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Or praise David Smith.

A reminder of IQAI's David Smith's '6p pre-FDA' view -

Paperstraw Posted in: IQAI Posts: 4 Price: 2.80 No Opinion
David 17 Jun 2019 12:53
"Always said he thought it should be sitting at around 6p pre-FDA ( see interviews from Q3/Q4 last year) and thats without pricing in Cortechs, the sales and the software development of the last 9 months"
https://www.lse.co.uk/profiles/paperstraw/

And now after Friday's close at 6.45p, that level has finally been reached - pre-FDA, as per schedule.

So well done to David Smith.

In comparison, how often do penny share bosses give a share price target that isn't met, or even close to being met?

David Smith's credibility and reputation, which were already very high, are now bordering upon the godlike.

Here's some more extracts from David Smith's 18.9.18 video interview on Proactive Investors:

Q. "Tell me a bit more about your own background here."

D.S. "Well I'm originally from the UK, as you can probably tell from my accent. I've been in medical devices for the last thirty years, in various different places. I've done some work in Australia. I've been in the US for a large part of the last thirty years – the last twenty three years.
Initially with very large companies, but more recently with start-up organisations. And I suppose most notably recently I was a co-founder of Tenaxix Medical, which was a vascular sealant company back in 2004. We raised twenty two million dollars over seven years, and then we sold that company in 2014 for 178 million dollars. So that went rather well, so I'm looking to follow on with that at Flying Brands."

Q. "What attracted you to Flying Brands? What did you like about the business?"

D.S. "Well, in previous companies I've been involved with there's always been the opportunity to produce a better medical widget. So something that was slightly better than the competitive product, and you would promote it to whatever doctor you were selling it to as a competitive product with these benefits. And while those companies were very successful, they were really incremental changes to what was already present and available to doctors. And the opportunity I saw with Flying Brands was really to create something of a revolution rather than an evolution in the way that healthcare was delivered. … And obviously for shareholders, it's a tremendous benefit."

Q. "And I would imagine there's increasing focus here on AI. Part of the proposed name change to IQ-AI."

D.S. "So IQ-AI: image quantification and artificial intelligence. Imaging quantification is I suppose a play on Imaging Biometrics: it means the same thing. ..."

Q. "And Imaging Biometrics, that would be the distributor for the software?"

D.S. "Yes. So Imaging Biometrics. Part of the strategy of acquiring a US-based company to complement the exisiting Stone Checker in the UK was that you would have reciprocity basically. So The US organisation is used for StoneChecker sales going into the US, and the European organisation is used for IB sales going into Europe."

The technological barriers to entry are also high.

IQAI's achievement is a tribute especially to Kathleen Schmainda, the founder of IQAI's subsidiary Imaging Biometrics.

In the words of IQAI's David Smith, she's a luminary in the field, and it's based upon her reputation that we're asked by other companies in the field to help them write their software, for a fee obviously, and help them get regulatory approval.

In fact, her role in IQAI could be likened to the role of Steve Wozniak in the early Apple Computer.

Thanks Novice.

As IQAI's RNS two days ago says, gadolinium-free imaging "offers the potential of a highly disruptive technology in radiology".

In fact it would virtually sell itself.

IQAI is making excellent progress towards this 'holy grail' type achievement, but in the meantime has multiple existing (and exciting) products, that it is selling right now.

So it's a perfect combination, especially as the future timescales are reasonable, there's plenty of evidence of achievability, and the costs are relatively low.

The potential additional upside from gadolinium-free imaging is enormous, especially for a company of this size, and long-term institutional investors in particular will be very attracted to that.

And here's a couple of extract from David Smith's 18.9.18 video interview on Proactive Investors, from the part where he's talking about FDA approval for StoneChecker software (a.k.a. 510(K) clearance):

• "I can tell you than 95% of 510(K) applications are processed by the FDA within ninety days. That's their goal ,and that's a goal that they consistently meet."

• "We submitted our application on August 22nd."

Here's a couple of extract from David Smith's 30.11.18 video interview on Proactive Investors, from the part where he's talking about FDA approval for StoneChecker software (a.k.a. 510(K) clearance):

• "We're more than halfway through the FDA's self-imposed goal of reviewing these within ninety days. And that's ninety days of FDA review time I'll remind investors. So if they ask you a question, they stop the clock. The clock doesn't start until we answer the question."

• "I would say that having worked on over thirty 510(K)s in the last twenty years there's nothing unusual here, this is a normal pathway that we're following.
As we get closer to the end of this, things tend to happen in a rush."

