The curious case of Nanox.Arc's development

Last week @Ehlyz on Yahoo linked to a webpage of the engineering firm Ziv-Av and wrote:

If you are still worried this company is fraud and there is no end product to sell, take a look at who is building their CT scanner, Ziv-Av, who is also a vendor for Mazor Robotics and other medical companies.

Sure enough, the engineering firm Ziv-Av claims that the Nanox.Arc device was developed by Ziv-Av's engineers, not by Nanox (Nanox supposedly only contributed a proposed x-ray source).

According to the webpage, published sometime in 2020 prior to Nanox IPO, Nanox.Arc is a revolutionary x-ray device that could do anything the current technology could, but it is smaller, more mobile, and at least 1/100 as affordable.  The device was developed in record time - just 3 months, from scratch and for peanuts (Nanox shows in its prospectus on page 9 less than $3 million in research and development expenses for the entire 2019).  It was this working prototype that supposedly led to the equity raise and Foxconn "endorsement" in January 2020.

The problem is that that the device shown on the webpage (Nanox.Arc version 1.0, according to Nanox tech webpage) is completely fake.  It cannot take any x-ray images because it does not have any x-ray tubes and any x-ray detectors.  It only has a battery and blue LED lights - no need for the special cooling system that Ziv-Av claims to have developed.   

Ziv-Av's claim that this was a "working" prototype also contradicts the draft registration statement that Nanox did not have a working prototype prior to February 2020 (that is, the equity raise in January 2020 must have occurred without a working prototype):

We have not produced a working prototype of the Nanox.Arc (page 9) 

Moreover, if the working prototype looked like what Ziv-Av is showing, then the device in the demo to Foxconn in December 2019 shown below must have used a non-working prototype - that is, the demo was fake.

device demoed to Foxconn, December 2019

Here is the list of all the false and weird claims by Ziv-Av on that webpage:

1.  Ziv-Av develops revolutionary and affordable CT scanner for Nanox

Nope, even if the device were not fake, it cannot be used as a CT scanner due to limited number of projections (a CT scan uses hundreds of projections at different angles per arc/rotation).  It is affordable only because it is completely fake. 

2.  Nanox is a medical imaging company which has developed a revolutionary CT device that is mobile, substantially smaller and extremely cheaper than the existing devices. 

Nanox now denies that its proposed concept device is a CT device, and says it is a tomosynthesis device (unable to generate axial slices).  The device is cheap only because it is fake - the main cost of a real device would be in the detector.

3.  Nanox’s CT technology is based on digital X-ray production using a MEMS component instead of conventional flame lamps enabling cost reduction by orders of magnitude. 

There is no such thing as digital x-ray production - the proposed Nanox x-ray source generates x-rays the same way as a regular $100 hot-cathode x-ray tube - by smashing a bunch of electrons into a metal target.  And the cost of a Nanox tube will always be higher than a regular x-ray tube of the same performance, as any non-defective chip will cost more to make than a filament (a piece of wire).  It is also apparent that Ziv-Av believes x-rays are generated by conventional flame lamps - not clear whether burning kerosene or lamp oil.

conventional x-ray tube per Ziv-Av ( image source: https://www.freeimages.com/photo/the-oil-lamp-3-1535516 )

4.  The device supports scans such as CT, mammography, fluoroscopy and angiography.

Nanox now denies the CT and mammography "support" (CT-like imagining with 11 sources is now a simulation only).  Fluoroscopy and angiography are still on the table for the concept device, but they would be extremely limited, as its device lacks the positional flexibility of modern low-cost C-arm devices.

5.  Ziv-Av engineers revolutionized the medical imaging system 

Nope - the medical imaging system is still the same.

6.  Nanox approached Ziv-Av for the design of the revolutionary digital X-ray machine and its prototype within a stringent timeline of three months.

This may actually be true.  But the only revolutionary thing was the complete fakeness of the device. 

7.  Among many other design features, Ziv-Av designed the arch of the scanner which scans the patient’s body from different angles. 

Oh, so the Arc idea came from Ziv-Av rather than Nanox...

8.  The arch is designed to work with a very high voltage of 70,000V which creates immense heat. 

The statement that 70kV is associated with immense heat shows that Ziv-Av engineers do not understand basic physics and engineering.  An x-ray tube that operates at 1mA generates less heat than a 100W lightbulb.  Also, 70kV tube voltage is too low for a general x-ray device (it could be ok for extremities). 

this lightbulb generates immense heat per Ziv-Av (image source: https://www.freeimages.com/photo/light-bulb-1531205 ) 

9.  Ziv-Av managed the heat dissipation by designing a cooling system. 

The cooling system in the device is fake and not needed, as there is no x-ray source.  Subsequent proposed device iterations by Nanox show that the proposed "cooling system" is just a CNC-cut metal slab - a simple, and not very effective, heat sink.

 

10.  Along with the arch of this amazing machine, Ziv-Av also provided the design of the machine’s table, mechanics, electricity, electronics and motion control system .

Wow - so the only thing that Nanox has developed was the proposed x-ray source, and everything else (fake, of course) came from Ziv-Av? 

11.  Through its specialists, Ziv-Av achieved a significant cost-reduction – realizing Nanox’ vision of affordability to all.

True.  A fake device without an x-ray source or a detector or even a high-voltage generator would be cheap and affordable, indeed.  And, as a plus, it does not even require radiation shielding.  The only downside - it can generate no images.

