Questions about timing

Nanox filed a 6-K today, claiming:

On August 12, 2021, NANO-X IMAGING LTD (the “Company”) received a request for additional information from the U.S. Food and Drug Administration (the “FDA”) concerning the Company’s last 510(k) submission of its multi-source device, Nanox.ARC. The submission file is placed on hold pending a complete response to the FDA’s list of deficiencies. The Company’s response is due within 180 days from the date of the request for additional information.

The Company plans to respond by the due date which is 180 days from the date of the request for additional information. The Company expects to continue to optimize and develop further features of Nanox.ARC and is considering submitting an additional 510(k) application for the next version of multi-source Nanox.ARC during the fourth quarter of 2021, which will benefit from the FDA’s feedback on the first version of the multi-source Nanox.ARC.

This confirms that the Arc submitted for pre-market notification is not the one that Nanox plans to market, just like the Nanox.Cart.

But what is more important is the timing.  Nanox did not mention any of this on its Business Update webcast on August 16, which showed improved images, some new tube prototypes, and some fancy user interface, but no technical data and no evidence that the Arc prototype is actually working.

What does a chip look like

This is what a MEMS chip looks like, according to Nanox' new website.

Notice the green solder mask, the well-laid copper traces, and the polished brass.  Nanox claims that this chip is its core technology.  Is there a better proof that Nanox is a complete fraud?

Junk @ Yahoo remarks that Bezalel Academy of Art and Design seems to train their students well, even the ones that can't graduate.

Previously, the chip looked like this (see circle in the middle):

Shay Azulay / Nanox via Engadget

Here is the actual size, per Nanox tweet, with the dust specks, etc.

Update:  Here is a snapshot showing the chip being placed in a tube cathode by CEI, which claims in the video that is ready to manufacture the Nanox.Tube.  Again, circles everywhere.

Update #2:   For reference, Nanox technology white paper is still on the "new" website, but the link has been removed.

The chip looks like this in the diagram in that paper:

A white square instead of a circle in the middle - no brass, and no copper traces...

Here is the chip under "microscope" (as it says in Korean) from an RSNA 2020 video:

Update August 11, 2021:  Edited a bit, for clarity.

Update August 16, 2021:  The convicted felon Dr. Kim claimed at the Business Update recorded webcast today that these are "mems" chips manufactured at Nanox temporary "clean room" facility in Korea.  Note the dust specs on virtually all the chips (unlike regular chips, these need to have an absolutely-clean surface if mounted in the proposed Nanox x-ray tube, or things go poof as soon as the high voltage is applied, in theory).

Aunt Minnie interviews Nanox

An interesting interview.  Note that the picture of the device is Arc version 1.0, per Nanox website, a fake plastic mock-up that had just a battery and blue LEDs, apparently developed for Nanox to scam the public and investors.  Note that a functional but limited-use (definitely not for "cancer screening") tomosynthesis device like this is possible to make, using regular dental tubes and custom detectors, but Nanox does not appear to know how, since the device has been redesigned multiple times since (and is not yet working).

Other things that stood out for me.

 

• CEO continues to insist that Roentgen invented x-ray devices.  The truth is he discovered x-rays using equipment invented by others - he did not invent anything.  CEO also continues to claim that nothing changed since x-rays were discovered, contradicting Nanox own technical paper that states (on page 1) that it was the invention of the hot-cathode tube by GE in 1913 that changed the world of radiology (Roentgen, of course, was using a cold-cathode tube, just like the proposed Nanox tube)
   
• The CEO continued to imply that its x-ray source needs only 40V at the emitter and is cool - but hot-cathode tubes need only 4V at the emitter and are just as cool (in both cases, 99%+ of the energy used by the tube is wasted as heat, nearly all heating the anode)
   
• The CEO claims that each of the x-ray sources in the Arc have been cleared by the FDA through the clearance of the Cart.  That is a lie.  The FDA does not clear technologies or x-ray sources.
  
  
• The CEO claims that its 40 kVp, 2mA tube is better than regular general-radiography tubes.  In fact, per 510k summary, the Nanox tube barely performs as a HEAVILY ABUSED cheap dental tube bought on eBay (and is likely a hot-cathode one).  For example, even Siemens dental stationary anode tube SR 120/15/60 is much better:  120  kVp, 26 mA.  Siemens general-radiography stationary anode tube SR 125/40/80 is 125 kVp, 32mA (all mA ratings for 0.1s, per standard).
  
  
• The CEO confirmed that comparable $250,000 x-ray tubes from a month ago have dropped in prices to $50,000 (first revealed at the recent Ladenburg conference).  Nanox proposed tube, being a cheap dental tube, is now supposed to cost $200 (vs $100 a few months ago, and vs $80 on eBay). 
   
• The CEO did not deny making deals in the United States.  It is illegal to make deals in the United States for device that has not been cleared yet (that's the whole purpose of the pre-market notification, aka 510K, aka submission for clearance)
   
• (The) Guy next to the CEO insisted the Arc is very different from existing tomosynthesis machines.  I wonder whether the FDA will agree that the device is as safe and effective as a legally marketed tomosynthesis device.
  
  
• The Arc has obtained regulatory clearance in Nigeria of all places?  On my blog, I explain a bit about the Nigerian Nanox scam - the "distributor" claims to be located in a sanctuary for HIV-infected women (the area is very poor, with sporadic access to water and electricity, and the Arc has no batteries), and everything about it is fake.  In combination with the pay-per-scan of dead women, it would be perfect for a money-laundering operation - very dangerous (and nearly impossible) for ordinary auditors to catch.  On a side note, diagnostic chest X-ray and all the bloodwork etc for an annual or preliminary checkup there is $24, all included.
   
• It was useful for me to hear that the predicate chosen by Nanox is a tomosynthesis device.

Update October 30, 2021:  An AI bot known as Narl (which reads as Little Ran, from left to right) is complaining on Yahoo that I have missed an important statement in the video.  Specifically, about 15:15, Ran says:

We are starting to ship

He does not say what they are shipping, but it is definitely not Nanox.Arc, as that one is still not working, as of October 27.