The 'rush' part at the end should be a giveaway to people that approval is about to happen, and IQAI must almost certainly have at least reached this stage.

Once approval is given, IQAI should have a day or so to issue an RNS before the news is published on the FDA's website, so there is some flexibility there.

Then after the RNS, watch out for a new David Smith video interview on the Proactive Investors website, probably later that same day.

His last video interview there, last month, had quite an impact on the IQAI s.p.

"Gadolinium Toxicity
shedding light on the effects of retained gadolinium from Contrast MRI

... In rough order of frequency as reported in our Survey of the Chronic Effects of Retained Gadolinium from Contrast MRIs,

Pain – aching; burning, tingling, and/or prickling pain (paresthesia); deep bone pain. Typically in extremities or joints, and sometimes in the location where the MRI occurred, like the head.
Dermal changes – like tight skin, lesions, hyperpigmentation. Most often in extremities.
Muscle issues – twitching – small, local, rapid contractions and weakness
Ocular problems – worsening vision, dry eyes, bloodshot eyes
Cognitive symptoms
Ear, nose and throat – tinnitus, swallowing, and voice problems
Low body temperature
Hair loss
Itchy skin
Balance problems
Swelling of extremities (edema)

There is one symptom experienced by many that transcends several of the symptoms listed above. It is a sense of an electrified, vibrating, twitching feeling typically just under the skin that is sometimes localized and at other times a more overall feeling. Sometimes it feels like something is crawling around under the skin. This is a particularly alarming feeling when first experienced as it is unlike anything that the person has ever experienced and it is very difficult to explain to doctors."

https://gadoliniumtoxicity.com/help/symptoms/

With the increasing evidence about gadolinium toxicity, the symptoms of which can be very unpleasant, this is an issue that is just going to keep on growing.

Can anyone familiar with the facts say that they would be comfortable having gadolinium injected into them?

But with the lack of perfect alternatives, it creates a dilemma for the medical community.

That's why, although it's recently been banned in South Korea, the US is only warning about it (and only since last year) rather than banning it.

Could gadolinium injections get through the FDA process? I don't think so!

IQAI looks to hold the keys to solving this immense problem.

And as the problem becomes more widely appreciated, investors will be on the lookout for any company capable of addressing it.

"Gadolinium 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.

Thanks LB, and thanks for your astute observations.

And thanks and well done to IQAI for today's excellent update on our gadolinium free imaging project.
Gadolinium toxicity lawsuits are just one of the reasons why IQAI is going to be huge.

Note that healthcare providers in the US have had to warn about gadolinium toxicity since May of last year.
And gadolinium dye was banned in South Korea at the end of last year.

IQAI's David Smith talked about gadolinium-free imaging in his 1st. November 2018 video interview on the Proactive Investors site.
Here's a summary of some of that part of the interview:
• Gadolinium 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.
• Gadolinium 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

Note that 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 gadolinium toxicity lawsuits etc., gadolinium-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.

IQAI's excellent progress in developing patented gadolinium-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 for that excellent new article Paperstraw.

It shows that we have disruptive technology at its very best.

"NEWS | NEURO IMAGING | JULY 05, 2019
Delta T1 Maps Provide Quantitative, Automated Solution to Assess Brain Tumor Burden
Clinical data shows Delta T1 maps from Imaging Biometrics on par with central reader analysis but offer substantial time and cost savings

July 5, 2019 — Imaging Biometrics LLC (IB) a subsidiary of IQ-AI Ltd., is highlighting a recently published study in the American Journal of Neuroradiology1 confirming the value of IB’s dT1 maps in streamlining routine radiology workflows and multi-center clinical trials.

The study confirms the value of IB’s dT1 maps in streamlining routine radiology workflows and multi-center clinical trials.

Objective, accurate and reproducible methods to measure brain tumor volumes are important in the assessment of treatment response. Contrast-enhanced magnetic resonance imaging (MRI) is the most common approach to monitor treatment, but it is highly variable and confounded by numerous factors including differences in vendor platforms, field strengths and general MRI system instabilities. It is well-acknowledged that these factors contribute to the large disagreement of up to 50-60 percent between neuroradiologists when assessing tumor burden and evaluating treatment response.

Quantitative dT1 maps offer an elegant and automated solution that overcome these challenges and, therefore, have the potential to cause a disruptive shift in how brain tumor burden is assessed. dT1 maps compare calibrated pre- (T1) and post-contrast (T1+C) anatomic images. The calibration process, exclusive to IB, translates the relative and variable MR intensity values to a fixed and consistent scale. This built-in step is independent of scanner platform, field strength and time point, and has been shown superior over manual tissue normalization algorithms.

