Nanox panics, deletes, then doctors a photo, and ... deletes again

On May 22, Nanox announced on its results call that it had 

 

entered into a three-year distribution agreement with a local partner in Morocco, Vital Tech SARL.  Under the distribution agreement, Vital Tech will purchase, deploy, and operate an estimated 270 Nanox.ARC units over three years for clinical use.  The execution is subject to acceptance test of the first unit and regulatory clearances. We have already received an import license. We have sent the first unit and our deployment team is on the ground as we speak...  The system is already at the hospital as we speak, and we have a team on the ground, which are going to operate it, and it will start to generate, of course, the images.

The announcement made no sense, as Nanox is supposed to enter into MSaaS service agreements for its fake ARC units and retain ownership, not sell the fake ARCs (more on those fake service agreements later).

But what followed made even less sense.  On June 14, Nanox tweeted and posted on linkedin this:

Nanox.ARC Medical Imaging System was deployed in CHU university hospital in Marrakech, which is a major healthcare provider in the Marrakech-Safi region and the entire southern region of the Kingdom, enhancing our presence in Africa and bridging the equity gap in medical imaging access. The system is currently operational and has initiated the process of scanning human patients. To learn more about Nanox.ARC visit our website: nanox.vision/nanox-arc#main #healthcareequity #Nanox #NanoxARC #medicalimaging #Radiology #vitaltech

and attached these photos:

On the next day, Nanox removed the above photos (and edited out the reference to "CHU" in the social media posts) and replaced the photos this doctored gem:

If you take a closer look at the reflections on the table, you will realize that Nanox digitally removed the logos of CHU Marrakech and Vital Tech from the wall, hoping no one will notice.  Within a day, Nanox gave up and finally deleted those social media posts, images and text altogether.

I am sure this is not the end of this story, but the fact that Nanox is so quick to doctor a photo makes another fact, the fact Nanox made at least two fraudulent submissions to the FDA at at least two fraudulent 20-F filings with the SEC, somewhat less incredible.

In the mean time, Vital Tech has this to say about the ARC:

Nanox forgot to tell its "distributor" that the fake ARC is not novel (Nanox argued in its fraudulent submission to the FDA that the device is substantially equivalent to an existing device, that is, not novel). Or that it uses a single x-ray source, just like "traditional single-source CT."  Or that it has nothing to do, otherwise, with a CT (the fake ARC is classified as a "System, X-Ray, Tomographic" product, instead of as a "System, X-Ray, Tomography, Computed").  Or that it does not have an innovative digital MEMS (no such thing as MEMs either) technology, which is quite easy to verify.  Or that it does not offer "high-quality imaging at a fraction of the cost."  Or that it can be used only adjunctive to a conventional x-ray (that is, an extra conventional x-ray machine is required).  Or that it needs a huge metal box in the room.  The "distributor," on the other hand, forgot to include any service or device cost.

And the question arises again:  which body part is being scanned with MSK tomosynthesis in this fake image and why?

Update June 20, 2023:  Vital Tech is, of course, fake (although some Chinese no-name ultrasound maker claims it sold a few devices through it).  Its website contact form does not submit anything, and the person behind it did not even to put a burner phone number or a fake address. 

Update June 26, 2023:  Mr. Samir Saliba put a phone number on the website: +212707761285.  Also, the link to the misleading (and misbranding) description of the fake Nanox ARC has moved.

Cancer is now eliminated worldwide

When Nanox Vision was announced in June 2019, Nanox made it clear that it was all about wiping out the cancer menace from the face of the Earth:

"If we manage to reach the 1x1x1 vision, we will be able to help save over 8 million people every year with regard to cancer alone," said Ran Poliakine, Founder of nanox[sic]. "This is the true democratization of healthcare, in which medical imaging will be accessible to all people globally and will cease to be the privilege of the few. We estimate that the economic savings will reach over US$1 trillion per year! That is an astonishing amount of money, which can now be diverted to better uses. The implications of our technology are beyond significant to humanity as a whole."

Now that the fake ARC has been "marketed" in the United States for two weeks, it turns out it is indicated only for musculoskeletal tomosynthesis "adjunctive to conventional radiograph," that is, an absolutely-useless imaging modality, according to ACR AC.

But maybe it can still help cure some cancer?  