12.  Ziv-Av excels in cost-effective prototype production.  Ziv-Av’s multidisciplinary engineers provided a turnkey solution from design to production of this innovative machine. 

It is innovative and cost-effective, as it is completely fake - a rarity!

12.  All the production, assembly & integration and tests were performed in Ziv-Av’s well-equipped workshop. 

No doubt.  Again, Nanox only contributed a proposed (fake) x-ray source.  

13.  The demonstrations of this perfectly working prototype helped Nanox raise $26 million within three months from many investors including ‘Foxconn-the IT industry giant’. 

By perfectly working, Ziv-Av means it can light up in blue using the built-in LEDs and a 12V battery, of course.

14.  From scratch to a revolutionary, cost-effective design as well as a working prototype – Ziv-Av accomplished all in just 3 months.

Nice.

What the webpage does not say is that the engineering firm's owner, Mr. Ziv-Av, at some point a chief scientist of the Israeli Ministry of Transportation, was convicted of securities fraud and then claimed that he did not know what he was doing.

Update:  Apparently, a Nanox promoter also tweeted about Ziv-Av last week, transforming CT or computed tomography into "3d tomo" (tomo simply means slice in greek), falsely claiming that a single (non-axial) slice meant CT-like capability, and insisting 70kV or less is not a problem for chest:

Chest/lung, musculoskeletal including skull likely on this 510(k) w/ enhanced 3D, slices, plus 2D x-ray. Cheap device. Will expand market.

Yeah, will expand the market with a completely fake device.

Update December 20, 2021:  Minor spelling correction.  

Another confirmation that Nanox.Arc is fake

Nanox tweets a short video today, confirming that Nanox.Arc is a non-functional fake "future product," rather than a real device in production.  So much for the 25 devices that were supposed to have already been made in March - they must have been all fake, too. 

 

Notice how the two assemblers just carry the arc with the empty tube housing and mount it on the device base.  No x-ray tubes means the device is non-functional and fake. 

The device also appears to lack a detector - the table is put directly over where the detector should have been.  Just another reason why the device cannot take any images and is fake.

But the two 12V batteries in the base below where the missing detector should have been may be real.

More later.

Lost in translation

According to a recent Google-translated Korean article about the planned fab, or factory, Nanox plans to make only 2,000 x-ray tubes a month.  

The investment is about 40 million dollars... Nanox plans to produce about 2,000 semiconductor chips and tubes per month for digital X-rays at [the planned Korean] factory. (google translated)

Something must be wrong with the translation by Google.  Making only 2,000 tubes a month means that the cost can never get to $100 a piece, a cost that would be competitive with regular Chinese tubes of equivalent power/performance.

from Slide 15, January 2020 investor presentation  

Here is the simple math:  Recouping just the capital investment at a $100 cost would require making 400,000 non-defective tubes, which would take over 16 years (given the supposed plan for 24,000 tubes a year ).  So, a $100 Nanox tube would not be possible with this fab, if the translated article is correct.

In an interview in September 2020, the CEO told a different story about that same planned fab:

We are shooting for quite a large capacity because we think that Nanox eventually will be in many, many devices, so we are planning for about 1,000 wafers per month (about 5:30 into the video).

Depending on the wafer size and layout, a real company making real MEMS chips of similar size, should get from less than 100 to nearly 200 chips per wafer, or about 40-100 non-defective chips per wafer (assuming yield of 40% and over).

Nanox wafers, annual report, page 66 

But what is Nanox going to do with over one million non-defective chips a year (or over three million by end of 2024)?  All the planned 15,000 Nanox.Arc devices by end of 2024 need only 75,000 to 165,000 tubes in total (depending on whether 5 or 11 tubes per proposed device).  There are only about "500,000 plus" x-ray imaging systems in the world (page 11, Varex filing)

The tube chart that proves that Nanox is a fraud

Nanox team does not (or pretends not to) understand basic x-ray physics and engineering.  Its "technology" webpage and white paper are full of false, nonsensical, and self-contradictory statements.

Probably the single best example is the chart illustrating the supposed superiority of Nanox "core technology" - a novel chip-based cathode incorporated in a novel x-ray tube (see page 55, annual report).  

the chart, with enhanced saturation and added 42MW label

The chart is prominent on the technology webpage and in the white paper, where it is labeled "Hight [sic] Voltage independence" (Figure 9).  The chart title "T-35 Gate-2 HV/Ia independence" is not explained anywhere, but apparently refers to a Nanox Tube with diameters of 35 mm, utilizing a gate version #2 (as supposed to version #1?), and showing the independence between the tube (high) voltage and the tube (or anode) current (Ia).

Nanox T-35  tube that needs 42MW of power

The chart is supposed to demonstrate that Nanox cathode can enable "specific current irrespective of the anode ‎voltage."

But the chart is completely non-sensical, for at least four different reasons. 

1. The current scale is simply wrong.

Nanox does not know how to write numbers using simple scientific or engineering notation.  Jeremy Rutman is more diplomatic when he states: 

we note that whoever produced this graph forgot to use a negative exponent for his/her current units.

The vertical (current) scale in the chart goes like this: 0A, 2,000A, 4,000A, 6,000A, 8,000A, 100A, 120A.  Note that the tube current in the most powerful x-ray tubes in medical diagnostic devices is less than 1A, and notice the sharp drop-off after 8,000A.

