Nanox is hiring

Nanox is looking for someone to develop the first generation of its fake x-ray tube using the fake Nanox.SOURCE chip.

The job description is the clearest admission so far that all the tubes Nanox has shown over the years have been fake (I can count at least 8 different "generations" of designs so far).  And, of course, any submissions to the FDA claiming use of any of said Nanox tubes must have been fraudulent.

Update April 20, 2022:  Job opening is still showing in the Career section of Nanox website.  I just noticed that Nanox seems to be confused about its own chip.  It calls it MEMS in the job description, but MEMs in the responsibilities. Of course, Nanox.SOURCE chip is just fake, but even if it were not, it is not MEMS, as there is nothing mechanical about it.  And there is no such thing as MEMs (even though Nanox 20-F filing insists on it).  Another thing I noticed is that it mentions that the job will require trips to Europe, however, Nanox European partner in the cold-cathode x-ray tube development scheme seems to have developed cold feet instead, as CEI salespeople now tell prospective customers that CEI is not making any cold-cathode tubes.  Finally, it is no longer true that Nanox is manufacturing "the x-ray tube" - the new fake Nanox Fab in Korea that was supposed to finally start making tubes suddenly can't make them, even though it is "operational."  I guess Nanox really needed to fill that job opening...

Chest protocol, the transformation

Nanox has been diligent in blurring all protocol-related data from its infomercial and the six accompanying "procedures" videos.  It missed just one bit (8m:54s into the infomercial).

That looks like 90 kVp, 5.8 (or 5.6?) mAs, and 3? tubes for the chest protocol.

During the Business Update in August, the chest protocol looked like 60 kVp, 50 mAs, and 5 tubes (7m:27s into the webcast).

Nanox.Arc was submitted for FDA clearance in June.  

Presumably the device had established protocols and was working at the time, unless Nanox committed fraud.  

But Nanox.Arc was not working last week, as evidenced by the infomercial.

Update:  To be fair, Nanox admitted Nanox.Arc was a "concept device" last week, and a "future product" not yet "regulatory approved" in August.  So, it can't have been a working product in June, with its protocols in hand, when it was submitted for FDA clearance, right?

Update:  A chest scan has to be quick, to avoid blurring from heart movement or breathing.  Movement-related blurring is especially damaging in tomosynthesis reconstruction, unlike in CT.  The faster, the better.  A live human is not a phantom, and can't stay completely still for the duration of the seconds- or minutes-long Arc scan, even if the Arc were real.  A nationwide survey revealed that the exposure time for a chest x-ray is typically about 20 milliseconds, and lower than 10 milliseconds when a digital detector is used.  If the exposure time were 10 milliseconds, then 5.8 mAs translates into about 200 mA tube current (3 tubes) and 50 mAs translates into 1,000 mA tube current (5 tubes).   The Nanox.CART dental tube, that supposedly validated the Nanox technology, could do just 2 mA (per 510K summary) and only at significantly-lower 40 kVp, according to Nanox, and it still required "liquid" cooling.  Just another way of showing that Nanox.Arc is still a fake.

A departure

A 6-K is filed after hours.  Stock not moving.  That could change.

On December 3, 2021, Jung Ho Park, a member of the board of directors of NANO-X IMAGING LTD (the “Company”), informed the Company of his intent to resign effective December 6, 2021, and the Company accepted his resignation. Mr. Park informed the Company that he decided to resign to fully devote his time to his role for the SK Group following recent reorganization in the Group.  His decision to resign did not arise or result from any disagreement with the Company on any matter relating to the Company’s operations, policies or practices. 

Under the Investor Rights Agreement between the Company and SK Telecom TMT Investment Corp (“SKT”), SKT has a right to appoint another director to the Company’s board of directors to complete Mr. Park’s term of three years and SKT intends to appoint a successor to Mr. Park

Ok, but what about disagreement not related to the company's operations, policies or practices?  And why wait for the successor appointment? 

cropped from image by Julian Brandt

Update December 8, 2021:  The so-called "recent" reorganization was announced back in August, when Mr. Park's new role was set to commence on November 1.  Why did he wait until December 3?   The departure is also suspicious for another reason:  the Korean fab, supposedly established with the "support" (per Prospectus) of SK Telecom, was supposed to receive its final equipment in November and start pilot production in its new building next month.  However, the comprehensive equipment list, complete with inventory numbers, on Nanox Korea website does not reflect any recent equipment acquisition, and just talks about making chips for household appliances (with outdated, over 20-year-old equipment that was there before November).

Update #2 December 8, 2021:  Mr. Park was given 100,000 options, in exchange for his employer investing 1,250,000 shares at $16 a share in June 2020.  The options vested on a quarterly basis, 6,250 at a time.  Mr. Park has not exercised any of them (the last batch vested on the day he resigned, December 3, I guess), at least as of the date of the annual report, and at this point, he won't make much, even if he does.  His "successor," if ever appointed, is supposed to be given 62,500 options with the same $16 strike, if I am reading the Prospectus correctly - again, not very appealing.  All this pales in comparison with what Dr. Kim, the convicted felon formerly at SK Telecom and now at the helm of Nanox Korea, received.