Nope.  Turns out, none of the common cancers can be detected with the device given its intended use as communicated to the FDA, even if it weren't completely fake (which it is, as no working ARC has ever been made).

image credit: https://www.cancer.gov/research/key-initiatives/moonshot-cancer-initiative

Peak Insanity

I would say we are at peak insanity.

Nanox gave away free shares to Johnson & Johnson months ago because Nanox AI failed its milestones, and all the promoters celebrate it yesterday.

Johnson & Johnson waited for months, until yesterday, to report the December 29, 2022 gift, just like it waited for about a year to report the previous, January, 2022 gift. Johnson & Johnson has never bought a single Nanox share.

But even the fact that the stock of a complete fraud like Nanox trades above $0 is pretty insane - a profitable vehicle for many, just like in any Ponzi scheme - until no greater fools are found.

Now, where and when can I get a scan of my muscles with the fake ARC? Neither Hadassah, nor Shamir, nor UGMC has a working (operational) one - these are hospitals located in Israel and Ghana that Nanox and the promoters like to throw around.

As of today, no working ARC has ever been made, and Nanox has absolutely no intention of delivering a working ARC anywhere.

How long do we think this will stay a secret?

Update May 15, 2023: Muammar Qadhafi offered a detailed timeline, which I include here verbatim below, but I disagree with his comments about transaction costs or divestiture - most-likely J&J ownership was constantly diluted due to stock option issuance to employees and/or contractors.

--- start of timeline ---

Jun 2018: J&J is a minor investor in Zebra (source https://techcrunch.com/2018/06/07/zebra-medical-vision-gets-30m-series-c-to-create-ai-based-tools-for-radiologists/)

Nov 2021: Nanox buys Zebra in an all-stock transaction and issues 3.25M shares to Zebra shareholders.

"On November 4, 2021, the Company consummated its purchase of 100% of the equity of Zebra Medical Vision Ltd... At closing, the Company issued 3,249,142 ordinary shares of the Company" (source Nanox 20-F page 48 https://investors.nanox.vision/node/7636/html)

J&J gets 192K of these shares, therefore their stake in Zebra was 5.92%. (Source JNJ 13F https://johnsonandjohnson.gcs-web.com/node/49671/html -- holding 192,429 shares)

Note: Some of the Nanox issued shares went to transaction costs which means J&J's stake might be around 6%.

Jan 2022: Nanox issues another 89K shares to ex-Zebra shareholders.

"In addition, on January 19, 2022, we issued 89,286 additional ordinary shares to the former shareholders of Nanox AI due to partial achievement of a milestone that occurred post-closing." (source Nanox 20-F as above)

J&J gets some of these shares but doesn't report till their filing for end-2022. (Source JNJ 13F https://johnsonandjohnson.gcs-web.com/node/51171/html -- holding 196,228 shares)

Note: Oddly J&J should have gotten over 5200 shares based on their stake, but they only reported +3799. Did they divest?

Dec 2022: Nanox issues another 2.65M shares to ex-Zebra shareholders.

"On December 29, 2022, the parties entered into a settlement with respect to any additional amount that could be granted under the Zebra Merger Agreement, according to which the Company issued Nanox AI’s former shareholders an additional 2,648,424 ordinary shares."

(source Nanox 20-F as above)

Note that another $100M - $9.33M = $90.67M worth of shares were to be issued upon Zebra hitting milestones, which didn't materialize. At end-Dec 2022 prices this would have been around 13M shares.

J&J reports their stake increased by 121K shares for Q1 2023 as the shares were likely paid out in Jan. (Source JNJ 13F https://johnsonandjohnson.gcs-web.com/node/51741/html -- holding 317,704 shares)

The problem here is based on their initial stake of 5.92% they should have reported +156,851. Therefore they sold off around 35K of Nanox shares in Q1.

--- end of timeline ---

Approval and Screening

I had somehow missed a piece written by three doctors on tomosynthesis.  It is intentionally misleading, but rather silly, so probably no need to go into all the details.   Its second sentence starts like this:

Since receiving FDA clearance in 2011 for screening mammography, digital tomosynthesis (DTS) technology has become virtually synonymous with 3D breast exams...

But it was FDA approval, not clearance.  Moreover,  the approval clearly states: 

THE SCREENING EXAMINATION WILL CONSIST OF A 2D IMAGE SET OR A 2D AND 3D IMAGE SET.