If we take the point on the Ia (tube current) line at about 6kV (or 6,000V) tube voltage, the current is about 7.0E+03A (or 7,000 A), which corresponds to power requirement of about 42 megawatts (42,000,000 W) to power just one Nanox tube.  That is the power output from the massive generator of a small power plant:

a 40MW generator

a modern 40MW power plant 

2. The tube voltage is too low

The tube voltage on the chart does not go above 30kV.  If Nanox cathode (and tube) can only withstand 30 kV tube voltage, then the tube cannot be used in diagnostic medical devices, except to perform mammography.  Nanox own technical paper states in the section with the chart:

Typical kV in radiography range from 40-120kV and 22-49kV in mammography

The problem is that a mammography tube needs to withstand currents up to 100mA, while the chart, even with  a "fixed" scale where + is replaced with -, shows that Nanox tube can do no more than 1.1E-02A, or 11mA (unclear for what fraction of a second).

Moreover, neither the ugly Nanox.Cart nor the fancy-but-fake Nanox.Arc devices can do mammography due to their design, and Nanox removed the link to the easter-egg mammography concept device from its webpage.  

3. The chart demonstrates nothing

The chart is clearly using made-up data rather than actual readings.  That is not surprising, as Nanox cannot manufacture the proposed chip (has no access to facilities to do so commercially) or assemble the proposed (ceramic) tubes.  Moreover, even if everything was ok with the chart, it still shows nothing special about Nanox cathode or tube.  Most modern x-ray sources are required and designed to maintain independent control of tube voltage and tube current, that is "HV/Ia Independence."

4. Energy is not measured in volts, and current is not power

The description of the chart on the webpage even shows ignorance of the difference between energy and tension and how each is measured:

The Nanox gate electrode practically "ejects" the electrons from the ‎cathode and controls the amount of X-ray radiation, enabling independent control of ‎the X-ray current (mA tube current) and the energy (kV) that is set at the Anode. ‎

While there is a relationship between the x-ray energy and the tube voltage, energy is not set in kV - tension (or voltage or potential difference) is.

Elsewhere on the tech page, Nanox claims that with its cathode technology 

the current's power is independent of ‎the voltage

But the current's power is very much dependent on voltage - in fact, power is current times voltage.

Update July 1, 2021:  The 510k summary shows that the "Nanox tube" described in the submission can't do more than 2 mA and it can do it only at 40 kVp tube voltage, confirming the tube chart in the white paper is complete fake and fraudulent. 

Update October 9, 2021:  The fraudulent chart is still present in the "updated" white paper (updated in August only with the new Nanox logo).  Even replacing + with -, the chart would still show 11mA, or more than 5x the value in the 510K summary.

How live was RSNA 2020?

The CEO insists that the RSNA 2020 demo was live.  But was it really live, or was only the artist performance live?

An observant anonymous commenter to this blog noticed the presence of two interesting batch files on the radiologists' displays, obviously prepared well in advance.

partial snapshot of the live recording, about 8:45 

  

The first one is named Reconstru*.bat (as in tomosynthesis reconstruction from plain 2D images), and the other one is named RSNA.bat.  Why did the radiologists and their helpers need those "automated" series of software instructions?  How live was the demo, really?

There are two other thumbnails/icons.  One is a shortcut to the RadiAnt DICOM viewer, a low-cost but capable viewer for x-ray images.  Interestingly, Nanox did not pay for the software and was using it on a trial license - not really a good sign for a company that was and is supposedly doing all these x-ray image tests in preparation of an imminent 510(k) submission...  The other thumbnail is a file folder named "live Nogah," in honor of the radiologist Nogah Shabshin, who was commenting on the (supposedly) live images during the (supposedly) live demo (and forgot to disclose its Nanox affiliation during her other RSNA 2020 presentation).  Why would she have her own file folder on Nanox equipment?

News in Nanox annual report

What's news and notable in Nanox annual report, relative to the Prospectus filed in February? 

Material weakness

We have identified a material weakness in our internal control over financial reporting in connection with the audit of our financial statements as of and for the years ended December 31, 2019 and 2020. (page 49)

Oops.  That's even before any revenues are recognized.

Dangling chips 

 As mentioned above, we currently manufacture the MEMs X-ray chips in the clean rooms located in Tokyo, Japan (page 15)

Nothing like it is mentioned above (in the annual report).  The rest of the statement, of course, is also false - the clean rooms located in Tokyo, Japan do not allow commercial use, and therefore Nanox cannot manufacture the proposed "digital" x-ray source that relies on those chips (and, in reality, there is nothing digital or MEMs about them).

 

No working Nanox.Arc

Although we have produced a working prototype of the Nanox.ARC and developed a prototype of the Nanox.CLOUD, we have not produced any of the approximately 15,000 Nanox.ARC units planned for the initial global deployment under the contract manufacturing agreement with FoxSemicon Integrated Technology, Inc., a subsidiary of Foxconn (“FITI”).  (page 7)

So, one working prototype of Nanox.CART, the one that got cleared?   But no working prototypes of Nanox.Arc?  Is this an admission, finally, that the RSNA 2020 demo of the Nanox.Arc was faked?  Why couldn't Nanox complete even one of the 10 prototypes that Nanox was supposedly assembling in November 2020 (according to the Q3 2020 results call)?  What happened to those mock-ups in all these production photos pushed by Nanox and its promoters this year?

