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.

Foolish misdirection

Nanox stock is up more than 15% today.  The catalyst may have been a nice promo that claims that Nanox, the healthcare disrupter, is about to receive FDA clearance within a month and start distributing its new X-ray device.

Quite interesting, given that Nanox claims that it has not submitted its magic device for FDA clearance yet.  Nanox claims instead that it has submitted another, a "single-source," device that it does not intend to market or ship or distribute or offer for subscription or service.    

Here are some of the factual inaccuracies and false implications in the promo:

• Nanox has a new kind of X-ray
• X-rays are kind of boring
• [X-ray devices] are very expensive
• MRI devices use or create X-rays
• A CT scanner costs about a million, 2 million, 3 million dollars
• Nanox has made a radical new discovery
• The traditional X-ray devices and CT scanners create X-rays by heating the machine up over 1,000 degrees Fahrenheit, might be 2,000 degrees Fahrenheit
• X-rays devices and CT scanners are incredibly hot machines and have to be cooled down
• The expense in X-rays devices and CT scanners is in cooling the devices down
• Nanox can create X-rays without having to manufacture all this heat and cool the machine down
• Nanox proposed machine is far cheaper (to manufacture), $10,000 instead of a $1,000,000
• Nanox will radically disrupt the market, and is also going to expand the market
• We are going to see a lot more X-rays
• The proposed Nanox machine (a rudimentary tomosynthesis device) can generate images that are comparable to MRI images or CT images, not just to traditional X-ray or tomosynthesis images.

Update (March 13/14, 2021):    thedudemd  @ Stocktwits disagrees that the factual inaccuracies are factual inaccuracies and argues that 

a)  "Traditional xray tubes used in cts do get incredibly hot; so much so that scanners automatically shut down if tube gets overheated,"  and   

b)  "ct scanners do cost millions of dollars."

Tubes or devices/machines?  The Fool contributor said that the traditional x-ray device or traditional CT scanner was being heated up over 1,000 degrees Fahrenheit, which is clearly not true.  These systems operate at room temperature.

But let's talk tubes.  Both the traditional and the proposed Nanox tubes use the exact same inefficient mechanism of generating x-rays, whereby nearly 99% of the heat is generated at the anode and nearly 99% of the energy used to generate x-rays gets wasted as heat.

Interestingly, the filament in the tiny incandescent Christmas tree lightbulb gets even hotter - 2,200 degrees Kelvin to 3,200 degrees Kelvin -  or 3,500 degrees Fahrenheit to 5,300 degrees Fahrenheit!  Each one filament operates at about 2.5 V consuming about 0.4 W, and there are hundreds of them on the tree.  Christmas trees must get incredibly hot and burn up instantly, no?

  

Photo by Jason  Krieger from FreeImages.com

Regarding costs - maybe the latest and greatest CT scanner could cost over $2 million, but you can buy a used one for $80,000, as described here and here.   Of course, the proposed fake five-source Nanox.Arc is in no way comparable to even the oldest, cheapest and abused CT, as it cannot generate axial slices, even in theory.  Moreover, it is not even submitted for clearance, according to Nanox.  The device that Nanox claims to have submitted for clearance is a single-source device that cannot be cleared.

Update June 3, 2021:  The Nanox single-source device that got cleared was the Nanox.Cart.

Why Nanox.Arc has no chance for clearance

Nanox has a nice video on its front webpage titled "Understanding Nanox technology & vision"  It is extremely misleading, and, thus, extremely useful to regulators.  It proves that Nanox.Arc has no chance for FDA clearance, not this year and not ever.

How so?  Well, about 40 seconds into the video, the mesmerizing voice proclaims:

Years of dedicated development by Japanese and Israeli scientists have achieved a novel X-ray source and device that bring hope by being more affordable by orders of magnitude than the conventional X-ray technology used today.

Oops.  See, the FDA clearance pathway is only for a device that is substantially equivalent to a legally marketed device.  A novel device will be immediately rejected, as it fails the RTA checklist, and must go through either a De Novo classification request or a PMA approval submission.  Either one takes years.

Incidentally, according to the same segment in the video, the device below represents the X-ray technology used today:

Unfortunately, that is a sketch of an MRI device, which has nothing to do with X-ray technology - note the "chimney," which is actually part of liquid-helium cooling system (the superconducting electromagnets require very low temperature to operate).

Thanks to ThreadEnhancer @ AuntMinnie for the novel tip.

The video was published sometime in February or March, 2020, that is, after the supposed January 2020 submission for clearance of the single-source device.

Update:  The MRI device in the sketch is a stylized Siemens MAGNETOM.

Update (March 13, 2021):  The video, of course, is not the only place where Nanox explicitly describes Nanox.Arc as novel.

Update April 5, 2021:  Nanox got clearance for a Nanox.Cart (the ugly device).  Nanox.Arc (a multi-source one) still has no chance of clearance, unless Nanox admits that the device is not novel. 

