Periodic Reporting for period 1 - ReLiV (Real time Liver disease early diagnosis through exhaled Volatile Organic Compounds sensing)
Reporting period: 2024-05-01 to 2025-04-30
Liver fibrosis is associated with both overall and disease-specific mortality. As the prevalence of chronic liver disease continues to rise, so does the patients with advanced fibrosis. The absence of effective screening tools for MASH (Metabolic dysfunction-associated steatohepatitis) and advanced fibrosis contributes to increased mortality from liver-related conditions.
Accurate diagnosis of MASH-related fibrosis is essential for effective risk stratification and therapeutic decision-making, including the pharmacological treatment.
Currently, liver biopsy remains the gold standard for diagnosing and monitoring fibrosis. However, it is invasive, carries procedural risks, and is expensive. Alternative non-invasive methods—blood-based biomarkers, FibroScan, and magnetic resonance elastography (MRE)— lack sufficient accuracy, are not widely accessible, or remain expensive.
Our portable, cost-effective, fast procedure, easy-to-use device is suited for large-scale, point-of-care screening. Its implementation in primary care settings can significantly reduce the number of undiagnosed patients and alleviate the burden on the healthcare system. We aim to build the largest breath signature database integrated with electronic health records, to drive innovation and enhance accuracy of risk stratification and disease early detection
Metabolic dysfunction-associated steatotic liver disease (MASLD), formerly known as NAFLD, has reached epidemic proportions, affecting nearly 40% of the global population—including children. It is now a leading cause of chronic liver disease and is closely linked to cardiovascular disease, diabetes, and kidney dysfunction.
MASH, the progressive form of MASLD, involves liver inflammation and fibrosis, with over 20% of cases potentially advancing to cirrhosis. By 2030, MASH prevalence is expected to double, along with a sharp rise in liver failure, cancer, and related deaths.
The impact is not only clinical but also economic: in Europe alone, MASLD generates over €35 billion in direct healthcare costs annually, with societal costs exceeding €200 billion.
Diagnosing MASLD and MASH early is difficult, as symptoms are often absent until advanced stages—leading to late diagnoses and poor outcomes. With rising prevalence, there’s an urgent need for accurate, non-invasive, and accessible tools that enable early detection without overburdening healthcare resources.
Fibrosis stage is the key predictor of liver-related mortality. A Point-of-Care tool that distinguishes advanced from mild or no fibrosis would greatly improve patient management—ensuring timely specialist referral while supporting primary care follow-up for low-risk cases.
Given the liver’s role in producing breath VOCs, non-invasive breath testing offers a promising solution. NaNose Medical’s DiaNose aims to meet this need—offering a cost-effective, accessible way to detect liver disease earlier and improve patient outcomes.
Accurate diagnosis of MASH-related fibrosis is essential for effective risk stratification and therapeutic decision-making, including the pharmacological treatment.
Currently, liver biopsy remains the gold standard for diagnosing and monitoring fibrosis. However, it is invasive, carries procedural risks, and is expensive. Alternative non-invasive methods—blood-based biomarkers, FibroScan, and magnetic resonance elastography (MRE)— lack sufficient accuracy, are not widely accessible, or remain expensive.
Our portable, cost-effective, fast procedure, easy-to-use device is suited for large-scale, point-of-care screening. Its implementation in primary care settings can significantly reduce the number of undiagnosed patients and alleviate the burden on the healthcare system. We aim to build the largest breath signature database integrated with electronic health records, to drive innovation and enhance accuracy of risk stratification and disease early detection
Metabolic dysfunction-associated steatotic liver disease (MASLD), formerly known as NAFLD, has reached epidemic proportions, affecting nearly 40% of the global population—including children. It is now a leading cause of chronic liver disease and is closely linked to cardiovascular disease, diabetes, and kidney dysfunction.
MASH, the progressive form of MASLD, involves liver inflammation and fibrosis, with over 20% of cases potentially advancing to cirrhosis. By 2030, MASH prevalence is expected to double, along with a sharp rise in liver failure, cancer, and related deaths.
The impact is not only clinical but also economic: in Europe alone, MASLD generates over €35 billion in direct healthcare costs annually, with societal costs exceeding €200 billion.
Diagnosing MASLD and MASH early is difficult, as symptoms are often absent until advanced stages—leading to late diagnoses and poor outcomes. With rising prevalence, there’s an urgent need for accurate, non-invasive, and accessible tools that enable early detection without overburdening healthcare resources.
Fibrosis stage is the key predictor of liver-related mortality. A Point-of-Care tool that distinguishes advanced from mild or no fibrosis would greatly improve patient management—ensuring timely specialist referral while supporting primary care follow-up for low-risk cases.
Given the liver’s role in producing breath VOCs, non-invasive breath testing offers a promising solution. NaNose Medical’s DiaNose aims to meet this need—offering a cost-effective, accessible way to detect liver disease earlier and improve patient outcomes.
Under this project, we have made significant progress in advancing our technology. We focused on enriching our sensing array, enhancing our alpha prototype, and conducting real-world validation for the stratification of MASLD patients with advanced fibrosis.
Our initial results are highly promising: we successfully identified advanced fibrosis in a cohort of over 55 patients, validated by liver biopsy, FibroScan, and FIB-4. Data collection is ongoing.
We are currently conducting clinical studies across 10 medical sites in the EU and Israel, gathering thousands of breath samples. These efforts—supported by this grant and additional secured funding—are also being used to validate our in-house fabrication processes, quality assurance protocols, supply chain reliability, and real-time system responsiveness.
Our initial results are highly promising: we successfully identified advanced fibrosis in a cohort of over 55 patients, validated by liver biopsy, FibroScan, and FIB-4. Data collection is ongoing.
We are currently conducting clinical studies across 10 medical sites in the EU and Israel, gathering thousands of breath samples. These efforts—supported by this grant and additional secured funding—are also being used to validate our in-house fabrication processes, quality assurance protocols, supply chain reliability, and real-time system responsiveness.
Breath analysis using nano-sensors offers a promising path to real-time, low-cost medical diagnostics. However, past efforts have struggled due to the complexity of identifying disease-specific VOCs and limitations of existing sensors, which are insensitive to breath markers and require high operating temperatures. NaNose Medical has addressed these challenges with DiaNose—a handheld, AI-powered diagnostic device using patented cross-reactive sensor arrays. Rather than pinpointing individual VOCs, DiaNose identifies a unique breath-print associated with disease states. It shows broad applicability across >20 diseases, with an initial focus on MASLD, a condition affecting ~40% of the global population and costing Europe over €235B (direct and indirect costs) annually. Current MASLD diagnostics are invasive, expensive, or lack accuracy. DiaNose offers a rapid, non-invasive, affordable alternative with >90% diagnostic accuracy and a per-test cost under €50. With the ReLiV project, we will advance and validate a beta prototype, bringing DiaNose closer to market as an accessible, point-of-care tool that improves outcomes and reduces healthcare costs.