Useful information

Here is what passes for useful information these days.  For a fact or a belief to be useful, it has to be ALL CAPS, and you can never tell which is which.  I have added my responses.

1. NNOX IS SITTING ON OVER $200 M IN CASH - THEY HAVE ENOUGH CASH TO LAST FOR MANY YEARS GIVEN THE CURRENT CASH BURN. 

Yes, that translates to less than $5 a share (and falling every day), not even accounting for expenses that will come once the real lawsuits start coming.

2.FDA CLEARANCE HAS ALREADY BEEN GIVEN FOR THE SINGLE SOURCE. THE MULTISOURCE IS SIMPLY A BUNCH OF THESE!  COULD SOMETHING GO WRONG - POSSIBLY BUT UNLIKELY AND IF IT DOES IM SURE THEY ARE WORKING CLOSELY WITH THE FDA TO RECITIFY [sic] TO ULTIMATELY GET APPROVAL. 

The FDA cleared a Cart (a device that Nanox does not intend to market), not an Arc (the device that Nanox claims will be its first intended commercial device) - and there are reasons to believe the 510(k) Cart submission was fraudulent.  The multi-source Arc is not just a bunch of Carts.  Moreover, the Cart was cleared for "hands, wrists, and fingers" only, while the Arc's intended use is even more restricted - just one body part (per press release). Nanox is not seeking FDA approval - it is seeking FDA clearance (and it is illegal in the United States to claim FDA approval when there is only FDA clearance)

3.THE KOREA FACTORY HAS THE ABILTY TO PRODUCE SOME 50,000 MACHINES PER YEAR - THATS ALOT !!!! THE REALITY IS IT WILL PROBABLY NOT ALL GO TO MEDICAL USE. 

There is no such Korean factory - the one that is being built will only supposedly make chips (and possibly tubes) enough for only 44,000 machines, or 24,000 machines, depending on the mood of the CEO, at full capacity (assuming 5 tubes per machine).  These chips, of course, cannot be used to make any commercial (functional) x-ray tubes.  The latest is that the machines are and will be produced (that is, assembled) in Israel - as of now, they are fake (have no x-ray tubes/detector, per "production" video).

Nanox has not licensed or sold or delivered any tube or machine since its predecessor announced the cold-cathode breakthrough in 2015.  No FDA clearance or approval is needed for non-medical use.

4.YOU HAVE SOME BIG COMPANY NAMES INVESTED IN THIS TECHNOLOGY - SK TELECOM AND FUJI. 

SK Telecom was introduced to Nanox by a convicted felon (based on his own testimony, now removed by Nanox), and issued a hilarious press release about curing cancer by causing cancer (the 1x1x1 initiative) with 5D (not to be confused with 5G).  Fuji invested in Nanox predecessor company in exchange for licensing rights that expired in June 2020 (per Nanox letter to the SEC) with Fuji walking away - there is no record in Nanox SEC filings that Fuji is still an investor.

5.BACK TO THE FACT THESE TUBES WILL NOT ENTIRELY BE USED FOR MEDICAL EQUIPMENT - CHANCES ARE YOU WILL SEE THE BEING LISCENSED [sic] TO SECURITY INDUSTRY AND MANUFACTURING INDUSTRY - XRAY TECH IS USED IN AUTO AND CHIP MANUFACTURING TO SEE IF CRACKS EXIST OR CHIPS PRINTED CORRECTLY . 

X-ray tech is used everywhere - true - and no specific regulatory approvals are needed in most cases (other than compliance with basic radiation safety regulations).  Nanox has been unable to sell or license even one cathode, tube or device, despite claiming to have commercial cathodes and x-ray tubes for at least a year (and, again, having made its latest break-through in 2015). 

6.THE FLOAT IS 50M SHARES OF WHICH 50% IS OWNED BY INSIDERS AND INSTITUTIONS. ONLY 25M SHARES EXIST FOR THE PEOPLE WHO WANT TO TRADE. THE REALITY IS SOME OF THOSE PEOPLE WILL BUY AND HOLD AND THUS FURTHER REDUCING THE REMAINING AVAILABLE SHARES. 

Institutions and insiders do want to trade and do trade.  The estimate for the 25 million "float" seems way off based on a brief perusal of the latest prospectus and the 144 forms.  WSJ has the float at 34 million, and my estimate is way higher.

7.DOES ANYONE REALLY BELIEVE CONSTRUCTION OF A BUILDING IN KOREA WOULD OCCUR IF THEY DID NOT HAVE POSITIVE NEWS ON THE POTENTIAL OUTCOME OF THE FDA SUBMISSION? IM SO SICK OF SEEING MISINFORMATION BEING POSTED. LETS KEEP THIS FACTUAL LIST GOING PLEASE - I WILL UPDATE AS PEOPLE MAKE INTELLIGENT TRUE STATEMENTS. YES THE STOCK IS VOLATILE - BUT ITS JUST TIME BEFORE THOSE HANDS GET TAKEN OUT AND THEN YOU WILL HAVE A SIGNIFICANT BUNCH OF LEGACY INVESTORS WHICH WILL HOLD FOR SOME TIME TO COME. WHICH LEADS TO MY LAST FACT/BELIEF. 

Yes, the construction of the building was committed while Nanox was having difficulties with its first 510(k) submission (I believe that is when the Arc started its transformation into a Cart).  That land purchase and building construction makes absolutely no business sense, since Nanox annual chip needs can be easily met by the production of a small fab for a few hours (even if the chip were not fake) and a small x-ray tube manufacturing facility in a country with low labor costs...

8. THIS COMPANY HAS TREMENDOUS OPPORTUNITY IN THE NEXT 2-5 YEARS. WHY> MEDICAL- LISCENSING [sic] AND ULTIMATELY THE POTENTIAL TO BE BOUGHT OUT BY A DIFFERENT COMPANY WITH A MORE ROBUST MANAGEMENT TEAM THAT WILL HAVE THE RESOURCES TO EXECUTE ALL OF THESE GREAT OPPORTUNITIES. THE CURRENT MANAGEMNET TEAM WILL DO A GREAT A JOB FOR NOW - BUT REALITY IS THIS THING WILL BE SOLD !!! AND I HOPE THEY REALIZE THE TRUE ENTERPRISE VALUE OF THIS COMPANY !!!!

