IQ-AI Regulatory News (IQAI)

IQ-AI Limited

("IQ-AI" or the "Company")

IQ-AI Files Patent for Contrast-Free Imaging

IQ-AI (formerly Flying Brands Limited) has filed a patent for gadolinium-free MR imaging of the brain and other organs.

IQ-AI intends to develop a technology that the Directors believe could completely eliminate the use of gadolinium-based contrast agents in MR imaging procedures. This could result in substantial savings in healthcare systems globally and avoid all of the emerging toxicity concerns associated with contrast agents. This invention is based on Deep Learning (DL) techniques using only non-contrast MR images as inputs.

David Smith, CEO of IQ-AI's operating subsidiaries commented "We are delighted to announce the filing of this patent. We believe the potential exists to develop, for the first time, a contrast agent-free imaging technology that should generate output comparable to traditional contrast-based imaging, offering significant savings to global healthcare systems. We now intend to develop the technology and conduct the clinical work necessary to prepare for worldwide regulatory submissions."

Gadolinium as a contrast agent: background and explanation

Gadolinium has been used for over 30 years as a contrast agent (CA) in imaging to allow health care practitioners to more clearly see abnormal, diseased, and even cancerous tissue.

It is estimated that up to 50% of all magnetic resonance imaging (MRI) and magnetic resonance angiography rely on the use of an exogenous contrast materials or agents, with gadolinium- based contrast agents (CAs) being the most common. CAs are administered intravenously and, when subjected to a magnetic field, enhance the diagnostic quality of MR scans by improving their sensitivity and/or specificity. MRI contrast injections improve diagnostic accuracy in some conditions, such as inflammatory and infectious diseases of the brain, spine, soft tissues and bones, by making images clearer so that the radiologist can better identify the location and extent of disease. The nature and extent of some cancers and benign tumours is best seen and assessed after an injection of CA. Also scans showing the function of blood vessels in real time can be carried out using CA's and many heart abnormalities can only be fully assessed with CAs.

Gadolinium is a rare earth metal. Compounds of gadolinium, in solution, are used as enhancing agents for MR imaging procedures due to their magnetic properties, and the way that they become concentrated in abnormal tissues in the brain and other body organs. Within the last 10 years, gadolinium-based products have been highlighted in numerous clinical papers showing their potential toxicity, retention in the human body for many years, and their potential to induce nephrogenic systemic fibrosis (NSF) in a small number of patients, particularly those with compromised kidney function.

Nephrogenic systemic fibrosis

Nephrogenic systemic fibrosis (NSF) is a rare debilitating disease resulting in skin contractures (or localised skin thickening and tightening) and internal organ damage. It has occurred with some gadolinium-based contrast media in a minority of patients with pre-existing severe kidney function abnormalities.

Gadolinium retention

Recently, it has been recognized that very small amounts of at least some forms of gadolinium contrast (about 1% of the injected dose) are retained in the tissues, mostly in the bones, with tiny amounts in the brain. This seems to be more likely with the same forms of gadolinium contrast that have a higher risk for NSF.

Allergy-like reactions

Less often, an itchy skin rash might appear a few minutes after the injection. This appears to be due to a mild allergy. It usually settles down by itself within an hour or so, but rarely it might be a warning sign of a more serious allergic reaction developing.

Workflow and procedural related issues

Proper injection/administration of the CA requires additional patient time (not to mention discomfort) and, if not injected properly, results in wasted CA material, inefficient use of resources, and wasted MR scanner time. In these situations, rescheduling the patient and performing another scan may be required to achieve an accurate diagnosis.

If successful, our development would eliminate the need of CAs and subsequently eliminate their associated health risks, streamline clinical workflows, reduce procedure costs due to contrast and administration, and conserve clinical resources (labour and equipment).

This invention is based on Deep Learning techniques using only non-contrast MR images as inputs, including T1-weighted, T2- weighted, fluid attenuation inverse recovery (FLAIR), and/or diffusion weighted- imaging (DWI) sequences. A collection of retrospectively collected inputs and the post-contrast T1+C as the target output are used to generate the Simulated T1+C image. The use of DL tools are increasing in application across a variety of fields and disciplines.

The approach described here generates an image analogous to post-contrast (T1+C) image without the use of an exogenous CAs. This image would be automatically generated within a few seconds and eliminate common operational and procedural errors plaguing current clinical practice.

In the USA alone, there were an estimated 39 million MR procedures performed in 2016. This equates to 19.5 million MR procedures that used CA's. Conservatively, if each dose of CA is $60, the direct material expense alone equates to roughly $1.2 billion. This does not include the indirect costs associated with operational inefficiencies.

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