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Hi Franco.

You used to do some good IQAI posting here last year - pity you stopped!

francobrett  6 Nov '18 Posts: 754 Price: 2.90 No Opinion
"Yes mate. The meditech revolution is coming and IQAI will be part of it. Right place, right time."
https://www.lse.co.uk/ShareChat.asp?ShareTicker=IQAI&share=Iq-ai-Ltd&page=15

The fact that FDA approval for Stonechecker software has taken so long shows how rigorous the process is, how advanced the product is, and also what a great achievement approval will be.
And one that will be monumental for IQAI's development, because America is such a vast and well-funded healthcare market, which is at the forefront of applying new technology.

This won't therefore be your 'average' good news: it will be gold-plated, company-transformative, 'talk of the town' news.

Therefore, I think that we can expect a very big immediate rerating upwards in the share price ... but that should be just for starters.
The general upward momentum could continue for weeks, months, and years.

And in terms of business, IQAI is chaffing at the bit to start selling StoneChecker into the multi trillion dollar US healthcare market, and has been investing into its business ahead of that, a very positive sign.

IQAI also appears to have a range of potential US reseller agreements lined up, which could be ready for signing once FDA marketing approval is received, if not earlier.

In effect, the FDA approval will be like removing a 'plug' to unleash a stream of positive IQAI newsflow.

So I would certainly anticipate that the IQAI s.p. will hit multiples of its current level in the not too distant future.

Wilfred,

The NICE endorsement is a terrific validation of StoneChecker software, so yes, it does support the likelihood of FDA approval.

But I think we're well past the stage where FDA failure was possible: it's now just a question of timing. And it does seem to be imminent.

And interestingly, it looks like the first UK StoneChecker sale (which wasn't separately announced at the time) followed soon after the NICE endorsement of StoneChecker in February:

30th Apr 2019 12:00 pm RNS IQ-AI Limited - Publication of Annual Report
"... The Company sold and installed its first StoneChecker software in South Korea through its distributor, demonstrating that the remote sale and servicing of the product is a viable business model. The Company will make international expansion a key objective for 2019.
In the first quarter of 2019 the Company completed its first sale of StoneChecker in the United Kingdom to the National Health Service. ..."
https://www.lse.co.uk/rns/IQAI/iq-ai-limited-publication-of-annual-report--r71ph7b8psdaq3w.html

It's almost as if they were waiting for the NICE endorsement before buying.

And on that basis, it bodes very well for StoneChecker sales in the US (and indeed reseller agreements) once the long-awaited FDA marketing approval is received.

Asia also looks to be a very promising market for IQAI, and one which is vast, and growing strongly.

Wilfred,

It was endorsed by NICE in February:

8th Feb 2019 10:29 am RNS IQ-AI Limited - Business Update

" ... The UK's National Institute for Health and Care Excellence ("NICE") has issued a Medical Information Bulletin on IQ-AI's StoneChecker Software, having evaluated the clinical value and cost effectiveness of the product. The StoneChecker software's regulatory approval process continues in the USA. ..."

https://www.lse.co.uk/rns/IQAI/iq-ai-limited-business-update-ewn88lzzrcxetip.html

Thanks for those two articles Paperstraw.

I would agree that the first article (21.6.19), that mention us, is non-commissioned, especially as it doesn't refer to IQAI, as opposed to its old name of Flying Brands.
As such it's impressive that we've been singled out, though perhaps not surprising for those familiar with the quality of this company.

The overall kidney stones market is actually forecast to be worth at least US$3 billion p.a. by 2023 as their prevalence grows, driven by risk factors such as obesity and high protein diets.

But despite this, relatively little funding is given to research and development in this field.

Stone Checker Software Ltd. is addressing this unmet clinical need, and clearly has a quite enormous growth opportunity: and in what is perhaps the hottest area of the stockmarket, i.e. meditech AI ... though one that really seems to have legs.

"ABOUT
Stone Checker Software Ltd is a health technology company focused on the development and commercialization of products to inform clinical management and to guide care for patients with kidney stones. The company is led by recognized experts in the field of clinical development and commercialization.
More than 300 million patients worldwide suffer with kidney stones and the majority of these are working age adults. Despite these numbers, relatively little funding is given to research and development in this field. Stone Checker Software Ltd aims to address this unmet clinical need by providing novel products for the healthcare market.Stone Checker Software Ltd is wholly owned by IQ-AI Ltd; a publicly-listed company on the London Stock Exchange: IQAI."
http://www.imagingbiometrics.com/what-we-offer/product-services/ib-stonechecker/

Though IQAI's other business, i.e. Imaging Biometrics, if anything has even greater potential than Stone Checker Software does.