Oh, the CEO is now being accused of not being robust.  This did not end well.

Thank you, THOMAS @ Yahoo. 

Update July 20, 2020:  New USEFUL INFORMATION by Tumble @ Yahoo:

they spent a decade of R&D on their cold cathode technology, which they have patented... since competitors won't be able to beat them (their technology), they will have to join them. And NNOX has already said that it will let others use its technology and in return NNOX will receive recurring royalty payments... in other words, even without being used in NNOX machines, their technology will be a source of recurring revenue

And my response:

Nanox did not spend a decade of R&D on the "cold cathode technology," as Nanox is just three-year-old corporation (Nanox was incorporated on December 20, 2018 and commenced operations on September 3, 2019, per annual report). Nanox predecessor got the tech for free from Sony, which got it for free from Candescent prior to year 2000. Useless tech - never worked!

In November 1998, [Candescent] announced an agreement with Sony Corporation for joint development of a 14-inch diagonal FED by the year 2000. Both companies pledged to spend $50 million on this effort. Most of the work would be performed at CTC's plants. A team of six Sony engineers were sent to San Jose to begin the work, with some additional staff dedicated to the project in Japan.

The money was not spent.  Candescent filed for bankruptcy in 2004.  Sony abandoned the technology in 2006, with the final bell ringing in 2009 - after all these years, Sony obviously knew that the technology is useless, not just for displays/detectors, but also for x-ray generation (Sony has had some x-ray-related business over the years).

Update July 20, 2020 #2:  About those cold cathodes - the only two successful commercial applications I am aware of are plasma displays (300V tube voltage) and CCFL backlight for notebooks (about 600V tube voltage) .  Both peaked in early 21st century: 1) plasma displays were too hot, shiny, and cost could not decrease - commercial sales stopped in 2014-2016, 2) CCFL consumed too much power and had somewhat short life - replaced with LEDs around the same tine plasma display sales stopped.  Of course, to make usable x-rays, the tube voltage is much higher, and cold cathodes simply can't cope (they short, melt, get dirty, and generally fail catastrophically).  My estimate of cold-cathode x-ray tube sales worldwide is less than 500 units a year (almost all using CNT, none using Nanox "Spindt" pins), primarily for industrial application  (some dental, and less than 100 units for limited diagnostics - mainly extremities).  It is good to remember that prior to the introduction by GE of the hot cathode in 1913, all x-ray and fluorescent light tubes used cold cathodes. So Nanox is quite mistaken in its tech "essay" that you could find hot cathodes in the really-old fluorescent lights.

A glimpse of the latest Nanox.Arc

Two new photos of Nanox.Arc were posted yesterday on twitter, but it is unclear when those were taken, by whom, and why the resolution is so bad.

The device is in the same shielded room used for the RSNA 2020 demo.  It appears the device still needs a HUGE external high-voltage generator, but it is unclear what tubes (size and specs), if any, are inside the Arc.  It is also weird that there are three persons sitting at the consoles, but there is nothing to be scanned on the "bed."  The device looks unsafe - what happens, if a patient hand (or long hair) gets stuck between the moving table and the moving Arc?

Cathode hilarity

 Today Entrepreneur teaches us that "AI Gives Outdated Industries a Makeover."  

AI transforms medical imaging

A revolution is brewing within the medical-imaging space as well. X-rays haven’t changed much in the past 100 years. We may have digitized all the technology surrounding them, but we have yet to make monumental changes. The cathode ray tube still has to be superheated for an X-ray to work, and the heating and cooling makes the machines very expensive. Fortunately, the AI solution developed by Nanox has made a breakthrough in X-ray technology, allowing the cathode (which is a vacuum tube that produces images when its phosphorescent surface is struck by electron beams) to operate at room temperature. Moreover, the company introduced the digital x-ray, which is the first innovation in x-ray technology in the past 126 years. The development of a new breed of medical-imaging infrastructure that can be deployed en masse, coupled with a radiology-services cloud platform, provides preventive care solutions on a global scale.

So, according to the author, x-rays apparently change every 200 years or so, but it is unclear in what way.  All the technology surrounding x-rays has been digitized, but in non-monumental way.  X-rays require cathode ray tubes - just like those old TVs.  And those cathode ray tubes have to be superheated, which makes them very expensive (they cost almost $100 on eBay, as nobody makes them anymore).  

Fortunately, an artificial intelligence solution is here to help.  That artificial intelligence has made a break-through discovery that the genuine intelligence could not make - it found a way to allow the cathode, which is the Trinitron vacuum tube used by Sony's TVs, to operate at room temperature (Sony TVs, if you remember, used to only operate in ovens set to 500 degrees Fahrenheit).  

Moreover, the company behind that artificial intelligence introduced digital (not to be confused with digitized) x-rays.  That is, apparently, the first innovation in x-ray technology in the past 126 years - in other words, everyone has been using the same-old cold-cathode (and, thus, digital) Crookes tube that Roentgen used in 1895 - no change since then.

Now, who is to blame?  The clueless author, the inept editor, or the cunning fraud that sprays all this nonsense in its press releases and investor presentations, and on its website and social media.

Korean math, again

Another non-sensical fluff piece sponsored by Nanox:

Nanox said that its Yongin plant will be annually producing 220,000 MEMS chips, enough to make 50,000 Nanox.ARC devices. The temporary facility in Cheongju currently has a monthly production capacity of 1,000 MEMS chips.

That is interesting.  220,000 divided by 50,000 is 4.4.  In other words, each Arc device will have 4 tubes and another very special partial ( 4/10, exactly) tube, just short of the 5 tubes in the investor presentations.   Also, Nanox has not disclosed any plans to make 50,000 Arc devices (only 15,000 by 2024).

The capacity is also wrong  - it was supposed to be 120,000 (based on the 10,000 a month from inventor presentations).

