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On 2nd. April IQAI RNSed a significant step forward in providing gandolium-free imaging, but the market didn't pick up on it ... perhaps because IQAI was so overlooked then, and also perhaps because the RNS was quite technically worded, and wasn't explicit enough about the gandolium-free aspect.

02-Apr-19 07:00 RNS-R Imaging Biometrics Update

"Michael Schmainda, President of Imaging Biometrics: "This is the first study that directly compares the single-dose (no preload), low flip angle method to the conventional double-dose method for creation of rCBV maps. This study is a significant step towards creating the standard in DSC MRI for brain tumor patients, and it has the added benefit of a reducing the amount of contrast agent required to obtain good quality output. This marks an important step towards our ultimate goal of providing a contrast free option for MR imaging." ..."

https://www.lse.co.uk/share-regulatory-news.asp?shareprice=IQAI&ArticleCode=43fhcv1k&ArticleHeadline=Imaging_Biometrics_Update

Tra1,

That's a good point about stamp duty.

I believe that IQAI is exempt because it's incorporated in Jersey.

Gandolium toxicity lawsuits are just one of the reasons why IQAI is going to be huge.

Healthcare providers in the US have had to warn about gandolinium toxicity since last May.

And gadolinium dye was banned in South Korea at the end of last year.

https://www.levinlaw.com/gadolinium-toxicity-lawsuits

https://topclassactions.com/lawsuit-settlements/lawsuit-news/856109-gadolinium-mri-dye-banned-in-south-korea-amid-increasing-medical-safety-concerns/

This was IQAI's first ever RNS (extracts only):

22-Oct-18 07:00 RNS 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." ...

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."

https://www.lse.co.uk/share-regulatory-news.asp?shareprice=IQAI&ArticleCode=4y23wcku&ArticleHeadline=IQAI_files_patent_for_ContrastFree_Imaging

But the market doesn't really seem to have picked up on it.

That's the thing with IQAI: it has so much that's great going for it that things can get overlooked.

Some good posting on here today, thanks.

I'd like to remind/tell people though that IQAI is actually a main-listed share, not AIM.

Snaffle,

The FDA doesn't restart the clock from zero when an application is updated.
They simply stop the 90-day clock until the updated is completed.

So the clock is still counting from last August.

The key thing is that the assessment of the application has now been completed.

Which means that it just has to be 'signed off'.

How long that takes depends upon the queue, but if IQAI's experts dealing with this expected June, that it's unlikely to slip much past that.

Today's placing wasn't at a big discount by penny share standards: a discount of under 20%, and in a situation where the share price was rising rapidly: just two trading days previously the s.p. had closed at 3.9p, which may have been when the price was agreed.

And it's more likely that people were begging to be let in on this relatively modest placing, at a giveaway price, than vice-versa.

Barely 7 million shares were issued in the placing: which is barely ten per cent of the number bought on the market in the last fortnight.*

It could have been good 'politics' to let people begging to invest at least get a foot hold, to keep them sweet, rather than just rejecting them.

Now they're in at such a sweet price, they'll be more likely to invest more at much higher prices.

**Wed. 12.6.19 - Wed. 26.6.19:- 131,730,849 IQAI shares traded.

StoneChecker software.

MH,

You are in at the start of what could be one of the all time great growth stocks.

Hold tight for the ensuing ride!

Trevor Brown knows what he's doing, and has more incentive than anyone for this to perform.

That's why he's conducted a placing giving just a few per cent dilution, but giving the company the security to accelerate progress to meet meditech AI demand.

And the placing price of 3.5p is fine: it underpins the rise from the last fortnight at the recent support level, and creates a more solid base to push upwards from here.

E.g.:
1. FDA approval imminent (any day now expected).
2. Extreme undervaluation compared to listed peers.
3. There has been consistent big buying for the last fortnight.

The company won't have satisfied demand for shares through this placing of 7,142,857 million shares.
About 130 million IQAI shares have been traded in the last fortnight.

For multiple reasons!

America is a vast and well-funded (multi-trillion dollar) healthcare market, which is at the forefront of applying new technology.

And kidney stones affect tens of millions of Americans during their lives.

From Fortune.com:-
"Kidney Stones Are on the Rise in the United States
By EMILY PRICE February 13, 2018
A new study suggests that both men and women in the United States are getting more kidney stones.
Between 1984 and 2012, kidney stones diagnoses increased more than fourfold among women and twofold among men, according to the study published Monday in the Journal Mayo Clinic Proceedings and reported on by CNN .
Kidney stones are common, affecting roughly 10% of the population at some point in their lives. ... "

As the population of the US is 329 million, and growing rapidly, there is clearly a huge and growing market for StoneChecker software in the US.

