Resonance Health Limited (ASX:RHT)

Resonance Health is an Australian MedTech leader specialising in the development and commercialisation of non-invasive medical imaging analysis technologies. With a focus on Core Lab and AI-powered products, the company assists clinicians and radiologists in the diagnosis and management of patients across various clinical settings. Its flagship product, FerriScan®, launched in 2005, offers precise liver iron concentration assessments essential for managing conditions like Thalassaemia and other iron overload related diseases.

Expanding beyond its Core Lab offerings, Resonance Health has developed AI solutions such as FerriSmart® and HepaFatSmart® for comprehensive liver health evaluations. These innovations, alongside research tools and calibration products for MRI machine accuracy, reinforce the company's commitment to advancing medical research and diagnostics. Resonance Health also provides extensive imaging services for global clinical trials, positioning itself as a key contributor to the medical diagnostics and research community.

SaMD (Software-as-Medical Device):

This original business segment focuses on medical imaging analysis software and services, generating $2.6M in revenue for 1HFY252. SaMD's core offerings include the regulatory-cleared products FerriScan®, FerriSmart®, HepaFatScan®, HepaFatSmart®, LiverSmart®, and CardiacT2. New automation initiatives have increase service centre throughput and the ongoing development of a new 'Non-Invasive MRI Liver Fibrosis' SaMD product, which continues to progress through its extended-proof-of-concept trial.

CRO Services (Contract Research Organisation):

Launched as "Resonance Clinical," this business unit provides end-to-end metabolic/liver clinical trial management and has secured significant contract wins totaling $20.1M since August 2023. In November 2024, CRO Services was awarded a second major-pharma clinical trial contract worth $13.8M over 24 months. The segment generated $1.7M in revenue for 1HFY25 and has developed a highly sophisticated team capability with $3.0M in invoiced and receipted revenue for the half-year.

TrialsWest:

Acquired in April 2024 for a total consideration of A$8 million, TrialsWest is a clinical trial investigator site business that generated $1.5M in revenue for 1HFY25. The acquisition has performed above expectations, with a second site opened north of Perth in August 2024 beginning to generate revenue in November 2024, and a third site planned for 2HFY25. TrialsWest operates as one of Australia's most experienced clinical research centres, partnering with leading pharmaceutical companies across respiratory and metabolic disease spaces. The expansion to three sites is expected to triple capacity and drive future growth.

Iron overload is a condition where excessive iron accumulates in the body, potentially leading to severe health complications. This condition can be primary, often due to genetic factors like hereditary hemochromatosis, or secondary, commonly arising from multiple blood transfusions.

Primary Iron Overload:

• Hereditary hemochromatosis is a genetic disorder causing abnormally high iron absorption from the diet. It's linked to mutations in genes that regulate iron uptake.

Secondary Iron Overload:

• Frequently seen in individuals who receive multiple blood transfusions, each of which introduces a significant amount of iron into the body.

Risk Groups for Iron Overload:

• Thalassemia
• Sickle cell disease
• Myelodysplastic syndrome
• Various types of anemia
• Cancer survivors

Dangers of Excessive Iron:

• Excess iron can deposit in major organs, particularly the liver, the primary iron storage site in the body, and eventually the heart.
• These deposits can lead to critical organ damage and health issues like cardiac failure or liver diseases.

Management and Monitoring:

• An accurate Liver Iron Concentration (LIC) measurement is crucial for determining the appropriate treatment to prevent further iron deposition and organ damage.
• Regular LIC monitoring helps in adjusting treatment plans and tracking the effectiveness of interventions to reduce iron levels.

Solutions for Iron Overload:

• FerriScan®, FerriSmart®, and LiverSmart®: These MRI-based products offer non-invasive, painless methods to accurately evaluate and monitor LIC. They are designed to assist healthcare providers in assessing the necessity and effectiveness of treatments aimed at lowering iron levels in patients with iron overload.

Evaluating and managing iron levels is vital for patients at risk of or diagnosed with iron overload, ensuring timely intervention and prevention of serious complications.