The secondary analysis of multicenter clinical trial data was performed by lead author Kathleen Schmainda, Ph.D., from the Medical College of Wisconsin, and colleagues. In total, 123 patients from 23 institutions enrolled in the study. The study compared IB’s dT1 maps to two primary readers and one adjudicator to manually delineate enhancing lesions. The results proved the dT1 method to be comparable to expert reads for determining early tumor progression and proved superior for further distinguishing treatment responders from non-responders at the week 8 time point. Another key outcome of the study was that only the dT1 method could predict differences in outcomes at the week 8 time point.\

For more information: www.imagingbiometrics.com

There was a not dissimilar pattern with David Smith's last but one Proactive Investors interview too, when a 7a.m. RNS was followed by a lunchtime video interview two days later:

28th Nov 2018 7:00 am RNS IQ-AI Limited - Imaging Biometrics® Update
https://www.lse.co.uk/rns/IQAI/iq-ai-limited-imaging-biometrics-update-3118ieo1rbuozot.html

IQ-AI focused on developing global markets for its Imaging Biometrics' products
12:29 30 Nov 2018
https://www.proactiveinvestors.co.uk/companies/stocktube/11392/iq-ai-focused-on-developing-global-markets-for-its-imaging-biometrics-products-11392.html

He speaks very well and is very informative, and is also clearly very business-savvy.

Thanks Longlad and LB28.

I would think that a 7a.m. FDA approval RNS is most likely.

Followed by a David Smith video interview on Proactive Investors later in the day, as indicated by DS in his 1.11.18 interview on that site.

This would follow the pattern last month, when the 7a.m. CorTechs deal RNS was followed by a David Smith video interview at 3.56p.m.:
12th Jun 2019 7:00 am RNS IQ-AI Limited - Business Development Agreement with CorTechs Labs
https://www.lse.co.uk/rns/IQAI/iq-ai-limited-business-development-agreement-with-cortechs-labs--czqc3skjljpyagz.html
IQ-AI on track to double sales in 2019 as it inks deal with CorTechs Labs
15:56 12 Jun 2019
https://www.proactiveinvestors.co.uk/companies/stocktube/13709/iq-ai-on-track-to-double-sales-in-2019-as-it-inks-deal-with-cortechs-labs-13709.html

And remember the share price impact of that last interview.

Thanks Degsy.

IQAI / Flying Brands actually had seven video interviews on Proactive Investors in 2018 (which are all still there), but the latest one last month was the first of 2019, after a gap of over 6 months.
However, their frequency should pick up again during the second half of this year, and indeed David Smith has promised another one right after the FDA approval RNS!

I posted a summary of the first part of David Smith's 1.11.18 interview last week (on 27th. June), that part being about gadolinium-free imaging.

Here's a summary of the second part of that interview, which was mainly about about StoneChecker software after the FDA approval:

Q. Discussions with potential partners where the US is concerned?

D.S.(laughing) Can't confirm or deny that.

Q. Interest in StoneChecker?

D.S. Yes, certainly there is interest; there have been discussions with large companies about the StoneChecker product.
But that's about as far as I can go at this point.

Q. Plan after FDA approval?

D.S. Well, there's a variety of options, and it's always good to have options:
• We could field our own sales team
• We could get involved in a business development distribution type deal for the product.
• We might for example take an investment from a large company and get involved in a joint venture for the product.
And I would say that all those things are on the table.

You'll be the first to know, right after we issue the RNS!

Q. Plans for StoneChecker outside the States?

D.S. We already have a distributor in South Korea.
We are fairly active in SE Asia through that network.
We have a no. of hospitals in Europe that are evaluating the product.

We're very pleased with how it's coming along.
It's always a challenge when you've got a small company with limited resource.
It's a challenge to roll-out new products because you can't do it like the big companies.
But by using some smart marketing tactics, talking to the right people, getting the key opinion leaders involved and having them do some of your marketing for you, you can make great strides.
And I can say that we're delighted so far with the progress both for StoneChecker and the Imaging Biometrics brands.

Q. What else on horizon apart from FDA approval?

D.S. • Move into liver from kidney and brain; intend to move into new body organs, to expand out footprint!
• 2018 results.
• Continued development of the gadolinium-free contrast agent (for imaging) product.
• You'll see more evidence of our moves into deep learning and artificial intelligence, and the click fee.