At the same time the investment was made, Nanox and SK Telecom agreed to 

explore and engage in good faith to develop a definitive agreement within six months of the date of the agreement for the deployment of 2,500 Nanox Systems in South Korea and Vietnam.

which is quite bizarre, really, since SK Telecom is no distributor of medical devices or a healthcare provider.  The agreement was supposed to be in effect until the end of this month, but "may be extended."  Sure enough, now the definite agreement is not likely to be signed, with Mr. Park gone.  Interestingly, neither South Korea nor Vietnam require FDA clearance, so the current "delay" with the FDA is no reason for not signing the agreement.  Nanox CEO did promise that Nanox had all the stuff needed to complete at least 1,000 Nanox.Arc units earlier this year.  But, for some reason, Nanox does not want to make them or ship them yet.

Finally, the official stance by SK Telecom in September, 2020 that 

major investors had already verified Nanox's technology and recognized its potential, 

and that 

We [that is, SK Telecom] have thoroughly reviewed our technology and investment value internally, 

now seems quite ridiculous given the ongoing SEC investigation, the RSNA 2021 infomercial, the chips for household appliances, and the new all time low of $13.90 the stock hit on December 6, the effective resignation date.

Pivot, or the evolution of fraud

Nanox.Arc circa March 2020:

Sort of like Star Trek’s fictitious “biobed,” the Nanox.Arc could provide a full-body digital X-ray scan down to the cellular level. 

“Because it’s digital, it’s multispectral. You don’t need different machines to do different kinds of imaging,” says Poliakine. That includes mammography, CT, fluoroscopy and angiography, for instance.

Nanox.Arc circa January 2021:

Angiography is out.  Still hope for CT (aka axial imaging), fluoroscopy, and maybe, just maybe, mammograpy (aka breast tomosynthesis)?

Nanox.Arc circa December 2021:

Fluoroscopy and mammography are out.

What is it that remains?  Axial imaging?  But Nanox.Arc can't do that either because it supposedly has just 5 tubes, not the 11 in that slide.

On the shapeshifting ability of skeletons

So, Nanox is showing a pelvis scan in its infomercial.   Things go well, until this happens at 13m:02s into the video.  

The pelvis phantom, with real human bones, has shapeshifted into an artificial skull.  But just for a fraction of a second.  Within a couple of frames, the skull transforms back into a pelvis phantom.

This is not an isolated phenomenon.  At about 13m:33s into the video, the pelvis shapeshifts into a hand.  The feet of the creature, alleged to be carrying a camera, move next to the patient table.  It is also revealed that the scout scan was never shown (a low-dose scout scan is often performed in real equipment making real scans to adjust the protocol for best image).

Conclusion:  Nanox.ARC is fake and did not make even the poor-quality tomosynthesis images shown by Nanox.  It is a mystery how those images were generated (and whether they were done manually or involved a robotic hand).  However, evidence suggests that it is possible that Nanox has discovered shapeshifters in our midst (luckily, no longer living).

Blurring timestamps to conceal time travel

There is interesting blurring in the Nanox infomercial.

For some reason, Nanox decided that it should hide the date/time the image was taken (October 10, 2021, 5:31:15pm, per DICOM data), but forgot to blur the same timestamp in the upper left corner.  Here is the unblurred timestamp from the hand scan video:

Why are timestamps important?  Because they reveal that the Nanox.Arc scan that supposedly generated that image never happened.  The timestamp was fake to begin with.  

Here is the supposed tomosynthesis stack generated by a pelvic scan.  The DICOM timestamp is again October 10, 2021, 5:31:15pm, to the second.  How come these two completely different scans finished at the exact same second?

What about the head scan?  That one is dated January 1, 2021 (no time shown).

But what about the Nanox.Arc scan that generated that hand image?  Did the scan actually happen?

According to the hand scan video, the scan took about 64 seconds (patient data is entered 00m:16s and scan finished 01m:20s into the video).

The problem is that the control pad (or the "operation console") shows something completely different - the scan took over 10 minutes, not just a bit over a minute, if it was done at all.  And it supposedly happened on November 22, 2021, more than a month after that blurred October 10, 2021 date, while involving an additional short jump back in time.

Here is the timeline of the hand scan, according to the control pad: 

4:44pm	Patient data is scanned (battery is at 37%, not charging)
	travel back in time 1 hour and 37 minutes, which drains the battery charge about 1/3
3:07pm	Select body region, protocol, prepare to start scan (battery is at 10%, charging)
3:13pm	Scan in progress, scan finishes, please wait for reconstruction to finish (battery is at 12%, charging)
3:17pm	DICOM preview, approved and finished (battery is still at 12%, charging)

Conclusion:  Nanox.ARC is fake and did not make even the poor-quality tomosynthesis images shown by Nanox.  It is a mystery how those images were generated (and whether they were done manually or involved a robotic hand).  However, evidence suggests that it is possible that Nanox has invented a time travel machine.