FerriScan, developed by Resonance Health Limited, is a non-invasive, MRI-based system specifically designed to measure liver iron concentration (LIC). This technology is pivotal for the diagnosis and management of patients suffering from iron overload conditions. FerriScan is recognised for its precision and reliability in LIC assessment and is utilised exclusively by healthcare professionals, not available for direct purchase by the general public.

Key Features of FerriScan:

• Non-invasive technology that does not require the use of contrast agents.
• No patient breath-holds are necessary during the scan.
• The accuracy of results is unaffected by liver conditions such as inflammation, fibrosis, cirrhosis, steatosis, or fat.
• Provides results that are accurate, reliable, and reproducible over time and across different MRI centres and scanner models.

How FerriScan Works:

• Patient Referred: The patient is referred for a quick, 10-minute MRI scan at one of the accredited FerriScan clinics.
• DICOMs Transferred: The DICOM files from the MRI are securely transmitted to the Resonance Health Core Lab.
• Analysis Performed: A team of expert physicists at the Core Lab conducts thorough analysis and quality checks.
• Results Returned: Results are produced within 2 business days and sent back securely to the referring physician.

FerriScan has conducted over 70,000 scans globally at more than 500 hospitals, with around 45 scans completed daily. This robust system is a key resource for healthcare professionals managing patients with conditions related to iron overload.

HepaFat-Scan, developed by Resonance Health Limited, is an MRI-based technology designed to evaluate hepatic steatosis (liver fat) with high diagnostic accuracy. This system plays a critical role in the assessment of liver health, specifically targeting hepatic fat content without invasive procedures. Like FerriScan, HepaFat-Scan is intended solely for use by healthcare professionals and is not available for direct purchase by the general public.

Key Features of HepaFat-Scan:

• Non-invasive imaging that does not require the use of contrast agents.
• Provides results that are accurate, reliable, and reproducible both over time and across different MRI centres and scanner models.

How HepaFat-Scan Works:

• Patient Referred: Patients are referred for a brief, 2-minute MRI scan at a certified HepaFat-Scan clinic.
• DICOMs Transferred: The MRI produces DICOM files, which are securely sent to the Resonance Health Core Lab.
• Analysis Performed: At the Core Lab, a team of expert physicists conducts detailed analysis and quality assurance checks.
• Results Returned: Results are generated within 2 business days and securely delivered back to the referring physician.

HepaFat-Scan's approach ensures a swift and accurate assessment of hepatic steatosis, facilitating better management of conditions related to liver health in a clinical setting.

The Cardiac T2* MRI method is a highly regarded technique for assessing iron loading in the myocardium, making it a crucial tool in the diagnosis and management of heart-related iron overload conditions. This method can be employed alone or in conjunction with FerriScan® as part of a dual analysis package to provide a comprehensive evaluation of total body iron stores.

Key Features of Cardiac T2:*

• Provides essential information for assessing the risk of cardiac failure or arrhythmia due to iron overload.
• Specific assessment of heart iron loading, crucial for diagnosing and understanding the severity of iron deposition in heart tissue.
• Offers valuable information for managing iron chelation therapy, which is critical in preventing and reversing iron-induced damage to heart tissue.
• Non-invasive method that does not require the use of contrast agents, although it does require patients to hold their breath during the procedure.

Importance of Assessing Heart Iron Overload:

• Heart iron loading can progress at a different rate or stage compared to liver iron loading, making it essential to monitor both to get a complete picture of a patient’s iron status.
• The immediate risks of iron-induced arrhythmia and cardiac failure can be identified through Cardiac T2* MRI measurements, providing critical data for timely intervention.
• Iron-induced damage to heart tissue can be halted and potentially reversed with appropriate and timely chelation therapy.
• Regular assessment of body iron overload through the FerriScan and Cardiac T2* Dual Analysis Service enables healthcare professionals to make better-informed decisions on the management of patients at risk of iron-induced organ damage.

This comprehensive approach ensures that patients receive optimal care for the management and prevention of complications associated with iron overload in the heart.