So, the DTS, that is 3D, by itself is not sufficient for screening, according to the approval.

And then it gets worse.

Why is all this important?  Nanox has been intentionally confusing its investors by promising FDA approval, when all it ever did was seek clearance (by submitting a fraudulent application to a fraudulent third party).  And, of course, tomosynthesis (other than breast) is a dead imaging modality that the ACR Appropriateness Criteria® don't even consider as ever being useful.

The authors, all on Nanox payroll, are Dr. Yuz, fined and put on probation for fraudulent medical practice in his youth, Dr. Dawson, who was fired but then pretended to be a whistleblower, and Dr. Katske, the man "credited" for the whimsical production known as RSNA 2020 Nanox live demo.

Update:  Jonathan @Yahoo questions whether Radiology Today has a disclosure policy that would force the 2nd two authors to disclose a financial interest in Nanox (all the three authors were affiliated with Nanox at the time of publication, of course).  He also loves the line “CT is burdensome to radiologists”.  He finally guesses that it is burdensome "in the same way developing a real product and generating actual revenue is burdensome to" Nanox.

The latest Nanox infomercial gets buried

Nanox has been extremely promotional in the past, as anyone, who follows the company's exploits, is well aware of.  However, its latest infomercial has received zero coverage, and its recording is not even available on Nanox website or anywhere else I have looked.  Something has changed.

The infomercial was first aired a week ago on a late-night Saturday (January 7) on Bloomberg Europe, when few (if any) watch.  Instead of detailed review, I am simply posting my tweets as I was watching live and then briefly going over the recording.

I was shocked by how sleazy it looked and sounded:  Was Nanox CEO really faking it, or does he belong in an institution?  Warm cathode!  Like a chip!

This extremely embarrassing infomercial starts with a blatant lie:

  

For over 125 years, x-ray technology has remained based on a hot cathode with a filament that generates extreme heat.

But the hot cathode was invented only 110 years ago (as Nanox itself states in the first page of its only technology white paper), and there is nothing extreme about it.

Nanox has not developed any digitally-controlled x-ray tube, of course.  On the other hand, all modern x-ray medical imagining devices, including those costing $500, use off-the-shelf digitally-controlled x-ray tubes.

We also hear another lie:

[Nanox.ARC] uses AI to process what it sees.

That is impossible, even if ARC were not fake (which it is), as there are no training data.  Nanox itself states that it will take 7 years for the data to come - in 2027 (it won't!).

The CEO lies that 2/3 of the world have no access to medical imaging.  That is easy to verify by just adding the population numbers from some countries and regions that provide medical imaging access to all.

He also lies that remote locations in the USA have no access to medical imaging.  Of course, he cannot name even one such location!  Remember, we are not talking about NAEOTOM Alpha - we are talking about portable x-ray or ultrasound devices that you can get for $500.  In fact, @djoupvik on Twitter shows that what is probably America's most isolated town, Utqiagvik, Alaska, has ready access to "X-Ray and CT examinations, mammograms, ultrasounds, and bone density tests." 

Erez claims Nanox will put ARCs in random places in Africa, but no word about electricity, radiation shielding, connectivity to cloud, and how the money will flow.  Remember, SK and Nanox also claimed that they would put 15,000 systems worldwide by year 2022.  Zero working ARCs have been made as of today.

Nanox CEO also tries to convince the viewer that the cold cathode is something new.  Little did he know what anyone who can read knows - Roentgen discovered x-rays in year 1895 using a COLD-CATHODE x-ray tube.

image source: https://www.dailymail.co.uk/news/article-6491287/Roentgens-human-X-ray-wifes-hand-1895.html

And then we hear another one:

It is a cold cathode.  It is like a chip that is the source that get [sic] the nano x-ray to the body, actually, to the detector, and based on this, we analyze the image itself.

Since there is no such thing as nano x-ray, substantial equivalence is impossible for the ARC, if it were real - something that the FDA might be interested in knowing...

The CEO then lies that what's different about the ARC is its ability to transform 2D x-ray images into 3D x-ray images - yet he knows that this had been done since the 1930s.  It is in the first paragraph of Nanox tomosynthesis white paper.   

He also claims that there is

an arc over the bed with tubes that are taking pictures.