And IQAI's 30.4.19 RNS uses the term "marketing clearance" in respect of "FDA approval" for StoneChecker.
This suggests that they're ready and waiting to start the marketing process immediately.

Like a coiled spring, and assisted by multiple resellers, active selling into the world's largest healthcare market should make for a very exciting stream of positive sales newsflow.

It's the right product and the right time, so there's every reason to believe that sales will accelerate rapidly.

Perhaps even "selling like frozen daiquiris in hell", as Ernest Hemingway would say.

P.S. Thanks Ivyspivey.

Note that the UK's NICE approved StoneChecker in February of this year:

08-Feb-19 10:29 RNS 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. …"
http://www.lse.co.uk/share-regulatory-news.asp?shareprice=IQAI&ArticleCode=hs1ykpb2&ArticleHeadline=Business_Update

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:

30-Apr-19 12:00 RNS 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. ..."
http://www.lse.co.uk/share-regulatory-news.asp?shareprice=IQAI&ArticleCode=s2k76zpj&ArticleHeadline=Publication_of_Annual_Report

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.

P.S. Thanks LB28.

About 90 percent of drugs that reach clinical stage development never make it to FDA approval and commercialisation.

Similarly, global energy consultant Wood MacKenzie has calculated the historical odds of a company making a commercial discovery from a frontier exploration well as less then one in 10.

Fortunately for IQAI, the odds on gaining FDA approval for a medical device are the polar opposite of the above: more like a 90% chance of SUCCESS! And that's for medical devices in general.

And in the case of IQAI's StoneChecker in particular, I think that we're now past the stage where it could fail. The main hurdles seem to have been crossed, and we're now at the 'rubber stamping' stage.*

That's why I think that the market is mispricing IQAI at the moment, at just 4.325p. It's factoring in real fear of FDA failure, when in reality that isn't justified.

Still, at least that means that the rise at approval should be even bigger than otherwise, and I fully expect IQAI to top the leader board when that happens.

And even that should just be for starters, triggering a period of share price momentum upwards, and business advances.

* StoneChecker was originally submitted to the FDA in May 2018. Under the FDA's 510k guidelines, manufacturers are required to compare the new product to an existing FDA cleared product. This represented a challenge since StoneChecker has some unique features which are not found in other "predicate" products. A CT machine software was chosen to establish "substantial equivalence" to StoneChecker, but after several discussions with FDA it was mutually agreed that a different comparator device be used. Consequently, the 510k package was resubmitted to them and they formally accepted it on 22 August 2018.
Since then other hurdles in the approval process have been crossed.

Also note that a few years ago, an eight-year study of FDA 510(k) review practices was published.
The study looked at over 24,000 510(k) medical device submissions cleared between January 1, 2006 and December 31, 2013.
One of the findings was that:
"Almost two out of threel [sic] 510(k) applications are cleared within six months."
https://www.meddeviceonline.com/doc/how-long-does-the-fda-k-review-process-really-take-0001

IQAI's 12th. June CorTech RNS is a massive endorsement of IQAI's products, and of their deal-making ability, linking with a partner of this caliber.

And it shows that there is a crying need for IQAI's products:
" ... help solve important clinical challenges faced by our global customer base."

There are challenges out there that need to be met, and IQAI's products can do that.

And with the CorTech team and their partners pushing them globally, the sales outlook is exciting indeed.

Note that CorTech have agreements with very big players like GE Healthcare and others.

"GE Healthcare is an American multinational conglomerate incorporated in New York and headquartered in Chicago, Illinois.[3] As of 2017, the company is a manufacturer and distributor of diagnostic imaging agents and radiopharmaceuticals for imaging modalities that are used in medical imaging procedures."
"Revenue US$18.3 billion (2016)"
https://en.wikipedia.org/wiki/GE_Healthcare

And more deals like this should follow, to back up David Smith's very bullish sales expectations for IQAI.

I wonder if RENX could make a bid for IQAI, which has been moving up strongly ahead of FDA approval for its StoneChecker software (due next week)?

Big buyer(s) seem to have been accumulating IQAI.

Even after its rise, IQAI's market cap. is still under £5M.

A quick look at RENX (which floated on AIM in November 2018) shows how ludicrously undervalued IQAI is at just a few million quid.