Here is the Korean text, in case of doubt.

The equipment shown in the article's photo appears to be Precision 5000 by Applied Materials, an almost 40-year-old CVD machine - baking the very innovative fake Nanox.Source!  Let me know, if I am mistaken.  

The Gospel according to Tumble

image derived from photo by Jeremy Bishop on Unsplash

First they said this company was a fraud and they didn't have the technology they claimed.   Then Ran went on and gave a live Demo showing they did.

Then they moved the goalposts and said that the demo was a scam and the technology wouldn't pass FDA clearance.  But it did. 

Then they moved the goalposts and said that Nanox has no way to mass produce the number of machines they claimed (15,000 by 2024).  Then Ran announced the purchase of a $40 million production factory and they went silent.

Then they moved the goalposts and said that Nanox only has clearance for a single source, and their commercialized device is the MULTI source, so until that gets FDA approval nothing that happened previously would matter.  Then, today, Ran announced that they submitted paperwork for the multi-source clearance and they are silent.

Now shorts are going to move the goalposts once again and say "they still haven't gotten multi-source clearance so it's still a scam".  Remember this post when they do get clearance in 2022 and shorts have to find yet another reason why they think this company will fail (that will ultimately get disproved once again) 

This company is legit, and longs who have done their research know they are sitting on a fortune to be made.

(as posted by Tumble @ Yahoo on June 17, 2021 CE, slightly edited.  The only truthful thing here is that Nanox is a fraud, indeed)

 

A confused press release by Nanox points to fraud

Yesterday Nanox issued a press release and filed a 6-K about its premarket submission to the FDA for a device called Nanox.Arc.  The press release contradicts numerous claims made by Nanox in the past, and contains at least one red herring.

510(k) means the device is not novel

Nanox had repeatedly claimed in the past that the Nanox.Arc device is novel.  Here is another instance, not covered previously:

Nanox.ARC, in collaboration with its companion cloud-based software Nanox.Cloud, is a novel digital x-ray device intended to provide end-to-end medical imaging services ..., according to Nanox founder and CEO Ran Poliakine.

Here is another:

...to use the Nanox ARC system on site for developing novel early-detection and screening protocols to promote global preventive healthcare practices.

The problem is a that a novel device, by definition, cannot be cleared.  Clearance aka pre-market submission aka 510(k) submission is simply a submission made to the FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) - definitely not novel.  The FDA explains:  

Novel devices include those brought to market through the premarket approval (PMA), humanitarian device exemption (HDE), and De Novo pathways, as well as a subset of those that are brought to market with 510(k) clearance or Emergency Use Authorization (EUA). Of the thousands of 510(k) clearances every year, the FDA considers only those devices with a breakthrough designation to be novel. In addition, in 2020, we are including first-of-a-kind devices authorized under our EUA authority as novel devices. Novel or innovative does not simply mean “new.” They address an unmet need, or may be safer or more effective than currently available alternatives. For FDA-approved and FDA-cleared medical devices, innovation, and safety are two sides of the same coin.

Nanox has not requested a breakthrough device designation.  The 510(k) submission therefore contradicts the claim that Nanox.Arc is novel.

510(k) confirms the RSNA 2020 demo was illegal

Nanox claims to have demonstrated Nanox.Arc version 2.0 at the "virtual" RSNA 2020 trade show last December.  Today's press release confirms the device had no clearance pending at the time of the demo.  This article explains:

A device that lacks FDA marketing clearance is considered "investigational," and therefore the company cannot promote, advertise or accept orders for it. The FDA considers such activities to be “commercialization of an unapproved device." The FDA does make some exceptions for trade shows, however,... [only if the device] is the subject of a pending 510(k) application. It cannot take orders or be prepared to take orders that might result in contracts for sale for the device unless limited to research or investigational use.”

So, since the submission was announced just yesterday, there was no clearance pending in December, which means the device was marketed illegally in December.

This can't be the first version of the "multi-source" Nanox.Arc

According to Nanox technology webpage, the first version of the multi-source Nanox.Arc looks like this:

That device is completely fake.  It is has no x-ray tube, no x-ray detector, no ability to scan - in fact, it is just a mock-up plus an LED light and a battery.  Version 1.5 on that webpage does not look less fake.

At RSNA 2020, Nanox CEO insisted that the design of the multi-source Nanox.Arc has been finalized (in its version 2) - he was just confused whether the device had 5 or 6 x-ray tubes:

The design was changed again in February 2021 - version 2.5? - and the device had no x-ray tubes or a detector.

The device, even if cleared, is not meant for shipping

The press release states:

We are excited to take this next step in our regulatory process as we move toward future versions of the multi-source Nanox.ARC, which will fulfill current and future contracts with service providers and collaboration agreements and allow us to achieve our global vision.

Apparently, the device, as submitted for clearance, is not meant to be delivered or commercialized.  So, why has then Nanox submitted a pre-market notification, that is 510(k)?  Why hasn't Nanox submitted a device that can actually be used? 

 

Nanox.Arc can scan only one human "body part"

The press release states:

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

Just one "body part?"  Which one?  There aren't many "body parts" that can be properly imaged in the supine or prone position using 3-D tomosynthesis.  None are considered "usually appropriate" by the American College of Radiology Appropriateness Criteria.

The "a" is a subtle change from the "the" on page 62 in the annual report, where Nanox claims:

 

Subject to receiving regulatory clearance, the first version of the multi-source Nanox.ARC that we expect to introduce to the market is expected to be a 3D tomosynthesis imaging system that produces a 3D reconstruction of the scanned human body part...

Not much use for a device that can image only one human body part, even if the device were available for free.  