A side note here:  Nanox never signed an agreement with FITI, according to the text of the contract manufacturing agreement.  The agreement was signed with a Japanese company that is not a Nanox subsidiary, according to public corporate records.

No ceramic tubes

We are evaluating, subject to completion of testing, a transition from glass-based X-ray tubes to ceramics-based tubes for cost efficiency purposes, which are the tubes to be used in the multi-source version of the Nanox.ARC, and we intend to enter into an agreement for such ceramics-based tubes with a new manufacturer in the future. (page 14)

That is, Nanox still cannot manufacture the ceramic tubes that the CEO claimed were used at the RSNA 2020 demo of both the Nanox.Cart and Nanox.Arc.  So, the RSNA 2020 demo was fake and the FDA 510(k) submission may have been fraudulent.

Fuji is out

We have not entered into any licensing agreements; however, we expect to enter into negotiations regarding a commercial arrangement with FUJIFILM Corporation for the licensing of our Nanox System. Any of the above factors may negatively affect the implementation of our Licensing Model, or cause our Licensing Model to fail. (page 12)

This is an admission that Fuji is not a Nanox Mamography OEM (that is, all Nanox investor presentations so far have been misleading ).  In the Prospectus, Nanox still falsely claimed:  

We are currently discussing the terms of a potential commercial agreement with FUJIFILM Corporation.

Chinese tubes 

We have, and expect to enter into, agreements with manufacturers and/or suppliers in China for the production of our X-ray tube, the Nanox.ARC and some of their respective components. (page 23)

Is this an admission that Nanox is using a regular low-cost, low-quality, hot-cathode Chinese x-ray tube and calling it "digital?"

 

A confused FDA: Cart or Arc

 

... we submitted a 510(k) premarket notification for the Nanox Cart X-Ray System... in January 2020... On January 30, 2021, we received additional information requests from the FDA which, among other things, require us to address certain deficiencies and questions, including requests that we provide additional support regarding the intended use of the Nanox.ARC and the comparability of the Nanox.ARC to the predicate device. We submitted our response to these requests on March 1, 2021. On April 1, 2021, we received clearance from the FDA to market our Nanox Cart X-Ray System. ...we may seek alternatives for commercialization of our Nanox Cart X-Ray System.  (page 32) 

Why was the FDA asking about Nanox.Arc in January 2021?  The device that got submitted and eventually got clearance is Nanox Cart X-Ray System, that is, the ugly Nanox.Cart, not the fake Nanox.Arc. The FDA should have asked about Nanox Cart X-Ray System, no?

Nanox also confirms that it still has no plans the market/commercialize the Nanox Cart X-Ray System even after its pre-market notification got cleared.

Update:  Muddy Waters tweets about Gilad Yron, the Chief Business Officer, no longer counting as an executive, which I missed (it is not clear what his current role is, if any). 

Update April 8, 2021:  Fixed some spelling.  Also, the Nanox.Cloud prototype developed by Nanox is just a collection of a few mock-up screens that use stolen images and contain non-sensical findings.  

Pumping while selling

 The CEO went on Bloomberg yesterday to pump the stock.  

He did not tell the audience that he put an order to sell 1,003,931 shares just hours earlier (at a low expected price of about $41).  The CFO sold only 40,533 shares.   Both selling according to a 10b5-1 selling plan supposedly adopted on March 4, 2021 (but that plan was not disclosed in the two prior 144 forms filed by the CEO)...  Nice.

There are some gems in the Bloomberg interview - more later.

Update April 7, 2021:  

Gem #1:  The tube the CEO is holding, while selling his shares, is fake, non-functional - it appears the vacuum sealing has failed (if there was ever one) - and cathode elements are falling off...

Gem #2:  5 tubes in Nanox.Arc, not 6.  The CEO insisted on 6 tubes in Nanox.Arc (and finalized design) at RSNA 2020. 

Gem #3:  The predicate device for Nanox.Cart is one of GE machines.  That indicates potentially fraudulent 510(k) submission, as all GE machines (that I am aware of) under the IZL product code can do Chest PA, the most common x-ray image done in the world, while Nanox.Cart, as demoed at RSNA 2020, can't.  The upcoming 510(k) summary should shed more clarity here.

Update December 12, 2021:  The interview is still available on Youtube.  The CART is not cleared for chest, only for hands, wrists, and fingers.

Nanox announces FDA clearance of something

According to the press release, Nanox

single-source Nanox.ARC digital x-ray technology has received 510(k) clearance from the US Food and Drug Administration (the “FDA”).

Quite interesting, since the FDA, by law, cannot clear a technology, only a device.  It is also interesting that the mythical single-source device is nowhere to be seen on/in Nanox website, SEC filings, investor presentation, or any other marketing materials or white papers. .

an ugly device demoed at RSNA 2020

 

Nanox also confirms that it does not intend to deploy the device for which it received clearance:.

The Company remains on track and expects to submit a 510(k) application to the FDA for its multi-source Nanox.ARC and the Nanox.CLOUD in 2021. If cleared, the multi-source Nanox.ARC will be the Company’s commercial imaging system that it expects to deploy broadly across the globe.

That is really interesting, as 510(k) clearance is also known as pre-market notification, so it makes little sense to clear a device that it is not intended to be marketed.