Update:  We were given a heads-up about the time machine in November:

 

Cold turkey

The price of a turkey in East Hampton, NY must be very high this year, so Mr. Richard Stone is selling (and probably already sold on November 19 to his broker) 200,000 shares of Nanox, cold turkey, at a value of $17.38 a share (according the the 144 form he emailed to the SEC).

This is about half of the shares he reportedly bought with cash on September 2019, pre-IPO.  His current holdings are a bit of a mystery, but the last 20-F states that he was a beneficial owner of a bit over 550,000 shares as of March 20, 2021 (includes options and warrants, outright and through intermediaries) 

Since the form was filed on November 19, a Friday, the stock lending/borrow fee has increased from about 7% to the current 57% (at Interactive Brokers).  It is not necessarily evidence of front running - when a large holder, who has lent his shares, sells, it typically takes a bit of time for the shares to become available to borrow from the new buyers.  The form was made public by the SEC on November 22, based on what I see in the webserver header.

Or just maybe Mr. Stone does not want to wait and see what will happen at the RSNA 2021 radiology conference next week.  See, Nanox started with a tweet like this in late October,

which has quickly transformed by the end of the month into this tweet:

 

What has Nanox never done before?  Tell the truth?

Mr. Stone is a Director of Nanox, and was a Director of Nanox predecessor since at least 2014.

Update:  In case it was not obvious, Nanox never traded below $18.30 a share as a public company, an all-time low it hit after Nanox disclosed a subpoena by the SEC on November 17.  Stock has fluctuated between that low and $20.57 since.

Update June 1, 2022:  Nanox filed a 6-K yesterday, stating:  "NANO-X IMAGING LTD (the “Company”) deeply regrets to announce that Mr. Richard Stone, a director of the Company, passed away unexpectedly on May 29, 2022. Mr. Richard Stone had served as a director of the Company since November 2019. Mr. Poliakine, the founder and chairman of the Board of Directors of the Company, commented, “It is with great sadness that we announce the passing of Mr. Richard Stone. He was a highly valued director of the Company and was an inspiration to all of us. Richard will be missed not only as a business colleague, but also as a friend and a true partner. We extend our deepest sympathies to the entire Stone family.”

Inflating the hedge

How does one know whether the market is approaching peak insanity?  Maybe it is the publication of an article like this.  The author argues that Nanox is a 

buy now and hold for the long haul 

stock because it is 

a way to hedge against runaway inflation.

That is completely nonsensical, of course, as Nanox has been telling investors that it plans to charge a FIXED fee per scan with its magical device, while its costs of manufacturing and other operating expenses will be subject to whatever inflation or deflation there is.  In other words, if Nanox were not a complete fraud, it would be the worst hedge against inflation.

Image by Marina Velmozhko at Pixabay

The author gets the rest of the Nanox story completely wrong, too. 

With an efficient way to produce x-rays, 

But Nanox has never proposed an efficient way to produce x-rays.  Its proposed x-ray tubes, it they weren't completely fake, will be just as inefficient as regular x-ray tubes, as the inefficiency happens at the anode, not the cathode.

The author claims that 

Nanox.ARC produces x-rays with silicon chips that use modest amounts of electricity. 

That is quite interesting, because no functional Nanox.ARC device exists, at least none was demonstrated at the August Business Update and the recent AI webcast (Nanox has changed the design of the ARC supposedly demonstrated about a year ago at RSNA 2020).  Moreover, even if it existed, it would use the same "amounts of electricity" as a regular tomosynthesis device for the same (actually, worse) image quality, as the proposed Nanox x-ray source would use the same amount of electricity as the current regular dental x-ray tubes.  And, of course, x-rays cannot be produced with silicon chips, at least not commercially (Nanox claims to use molybdenum in its proposed chip, which happens to be fake).

Finally, the author confuses Nanox.CART with Nanox.ARC and FDA approval with FDA clearance.  Nanox has never shown a picture or photo of Nanox.CART, the only Nanox device that has been cleared by the FDA (and even that clearance appears a result of fraud by Nanox, based on what can be glimpsed from the published 510k Summary).  Also, FDA approval is completely different from FDA clearance under United States law, and claiming FDA approval when a device has been cleared is illegal.  Nanox has never submitted Nanox.ARC for FDA approval (or at least it never told the public about it) - it claimed in a June press release that it had submitted it for clearance only.

The single source Nanox.ARC has already been approved by the FDA, but the company's first attempt to earn approval for a multi-source device didn't work out.

I also have an issue with the archaic term used for CT,

Computer-aided tomography,

but that's probably a topic for another post (simplistically, the key difference between the old tomography, now called tomosynthesis, and CT is that the former can't do axial slices).  Needless to say, the proposed Nanox.ARC is not a CT device but a tomosynthesis device, according to Nanox.  What is the difference?  CT has something like 10%-20%, and growing, share of the medical imaging market using x-rays, and is considered the gold standard in many if not most x-ray diagnostics scenarios, while tomosynthesis (other than specialized breast tomosynthesis, which the proposed Nanox.ARC cannot do) is never "usually appropriate," according to ACR, and has less than 1%, and declining, market share.  It gets worse - the "tomosynthesis" images that Nanox has shown so far have no diagnostics usefulness whatsoever.