Tomosynthesis is a failed modality

The press release claims there

 

exists a significant unmet medical need globally for a more accessible and cost-effective medical imaging solution

Presumably, a tomosynthesis device like the proposed Nanox.Arc could meet that need.  However,  tomosynthesis is a failed modality, with possible exception of digital breast tomosynthesis (DBT), which Nanox.Arc cannot do due to its design.  Tomosynthesis (also known as tomography, not to be confused with CT or computed tomography) has existed since the 1930s in one shape or another, but its share (DBT excluded) has been less than 1% of unit shipments of diagnostic x-ray devices in the United States and probably even less in the world (based on a preliminary and unpublished analysis of FDA's x-ray assembler data files).  Yes, it is cheap (maybe 10-20% more expensive than plain old x-ray devices - sometimes just a software update is required), but from diagnostic point of view, it is not much better than taking two or three plain radiographs, and it cannot compete with the "gold standards" such as CT or other non-x-ray technologies.

Nanox.Arc is not designed for easy setup and operation

The press release states:

The system is being designed for easy setup and operation with multiple alternately-switched X-ray tubes arranged around the patient.

However, the RSNA 2020 demo revealed that the device requires an external high-voltage generator.  Also, the annual report states that need for 

potential customers to invest in the required safety infrastructure, including customary X-ray shielding, to allow the Nanox.ARC to be safety operated.

The device, as demoed at RSNA 2020, is slow.  The scan of a simple "body part," a phantom hand, took about 45 seconds.  Imagine holding your breath or lying completely still for 45 seconds to prevent image blurring.

The single-source Nanox.Arc transformed into Nanox.Cart

The press release reiterates:

Nanox received FDA clearance of its single source Nanox Cart X-Ray System in April 2021

But that April clearance was initially supposed to be for the single-source Nanox.Arc (Prospectus, Page 1).  To this date, Nanox has never shown a picture or photo of the "Nanox Cart X-Ray System" anywhere.

Nanox has not developed a commercial-grade digital X-ray source

The press states that Nanox 

is developing a commercial-grade digital X-ray source designed to be used in real-world medical imaging applications

In other words, it has not developed it yet.  So what x-ray sources are used by Nanox.Arc, the one just submitted for clearance?  All signs point to regular (but poorly crafted) hot-cathode x-ray tubes.  

The press release never mentions any cold-cathode x-ray tubes.  The cold cathode is supposedly the core Nanox innovation, but the CEO is apparently unware that x-rays were discovered in 1895 using a cold-cathode x-ray tube. and that tube was completely driven off the market by the invention of the hot-cathode tube in 1913 by GE. 

Just too good to be true

Steven Koepke, who goes by koepkesd @ Stocktwits and Steven @ Yahoo, has been busy reading this blog while trying to justify the lies by the Nanox CEO that somehow the $200 (or $100, depending on the day) Nanox.Tube can replace the $150,000 modern CT tube (these are "list prices," of course).

For the longest time I was trying to figure out how Ran can claim that his field emitting device (FED) can generate x-rays on par with the high end x-ray tubes used in CT machines. Those large tubes can generate 800 to 1,000 mA at 120 kV. They also cost $120,000-$150,000. Here is the math. The MEMS (FED) chip has an active area of 0.126cm^2 (4mm diameter on chip in diameter and the power level was communicated at 2.5A/cm^2. The power is concentrated down via focusing device onto the tungsten anode. The basic math provides the power of the beam to be 314mA and 120 kV (per conference call last week). That's quite close and running multiple sources in parallel amplifies the power. Cost comparison: 5 small tubes @ $100 vs $150,000 for singe large CT device tube. Micro-X has a similar arrangement working today with a CNT device (also Field Emitting Device)

 

So, what's wrong with his reasoning?

There is no such thing as a field emitting device.  FED refers to a failed display technology -  a field emitting DISPLAY.  It does not contain "a field" of emitters, as Nanox CEO believes - it emits electrons induced by an electrostatic field.  It is not a more efficient or a cooler way to generate x-rays - all x-ray tubes, whether using a cold cathode (based on the field effect) or a hot cathode (using a hot filament) to emit electrons, have about 1% efficiency as 99% of the energy applied to the tube gets wasted as heat at the anode.  A hot filament uses a lower voltage - about 4V - than the 40V (or way more) needed by a cold cathode.  Roentgen discovered x-rays in 1895 using a cold-cathode (gas discharge) tube.  GE invented the hot-cathode x-ray tube in 1913 and obliterated the cold-cathode ones.

The proposed Nanox.Source chip is not MEMS, as there is nothing mechanical about it.  The chip is not real, or commercially available, of course, as Nanox has no ability to manufacture it commercially, at least not yet.

The current density of 2.5A/cm^2 comes from a fraudulent, that is, intentionally misleading, 2015 datasheet by Nanox predecessor, which I have previously linked here on this blog. 

The Nanox.Tube cannot do 314mA and 120 kVp.  The one used in the Nanox.Cart can do up to 2mA and up to 40 kVp, at most (or 0.08 kW, per 510K summary).  The CEI one can do up to 1mA and up to 100 kVp (or something like 0.1 kW, per CEI video).  The tube used by GE in the predicate device for Nanox.Cart can do about 40 kW - it has a rotating anode.  The CT tube can do about 120 kW (using Steven's numbers). So, to replicate the power of a $150,000 CT tube, one needs to use, oh, something like 1,000-1,500 Nanox tubes that cost $100,000 or more.  An after-market CT tube will cost less than $100,000, of course.  All this has been already discussed last year.

Micro-X has a 4.8 kW tube (a bulky stationary-anode one) - it uses carbon nanotubes, which Nanox says is impossible - it sells a few units a year.  The biggest CEI tubes are smaller sizes than Micro-X's and go up to about 2.5 kW (also stationary-anode ones).  

Update June 10, 2021:  Investors will eventually blame Nanox CEO for their delusions.  Steven continues:

The anode temperature becomes the challenge with the NNOX tube. CEI states that their tubes can handle about 60KJ. The RSNA video shows the bed is moving through the sources quickly (15-20 seconds for whole body). My guess is that NNOX is using high current short bursts to keep the anode temperature under control. In the video they may have used 300mA for up to 0.2 seconds to make 10 shots (capturing 8" per shot) while the cart moves through. 300mA x 0.2 X 10 shots = 60KJ. You can't shot this with dental tubes like that. They don't have the current and the image gets too blurry.