But what is truly astonishing is that Nanox does not state in its press release that the device uses Nanox proposed "cold-cathode" x-ray source.  So does the device that just got cleared use a regular hot-cathode dental tube?

As of now, there is no public confirmation of the clearance by the FDA.  On Monday morning, the FDA should update its clearance database, and if the device got indeed cleared as Nanox claims, we will learn the product code, the name of the Third Party, and the date the Third Party recommended clearance, if there was any Third Party to begin with.  But we will have to wait for 30 days to read the Summary, where the predicate, intended use (extremities only?), and some tech characteristics will have to be made public...  And then Nanox will have some explaining to do - how do you enable early detection of cancer (also known as Nanox vision, or the oxymoronic "screening of symptomatic patients"), when all you are cleared to do is image broken wrists or feet?

Update April 4, 2021:  There is an argument floating around that an FDA clearance proves that the company is not a fraud.  The argument is flawed for at least three reasons:

1. Nanox claims that its Nanox.Arc device is novel.  A clearance, however, means that the company demonstrated that the device to be marketed is substantially equivalent to a legally marketed device.  Oops.  How can it be novel, if it is substantially equivalent to something already on the market?
2. A clearance is also known as pre-market notification.  But Nanox says that it has no plans to market/sell/ship/commercialize/deliver/deploy its single-source device.
3. Theranos, the fraud, also got clearance (in July 2015) for a device it did not intend to sell.  By January 2016, the federal government was after it.

Update April 5, 2021:  According to the FDA database, the device that was cleared is a cart - "Nanox Cart X-Ray System" - notice it is not named a (single-source) Nanox.Arc.  The product code is IZL (a mobile x-ray system).  There is no product code for a detector (MQB), so the device has no built-in detector, and so it cannot take images by itself (but should be able to use any $25,000+ cleared detector).  The clearance was recommended by a Third Party, Accelerated Device Approval Services, on December 28.  The summary should be released around May 1st.

KvP / mA - the shocking proof that Nanox is a fraud

Nanox prospectuses are riddled with false and misleading statements some consider to be material.  Here is a recent example that always trips Nanox promoters.

In a paragraph-long section in the latest prospectus titled "Multi-spectral imaging capacity using one X-ray source" (pages 83-84), Nanox states that it has (only) one "working prototype" and that prototype "uses 60 KvP / mA."  

The elaborate and nonsensical explanation of this novel metric, KvP / mA, may simply be a roundabout admission that the prototype's tube (almost certainly an "analog" dental/industrial one, with a hot-cathode and of low quality) can handle no more than 60 kV tube voltage.  Such a low tube voltage would render it ineffective for general diagnostic imaging (but could be ok in special cases, such as extremities, depending on its remaining tech characteristics).

Nanox mentions the "KvP / mA" metric five times in that section with the exact same spelling, and refers to it interchangeably as "a ratio" or "a combination" that demonstrates the superiority of the "novel" x-ray source, and that reflects "complete independence and separation between the strength of X-ray penetration and the amount of photons for illumination."  Elsewhere in the prospectus, Nanox claims that a slightly different spelling, "kVp/mA," represents energy with its acceptable range of values specified in industry standards:

The Nanox.ARC, using our X-ray source, is being designed  ...  to have a full kVp/mA energy throughout range as per industry standards (page 85) 

According to Nanox, the first component of the metric, KvP, "represents the speed of electrons that gives the X-ray its penetrating power," rather than misspelled tube voltage.  The second component, mA, "represents the amount of photons or brightness levels of the X-ray image," rather than tube current.

Ok so far?

Nanox then proceeds to make various assertions about modern x-ray sources:

For legacy X-ray sources, KvP / mA ratios were codependent in a linear relationship and each X-ray source could only produce one set of KvP / mA combinations dedicated for a particular use (for example, either tissue images or bone images, but not both simultaneously).  We believe our X-ray source technology can produce multi-spectral imaging from one X-ray source, which allows for variable energy levels to be controlled during one scan.  With multi-spectral imaging, one source chip can be used for multiple types of scans, such as head-scans, abdomen, mammography and angiograms, involving both soft and hard tissues at variable densities, simultaneously.

Those claims translate into the following false statements:

• modern diagnostic x-ray systems cannot image human tissues
• a bone is not made of tissues
• a particular intended use requires only one specific tube voltage/tube current combination
• tube voltage cannot be controlled independently of tube current in modern systems
• modern systems cannot vary photon energy levels (for example, by varying tube voltage) while scanning
• the relationship between tube voltage and tube current in modern x-ray sources is only linear
• it is impossible to use the same modern x-ray source for imaging tissues of different densities or for different radiological scans/examinations

Nanox then illustrates the "functionality and capability of multi-spectral (separation) imaging" of its proposed novel x-ray source, apparently not to be confused with modern spectral or energy-resolved imaging.

According to the diagram, a Nanox device can image six separate sets of body parts by using six different tube voltages and a fixed tube current, that is, six different ratios of tube voltage and tube current, which appears to contradict the single "60 KvP / mA" ratio that Nanox claims to be using.  The diagram also implies that imaging blood vessels with the proposed novel source requires much higher tube voltage than imaging lungs, and that the difference in tube voltages between imaging blood vessels and lungs is 5x the difference in tube voltages between imaging bones and lungs (worse, if the chart uses a log scale).

If all this was too long or too technical to read, here is the summary:  there is no such thing as KvP / mA or multi-spectral imaging.  That is Nanox for you.

