
- Target: Completion of final clinical trials and key regulatory milestones before March 2027
- Commercial Launch: Targeting commercial placement of the product by April 2027
- Conditions: Subject to successful clinical validation, independent evaluation, regulatory timelines, and applicable regulatory approvals
Market Context and Potential
- Global Burden: 2.4 million women diagnosed with breast cancer and approximately 694,000 deaths worldwide in 2024
- Market Size: Global breast cancer diagnostics market valued at USD 5.9 billion in 2025, projected to reach USD 11.4 billion by 2033 (CAGR 8.8%)
- Future Projection: IARC projects more than 3 million new cases annually by 2040
- Technology Differentiation: Radiation-free alternative to conventional screening methods with potential for wider accessibility
Strategic Initiatives
- National Programs: Representations made to respective authorities for consideration of inclusion in national breast cancer screening programmes
- Insurance Coverage: Representations made to Insurance Regulatory and Development Authority of India (IRDAI) for consideration of insurance coverage
- Objective: Improve affordability, accessibility, awareness, and participation among women in breast cancer screening
Management Commentary
Sachidanand Upadhyay, Managing Director, stated: "The approval of the final clinical trial stage marks an important milestone in taking this technology from innovation towards broader clinical validation. With successful trials already completed in India and further trials planned across the USA, Great Britain and Europe, our objective is to establish a robust clinical and regulatory pathway for an accessible, radiation-free and affordable breast cancer screening solution. We remain focused on taking this technology to a global platform, subject to successful clinical validation and regulatory approvals."
Collaboration Details
The collaboration with C-MET combines C-MET's research and development expertise with Lord's Mark's manufacturing and distribution capabilities, with the broader objective of developing and commercializing indigenous healthcare technology at scale.
Long-term Objectives
Lord's Mark intends to make the technology increasingly accessible and affordable, with the long-term objective of supporting wider breast cancer screening across India and international markets.