He is right that a typical dental tube (which has a better performance than the Nanox tube) cannot do 300mA.  He is also right that at some point, the heat capacity of the anode becomes a challenge (the anode temperature is not really a problem - it is the temperature of a part of the anode, the tungsten target, that is the challenge).

But Steven does not understand what heat capacity means.  Yes, one of CEI's most powerful medical tubes, OX125-06, can handle 60 kJ (CEI only makes stationary-anode tubes).  But that does not mean that it can do 300 mA or that 300 mA  x 0.2 s  x 100 kVp  x 10 shots = 60 kJ.  Nor does it mean that you can do 5 A x 0.2 s  x 60 kVp x 1 shot.  CEI provides nice charts in its datasheets to explain the interplay between heat capacity, tube current, tube voltage, and time.

As the charts show, the tube cannot do more than 35mA at 60kVp for 0.1s or more than 20mA at 110 kVp for 0.1s. But it can do 15 mA at 100 kVp for 10 seconds.  The RSNS 2020 demo, which we now know was fake, never demonstrated a full-body scan - it scanned three phantom "organs." The "hand" scan consisted of 45 "shots" or images ( 5 tubes x 9 tilts/translations) - it took about 50 seconds for the images thumbnails to appear on the display.  That is about 1 second per shot, not 0.2 seconds (and we don't know what that's even real).

The CEI OX-70, a dental tube,  can do about 32mA at 60 kVp for 0.1s or more than 20mA at 90 kVp for 0.1s.  It can do 10mA at 90 kVp for 10 seconds.  Here is some summary table from CEI's datasheets.  Stationary-anode tubes all look kind of the same.  The tubes that do less than 100 kVp are "dental" and typically tolerate half the current than the "medical," and are a bit smaller. 

Model	Voltage  kVp	Current mA, 0.1s	Current mA, 100kV	Focal sp. (mm)	Diam. (mm)	Length (mm)
Small/Dental tubes
OX/70-P	70	19	N/A	0.8	30	72
OX/70-5	70	11	N/A	0.5	30	72
OCX/65-G	70	12	N/A	0.8	30	76
OX/70-4	70	9	N/A	0.4	30	72
OX/70	90	21	N/A	1.2	30	82
OX/90	90	9	N/A	0.5	30	83
OCX/70-G	70	12	N/A	0.8	30	65
OCX/70-G4	70	8	N/A	0.4	30	65
Medical/Mobile tubes
OPX/105	110	18	2.5	0.5	42	125
OPX/105-4	105	17	2.5	0.4	42	95
3D/cone-beam CT tubes
OCX/100	105	20	4	0.5	46	140
OX/100	100	26	1.5	1.0	35	85

Recall, the Nanox tube in Nanox.Cart can do only 2mA at 40 kVp (for 0.1s -1 s).  The CEI Nanox tube can do only 1 mA at 100 kVp for 40 seconds (per CEI video).  The CEI OX-70 dental tube can do about 40 mA at 40 kVp for 0.1s, about 25 mA at 40 kVp for 1s, and about 3 mA at 90 kVp for about 40 seconds (per datasheet charts).  If Nanox tubes perform like poorly-made hot-cathode dental tubes, they probably are.  No mystery Nanox.Source chip required.

Update June 10, 2021:   Just to clarify, regular dental tubes (just one or 5 ) can definitely replicate the fake RSNA 2020 Nanox.Arc demo.  The "hand" scan took about 50 seconds for 45 images.  Let's see whether a dental tube can do 45 images at 45 seconds, that is, a bit faster.  A CEI dental tube operating at 90 kVp can do 3mA continuously for 45 seconds, so each exposure (image) will be 3 mAs at 90 kVp.  The Nanox.Cart demo at RSNA 2020 image needed just 1.5 mAs at 40 kVp (so, significantly less than 1/4 of what the CEI dental tube can supply).  Commercial fluoroscopy equipment does ok with 100 kVp and 1 mAs for each frame (image) at 30 fps.  So, sure, with a good enough (expensive enough) detector, you can do the Nanox.Arc tomosynthesis within 45 seconds.  But the detector (regardless of the tubes used) won't cost anywhere near $10,000.  And no one would like to look at the images (the American College of Radiology never considers a tomosynthesis procedure to be "usually appropriate,"  except for breast, which the Arc cannot do).

The Nigerian Nanox scam

Nanox promoters appear confused about a Nigerian website claiming to be a distributor of the (fake) Nanox.Arc.  Let's dispel that confusion.

While there is a legally-registered company Eileeno Pharma Ltd, there is no evidence that it is doing (or planning to do) any business, and the website is clearly fake.  The real Eileeno Pharma Ltd may not even know the website exists, as it was published only recently.

Here is how one can verify that the website is an obvious fake.  The image below is supposed to show the company's building:

However, a quick google search reveals that the image was stolen.  The image actually shows the Gaston Avenue Medical Office Building in Dallas (3417 Gaston Avenue, Dallas, TX 75246, USA) 

So, probably somebody is just trying to pull off a Nigerian Prince scam in the Nanox scam universe, with Nanox being the victim, or at least an innocent bystander (in this case).  Executing a scam like this can't be too hard, given all the other scams in that universe and the pool of eager Nanox "investors."

Update July 12, 2021:  And here comes Nanox belatedly claiming its Nigerian (scam) agreement is real, for a 1,000 "systems."  Also, another image, supposedly showing  the Nigerian distributor's offices in its business profile section, is stolen, from a project by Pacific Design Architecture, a California architectural firm.  Nanox was the Nigerian Prince all along.

Note also that the "distributor" claims that 

1/3 of the world population have no access to medical imaging to diagnose varied forms of diseases before they metamorphose to expensive to treat and life threatening cases.

while Nanox claims exactly the opposite in the press release (that is, 2/3).