So we have two cracking growth businesses in one share, priced at a relative pittance, in a sector that investors can't get enough of.

The market has just started to wake up to the IQAI opportunity, but this has a lot further to run yet.

One of the multiple advantages of IQAI's StoneChecker software product is that it is used on non-contrast enhanced CT scan images of the kidneys, i.e. gadolinium-free.

And that's particularly important in this area, because kidney stone sufferers are more likely to have compromised kidney function, and this group are particularly vulnerable to gadolinium toxicity.

This is clearly a major selling point for StoneChecker.

And now for some curious 'synchronicity' between 'needle-less' technology and artificial intelligence. -

The co-founder of 'needle-less' device company PowderJect Pharmaceuticals, Lord Paul Drayson, last August floated his new company on AIM ... Sensyne Health (SENS) ... an AI health company!

He would just love IQAI, with its health AI, and patent for needle-free (i.e. gadolinium-free) imaging!

SENS's market cap. at its IPO price of 175p was £225M., which further demonstrates investor enthusiasm for this sector, and the shortage of available stocks.

SENS is currently 162p, market cap. £208.3M. Its interim turnover was £39K.

17th Aug 2018 8:04 am RNS Sensyne Health PLC - Admission to AIM & First Day of Dealings

"Sensyne Health plc

Admission to trading on AIM and First Day of Dealings

Oxford, UK; 17 August 2018: Sensyne Health plc ("Sensyne Health" or the "Company"), a British clinical artificial intelligence company, is pleased to announce that its ordinary shares have today been admitted to trading on the AIM market of the London Stock Exchange under the ticker SENS ("Admission") and ISIN GB00BYV3J755.

Admission details:

· The Company has successfully raised gross proceeds of approximately £60 million through an oversubscribed placing of 34,285,714 ordinary shares at a placing price of 175 pence per share.

· On Admission, the Company will have 128,571,514 ordinary shares in issue.

· Peel Hunt LLP is acting as Nomad and Broker to the Company.

Lord (Paul) Drayson, CEO of Sensyne Health, commented:

"Today marks an important milestone for Sensyne Health. The strong support from institutional investors for our IPO will enable us to grow our team of highly skilled clinicians, data scientists and software developers to use the power of clinical AI to improve patient care and accelerate the development of new medicines. Our evolution into a public company has already stimulated further business development interest in our work and we are delighted to begin life as a plc on the London Stock Exchange. I would like to thank both our existing investors and new investors for sharing in our vision and for providing us with the resources to make the vision a reality over the next few years." "

https://www.lse.co.uk/rns/SENS/sensyne-health-plc-admission-to-aim-and-first-day-of-dealings-tave75995r149wc.html

This should have been in the very end of my last post, but most of it was cut off:

"While these two approaches offer instant reductions to GBCA use and improved workflows, the Company is committed to ultimately introducing a GBCA free product."

https://www.lse.co.uk/rns/IQAI/iq-ai-limited-publication-of-annual-report--r71ph7b8psdaq3w.html

It's worth noting that IQAI already offers reduced-gadolinium imaging, a major selling point, although it's ultimately committed to introducing a gadolinium-free alternative, as outlined in its recent annual report (extract below). -

30th Apr 2019 12:00 pm RNS IQ-AI Limited - Publication of Annual Report

"Gadolinium free imaging

Gadolinium is a rare earth metal which has paramagnetic properties. When used in conjunction with Magnetic Resonance Imaging ("MRI"), it can enhance the visualisation of soft tissues such as those found in the brain. Compounds formulated using gadolinium are the primary contrast agents used in radiology. The clinical literature is replete with articles highlighting Nephrogenic Systemic Fibrosis (NSF) and recent findings about gadolinium deposition in the brain.

While concerns about the long-term toxicity effects of gadolinium-based contrast agents ("GBCA") are unknown and more research is needed to substantiate any link to health issues, radiologists would like to move away from using GBCAs if a suitable alternative could be offered. This would eliminate any potential risks of using GBCAs, streamline clinical workflows and save significant material expense.