To be fair, the author hedges at the end of the article:

A fuzzy timeline for resubmitting an application to the FDA for a multi-source device combined with a lack of revenue makes this an ultra-high-risk stock at the moment. Cornering the market for x-ray equipment could be so lucrative, though, that it's probably worth the risk.

Great visionary

I think the company's outgoing CEO should be revered as a great visionary.  According to today's press release, the company spent $665K in the September quarter on "Class-actions litigation and SEC matter." That was months ahead of the "SEC matter" subpoena received on November 8 (per results call today).  That is what I call a foresight!

Image by nvodicka on Pixabay

The Division of Enforcement of the U.S. Securities & Exchange Commission (the “SEC”) has notified the Company that it is conducting an investigation to determine whether there had been any violations of the federal securities laws. The Company has been providing documents and information and has now received a subpoena from the SEC requesting that the Company provide documents and other information relating to the development cost of the Company’s Nanox.ARC prototypes, as well as the Company’s estimate for the cost of assembling the final Nanox.ARC product at scale.

But somehow the company forgot to tell us about all that in its November 11 press release.  The stock has been dropping on "no news" since that November 8 date, of course.

Nanox celebrates the International day of radiology

Nanox celebrates.  

That is, Nanox CEO lies again on his blog.

First, he admits that Roentgen used a Crookes-type tube, which is a cold-cathode tube, when he discovered x-rays 126 years ago. not a thermionic or hot-cathode tube, as he has repeatedly lied in the past.  Then he correctly states:

Not many people know this, but for over 100 years the technology for generating X-rays has not changed.

Exactly right.  In fact, no one knows that for over 100 years the technology for generating x-rays has not changed, because it has.  With the invention of the hot-cathode tubes, or thermionic-emission tubes, by GE in 1913, the market share of cold-cathode tubes declined to basically nothing.  Other sources of x-rays were discovered and invented as well, such as the radioisotopes and the synchrotron.

So it is not completely true that 

In any X-Ray machine, the rays are still produced by thermionic emission technology...

but it is completely false that 

... that requires massive heating to develop the X-rays.

because the tiny Christmas tree lights, say 0.4W each, are hotter than the "hot" filament in a typical x-ray tube.

image based on Petr Kratochvil's work 

The real heat comes from the inefficient way of generating x-rays in any x-ray tube, be it cold-cathode or hot-cathode.  Electrons smash into the target/anode and only less than 1% of the energy is converted into usable x-rays, while the rest gets wasted as heat.  Yet, it is not a bigger problem than using, say, a 200W incandescent light bulb.

The outgoing CEO continues to lie:

Nanox developed the Cold Cathode X-ray tubes that are much smaller, and as per their name emit X-Rays at room temperature, which leads to considerable energy and cost savings.

Nanox has not developed any functional cold-cathode tubes - they are all fake and bigger than the regular dental tubes they are supposed to replace.  Even if they were real, they would not emit x-rays at room temperature, because the anode temperature can reach 5,000 degrees Fahrenheit.  And, of course, cold cathode does not mean cold or room temperature, it just means electron emission above the emission by the thermionic effect alone. The proposed Nanox tube, if ever made functional, will not bring any energy and cost savings -  just the opposite, as evidenced by all cold-cathode tubes in the past characterized by poor and unreliable performance and short life.

Mr. Poliakine then contradicts himself:

But even before Coronavirus, most of the people in the world did not have access to medical screening because they couldn't afford it or are too far away from a machine and a doctor. Nanox aims to change this.

That is a complete lie, of course, but you should forgive him, as a con-artist has often other things to worry about than remember what he wrote in his own blog more than a year ago:

In Israel, as in practically every country in the world, we have a real shortage of testing kits. Lung scans on the other hand are accessible, cheap, and the results are immediate - a critical factor in patient outcomes and in preventing the spread of the infection.

Lung scans, in practically every country in the world, are accessible, cheap, and the results are immediate, wrote Mr. Poliakine.  Lung scans are some kind of medical imaging, no? Typically, using x-rays, no?  Even CT (as shown in his March 2020 blog post)? 

Join us in our journey.

Sure.

For educational purposes only

The latest tweet by Nanox shows that its device can teach first graders the concept of an analog clock.  It has no x-ray tubes, and is for educational purposes only.

Too bad first graders are not allowed to attend RSNA 2021.

Concerns about the outgoing Nanox CEO

He apparently tweeted this, and someone caught him:

The tweet is now deleted.  "Nanon" and "ARK." Is he now busier swindling the Israeli state?  Or did I misunderstand the source of those $40 million?