On the same page, the distributor explains:

We are in partnership with NANOX Vision Ltd, to deploy medical imaging machines and ensure services at faith based, private and public health facilities across the country, which will also be affordable with a drive to ensure each Nigerian carry out comprehensive medical check once a year to proactively manage their health avoiding medical emergencies plus the attendant high cost including unnecessary deaths. To fast tract this project implementation we are focusing simultaneously on the faith base with a spread of nearly 4400 health facilities and providing about 46% of the health care services needs of the Nigerian populations especially those who are remotely habited. EiLEENO is partnering with ECHO Lab Ltd, with over 22 years experience in medical imaging services in Nigeria mostly with the public and private health institutions.

and 

EiLEENO Pharma Ltd, is projected to deploy nearly 2000 units of NANOX Digital X-ray machines in about 2000 health institutions and hoping to reach about 100m Nigerians within the next 2 years. 

But there is no such thing as NANOX Vision Ltd, as far as I know.  And the press release says 1,000 rather than 2,000.  And what about those 3,400 facilities that won't get their Arc?  Finally, the 100 million number is made up.  It uses a very old and unsupported "recommendation" of 1-machine-per-50,000-people developed by the WHO for a general purpose x-ray device and ultrasound, not for the limited-use Nanox Arc.

Update July 12, 2021 #2: This gets funnier and funnier.  The picture sitting next to the claim that the distributor will deploy 2,000 Nanox "Digital X-Ray" machines is an Unsplash photo of an "Eye diagnostic machine" taken in India.

Photo by Syed Hussaini at Unsplash

Update July 14, 2021:  Junk @ Yahoo notices that EiLEENO's website  cover pic is stolen from the contractor Millie and Severson (a photo of the interior of Good Samaritan Medical Pavilion, Los Angeles, CA) and EiLEENO didn't even bother to rename the filename.  Junk says: 

Their facebook, twitter, instagram and linkedin lead to SitePad Website Builder. I could make a better website in 3 hours.  

Update July 14, 2021 #2:  Nanox CEO claimed  (at about 16:30 into the presentation at the Ladenburg conference today) that the 4-year Nigerian contract (backed by a letter of credit) is for 10 scans a day for $7 each for 250 days, resulting in $70,000 "cost" (diagnostic not included, and assuming zero interest rates).  That is somewhat different from Slide 28 in the same presentation showing the "illustrative" model of 7 scans a day for $14 each for 23 days a month  (for 3 years), resulting in about $81,144 "cost" (again, diagnostic not included, and assuming zero interest rates).

Update September 16, 2021:  Junk @ Yahoo earlier pointed to this source, which shows 1,100 Nigerian Naira cost for chest X-ray single view scan in 2018, or about $3.  Junk also found numerous real x-ray systems on jiji.ng (such as this) for less than $10,000.  In other words, Nanox Arc makes no business sense in Nigeria (or anywhere else), even if it were real.

Update January 12, 2022:  One thing I missed in the press release was that it was issued from KADUNA, Nigeria, implying EiLEENO Pharma is located in that city.  However,  EiLEENO Pharma was always and still is located in Jos, which is a different city in another State, according to its corporate records and confirmed by the linkedin profile ( Jos is about about 150 miles from Kaduna).  Website gives two locations, both in Jos:

Headquarter: EiLEENO Complex behind JMDB Quarters, Metropolitan Avenue, Tudu-wada, Post Office 1924 Jos, Plateau State. 

Office Annex: Plot 22 Citrus Estate, Behind National Open University, directly Opposite Plot 34, Mun-Gyel, P.O. Box 1924 Jos, Plateau State.

Notably, Nanox Chairman insisted during the AuntMinnie interview published on July 16, 2021:

Nigeria, for instance, we are already cleared, we can go tomorrow

This was never mentioned by Nanox again.  Never ever.  No shipments to Nigeria have been reported as of yet.

A linkedin video released last month claims a contract between EiLEENO Pharma and Catholic Secretariat of Nigeria for deployment of Nanox.ARC.  No press release was issued, but the WhatsApp photos dates imply December 14, 2021.  Interestingly, the Secretary General claims in the video that its a "two-year opportunity."  The Nanox press released claimed the "contract" with EiLEENO Pharma is for 4 years.

If you build it, who will use it?

Nanox.Arc device, as it stands today, is fake.  But what if Nanox used its $200+ million cash to actually design and build its proposed device?  Will it be useful?

Nanox claims that its proposed device uses a modality ("imaging technique") - tomosynthesis - that is supposedly "widely used for early detection" of something.

Subject to receiving regulatory clearance, the first version of the Nanox.ARC that we expect to introduce to the market will be a 3D tomosynthesis imaging system. Tomosynthesis is an imaging technique widely used for early detection, that is designed to produce a high-resolution, 3D X-ray image reconstruction of the scanned human body part for review by a professional diagnostics expert (annual report, page 56)

Tomosynthesis (previously called x-ray tomography, focal plane tomography, etc) has been available since 1930s - it should not to be confused with CT or computed tomography, which can visualize axial slices and individual voxels.  

tomosynthesis vs. plain, per Nanox demo at RSNA 2020 

Even though various medical device manufacturers have pushed it over the years, its use has never been wide.  It never added much to simple x-rays taken from different views... 

In 1993, the American College of Radiology (ACR) started work on developing guidelines for radiology to eliminate inappropriate utilization of radiologic services.  Today,

ACR Appropriateness Criteria are evidence-based guidelines to assist referring physicians and other providers in making the most appropriate imaging or treatment decision for a specific clinical condition. Employing these guidelines helps providers enhance quality of care and contribute to the most efficacious use of radiology.

Of the nearly 1,000 radiological procedures covered by the criteria, only three are based on tomosynthesis, and all three involve breast tomosynthesis, which is usually appropriate for breast cancer screening and diagnosis:

• "Digital breast tomosynthesis diagnostic"
• "Digital breast tomosynthesis screening" 
• "Digital breast tomosynthesis short-interval follow-up"

Elsewhere, tomosynthesis is mentioned maybe a couple of times in the narrative discussion or literature search as part of the regular x-ray modality analysis (for example, here and here), but clearly it is not significant enough to deserve any attention as a specific imaging procedure indicated in specific diagnostic scenario.