IB has filed a patent for gadolinium free imaging. Using deep learning networks, analogous images can be generated from anatomical and functional images acquired without any exogenous contrast material. Though the development and regulatory timelines are significant, the Company already has technologies that reduce the use of GBCAs. Specifically, the Company's patented Simultaneous Perfusion Imaging with Consecutive Echoes ("SPICE") technology eliminates one (preload) dose of the required two administrations of GBCA during image acquisition for brain tumour perfusion analysis. This patent has the additional benefit of providing both dynamic susceptibility ("DSC") and dynamic contrast enhanced ("DCE") parameter maps using a single MR acquisition. Both DSC and DCE imaging provide biological and physiological information about the brain.

In addition, one of IB's founders, Kathleen Schmainda PhD, was the lead author for a study that appeared in the American Journal of Neuro Radiology in April 2019, "Moving Towards a Consensus DSC-MRI Protocol: Validation of A Low Flip Angle Single Dose Option as a Reference Standard for Brain Tumours". This study identified that using IB Software to process data acquired on 3T MRI systems configured with low-flip angle settings produced output comparable to the accepted double contrast dose method. Thus, the preload dose of contrast can be eliminated without compromising image quality. Moreover, the output was further enhanced when IB's exclusive machine-learned calibration technology was applied. The results of this study were presented at the 2018 ASNR Meeting and, more importantly, offers clinicians immediate access to a lower GBCA alternative.

While these two approaches offer instant reductions to GBCA use and

"Gandolinium will no longer have to be injected into the patient, so patients will love it, as they won't get needled, and there is no health threat."

And investors will also love it, judging from the example of Powderject Pharmaceuticals:

"Powderject raises £35 million in flotation:
This article was originally published in Clinica
16 Jun 1997 NEWS
Executive Summary
Powderject Pharmaceuticals (UK) raised £35 million ($57 million) when it floated last week. The company offered around 18.9 million shares at 185p each, valuing Powderject at £109.3 million. The offer was oversubscribed. The company has developed a needle-less device for the delivery of vaccines, genetic material, drugs and local anaesthetics (see Clinica No 624, p 18). Dealings in ordinary shares will commence on June 17."
https://scrip.pharmaintelligence.informa.com/MT084994/Powderject-raises-pound35-million-in-flotation

PowderJect Pharmaceuticals was spun out of the University of Oxford in 1993.
And in 2003 the company was taken over by the American Chiron Corporation for £542 million.

The global market for contrast agents (a.k.a. contrast media) is worth over four billion US dollars p.a., and growing:

"The global contrast media market is projected to reach USD 5.53 Billion by 2022 from an estimated USD 4.40 Billion in 2016, growing at a CAGR of 3.9% during the forecast period. Growth in the contrast media market can primarily be attributed to factors such as increasing number of approvals for contrast agents and increasing number of public & private diagnostic centers. The increasing number of research and funding activities for research of contrast agents and their applications provide immense opportunities for players, in the contrast media market."
https://www.marketsandmarkets.com/Market-Reports/contrast-media-market-911.html?gclid=EAIaIQobChMIuJfes5WW4wIVipPtCh0R5wnAEAAYASAAEgKL-fD_BwE

So with the threat of gandolinium toxicity lawsuits etc., gandolinium-free imaging could be a real money-spinner.

If it captured even one per cent of the market for contrast agents, this would equate to revenue of over US$40M. p.a.

And with all its benefits (see 1.11.18 David Smith interview), it would virtually sell itself:

• Gandolinium toxicity lawsuits are a huge issue.
• Roughly $1.2 billion p.a. is spent on contrast agents in the US alone (used in about half of imaging procedures), so eliminating the need for these will bring massive direct cost savings.
• Gandolinium will no longer have to be injected into the patient, so patients will love it, as they won't get needled, and there is no health threat.
• Radiologists will love it, as there is no diminishment of imaging quality, and it will speed up their practice so they can see more patients.
• Health care authorities (e.g. the NHS) and health insurers will love it.

IQAI's excellent progress in developing patented gandolinium-free imaging could therefore be a 'licence to print money'.

And IQAI already has multiple other products with huge potential, some already FDA-approved.

Thanks Kiwi.

I think that in the long term a £100M. cap. is possible, if the company isn't bought out first. That's actually less than IQAI's David Smith sold his last company for, and the plan here is to deliver sales of £ tens of millions p.a.

David Smith sold his last company for $178M., and before that played a leading role in driving sales at Biocompatibles from 0 to over £40M.
(Biocompatibles was acquired by BTG in 2010 for £177M.)

Thanks Marcus.