Update:  The "ARK," of course, is the CEO's Freudian slip regarding ARK Fund's Israel Innovative Technology ETF (ticker: IZRL) - ARK is required to hold Nanox stock, even though Nanox is a fraud.

Remember, remember

Remember that Bloomberg piece that Nanox tweeted in early March?

A forward-looking statement is typically a safe-harbor statement, but what if the CEO of Nanox, Mr. Poliakine, did know at the time that ALL the 25 ARC systems were fake and non-functional (the photo obviously shows fewer than 25 systems anyway) and that Nanox was not on pace to make and ship 1,000 units by the end of the first quarter of 2022 at the latest?

I mean, how can Nanox be on pace to ship those 1,000 systems, if they have no x-ray tubes and if he knew that the tomosynthesis reconstruction algorithms create images that may be useful for diagnosis of aliens, but not of humans?

How to tell that a clean room is not clean

How to tell?  Easy.  You look for the fake dust particles that the video editor introduces subconsciously in the video walk-down of  the fab and then posts that clip in the lowest-possible resolution on Youtube.

Nanox temp Korean FAB featuring  Nikon 
NSR-S204B scanner introduced 23 years ago.

Alien lifeform discovered

Today's Nanox AI event showed a sample image from "nanox.Arc demo unit" that was not submitted for regulatory approval. 

Can someone explain what I may be seeing here - aren't there too many bones?  Was this early detection of an alien lifeform living inside a phantom human hand?

Update November 5, 2021:  The recording of Nanox AI event posted on Youtube has been made private and cannot be viewed anymore.  I wonder why.  Time to notify the FDA about the alien discovery by a device about to be cleared?

Update November 9, 2021: Recording is viewable again, under new URL.

Update November 14, 2021:  I was asked on Youtube how I can be sure that the June submission for FDA clearance was fraudulent.  Dr. Orit, the Chief Medical Officer, admitted during the webcast that 1) the Nanox.ARC device is currently under development (49m:44s), and the "images" [including the disastrous tomosynthesis slab of the "alien lifeform" hand] are currently not usable for diagnostic purposes - "it is still being developed" (52m:07s).  Therefore, the device submitted for clearance in June was not ready to be marketed or tested, which is fraud.

Language confusion

Nanox states in each of its recent press releases that 

Nanox ... is an Israeli corporation 

Surprisingly, its website lists only English, Korean, Chinese, and Japanese as available languages.  The country's official language, Hebrew, is somehow missing.

 

This is not an accidental omission.  The website of the CEO's related scam, DHI 2048, which describes itself as 

UAE-based organization 

is only in English, and has no option for Arabic, the official language of UAE.

Why is that?

Half and half

During the August 16 Business Update, which was supposed to show the latest and greatest by Nanox, Dr. Kim, a convicted felon, said:

... we are now manufacturing MEMS chips from our own facility [in Korea]

Turns out, they were not manufacturing MEMS chips in Korea, at least not in a finished form.

According to his latest interview, things are done half in Korea and half in Japan (just as the CEO had described during an earlier results call on August 11).

Here is the translation:

The [fake] chips are made in Japan [not in Korea]

we can't process wafers from beginning to end [in Korea] 

we don't have the equipment to do so

we just don't

so of the 100 [fake] wafer processes, 50 are 

done in Korea, then the wafers are 

sent back to Japan to do the remaining 50.  

Then a fake chip emerges and propels a magic Japanese x-ray tube to Israel, or something like that.

Update October 23, 2021:  While Dr. Kim's statements agree with the CEO's August 11 statements, they disagree with the CEO's statement during the August 16 Business Update.  Nanox CEO lied when he said that the chip was made in Korea - Dr. Kim said it was made in Japan (while only partially pre-processed in Korea).  One can argue that it does not matter, since the chip is fake, anyway.

Lost in translation

Nanox just can't make up its mind about the capacity of its unfinished fab.  In a recent interview by Hankyung Global Market, the president of Nanox Korea, who is a convicted felon, said something that got translated into 4,000 wafers a month.

Just a month ago, that future capacity was supposed to be close to 1,000 wafers a month.  Using the "100 chips per wafer" average previously given by him, we are now supposed to believe that Nanox will be soon churning out 4,800,000 fake chips a year, enough to make nearly 100,000 fake Nanox.Arc devices per annum, given the current design of 5 fake chips per device (and assuming 100% yield).  Just last June, the full annual capacity was supposed to be only 120,000 fake chips (10,000 a month).  Quite a ramp up, isn't it?  It is very easy to ramp up fake chips in an unfinished fab.

But maybe he did not mean 4,000 wafers - may be he meant 4,000 chips a month?  Well, then this is a severe contraction, as the CEO was planning a year ago for 1,000 wafers a month (or about 1,200,000 chips a year).  But he then also thought that Nanox.Arc has only 7 of these fake chips (not 5 and not 11, as various videos and investor presentations show).

Update:  Not to be confused with the April loss in translation (2,000 fake chips a month).