The real problem is that the proposed Nanox.Arc cannot perform digital breast tomosynthesis, contrary to Nanox claims in March 2020 about no-squish mammography.  In its own mammography white paper, Nanox admits that breast tomosynthesis requires compression (squishing) and a completely different mechanical design, which makes scanning of other organs, such as lungs, impossible.

So here we have it.  According to the American College of Radiology evidence-based guidelines, the use of Nanox.Arc, as proposed, will not be "usually appropriate" under any clinical scenario.

To make this fit into the hole for this

Nanox tube video exposes a problem with the fake 25 Nanox.Arc devices that Nanox claimed to have completed, and the 1,000 devices for which it claimed to have sourced all the metal parts.

Here are the holes for the x-ray tubes in the devices (3 shown, out of 5 holes).  Nanox never filled those holes with tubes.  

https://twitter.com/nanox_vision/status/1384873902766231557

And here is the new Nanox tube.

Nanox has to find a way to make this glass tube fit into the hole and housing (head) designed for the fake ceramic tube, which was shorter and which had an x-ray exit flange closer to the cathode end.  By just looking at it, drilling new holes, manufacturing an adapter, and repositioning (tilting/rotating) the tubes won't be enough - substantially the entire metal enclosure needs to be redesigned, manufactured, and reassembled.

NASA may have had an easier job.

"We gotta find a way to make this fit into the hole for this using nothing but that.”
a scene from Apollo 13 (1995):

Still a scam

If the recent Nanox tube video was meant to demonstrate that Nanox is not a fraud and the Nanox tube is real, it failed.  The video is misleading and self-contradictory.

The video shows that the new "high-power" tube is very similar to the rest of CEI's low-power hot-cathode tubes made of glass, but is of subpar power.  For example, the control software screenshot shows that the tube supposedly operated at 100kV and 1mA for 40 seconds.  However, CEI's "3D" tubes, or tubes designed for cone-beam CT medical devices, can do 1.5mA (model OX/100) or even 4mA (model OXC/100) at that tube voltage indefinitely, based on the anode's cooling rate, and can be smaller, contrary to the the text on the video (model OX/100 is shorter than the 5-inch-or-so "finished" Nanox tube shown in the video).

Also contrary to the text in the video, the supposed Nanox tube is not cheaper to manufacture than CEI's regular hot-cathode tubes (a chip will always cost more than a filament).  There are simply no "special cooling and rotation mechanics" in any of the tubes made by CEI, which makes stationary-anode tubes exclusively.

 

Nothing in the video shows any "digital" operation either.  The tube works just as any other regular hot-cathode x-ray tube made by CEI - electrons emitted by the cathode get smashed into a metal target (anode), and about 1% of the energy released comes out as x-rays.  The video does not show how the electrons are generated - Nanox white paper says about 50V is needed at the "gates" grid on the chip, but the control software screenshot confusingly shows the typical 4.1V that is used for heating the cathode (although no filament current, "A fil", reading indicates that circuit may have been disabled).  

Finally the text of the video is misleading as it claims that the current x-ray technology has been used for over 120 years.  Nanox own white paper states that the "modern" hot-cathode technology was invented in 1913 by Coolidge - that is less than 120 years ago.  Roentgen discovered x-rays over 120 years ago, but he used the outdated cold-cathode technology, the one that Nanox is proposing.  

In summary, the video does not really prove that the Nanox cold-cathode "technology" works or that it even exists. 

Modern tube production, according to Nanox

Nanox shows how a modern tube production facility looks like in the new "tube" video on its website (an exact copy of the video leaked a few days ago).  No comments should be necessary.

Rust, paper, damaged insulation, and a bare hand contaminating a mystery tube element that appears to be checked for continuity with an incandescent (hot-filament) lightbulb.  But can you blame the poor CEI?  The Chinese competition has copied its tubes and offers them at half the price, at about $100 on Alibaba (Kailong's catalog, pages 4,5).  CEI claims to have spent 600,000EUR on technology since 2014 "for expanding the range of products and for reducing tubes costs."  Apparently, that wasn't enough.

Update May 1, 2022:  Nanox rereleased this video on YouTube, then it made it private recently (sometime earlier this year, I believe), and now it still lists it in the media section of its website.  Clearly, CEI is no longer a tube OEM partner of Nanox, having failed to produce even one working Nanox tube, just like everyone else who has ever tried (not a surprise, since the core component, the Nanox.SOURCE chip, is simply fake).

One of the many problems with this video, other than the fake tubes, is that it reveals Nanox own confusion about its core technology, the Nanox.SOURCE chip.  For example, here Nanox claims that its fake Nanox.SOURCE chip is a "novel digital x-ray source."   Yet its technical white paper describes the chip as a source of electrons.  Electrons are quite different from x-rays, which happen to be photons.  And, of course, there is nothing novel or digital about it - this is a failed 1970s technology (Spindt array) and the x-rays made by a tube using it is just as analog as any other x-ray tube - electrons gets smashed indiscriminately into a metal target to make x-rays.

When your own supplier exposes you as a fraud

At the Berengerg investor presentation today, Nanox CEO confirmed for the first time the name of its new supplier, CEI (Slide 17).

The problem is that CEI has a public website.  There we learn that the company's average production was 18/22,000 tubes/year and the revenue (turnover) in year 2007 was 3.4 million euros (things went downhill since).  So what exactly is the problem?  Well, the average price of CEI's legacy x-ray tubes, using those numbers above, comes to about EUR170 a piece (that's about $230 a piece at 2007 exchange rate).

But Slide 16 in the investor presentation had just stated that legacy x-ray tubes sell for $150,000 (that's almost three orders of magnitude discrepancy!).

And based on video leaked by Nanox, the Nanox tube that CEI is supposedly almost ready to make is a bit larger, not smaller than the legacy tubes that CEI makes.

Ooops!  Looks like CEI exposed Nanox as a fraud.

Now, yes, it is true that some x-ray tubes do indeed cost $150,000 or more.  But those tubes have nothing to do with the tubes that CEI is supposedly about to make for Nanox (as their power and performance is three orders of magnitude higher, too).