Renalytix Ai Plc (RENX) 285.0p Market cap. £153.4M.
http://www.lse.co.uk/SharePrice.asp?shareprice=RENX

From RENX's half-year report on 25/03/2019 -
"Renalytix AI plc (AIM: RENX), the AIM quoted developer of artificial intelligence-enabled diagnostics for kidney disease, announces its inaugural unaudited interim results for the six months ended 31 December 2018. ...
RenalytixAI was created to apply artificial intelligence (AI) enabled precision diagnostics to address one of the largest and costliest disease indications in medicine today. ...
We believe the regulatory and reimbursement policy environment in the United States continues to be favourable for advanced in vitro diagnostic commercialisation and adoption. In preparation for commercial sale of KidneyIntelX(TM), we have progressed several key operational elements that support formal reviews by FDA and the Centers for Medicare & Medicaid Services (CMS) as first steps towards U.S. regulatory and reimbursement approvals. Our Q-submission meeting with the FDA for KidneyIntelX(TM) was held in February 2019, and a request for parallel CMS reimbursement review with the FDA was submitted in March 2019. ..
The Group is currently in its initial development phase and therefore has not yet commenced revenue earning. ..."

Often the key difference between the success or failure of a company is STRATEGY.
And that's where an experienced NED (non-executive director) can be worth his weight in gold.

It's clear from relevant RNSes that Trevor Brown was key in the strategy development of both AVO and FDBK, to the huge benefit of both companies.

Moreover, he was also a strategic investor in both companies, just like at IQAI.

His business savvy is clearly extraordinary, and his judge of investments and investment timing top notch.
Coupled with a rare level of integrity (as shown by funding IQAI at a massive premium - and how many directors would do that), and what's not to like with him?

And another similarity with IQAI is that TB isn't taking the day-to-day lead on operations here.
That's under the overall control of IQAI's August 2018 appointment David Smith, who sold his last company for $178M., and compared to the $22M. it raised from investors:
http://www.lse.co.uk/share-regulatory-news.asp?shareprice=FBDU&ArticleCode=jrprb8z4&ArticleHeadline=Appointment_of_CEO_to_the_Operating_Subsidiaries

David Smith knows who to drive sales from zero to tens of millions of dollars, because he's been there before, and has stated his intention to do it here.

So with Trevor Brown overseeing strategy here, and David Smith overseeing operations, it looks like a perfect combination, and one with formidable potential to create something big here.

In fact, this duo remind me a bit of the pair behind legendary thousand-bagger Halma: David Barber & Stephen O'Shea:
https://www.ft.com/content/b721b37a-efa7-11d8-b4ef-00000e2511c8

Let's "seek truth from facts" and examine Trevor Brown's record: the share price performance during his two previous listed directorships prior to here. -

1. ADVANCED ONCOTHERAPY (AVO) (formerly CareCapital): 28.6.12 - 30.8.13.

Share price rise from approx. 25p to approx. 92p: GAIN OF C. 268%.

2. FEEDBACK (FDBK): 13.1.14 - 8.6.17

Share price rise from approx. 0.85p to approx. 3.75p: GAIN OF C. 341%.

= AVERAGE INCREASE OF c. 304.5%.

In summary, on the key metric of share price performance, Trevor Brown has really delivered the goods: an on average QUADRUPLING of these two share prices.

(I've posted fuller info. in post 922 on the ADVFN IQAI thread.)

What happens to IQAI (the business and the share price) after the imminent FDA approval for IQAI's StoneChecker software: which is expected by the end of June.

The fact that FDA approval 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. -

08-Feb-19 10:29 RNS Business Update
"...Meanwhile IQ-AI continues to seek business development relationships that will expose its products to a broader audience worldwide. Several marketing and distribution alliances are under active consideration. These will be evaluated, and if appropriate, will be announced in the next few months...."
http://www.lse.co.uk/share-regulatory-news.asp?shareprice=IQAI&ArticleCode=hs1ykpb2&ArticleHeadline=Business_Update

30-Apr-19 12:00 RNS Publication of Annual Report
"... The Company will focus on four areas of revenue development in 2019:
1. Sales development of existing products
During 2018, the Company sold or trialled software at many of the United States' most well-regarded hospitals and specialist clinics. IB Neuro remains the only 'biopsy confirmed' neuro perfusion software available on the market. Publicising this to all potential users is a key element of the Company's 2019 plans. We also intend to explore collaborative business relationships where our sales reach can be expanded by encouraging other companies' sales teams to promote our product for financial reward. This work is already underway with a series of resellers such as aycan Medical Systems, QMENTA, Blackford and Medimsight. ..."
http://www.lse.co.uk/share-regulatory-news.asp?shareprice=IQAI&ArticleCode=s2k76zpj&ArticleHeadline=Publication_of_Annual_Report

All this bodes well for a period of very positive IQAI newsflow in the near future, driving the share price to much higher levels ahead of the next fundraising.

That's an interesting theory LB28.

For a large health tech company acquiring IQAI would be peanuts, but logically they'd prefer to wait until after the FDA approval ... which is now imminent: i.e. expected in June, which leaves just 6 trading days after today.