Update:  Nope, not an April Fool's Day joke.

Update:  Nanox predecessor called all this "Independant [sic] KVP [sic] /MA [sic] control."  It also called it "5D X-Ray Multi-spectral imaging"

We call it the 5th dimension of X-Ray, the ability to create an MRI like multi-energy derived image, which provides a novel separation between bones, hard tissue, soft tissue, lesions, cardiovascular system and more. ‍

Quite exciting, given that MRI has nothing to do with x-rays (it is a completely different technology) and that the old-style legacy 4D energy-resolved x-rays operate only in the four dimensions of space-time.  But then something happened, and Nanox never mentioned 5D ever again, to my knowledge.

Update:  Of course, kVp and mA are independently controlled in virtually all x-ray devices using legacy x-ray tubes, going back to year 1913 (some portable x-ray medical devices have fixed kVp and/or mA, for simplicity). 

Marketing vs reality

Nanox greets us this morning with another tweet, as it is about to fail its milestone which called for "FDA approved" by the end of the day today.

Wow, that proposed "digital" source will make x-ray systems not only affordable, but cool and multifunctional, too?  

Guess which of the two devices below belongs to Nanox?

Device 1.

Device 2.

Nanox claims that the ugly Device 1 is the only one it has submitted for FDA clearance and it does not intend to market it.  Device 2 uses the 100-year-old technology, and so does Nanox device, I believe, even though Nanox denies it.  Device 2 has been on the market since last year.

Update:  Nanox failed to get "FDA approved" in Q1 2021, and missed its "milestone."

Update April 5, 2021:  Nanox got clearance for a Nanox.Cart (the ugly device).

The "nano" in Nanox isn't

So, Nanox has been boasting in the technology section on its website: 

Over nine years of development by a Japanese and Israeli engineering team, produced a ‎stable Cold-Cathode field emission MEMS silicon‎. Using proprietary Micro-Electrical-Mechanical-Systems (MEMS) techniques, ‎millions of nanoscale gates are fabricated on each silicon chip. ‎Nanox emitters are far more uniform than carbon nanotubes (CNT) and are orders of ‎magnitude smaller than conventional Spindt-type cathodes‎. ‍

But is any of it true?  For example, has Nanox been able to miniaturize a technology that was a complete failure and make it potentially successful?  The answer is:  No!

If Nanox' emitters are "orders of magnitude smaller" than conventional Spindt-type cathodes, this means they are smaller than 1/100 the size of the "conventional" emitters (that's two orders of magnitude).  Here is how Nanox emitters are supposed to look like under an electron microscope (Slide 13, January 2021 JP Morgan presentation).

They look tiny, but how tiny are they?  Nanox is withholding that information.  Luckily, Nanox predecessor company has already published the original image - in early 2016, in a one-page "Nanox Technology Brochure" - with an embedded scale in it, like any regular image, or micrograph, generated from a commercial electron microscope.  All we have to do is use that scale to measure the diameter of the gate holes and the distance between them, and compare to say state-of-the-art Spindt emitters twenty years ago.

Aha.  So the holes are about 300nm in diameter and the distance between them is about 500nm.

And, what was the state-of-the-art twenty years ago, in year 2001?  Here is a picture from the Motorola paper titled "Field Emission Displays: a critical review" 

Uh-oh.  Turns out the Spindt holes from Candescent Technologies were actually smaller - 100nm in diameter, and intentionally placed at random distances.

Is it possible that somehow Nanox' team did not know about those developments twenty years ago?  Nope.  Here is why.  According to the unofficial history of the Spindt scam,  three years prior, Sony, desperate to maintain its relevance in the TV market, but completely clueless, joined forces with Candescent.

In November 1998, CTC 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

Motorola had already canceled its project in 1999, thus the paper in 2001, due to inability to "solve some basic technology problems."  Candescent went bankrupt in 2004.  It took Sony a few more years to realize its mistake, but the $1 billion R&D spending is a complete myth.

So, to reiterate, ‎Nanox emitters are not orders of ‎magnitude smaller than conventional Spindt-type cathodes‎ - they are, in fact, LARGER.  Not that it matters, because Nanox, contrary to the false claims in the Prospectus and elsewhere, has no access to facilities to fabricate them commercially.

And the "nano" should have been a red flag anyway - MEMS in the supposed Nanox "Cold-Cathode field emission MEMS silicon" stands for micro-electro-mechanical systems.  Electro, not electrical.  Micro, not nano.  And there is nothing mechanical (moving) - the "electro-ns" do not count.

Ok, but what about those 100 million emitters in Slide 13 above?  Well, that number is possible.  Assuming those are positioned in a 10,000 x 10,000 square, and assuming 800nm distance between the tips, that gets us to a 8mm x 8mm "chip," ballpark.  But such a chip, even if it were real, is not changing anything.

In case anyone was wondering how big the Spindt emitters were 50 years ago, here is a diagram and a micrograph from the 1976 Spindt paper.  The gate hole diameter is 1,500 nm.  So Nanox emitter is just 1/5 of it, not 1/100.

Update March 29, 2021:  reworded and added the original Spindt emitter size.

Update March 29, 2021:  Wikipedia's page on Field Emitter Arrays have an interesting entry about nano-Spindts.