Well, RENX floated at a fairly high market cap.: £65.12M. at its IPO price of 121p last November. It probably had private equity backers with the connections & clout to float it at this sort of level.
And for a growing company, a share price that grows from that level can develop good momentum as funds buy in to track it.
It tends to be harder for an already listed share to get up to that sort of level, partly because you get bouts of profit-taking during the move up.
Institutions are more likely to start buying IQAI when it's multiple of it's current market cap., when paradoxically it won't be so cheap., partly because of liquidity considerations.
And that's where private investors have an advantage over institutions.

In addition, the kidney disease market is larger than the kidney stones market ... though that's still a billion dollar market, and IQAI has multiple other products too.
And a larger market is more likely to attract competition from big players.

Legendary thousand-bagger Halma (which was once IQAI's size, but is now in the FTSE 100) has done pretty well out of targeting 'niche' markets:

"A very secretive success story
Peter Marsh AUGUST 16, 2004
Asked to describe his company's style, Stephen O'Shea says: “We try to hide as much as we can.” Mr O'Shea is chief executive of Halma, a UK engineering company based in Amersham, a town tucked away in Buckinghamshire. It specialises in what he calls “unrecognisable niches” of the fast-growing health and safety industry. ... "
https://www.ft.com/content/b721b37a-efa7-11d8-b4ef-00000e2511c8

IQAI's market cap. at 3.8p (including the news placing shares) is £4.84M.

Whereas RENX's market cap. at 320p is £172.2M.

So if IQAI even moved to just a tenth of RENX's market cap. (£17.2M.), that would put it on about 13.5p (other things being equal).

Renalytix Ai (RENX) has surged 20p today (6.7%) to yet another all-time high: 320p, market cap. market cap. £172.2m.

The meditech revolution is coming, but meditech AI (artificial intelligence) stocks are in short supply.

Note that Renalytix Ai is a similar business to IQAI: RENX is AI for kidney disease, whereas one of IQAI's two businesses is AI for kidney stones.

But IQAI is more advanced in two key areas:-

1. FDA progress.
FDA approval for IQAI's StoneChecker software is expected imminently.
And IQAI's Imaging Biometrics already has FDA-approved products.

2. Revenues.
IQAI already generating significant revenues, and which are expected to more than double this year.

Thanks Clumpet.

Just to clarify my first post on this subject yesterday:
healthcare providers in the US have had to warn about gandolinium toxicity since May of last year.

"The manufacturers of these GBCAs failed to warn healthcare providers of this danger until May 21, 2018."

Thanks Kiwi,

And thanks for your posts as well, which are very helpful.

I've been researching IQAI over the last few months, and the more I've found out about it, the more I've liked it.

It may consolidate around this level for a while, which I'd be quite happy with, as it will be a nice opportunity to top up my holdings.

Though obviously the moment the FDA approval comes through it will take off again, if not earlier.

Gadolinium-free MR imaging may be why David Smith has said that IQAI's brain scanning software could actually outsell StoneChecker software.

Last August David Smith did a series of investor lunches, introducing himself, explaining the company products and future pipeline and laying out his vision for the company.

Here are a few points from one of those presentations:
• His deal is largely equity based, so he is aligned with us.
• Whilst StoneChecker has great potential, the real winner could be the brain scanning software of IB, which should be extended to other areas. Liver was mentioned as achievable with minor tweaks.
• His plan is to deliver revenues of $20M. to $30M. annual within the next few years on existing products but double that with ‘planned’ products.
• He mentioned the possible need to land grab in order to build the business quickly at which point they would probably be taken out by GE or Phillips who provide the hardware but have poor software that is 20 years old in many cases.

IQAI's David Smith's 12th. June 2019 video interview with Proactive Investors didn't explicitly mention gandolium-free imaging, as he had so much else to cover, although "develop new products" was one of the four areas for growth that he outlined.

He did though talk about it in his 1st. November 2018 interview on that site.
Here's a summary of some of that part of the interview:

• Gandolinium toxicity lawsuits are a huge issue.
• Roughly $1.2 billion p.a. is spent on contrast agents in the US alone (used in about half of imaging procedures), so eliminating the need for these will bring massive direct cost savings.
• Gandolinium will no longer have to be injected into the patient, so patients will love it, as they won't get needled, and there is no health threat.
• Radiologists will love it, as there is no diminishment of imaging quality, and it will speed up their practice so they can see more patients.
• Health care authorities (e.g. the NHS) and health insurers will love it.

https://www.proactiveinvestors.co.uk/companies/stocktube/11075/iq-ai-s-david-smith-updates-on-patents-and-stonechecker-fda-process-11075.html