 I mean, those fake tubes sound a lot like cameras rather than real x-ray tubes, don't they?  Real x-ray tubes don't take pictures - they emit x-rays.

In the mean time, the producer states:

Legacy x-ray systems are widely deployed...

and inadvertently exposes the earlier "2/3 of the world population" lie uttered earlier in the infomercial.  The CEO replies:

We are not competing with the CT, ok, we are not competing with the x-ray...

The FDA may be interested to know that, as well, as it has relevance to finding predicate in that clearance submission Nanox claimed to have filed last September.

And then I get bored, because the CEO starts talking about CT, which is a proven and widely-available medical imaging technology, and 

when you do a CT, there is [sic] a lot of data...  We are planning to super-power the data...

So we should just buy the $20,000 CT, then, instead of waiting for the free but fake ARC?

That really looks like the future of medical imaging,

says a producer at the end.  Nice.

Update May 3, 2023:  Infomercial now posted on YouTube.  Given the stated ARC indications by Nanox in the 510k, it is clearly misleading.

Proving that Nanox is a fraud with a phone

An amazing piece of research has been posted on Reddit today.  I won't spoil the surprise, but you can read the details there, and make sure you have your phone!  Yes, anyone with a phone can now prove that the ARC Day demo was either fake or the ARC device (which includes the tablet, per head of ARC division) is malfunctioning horribly.  The malfunctioning possibility is bad, because Nanox claims to have 1) submitted this device for FDA clearance in September and 2) used it in human trials.  While the author does not spell it out, any submission of this device for clearance or approval to the FDA or any other regulatory agency should be presumed fraudulent - either the device is fake or it is malfunctioning, and Nanox obviously knows it.

I won't address all the "objections" I saw in that thread and elsewhere, but the issue clearly has no relation to time differences or date formats among countries.  Personally, I used an Android phone and the first free QR reader app I could find.  Here is a frame grab from the ARC Day video that worked for me.

Update January 25, 2023:  If you follow the dates of birth shown on the tablet through the video on different screens, we get:

1. 1980-06-08 (a "hidden" string in the QR code)

2. 07/06/1980 , confirmed with a push of a button

3. SUN JUN 08 1980, confirmed with a push of a button

A new theory has been proposed by bjol81@stocktwits that the app simply converted the string 1980-06-08 into Israeli time 1980-06-08 00:00:00, which was then stored as 1980-06-07 22:00:00 UTC due to the time difference between GMT/UTC and Israeli time.  However, in the final screen we still see SUN JUN 08 1980, which would mean there was another output conversion to Israeli time, but displayed in a format that is not standard in Israel.

Update March 7, 2023:  An interesting piece about software bugs that killed:

Likely not relevant, as accumulating evidence from Ghana points to the ARC being simply fake rather than malfunctioning (no detector, no x-ray sources).

Real or not?

While we await the official replay of the November 16 ARC Day magic show, Jonathan at Yahoo has requested to see the "real" images of real organs (a hand and a foot) in real healthy humans made by a real x-ray machine and the fake ARC at Shamir Medical (the device supposedly appeared there more than a year ago in a regular room, per Israeli press, and had since reappeared in a specially equipped x-ray room, per CEO).  The DICOM data of the regular x-ray images appear to show those were done on November 14 in the early afternoon.  According to Israeli's MOH website, the human trial had not started at that time (and had not even started recruiting).  I am posting here some frame grabs without any further comment for now, to prevent biasing readers' opinion.  The Nanox radiologist claims the wrist patient is 63 years old and weighting over 100 kg, and the foot image was from another patient (but she "failed to notice" a big "R" sign on the image of a LEFT hand made by the fake single-source version of the ARC two years ago).

     

Update November 18, 2022:  Nanox has put a replay on Youtube.

