Australian healthcare company Resonance Health (ASX: RHT) has received 510(k) clearance from the US Food and Drug Administration (FDA) for FerriSmart, its ground-breaking artificial-intelligence capable machine learning solution for the quantification of liver iron concentration (LIC).
The clearance allows Resonance to distribute FerriSmart and commercialise it across the US, which also furthers the company’s overarching mission to develop non-invasive medical imaging software and analysis services for the medical industry.
Resonance’s products are already used by clinicians in the diagnosis and management of human diseases and by pharmaceutical companies in their clinical trials.
FerriSmart automatically analyses magnetic resonance images (MRI) “from most scanner makes and models” and returns a liver iron quantification result “within seconds”, according to Resonance.
The FDA’s clearance is potentially commercially significant because it marks the first step of subsequent development, and longer-term, commercialisation within the largest healthcare market in the world today.
Resonance has revealed that it intends to deploy FerriSmart via channel partner platforms such as the Blackford Platform which allows FerriSmart to “integrate seamlessly into radiology workflows, delivering results efficiently to radiologists and clinicians,” according to Resonance.
The FDA has cleared FerriSmart for several specific indications.
First, it will be used to measure liver iron concentration in individuals with confirmed or suspected systemic iron overload.
Second, it will monitor liver iron burden in transfusion-dependent thalassemia patients and patients with sickle cell disease receiving blood transfusions.
Finally, FerriSmart is intended to aid in the identification and monitoring of non-transfusion-dependent thalassemia patients receiving therapy with deferasirox – a medication used to reduce chronic iron overload in patients who are receiving long-term blood transfusions for conditions such as beta-thalassemia and other chronic anaemias.
Today’s FDA clearance supplements Resonance’s existing regulatory clearance obtained in July 2018 from the Therapeutic Goods Administration (TGA) in Australia and the CE Mark in the European Union, also granted in July this year.
The newly-acquired FDA clearance makes FerriSmart the only regulatory approved artificial intelligence tool for use in liver iron quantification – a unique differentiator that could position Resonance Health at the forefront of medical imaging.
To date, Resonance Health has established a global distribution network of over 450 hospital centres and has successfully obtained regulatory clearance for five medical devices.
Resonance has said that it is now working towards expanding its distribution network via channel partner collaboration and claims it has an additional eight multi-year work orders from pharmaceutical companies worth approximately US$2.4 million (A$3.26 million) – orders that were signed just in 2018.
A further boost for the development of FerriSmart was the recent R&D Tax Incentive refund of A$326,470 for the past financial year from an Australian Government program.
The R&D Tax Incentive allows early-stage companies such as Resonance to receive cash refunds for 43.5% of their eligible expenditure on research and development over a predetermined 12-month period.
The incentive refund results from Resonance Health’s ongoing studies on liver and metabolic disease, improvements to core services, and the finalised development of FerriSmart.