Iq-ai Ltd Regulatory News (IQAI)

IQ-AI Ltd

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

Update on Gadolinium Free Imaging Project

Further clinical evidence has been presented to suggest a clear connection between gadolinium-based contrast agents used in imaging, and adverse health issues in patients.

Clinical studies published1 in just the last 3 to 4 months (the titles of which are referenced below this announcement) have reinforced radiologists' beliefs that gadolinium-based contrast agents ("GBCA") may create long term health issues for patients. These principally fall into three categories:

1. Nephrogenic systemic fibrosis ("NSF")-a rare debilitating disease resulting in skin contractures and internal organ damage, has occurred with some GBCA media in a minority of patients with pre-existing kidney function abnormalities;

2. Bone and brain deposits in vulnerable patients- particularly occurring in children or patients receiving frequent imaging, for example, multiple sclerosis patients; and

3. Other systemic issues- such as skin rashes, aching joints and cognitive impairment.

For some time, IQ-AI's subsidiary, Imaging Biometrics ("IB") has been developing a portfolio of products designed to initially reduce and ultimately, eliminate the use of GBCA products in magnetic resonance ("MR") imaging. IB currently offers two methods that eliminate the "pre-load" dose of GBCA during the acquisition of dynamic susceptibility contrast ("DSC") image data. Until now, the double-dose approach was widely acknowledged as the recommended method to acquire DSC data. It provided a better "signal-to-noise" ratio on MR scanners which resulted in higher quality images. The elimination of the pre-load dose reduces a patient's exposure to GBCA, fosters a more efficient clinical workflow, and saves contrast material. IQ-AI has several projects in this area, namely:

- Dual Echo, also known as, SPICE ("simultaneous perfusion imaging with consecutive echoes") - this is an IB Patent (8,670,602). A combined MR acquisition and post-processing technology that eliminates the pre-load dose of gadolinium, generates both DSC and dynamic contrast enhanced ("DCE") parameter maps and improves the quality of the maps because it eliminates some of the more problematic acquisitions. This capability is built into the IB Neuro X2 platform and at least one site is using it with a Philips MR scanner to generate the DSC parameters. While DSC imaging directly applies to neuro cases, some sites use both DSC and DCE imaging to assess brain tumor progression. They each provide different information useful for diagnostic interpretation. Using SPICE, twice the information can be acquired using the same resources previously required for acquiring one set of information.

- Low Flip Angle - this new option is an attractive alternative to the recommended double dose standard. When used with IB's contrast leakage correction technology available in IB Neuro, data acquired without the pre-load dose of GBCA produce images comparable to the accepted double-dose standard. The flip angle is essentially the power of the radio frequency pulse used when collecting MR images. The low flip angle method was the result of a multi-center trial using data acquired on 3T MRI scanners. The multi-center team is now validating this approach on 1.5T MR scanners.

- Simulated T1+C - this product would generate an image analogous to a post-contrast image using information provided from images acquired, but without any administration of a contrast agent. T1 (or T1 weighted) images, both with and without GBCA, are used routinely in MR imaging. As its name implies, MR uses magnetic fields and radio frequencies to excite protons within tissue. As radiofrequencies are "pulsed" on and off, the protons excite and relax. The magnitude of the excitation vary depending on tissue type. Computer algorithms analyse this information and produce detailed anatomical images. For example, clinicians rely on T1+C (with contrast) images to identify the location and the extent of brain tumors. The contrast agent accumulates more in unhealthy tissue and appears brighter, or is enhanced, on MR images. This enhancement helps clinicians diagnose and treat patients. The ability to create a simulated or contrast-free T1+C image offers the potential of a highly disruptive technology in radiology.

- Simulated T1 +C: Version 2.0 - a development of the zero GBCA product, but one that is continuously updated through Machine Learning to produce an AI version that improves diagnosis even further over time by comparing results to a database of ever-increasing size.

Trevor Brown, Chief Executive Officer of IQ-AI, commented: "Through its wholly owned subsidiary, Imaging Biometrics, IQ-AI is committed to lowering the GBCA doses used for all populations, but particularly those most vulnerable to gadolinium deposition disease. The gadolinium free imaging project, if successful, will have a significant impact on the revenues of the Company over coming years. We will continue to update shareholders as matters progress."

On 19 October 2018, IQ-AI announced that it had filed a patent for gadolinium-free MR imaging of the brain and other organs. The patent application is under review with the Unites States Patent and Trademark Office.

The Directors of the Company accept responsibility for the contents of this announcement.

-ENDS-

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1Clinical Case Studies published

1. Gadolinium Deposition in the Brain in a Large Animal Model: Comparison of Linear and Macrocyclic Gadolinium-Based Contrast Agents (Radbruch et al, Investigative Radiology, 1 July 2019).

2. Contrast media and cutaneous reactions. Part 2: Delayed hypersensitivity reactions to iodinated contrast media (F Tasker et al, Clinical and Experimental Dermatology, 4 June 2019)

3. An Initiative to Reduce Unnecessary Gadolinium-Based Contrast in Multiple Sclerosis Patients (Rudie et al, Journal of the American College of Radiology: JACR 6 May 2019)

4. Increased Retention of Gadolinium in the Inflamed Brain After Repeated Administration of Gadopentetate Dimeglumine: A Proof-of-Concept Study in Mice Combining ICP-MS and Micro- and Nano-SR-XRF (Wang et al, Investigative Radiology, 26 April 2019)

5. Gadolinium-based contrast agents - review of recent literature on magnetic resonance imaging signal intensity changes and tissue deposits, with emphasis on pediatric patients (Blumfield et al, Pediatric Radiology 2019, 49 (4): 448-457)

About IQ-AI Ltd 

IQ-AI, Ltd, the parent company of StoneChecker® and Imaging Biometrics®, is focused on advanced and state of the art medical software and services. (IQ-AI.ltd). Imaging Biometrics develops and provides visualization and analytical solutions that enable clinicians to better diagnose and treat diseases with greater confidence. Through close collaboration with top researchers and clinicians, sophisticated advancements are translated into platform-independent software plug-ins which can extend the base functionality of workstations, imaging systems, PACS, or medical viewers. By design, IB's advanced visualization software seamlessly integrates into routine workflows. Please visit www.imagingbiometrics.com for further information.  

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About Imaging Biometrics™, LLC

Imaging Biometrics, a subsidiary of IQ-AI Limited (LON:IQAI), develops and provides visualization and analytical solutions that enable clinicians to better diagnose and treat diseases with greater confidence. Through close collaboration with top researchers and clinicians, sophisticated advancements are translated into platform-independent software plug-ins which can extend the base functionality of workstations, imaging systems, PACS, or medical viewers. By design, IB's advanced visualization software seamlessly integrates into routine workflows. For more information about Imaging Biometrics, visit the company's website at www.imagingbiometrics.com.