Nanox is shipping, or not

A Korean promo (citing "a statement to the industry" made on June 22, written on June 24, embargoed until June 27, and since removed with no explanation, but cached) claims that Nanox has shipped its first x-ray units.  But they are not the fake ARC tomosynthesis devices that management has been promising - they are Remedi's generic portable dental devices, that the FDA has been clearing for extremities, but not chest (see April 21 blog post): 

First, it signed a supply contract with Nasdaq-listed Nanox worth 150 billion won [about $155 million] for a 'compact X-ray solution'. It is a four-year supply contract for the African region. It is known that the initial volume has already been successfully sold, and follow-up procedures are being followed. The compact X-ray solution is a product made with Remex-KA6 and Vieworks (100120:KOSDAQ) 's X-ray detector into a package. It is expected to contribute to improving the level of medical care in Africa, where equipment is poor, as it is easy to move and easy to perform radiography. [google translated]

The whole thing makes no business sense, just like everything else Nanox.  But the article was written by the same author who has written all previous promo pieces about Remedi (and correctly announced the $1 million investment, weeks ahead of Nanox disclosure).

The reason it makes no sense is that portable x-ray devices of similar specs can be imported from China for $600 a piece (and used with film, or about $1 an image, if one wants to skimp on the digital detector, and just take a photo with a phone and upload it to some cloud for free).  But, of course, given a choice, clinics would probably opt for a $10,000 used general x-ray system that can do all standard x-ray imaging procedures, including chest.  Diagnostic imaging services in Africa are widely available and cheap, too - a regular chest x-ray can be as low as $3 in Nigeria, for example (compare to the fake 4-year,1000-unit Nigerian MSaaS agreement, signed about a year ago, supposedly stipulating a $7 payment to Nanox, with no diagnosis).  Assuming a $30,000 "cost" for the Remedi/Vieworks packaged unit, this 5-year "African" contract is about 5,000 units in total!  It is just never going to happen.

Nanox hinted that this was coming in the 20-F filing on May 2 (page 63):   

For example, we recently invested $1.0 million for approximately 1% of the shares of Remedi co Ltd. (“Remedi”), a Korean radiation specialist company in radiography and therapy based on X-ray components. Remedi is a privately owned company, and we have an ongoing collaboration in the development of the high voltage power supply for Nanox.ARC. We are in advanced negotiation with Remedi to explore the possibility of connecting Remedi’s two-dimensional (“2D”) imaging systems to the Nanox.CLOUD and the Nanox.MARKETPLACE, creating a mobile 2D X-ray system that enables remote readings of scans with AI-powered imaging analysis and a global teleradiology solution. Subject to the completion of the negotiation and successful integration of the 2D system, we aim to distribute this system to our MSaaS customers.

One has to wonder what will "happen" with the Nigerian agreement for the fake ARC.

So, here we go - Nanox is pivoting from a developer of a novel device that would cure cancer and democratize health care to a distributor of overpriced dental machines.  Not good enough even for a decent money-laundering operation.

Update July 16, 2022:  The promo has been republished on July 12.  It now claims "the statement to the industry" was made on July 11, thereby reconfirming Remedi as a likely hopeless scam that has been trying for years to list on KOSDAQ.  The story is mainly unchanged from its June 24 version, but it no longer contains the statement by Nanox CEO and references to SK Telecom and LG.  It does retain the obviously misleading claims about the "ultra-compact X-ray tube" (Remedi actually uses regular off-the-shelf dental tubes in its devices).

Update September 15, 2022:  Another paid promo by Remedi, published in July, supplied further evidence that Remedi is a scam, if not an outright fraud.  The company suddenly declared there that its supposed $155 million contract with Nanox is now confidential, only days after bragging about it in all detail.  Also, for the first time, the company admits that its factory is not actually utilized for production (supposedly due to nearby residents objecting to the company making x-ray products), and, hilariously, is being redesigned as a virtual-reality "Metaverse" demo site. Its listing on KOSDAQ, promised for years, has, strangely, not materialized yet.

A Remedi for fake SOURCE, TUBE, CART, and ARC?

 A strange article appeared in the Korean press, supposedly written on April 18, but embargoed until 4 hours ago.  It appears to claim that Nanox may have invested about a $1 million in the Korean company Remedi, based on google translate.  The article mentions that Remedi makes a small hot-cathode x-ray tube and a generic handheld dental medical device that has sold about 1,000 units since it started selling in 2017.  The device is similar looking and has similar specs as devices offered by other manufacturers all over the world, including sub-$600 units from China.  

Remedi may have an FDA clearance, but clearly has to do a lot of work to gain a meaningful share in the world market.  Its website has numerous typos, such as

Hogh[sic]-Voltage Generator, or

Remex is the best provide[sic] diagnostic imaging.