Nano-Spindt arrays represent an evolution of the traditional Spindt-type emitter. Each individual tip is several orders of magnitude smaller; as a result, gate voltages can be lower, since the distance from tip to gate is reduced. In addition, the current extracted from each individual tip is lower, which should result in improved reliability.

How did this incorrect and misleading entry wind up on wiki?  After checking the edit history, it turns out Nanox added it on December 22, 2015, a few days after the failed attempt by Nanox predecessor to market its fake cathode at RSNA 2015 (Nanox current CEO was then the Chief Strategy Officer).  Here is who added it:

My name is Joshua Lilienstein. I am an American medical doctor, now specializing in medical device development. I currently serve as Chief Medical Officer for Nanox Imaging, Plc., a Japan-based startup. Nanox's core technology is the field effect cathode. I will be editing entries that pertain to this technology, and specifically, in its application to medical imaging. I am aware of Wikipedia's Conflict of Interest policies, and will endeavor to abide by them.

At least he was honest about something.

He referenced an interesting paper that does not support his wiki entry in any way, but describes the long-lost x-ray detector, SAPHIRE, that was supposed to use nano-Spindts.  This is a flashback to the times when Nanox team "believed" that the x-ray detector was more important than the x-ray source.

CT vs Tomo vs Fluoro

I have been having some interesting discussion with Nuno Lemos aka StockZombie @ Twitter, who has compiled his due diligence on Nanox at "Nanox Vision – a fools gold?"  

Here is some feedback on some of his points. 

Can you replicate CT with Tomo?

Nanox has been misleading the public, investors, and medical professionals for quite some time that it can do CT (including the "noise-free simulation" slide shown on the TV screen near the end of the RSNA 2020 presentation, 24:04).

That simulation was supposedly done with an imaginary device with 11 sources and detectors that don't exist.

But Nanox admits in its Prospectus that it intends to do only tomosynthesis - no usable axial slices can be produced.  CT or CAT is a short-cut for Computed Axial Tomography.  See also below.

Does the proposed Nanox.Arc 2.0 have 5 or 6 x-ray sources?

The information about the 5 x-ray sources comes from a video showing the making of Nanox.Arc 2.0.  If one pays close attention at 0:19-0:20, one can see the holes of the 5 sources.  I tweeted about it and so did Nanox promoter, but he did not count the holes.  

counted by me

not counted by promoter

The CEO was lying throughout the RSNA 2020 presentation that the device had 6 x-ray sources.  If the sources were so precious and novel, he would have gotten a least the number correct, as this was the first public demo of the source.

Here is how Nanox advertised its presentation on its exhibitor page at RSNA 2020:

Nano-X Imaging Ltd Nanox is a developer of MEMs based electrons field emitter cold-cathode, enabling the manufacturing of digitally controlled, low-cost x-ray tubes. Nanox's technology is under third party review, pending 510k clearance. Please join the Virtual Meeting Room button below at 10:30 am CST on Thursday, December 3 for a Featured Demonstration as Nanox unveils a proprietary digital X-ray source based on a silicon MEMs electrons field-emission technology. The presentation debuts a novel X-ray tube that emits digitally controlled X-ray pulses and can be used across multiple medical imaging use cases. https://www.nanox.vision 

So, what is the main proposed modality of Nanox.Arc 2.0?

Page 1 of the Prospectus explains that the main use of the Nanox.Arc that Nanox supposedly plans to commercialize is tomosynthesis:

Subject to receiving regulatory clearance, the first version of the Nanox.ARC that we expect to introduce to the market will be a three-dimensional (“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

Slide 8 from the March 17, 2021 Oppenheimer presentation states: 

The Nanox.ARC 3D computerized tomosynthesis:  New breed of medical imaging.  

Also, if one looks carefully during the RSNA 2020 presentation video (for example, at 12:55), what Nanox appears to be doing for any "scan" is collecting 45 images (5 sources x 9 tilted positions) and creating synthetic slices from them in a plane parallel to the flat detector placed in the "box" below the arc.

Can the proposed Nanox.Arc, either single-source or 2.0, do fluoro?

According to Nanox, Nanox.Arc can do fluoroscopy (even though it is not its main use case), but Nanox can also license its proposed x-ray source to traditional device manufacturers to incorporate in their own fluoroscopy systems (the white paper addresses that second case).  Today's fluoroscopy systems are very simple - a single source (pulsed, for two reasons - to prevent source overheating, and to reduce radiation exposure) and a fast detector (10+ fps) - clearly a single-source Nanox.Arc can do it (for say, $200,000/unit) ,assuming a powerful enough hot-cathode dental source with a stationary anode (but the best price quote for a new system I have gotten is $28,500/unit FOB Shanghai, and it is not cleared yet in the USA, so it cannot be used as a predicate).  

Slide 20 of the January 2020 presentation at JP Morgan shows the multi-source Nanox.Arc device doing "3D fluoroscopy" (I guess you need a Hololens or Oculus headset for it) using 3 of the 5 sources. 

Yes, fluoroscopy has its own product code(s) for 510K clearance purposes (for example, JAA), but a system can have more than one product code for clearance purposes.

Update:  Here is the completely-misleading slide from the January 2021 JP Morgan presentation that shows that the proposed Nanox.Arc 2.0 can replace the Chinese fluoroscopy system, among others.  See also my previous post, focusing on cost.

An early easter egg

Nanox removed the link to its Mammography white paper from its webpage sometime in January 2021 (the paper was first published in late November 2020 in the company's RSNA 2020 virtual booth, and then a link to it was posted on the front webpage in December 2020).  There must be something very important there for Nanox to remove it. 