Dry run

It appears that Nanox CEO really wants to admit that the 510(k) submission to the FDA in June was fraudulent.  In an interview with Korean Economic TV (wowTV), conducted in early October, he supposedly said the following when asked about the commercialization plans for Nanox.Arc in 2022:

We expect 2022 to be the year of Nanox equipment deployment. It won't be on a global scale, but we still expect deployments to be completed in some countries. We have already demonstrated the Nanox.ARC several times before the last RSNA [meeting in December 2020]. Therefore, interest in Nanox is increasing and it is getting very close to mass production. But we're at the doorstep of getting medical regulatory approvals. To this end, Nanox plans to do a final check to see if the system is working properly through a process we call 'dry run'. As such, we are looking forward to seeing the Nanox Arc in action in the field within 2022.  [rough translation from Korean with google translate]

Hmm, if the final check of the Nanox.Arc has not even started, then the submission for FDA clearance in June was clearly incomplete and fraudulent.  If Nanox does not know yet whether the device is working properly, than, obviously, it cannot claim that the device is substantially equivalent to any device on the market.

The problem is that neither wowTV nor Nanox released the full interview, so right now there is no way to check whether the CEO really said all that.  The version of the interview released on Youtube is substantially edited, with large portions, including this particular statement, cut.  

Some of the main takeaways from the shortened version are:

Takeaway 1:  The upcoming world-class CEO was quite incoherent (not a surprise, since has was fired from his position as a Chair of Hadassah Medical in December last year).  Here is what he said. 

As were are right now in the middle of the process of planning the [?] operating for next year, and following our visit next week in Korea, we are already deep into the process of planning for next year.  Following these 3 acquisitions which the closing will be in the next few weeks - we expect and we thought that the closing of Zebra will be in October - we don't see any challenges to do so - next will be USARAD and MDW, and once we complete the post-merger integration, that's actually what we do right now, we are planning to go for the next step. And the next step is to finalize the products, do the final submission to the FDA, make all the preparations for the mass production. and start to get the regulation approvals in various countries, as well as the selling and implementing and bring to the deployment of the agreements that were already signed and new agreements that will be signed in the very near future.  At the same time we are going to explore and expand the revenues that we already have in Zebra and MDW and USARAD - actually scale it up to become more and more, and implement the agreements that were signed with Zebra on the AI and the population health - and what we call the Robodiologist going forward - so basically the whole theme will be next year execution, implementation, deployment, and scaling up.

Takeaway 2:  The current CEO falsely claims, again, that the FDA clearance of Nanox.Cart is a key validation of Nanox digital x-ray source and that the FDA said that "this technology actually meets a predicate device."  The truth is that the clearance was a farce, as evidenced by the contradictory 510(k) summary regarding the source (such as its target angle), there is nothing digital about the supposed x-ray source (tube) in the Nanox.Cart, and that the FDA does not clear technology but only a specific device.

Takeaway 3:  The current CEO reversed two statements in the June press release and now claims the "first-version" device submitted for FDA clearance in June will be the one that will be made and deployed based on the signed agreements with customers.  The press release had stated,

The first version of the multi-source Nanox.ARC will be followed by future Nanox.ARC versions,

thereby implying that the device submitted in June will not be commercialized, just as the Nanox.Cart.

He also reversed the statement in the press release about the device's intended use:

Nanox.ARC is a 3-D tomosynthesis imaging system that produces scans of a human body part.

In the interview, it is back to full-body scanners (not a body part).

Takeaway 4:  The usual lies by the current CEO that most of the population of the world do not have effective access to medical imaging, that Wilhelm Roentgen invented x-rays 126 years ago with a hot cathode, that micro-electromechanical is nano-scale or that the proposed Nanox chip has anything to do with either, and that chip-based tubes are digital, colder, lower-voltage, and less expensive than regular dental tubes. 

Takeaway 5:  The current CEO can joke:

I said before, X-ray was invented 126 years ago, Nanox - we are inventing now.  So we should look forward another 126 years of Nanox different product - coming from Nanox technology, because we believe that this is the technology of the future for medical imaging.

It is funny, because it is an inside joke, of course.  X-ray was not invented, and Nanox is not inventing anything now.  The real Nanox products will come in 126 years - you just have to look forward to them - it is a technology of the future, not of the present.  In other words, the FDA, for the first time ever, has approved a technology that will not exist for another 126 years.

Pathological

If Nanox had even one bit of useful technology, why would the CEO be compelled to lie every time about it when he speaks publicly?

 

Source: wowTV

Following is an excerpt from the CEO interview at the unveiling ceremony of the unfinished Nanox Korean FAB that is supposed to produce fake chips and come online in the middle of the biggest chip glut next year.

126 years ago Wilhelm Roentgen invented the Edison light of X-ray, called X-ray.  It is analog.  It is based on heat.  Nanox invented the LED of x-ray, which is cold and digital, and much reduced cost.  X-ray was based on filament, but with Nanox, it is based on semiconductor.

We are very close to SK Hynix, which is one of the largest MEMS semiconductor manufacturers, and it is very similar to what we do here.