Still, the device has better performance than the fake Nanox.CART, in addition to being battery operated, and can be cleared for the same (and more) indications with an addition of a very thin filter.  The existence of such low-cost portable battery-operated x-ray devices makes a device such as Nanox.ARC redundant, even if it were real (which it is not!).

So why would Nanox, which is supposed to have a superior cathode, tube and device technology, invest in Remedi, a dinosaur making hot-cathode tubes and single-source devices?

Update: According to Remedi's website, the company also makes some other x-ray components and systems, including dental detectors, micro and dental CBCT, and radiation therapy devices.

Update April 22, 2022:  Remedi's small hot-cathode tube that needs no cooling mechanism or rotational mechanics, with length of about 1.6 inch, if we believe this picture.

Update April 22, 2022:  A similarly-worded article by the same reporter in the same publication appeared in December, claiming the same 1,000 units, and so implying that Remedi has sold absolutely nothing in the past 4 months.

Update April 25, 2022: Remedi's small hot-cathode tube may be a fake.  A 2019 manual for the T100 device shown above states (page 31) that the device is using a regular Toshiba tube.

Update April 26, 2022:  Remedi's device sold for $4,800 in early 2019.

Update May 5, 2022:  There is a problem with Remedi's KA6 device, the dental device masquerading as a hand-held portable x-ray device. In violation of FDA rules, Remedi marketing materials claim the intended use includes chest, head, abdomen and extremities, yet the device is only cleared for extremities.  

The device uses a regular Canon/Toshiba x-ray tube, D-041SB.  According to Nanox 20-F filing, this device may be sent to the MSaaS customers instead of the fake Nanox.ARC, thus democratizing healthcare and propelling the universe.

Update July 13, 2022:  TechNer08827503@Twitter noticed that the Remedi device (the "dental" version, but same hardware) is quoted for $1,650 in Indonesia, however, the price quote has remained unchanged since at least September 2020, so it may not be real and/or reliable.

Update July 25, 2022:  The smallest commercial x-ray tube currently on the market is likely the disposable S700 (link) made by Xoft (a sub of ICAD:NASDAQ) with a diameter of just about 2mm and length 15mm, a hot-cathode water-cooled one used for radiation treatment (50 kV, 0.3mA).  Not much demand for it.

April Fool's Day

Nanox is laughing at its investors today.  About an hour ago, it posted a short promo on linkedin for the upcoming re-opening of the new Korean Fab (the opening of the same Fab that was celebrated with great fanfare in October, with many Israeli and Korean dignitaries present and wide coverage by the Korean media):

If you take a good look, you will see giant white dust balls flying casually through the clean room, mostly emanating from the lower left corner.

I am not sure whether the dust balls are supposed to symbolize electrons or photons, or just the "culmination of the founders' vision," but I am pretty sure the clean-room "operator" in the bunny suit is typing:  THE JOKE IS ON YOU on the white keyboard.

Happy April Fool's Day!

A breakthrough

The Chairman of Nanox Korea, a convicted felon, decided to update his Facebook profile picture on February 25th.

In the comments about it, he clarifies that this is not an image of his head: 

• 혈관조영된 skull phantom 을 90KV, 14mA, 50mS 으로 calibration 없이 실험실에서 날거로 촬영 [which Google translates as Angiographic skull phantom was taken raw in the laboratory without calibration at 90KV, 14mA, 50mS]
• Digital X ray source(spindle type electron emitter)

And then he states:

1년 반 고생한 보람이지. 이제 본격적인 시작. 자네도 바빠질거야,

which Google translates as:

One and a half years of hard work paid off. Now it starts in full swing. You will be busy too.

So, is this some kind of a breakthrough?  Does Nanox finally have a working x-ray source that can be used in medical diagnostic imaging?

Based on what the Chairman wrote, the answer is simply no!  How come?  Isn't 90 kVp, 0.7 mAs (implied from 14 mA x 50 ms ) good enough?  That's not much worse than a regular cheap and small dental tube (such as CEI's OX/90, for example) that one can get for less than $100 on eBay, no?