Maybe it is this:

The first application for [Nanox novel x-ray source] technology is breast tomosynthesis using Nanox’s small X-ray sources in an arrayed series.

Proposed stationary array head (design concept)

Doesn't look much like the multi-source Nanox.Arc, which is supposed to be the first commercial device using the proposed Nanox source, does it?

The paper itself is self-contradictory.  It claims on page 14 that the scan time of one 3D image in present breast tomosynthesis is 15 seconds - moving tube between shots.  But on page 17, the paper admits that the gantry of the 10-year old Hologic machine takes only a total of 4 seconds for the scan (this old intro confirms it).

Why is this important?  Fujifilm, the first potential licensee for Nanox source (see page 88 and II-3 in this registration statement), declined to license the technology when its rights expired in June 2020, but Nanox insists that Fujifilm is still its strategic shareholder and a Mammography OEM (presentation slides 3 and 35 from JP Morgan conference in January 2021).  Nanox also told the press in March 2020 that its Nanox.Arc can perform no-squish mammography, which, of course, it can't (not even in theory):

It could perform tests such as ... a no-squish mammogram for women.

More later.

Update March 31, 2021:  Nanox promoters insist that Fujifilm invested in Nanox.  According to Nanox draft registration statement filings with the SEC, that is not really correct.  For example, the December 2019 filing states that in May 2019, Nanox Gibraltar (that is not Nanox, but its predecessor) issued 1,583,710 ordinary shares to FUJIFILM Corporation for an aggregate purchase price of approximately $3.5 million, and in exchange FUJIFILM was granted a right to first negotiation for license - a right that FUJIFILM declined to exercise and it expired.  A draft filed in August 2020 mentions the same number of shares, but the prospectuses filed in August 2020 and February 2021 do not mention any Fuji shares.  It is rather strange that the number of shares remained the same between December 2019 and August 2020, as a January 2020 press release by Nanox implied that Fujifilm participated in another funding round.

Foxconn is joining Fujifilm, SK Telecom, and other private investors, who have previously invested in the project, as part of a round that is aimed to support Nanox’s development, commercialization, and deployment of its Nanox System.

The press release, issued just before the supposed submission for FDA clearance, is also remarkable because it proves that the Nanox device (presumably, the multi-source one) cannot be cleared. 

The Nanox System is composed of the Nanox.Arc, a novel digital X-ray device...

Novel devices, by the dictionary definition, are obviously not substantially equivalent to any device on the market. 

Update April 12, 2021:  Nanox promoters continue to insist that Fujifilm invested in Nanox, citing a crunchbase entry about the Series B round.   However, it appears crunchbase simply misread the tricky Nanox press release.  

Foxconn is joining Fujifilm, SK Telecom, and other private investors, who have previously invested in the project, as part of a round that is aimed to support Nanox’s development, commercialization, and deployment of its Nanox System.

See, the press release never states that Fujifilm invested or is about to invest in Nanox.  It says that Fujifilm invested in "the project" (that is, Nanox Gibraltar, a Nanox predecessor).  And it does not say that Fujifilm is participating in this round.  In any case, all subsequent SEC filings confirm that Fujifilm did not invest in Nanox - either in that round or thereafter.  As confirmed by the recent annual report, Fujifilm is neither a strategic investor in Nanox nor a Mammography OEM for Nanox, contrary to all investor presentations. 

see, for example, page 3 and 35 in January 2021 presentation at JPM conf.

How does the device look like?

Nanox website, investor presentations, social media, press releases and promo pieces are all littered with designs and photos of various versions of the fancy but fake multi-source Nanox.ARCs.  But you will never find the single-source device that Nanox claims to have submitted for FDA clearance in January 2020.  Not once.

So, how do we know for sure what the device is supposed to look like?  Is it the ugly one that supposedly took the radiograph of the CEO's hand at RSNA 2020 or some fancy multi-source one with just one tube activated?   Has Nanox ever stated, in writing, how the device looks like?

Yes.  A presentation slide helps here - this one, Slide 22, is taken from the January 2021 JP Morgan presentation deck.

It states:

On the left the hand of Ran Poliakine, Nanox s CEO, as was taken during the 2020 RSNA live demo, using the Nanox single source device with the Nanox tube;

So the ugly device from the RSNA 2020 live demo is indeed the device Nanox claims to have submitted for FDA clearance. 

Update April 5, 2021:  Nanox got clearance for a Nanox.Cart (the ugly device).

Does the FDA ever disagree with the Third Party recommendation?

Let us assume for a moment that Nanox were not a fraud and the Third Party did indeed recommend SE on December 28, 2020.  Is it possible that the FDA disagrees and issues an NSE decision anyway?

The FDA's "Third Party Review Organization Performance Report" that comes out each quarter can be very useful for answering such a question.  The latest one has this nice table.

Turns out, it is not very likely, but it is possible.  Of the 75-85 submissions each year, the FDA disagrees in 1 or 2 cases.  Between 5 and 10 submissions are withdrawn or deleted (basically, the submitter gives up).  Interestingly, no Third Party seems to make an NSE recommendation - I guess that's why they are paid the big bucks by the submitters.

Update April 5, 2021:  Nanox beat the odds and got clearance for a Nanox.Cart (the ugly device).