Lie Number 1:  Wilhelm Roentgen did not invent x-rays - he discovered them using equipment that already existed - the cold-cathode tube.  He said so in the first paragraph of his paper:  

... a Hittorf's vacuum tube, or through a well-exhausted Crookes' or Lenard's tube."  (translation, original).  

Nanox CEO is, of course, aware of this fact, as the Roentgen paper is cited in the first paragraph of Nanox own white paper on cold cathodes.

Those are all cold-cathode tubes and they do not have filaments.  The filament-based or "hot-cathode" x-ray tube was not invented until 1913, according to the first page of Nanox white paper. 

Lie Number 2:  X-ray generation for medical imaging is not and was never based on heat.  Heat is a side effect of the inefficient way of x-ray generation in the x-ray tube.  In any x-ray tube, electrons driven by very high voltage smash into an anode target, and release less than 1% of their energy as useful x-rays, while the rest is wasted as heat.  The process is exactly the same for both the cold and hot cathodes.

Lie Number 3:  Nanox has not invented anything.  Nanox proposed x-ray source is supposed to be a cheap dental x-ray tube -  it has nothing to do with an LED.  X-rays, unlike visible light or even UV light, cannot be generated by LEDs, as the semiconductor bandgaps are not wide enough.  The proposed Nanox tube is just as analog and digital as the regular dental x-ray tubes, but would be more expensive if real (because any chip, obviously, would be more expensive than the filament - a short piece of wire) and would have worse performance. Of course, a fake Nanox tube must cost less than a regular dental x-ray tube (which can be bought on eBay for $80 or so, nowhere near the $150,000, or $50,000 lately, claimed by the CEO elsewhere).

Lie Number 4:  Nanox proposed (and fake) x-ray source is not based on semiconductors.  Nanox annual report states (page 59): 

Our X-ray source is a MEMs-based semiconductor cathode that achieves electron emission by a non-thermionic low-voltage trigger to approximately 100 million nano-scale molybdenum cones that act as multiple electron “guns,” instead of a single heated filament.

Molybdenum, however, is not a semiconductor (it is as conductive as the filament's tungsten)   Oh, and Nanox "low-voltage trigger" is supposed to be 50V (per white paper), while traditional filament uses less than 5V.

Lie Number 5:  SK Hynix is not one of the largest MEMS semiconductor manufacturers.  Those would be Bosch, Broadcom, Qorvo, STMicroelectronics, Texas Instruments, Goermicro, HP, Knowles, TDK and Infineon.  SK Hynix makes real memory chips, while Nanox has never designed or made a single working chip that can serve as a cold cathode of a commercially-ready x-ray source, contrary to its investment presentations.  The proposed Nanox chip is not MEMS anyway, as there is nothing mechanical or moving/vibrating/resonating/etc. about it - it is supposed to be just a bunch of pins in round "holes."

Update:  SK Hynix is nowhere to be found in this chart by Yole, even though SK Hynix insists that it has some MEMS business (microphone and pressure sensors planned on its foundry side).

Half baked

Nanox August Business Update webcast, supposed to show "the latest and greatest of Nanox" (per CEO), demonstrated that Nanox has no working Nanox chip, x-ray source, or Arc, contrary to the intentionally misleading claims read by the webcast participants, and confirmed that Nanox had submitted a non-working medical device for FDA clearance in June.

Here is a particularly hilarious snapshot from the webcast.  It is supposed to show the next-generation high-power x-ray tube successfully developed by the Nanox Korea team led by a convicted felon, Dr. Kim.

The incomplete tube (missing a cathode) is supposedly going into a vacuum oven to be baked, for no reason.

The same type of tube, with the ridiculous disk insulator, is also shown here inserted into an Arc.  This time it supposedly has a cathode, but the high-voltage cable is simply wedged into the anode.  If the tube were ever powered, the disk insulator won't help - arcing [pun intended] would immediately occur at the cable connection.

That is how Nanox may have already admitted that the Arc was a non-functioning "future" product in June (when submitted to the FDA).  And, no, the glass Nanox tubes didn't look any better:  CEI showed how it uses aluminum foil to bake those appetizer (that is, fake and malfunctioning) tubes.

What passes as a fact in the Nanox universe

From a Yahoo post by what appears to be a poorly-written AI bot (all mistakes and errors left intact): 

Did you know years ago, after an xray, you had to under go treatment for xray burn.? The goal in xray is less radiation, precise dosage / area control. Ask which is more controllable, digital or analogue. Start to see the future, instead of a few months ahead. Someone can... 

 , I asked the surgeon if all those x-rays may have been a cause. He said that any x-ray taken before 1990 could be classed as a "dirty" x-ray, due to incorrect dosage or leakage from the machine, and failure to shield those parts of the body not being x-rayed.

Source:  National Museum of Health and Medicine, circa 1915

So, here you have it, if you believe that everyone x-rayed prior to year 1990 had to undergo treatment for x-ray burns, you may as well believe that Nanox is not a complete fraud.

This is how desperate Nanox has become.