The real problem is with what the Chairman writes about the "digital" x-ray source.  He is not an art school dropout, like Nanox Chairman - he supposedly has an engineering degree and spent at least some of his life, while not in prison, handling chips.  So he knows, or must know, that there is no such thing as a "spindle type electron emitter."  He might have meant a Spindt-type electron emitter, but a US-educated "engineer," who is supposed to be responsible for manufacturing the company's core technology at a brand new Fab cannot make such a mistake (if the technology were real, and if any manufacturing were to occur in the near future).  Moreover, while the electron emitter, if it were real, may have been somehow viewed as "digital," the x-ray source itself, that is, the tube, is definitely not digital, as the x-rays are supposed to be generated by indiscriminate and uncontrollable smashing of electrons onto a metal target - nothing digital about that.

Valentine's Day surprise

Nanox surprised its fans with a nice Valentine's Day gift yesterday.  A red heart on a blue x-ray, together in a nice Facebook post:

When your days and nights are spent in the pursuit of developing innovative global health care solutions and working to reinvent medical imaging, days like today remind us to appreciate those who love us and give us the strength to carry on. Happy Valentine’s Day to everyone who pushes us forward. #healthcare #valentine

Could this be an image from the new Nanox.ARC, with automatic heart detection by Nanox AI?  Turns out, no.  The chest image is just a stock-photo montage, uploaded in February 2007 and probably taken much earlier.

The Facebook post was probably made to divert investor attention from the massive sales by Director Stone last year, revealed in a 13G/A filing a few hours later.  Typical Nanox!

Now we know

Now we know why Nanox issued that misleading press release on January 11. 

We also know why Nanox management held a hastily-arranged virtual briefing for its Korean audience on January 14, where the same old lies were repeated, but nothing of substance was announced.  Amir Ben-Shalom, Ph.D., described as the former(?) Chief Science Officer of Nanox, and whose name pops up in all the scams concocted by the former CEO Poliakine, reportedly opined:

it will not be long before FDA approval.

Here is why:

In a pre-market 6-K submission filed yesterday, Nanox revealed that its June 510k submission to the FDA was withdrawn on January 12.  With the withdrawal, Nanox effectively admits that the complaint in the class-action lawsuit had merit, that is, Nanox failed to disclose in June that

(i) Nano-X's 510(k) application for the Nanox.ARC was deficient;  (ii) accordingly, it was unlikely that the FDA would approve the 510(k) application for the Nanox.ARC in its current form;  (iii) as a result, Nano-X had overstated the Nanox.ARC's regulatory and commercial prospects

As a result, the stock hit a new all-time low of $10.70 yesterday.

On a side note, as an example of the nonsense that went on at the Korean briefing, let's take a look at two images:

Nanox still insists its Nanox.SOURCE chip is a FED:

But the 20-F filed by Nanox clearly states that the FED is a type of a failed display, not a chip or a cathode (page 59):

Our technology has its roots in field emission display (“FED”) technology. FED technology was originally developed by Sony with other technology partners, for television screens and monitors, offering a novel way of lighting screen pixels compared to traditional cathode-ray tubes that were based on a one-source electron gun beam. The field emission display innovation used multiple nano-scale electron guns to achieve a much higher quality image with significantly reduced motion blur effects. In 2009, after having invested substantial resources in the development of this technology for over a decade including through a joint venture called Field Emission Technologies, Inc. (“FET”), Sony ceased development of the project.

Since when is Nanox in the display business?

Here is another interesting image, supposedly comparing a phantom chest image generated by "existing x-ray" (top) with that by Nanox.ARC (bottom).  It exposes Nanox as a fraud.

How so?  First, if the bottom image is not from an "existing x-ray," then it follows Nanox.ARC does not exist.  Second, it shows that Nanox didn't even bother to license the cheap DICOM software used to show the images, and is instead using a "fully functional trial version."  Third, the timestamp of the "existing x-ray" chest image, "10/10/2021 17:31:15," exactly matches the timestamp of the supposed tomosynthesis image of a pelvis phantom generated by Nanox.ARC shown in a video from the RSNA 2021 deck, indicating that Nanox is using tampered DICOM files.

Update:  Dr. Ben-Shalom disappeared from Nanox "leadership" roster by mid August 2021.

Update:  In November 2019, Poliakine told a consultant that the "FDA approval" was expected in early 2020.  Oh, and 

Aiming to have 15,000 systems deployed globally by 2022.

Nanox is panicking

After the stock price hit an all-time low of $11.79 yesterday, the CEO of Nanox has decided that enough is enough and issued a misleading press release this morning.