2019 is a very exciting year. I look forward to it.

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

It's now about three and a weeks since IQAI's David Smith's 12th. June 2019 video interview with Proactive Investors, so it's worth revisiting.
Here's a summary of the interview:

Four areas of growth for the business:
• Sell more of what we have.
• Expand internationally.
• Develop new products.
• Develop our contract (project) and grant income.

Moving more to a subscription based model with the new IB server product:
• Historically the company has sold a $35,000 product that is installed one time.
• The new model has increased the overall value of the average sale.
• Have a no. of prospects that we are developing right now that are more than $100,000 each.

Since the annual report was issued (30.4.19) we have expanded into more markets overseas.
The CorTechs Labs distribution agreement gives us access to their entire global network.

StoneChecker FDA approval:
• StoneChecker is specifically part of the new CorTechs Labs agreement.
• IQAI has contracted with a company named Experian Consulting, run by a regulatory guru named Michael Billig.
• He has a 100% record of getting products FDA approved.
• " ... no additional substantive questions that they wish to ask."
• " ... simply in a queue waiting for it to pop out the other end."
• " ... hope to announce that news very soon."
• "We're very confident that we'll get approval."

Improving our grant and project work.
This is really nice income that underpins the finances of the company.
Have been quite busy with grant applications, based on our relationships both with the Medical college of Wisconsin and also the Mayo Clinic
Have extended some of the existing projects that they have ongoing.

Second half:
• Looking to convert some of those in excess of $100,000 sales leads that we have.
• They've been cooking along for some time now so we expect to convert some of those.
• We're looking to train the CorTechs Labs sales people during the month of June, so in the second half they'll be out selling the product on our behalf as well.
• We look forward to the StoneChecker approval, and the consequent sales both through CorTechs Labs and independently throughout the world.

https://www.proactiveinvestors.co.uk/companies/news/220929/iq-ai-becoming-a-leader-in-the-field-of-medical-imaging-diagnostics-220929.html

As well as being an excellent play on the booming medtech market, IQAI's selling in Asia makes it an excellent play on the booming medical tourism sector:

"Medical Tourism in Asia-Pacific Growing Rapidly
November 2, 2017
Bart Van den Mooter
Principle & Founder of TforG – an IQVIA company

Asia-Pacific is the fastest-growing region in the global medtech market. This growth is fueled by public health care reforms, but even more so by the rapidly expanding private sector and with medical tourism, a connection not often made when the booming medtech market is talked about.

In most Association of Southeast Asian Nations countries, medical tourism represents a third or more of private hospital revenues. With every country looking to extract a piece of this pie, competition between countries and hospitals is intensifying.

How Big is Medical Tourism?
In 2016, between 105 and 120 million medical tourists traveled abroad to seek health care services. This number is expected to grow by 10-14 percent annually in the coming three years. Worldwide medical tourism generated 150 billion euros ($177 billion) in 2016 and is expected to grow to 200 billion euros by 2020. ...

Impact of Medical Tourism on Medtech
Due to fierce competition, private hospitals in the region regularly upgrade facilities and increase capacity. Recently, the sector has started attracting more international hospital groups and investors seeking to enter this lucrative market. ..."

https://www.brinknews.com/medical-tourism-in-asia-pacific-growing-rapidly/

Thanks Franco, apology accepted.

I know that it must be frustrating to have sold out near the bottom, just before the big rise.

But as the saying goes: "Sometimes you win, sometimes you learn."

Franco,

I haven't read your entire posting history (why would I?), I just remembered your posting on IQAI last Autumn.

You were the one who said:
"But I had to give it a timescale which was six months ... "

If meant six MORE months, rather than six months per se, then you should have said that.

There's no disrespect in an honest misunderstanding, which this clearly was.

Conversely, you calling me a ramper was so respectful wasn't it!

Franco,

Well, if you have a 'six months max. hold' rule, then now would be a very nice time to buy: you could sell just in time for Christmas!

francobrett Premium Member 30 Oct '18 Posts: 749 Price: 2.80 No Opinion
"It's certainly a good one for the ISA in my opinion, with regard to timelines and potential gains that you wouldn't want to pay tax on"

francobrett Premium Member 30 Oct '18 Posts: 749 Price: 3.10 No Opinion
"Good choice SSmith imo. One to hold for a while."

https://www.lse.co.uk/ShareChat.asp?ShareTicker=IQAI&share=Iq-ai-Ltd&page=15