Update #1 October 11, 2021:  A snapshot from a Nanox video documenting tests done by Foxconn in December 2019 reveals that the "digital" Nanox x-ray source is unsafe because of poor filtration (spews too much low-energy x-ray radiation that is useless for diagnostic imaging but gets absorbed in soft tissues and causes cancer).

An HVL of 1.17mm Al fails the FDA's 1.3mm limit (see 21 CFR 1020.30m, Table 1) and the European standard's 2.0mm limit (see IEC 60601-1-3, 2013 edition, Table 3) - links in References.  It is a good bet that Nanox never showed this scary test result to the FDA.

 

Update #2 October 11, 2021:  The bot insists

 

the second half [of the above Yahoo post] was from a cancer paitent [sic]. No mistake.

 

What can one say about such an accusation by a bot of pervasive world-wide medical malpractice involving all x-ray use prior to 1990?  Here is the current position of the American Cancer Society.

Update #3 October 11, 2021:  The bot falsely claims the above Yahoo post

 

Its [sic] from American cancer society page.. [sic]

 

It is essentially a modern version of ELIZA.

A coal miner under the Arc

Not possible, says the United States Code of Federal Regulations.  Coal mine operators are required to provide radiographic examinations to each coal miner, and, for some reasons, the law insists on certain minimum specs of the equipment.  Nanox.Arc cannot meet them.

Original credit:  Jean Beaufort

Here are some of the specs for a digital radiograph (42 CFR 37.42) that Nanox.Arc fails:

Every digital chest radiograph taken as required under this section must be a single posteroanterior [PA] projection

Nanox.Arc cannot take PA projections (it can only do supine AP).

Radiographs must be made with units having generators which have a minimum rating of 300 mA at 125 kVp. Exposure kilovoltage must be at least the minimum as recommended by the manufacturer for chest radiography.

Nanox tube is rated just 2mA at 40 kVp, per 510K Summary for Nanox.Cart.  Nanox partner CEI has been supposedly trying hard for months to make 1mA at 100 kVp, but has failed so far.

The distance from source or focal spot to detector must be at least 70 inches (or 180 centimeters if measured in centimeters);

The Arc is too tight and the distance is less than 40 inches.

The geometry of the radiographic system must ensure that the central axis (ray) of the primary beam is perpendicular to the plane of the CR imaging plate, or DR detector and is correctly aligned to the grid;

The requirement above is met by only one of the 5 tubes in the Nanox.Arc, in only one, the no-tilt, position of the Arc.

Now, if the Arc cannot even do a simple radiograph worthy of a coal miner,  why does Nanox still tell investors that the Arc can be used for chest diagnostics?

Slide from Cantor investor presentation (September 29)

Moreover, does the FDA clearance submission of the Nanox.Arc list chest diagnostics as an indication/intended use?  That would be a bit fraudulent, no?

Disappearing years

 

Predecessor logo (2015-2019)

In early 2016, Nanox predecessor claimed it already had the technology to change the world of medical imaging, security sciences, and telecommunications:

NanoX Technology 

After more than 20 years of research and development [placing the beginning before 1996], with over $1B invested, our team of engineers has created a technology that will form the core of the next generation of vacuum electronics. Nanox field-effect electron sources will allow engineers in diverse industries to overcome decades-old impediments to innovation. Nanox technology will open the door to quantum leaps in medical imaging, security sciences, and telecommunications.

While the fake $1B number remained, six years of research and development disappeared.  For example, Nanox current tech page claims over 19 years [placing the beginning before 2002].  Years don't disappear, unless the story and the technology is fake.

Also interesting is the list of frequently-asked questions about Nanox in February of 2016.

Q: How much do Nanox emitters cost?

A: Nanox will enter the market as a technology license provider, not as a component supplier. We are committed to working with our co-development partners to craft business relationships that allow both sides to capture maximum value from their investments.

Because the technology was and still is a scam, no one has licensed it.  Not even Fuji, which is fraudulently listed as an OEM above.

Q: How large are Nanox cathodes?

A: Nanox cathodes are created from standard silicon wafers using well-known MEMS fabrication techniques, and can be created in any shape, size, or configuration.

Nanox now claims the (fake) cathodes are about 1cm2.

Q: What current density has been achieved?

A:  Over the past year, Nanox has made numerous improvements that have resulted in large jumps in current density. We are now routinely testing emitters rated at 2.5A/cm2

If the emitters were real and had current density of 2.5A/cm2, the Nanox tube would have been a very powerful one - 100,000W (40,000V x 2.5 A/cm2 x 1 cm2), capable of doing soft-tissue CT.  Instead, the Nanox tube is just 80W, which is worse than the cheapest used dental tube you can buy on eBay.  So, Nanox predecessor "exaggerated" by more than 3 orders of magnitude (or, a factor over 1,000x), even if the technology were not completely fake (which it is).

Which brings us back to the most frequently asked question about Nanox today:

Q: When is the FDA approval coming?  

And the answer is:  

A:  Never, as Nanox has not submitted for FDA approval.