The press release is titled:

Nanox Announces Issuance of American Medical Association New Category III CPT® Code for Its Coronary Artery Calcium Population Health Solution

It turns out, however, that the new CPT code has nothing to do with Nanox AI or detecting any coronary artery calcium.  Here is the long description of the code:

Quantitative computed tomography (CT) tissue characterization, including interpretation and report, obtained with concurrent CT examination of any structure contained in the concurrently acquired diagnostic imaging dataset (List separately in addition to code for primary procedure)

It is a generic experimental code for quantitative, not necessarily AI, analysis of CT images (remember, those expensive and hard-to-get images that Nanox.ARC is supposed to replace worldwide by "democratizing imaging" and "propelling the universe").

The pdf file with the new code was created on December 17, modified on December 28 (per metadata), and finally published on AMA's website on January 1 (per official schedule).

So that was more than a week ago.  Why wait until this morning to issue the press release?

All this in the middle of a formal SEC investigation for fraud.  

Very brave of the new CEO!  Or not.

How x-rays are generated

Here is how x-rays are generated, according to Korean-based Nanox promoters on Yahoo and Twitter:

We inform investors of Nanox who want to democratize global medical care with innovative technology. Flowchart of how to make an X-ray

1. Substance (object)

2. Apply heat, light, impact, etc. to the material (object) 

3. Heat, light, impact, etc., emit electrons from the received material (object) (electron emission or field emission)

4. When the protruding electron collides with an object, x-rays are emitted. depending on what 1 is here

※Double metal (mems) such as Nanox molybdenum or gallium

※Other company's carbon nanotubes (cnt)

Note that the above algorithm is written in English - it is not a translation. Here is it with a specific object, such as a cucumber:

1.  Cucumber

2.  Apply heat, light, impact, etc. to said cucumber

3.  Heat, light, impact, etc., emit electrons from the received cucumber

4.  When the protruding electron collides with another cucumber, x-rays are emitted.

Now you know how x-rays are generated, Gangnam style.

Update:  Steve @Yahoo makes a good point about the heat, and asks:

Are you finally admitting that the Nanox cold tube isn't cold after all? You're using the word "heat" when describing how to make x-rays, yet one of the values of the Nanox tube is that it's a cold tube and doesn't make any heat to make an x-ray beam. So are you admitting that the company has been lying this whole time?

Nanox investors were never told that a cold cathode can get quite hot.  A cold cathode simply emits more electrons than can be supplied by thermionic emission alone.

Update:  The author of the above algorithm has offered further clarification:

X-ray X-ray When electrons collide with an object, radiation with strong penetrating power (electromagnetic wave) is emitted. This radiation is called x-ray. Usually, a flow of high-speed electrons collides with a material, and at this time, short-wavelength electromagnetic waves are generated, which are called x-rays. It was first discovered by Wilhelm Roentgen in 1895 and is also called the Roentgen ship.

So, now we further learn that:  

1. You don't need high voltage to generate x-rays (just a few volts potential should provide enough energy for the electrons to generate x-rays when smashing into an object, such as a cucumber)
2. A Roentgen ship is a thing.

Update:  The author's rebuttal to my understanding of his x-ray generating algorithm is as follows, verbatim:

If you go to the RxR blog, 1. There are psychopaths in the world who compare objects (substances) to cucumbers. Is this common sense? RxR is not a citizen of a country with a public education. It cannot distinguish between conductors, insulators, and semiconductors.

저가 RxR과 대화해본 결과 결론은 RxR은전기전자의 기초를 전혀 모릅니다. 도체.부도체.반도체.전자방출.전계방출.전자.원자.핵 전기전자 기초를 모릅니다. 속지마세요 가짜냉음극도매상 이거나 무식한 공매도 하수인 입니다.

Update January 2, 2022:  Jeremy @Yahoo points out, correctly, that, 

if you apply enough heat and light to the cucumber you will surely get x-rays, also from protruding electrons hitting the relativistic cucumber. See xkcd's relativistic baseball.

I had foolishly failed to consider a cucumber that had been accelerated to relativistic speed prior to step 1, or the use of a small nuclear explosive device in step 2.  In either case, of course, Nanox.ARC becomes a single-use disposable device, and the patient never returns for another annual diagnostic check-up.

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).