You can't have it both ways

Even the best artists (scam artists included) slip sometimes - they are human, after all.  Let's take a listen to what the CEO has to say in the Nanox "vision" video released in late November ahead of RSNA 2020:

"Our mission is to democratize medical imaging, to make it way more available.  There are simply not enough machines today - it is too expensive - expensive to buy, expensive to maintain, expensive to operate, and therefore not very practical." (starting at 47s)

So, medical imaging  is not practical and accessible today?  

Here is what he wrote in his March 30, 2020 blog post:

In Israel, as in practically every country in the world, we have a real shortage of [COVID-19] testing kits.  Lung scans on the other hand are accessible, cheap, and the results are immediate - a critical factor in patient outcomes and in preventing the spread of the infection.

He can't have it both ways.  Chest (or lung) radiographs represent the majority, about 40%, of all imaging procedures performed worldwide, according to the World Health Organization (Communicating Radiation Risks in Paediatric Imaging, page 16).  The CEO states that they are accessible, cheap, and with immediate results in practically every country in the world.  So, it seems there are enough medical imaging machines, they are not expensive, and they are easy to operate and quite practical, no?  Poof goes Nanox vision!

In his blog post, he also states that Nanox machines

can be installed not only in medical facilities but also in offices and even retail locations, so people don’t need to drive hours to get to a scanning machine.

But Nanox now admits that is not possible - Nanox proposed machines leak radiation - and any potential deployments of those proposed machines, in the unlikely event that they ever become real, is at risk due to:

the inability or unwillingness of potential customers to invest in the required safety infrastructure, including customary X-ray shielding, to allow the Nanox.ARC to be safety[sic] operated (page 17, prospectus)

 

Nanox is faking it and stealing

Nanox posted a promotional video today titled "NanoxCLOUD Demo Flow" and then removed it (after some comments on it emerged).  It appears Nanox stole some sample CT images made 15 years ago from a French DICOM viewer vendor and used them to make the video, in violation of the owner's terms of use which prohibit commercial use.  A snapshot from this video has previously appeared in Nanox investor presentations, but the resolution was too low to make any conclusions. 

Here are two shapshots of interest (red ovals for the fun stuff).

Update February 19, 2021:  Note that the findings in the diagnostic report, obtained with the help of Artificial Intelligence (AI), mention "T2 hyperintense white matter lesions," which is mAgIc, since it is impossible to see such lesions in an x-ray or CT scan (white matter hyperintensities are lesions in the brain that show up in an MRI scan as areas of increased brightness when visualized by T2-weighted magnetic resonance, I am told, see also)

Update February 23, 2021:  Nanox is apparently telling people that this video was not supposed to be published.  Unfortunately, Nanox has already shown the stolen images in the past.  Here is Slide 33 from Nanox September 2020 presentation to investors.  What do you see in the lower right corner?  Stolen images.

Asking stupid questions

So, a stupid question arose today in a discussion about what would be a plausible defense by a scam artist.

Question: Did Nanox CEO graduate from Bezalel Academy of Art and Design, or not?

Checking English-language internet sources left me confused.  This one says he only attended the Academy, that is, he did not graduate.  Another one says he received a Degree in Industrial Design there.

In a November 2020 blog post, the CEO states:

When I submit my bio (prior to lectures or interviews), my educational background often surprises people. I do not have a degree in machine engineering, computer engineering, or in any type of engineering for that matter. I studied arts and design at the Bezalel Academy of Arts in Jerusalem.

So, he did not graduate, after all?

According to a Muddy Waters report,

Charismatic CEO Poliakine appears to have no formal training in radiology, physics or medicine—or to have even finished college. His only academic credentials seem to be a two-year stint he spent at the Bezalel Academy of Arts and Design. Our investigators contacted a Bezalel administrator who confirmed that he did not graduate (page 42)

In his blog post he essentially describes himself as a modern Leonardo Da Vinci, "the great artist and innovator," but with the inclination to ask stupid questions:

This is something I do all the time: go into new areas and ask stupid questions. I have no choice: I am not an established scientist or a researcher with formal education. So I go in and ask the kind of questions that people who’ve been in this field for a while would not consider asking. 

Essentially, he is paraphrasing Meredith Perry of the fraud uBeam (now, SonicEnergy).  The problem in the real world, of course, is that if people take time to answer all the stupid questions, there is no time left for anything else.

It is a great defense, though  - I did not know what I was signing or talking about - I am an artist.  And an artist is allowed to pretend to be something more:

I am a technologist. I want to tell you about the technology of Nanox... (02:05 in the RSNA 2020 demo)

 

And then to lie outright that Wilhelm Roentgen used a hot filament to discover X-rays (Nanox own technology white paper, published just a few days prior, states that the hot filament was introduced by GE's Coolidge, many years after Roentgen's discovery)... 

The dictionary seems to define technologist as an expert in a particular field of technology, not just an artist.

Nanox.Arc assembly quality?

This looks like shoddy assembly quality and cheap disintegrating plastic.  Or is the camera lying?  From video titled "The making of Nanox ARC" (about 1:06 into video).

Nanox.Arc is not production-ready

The multiple-source Nanox.Arc "prototype" shown at RSNA2020 supposedly represents what Nanox is "going to make," with the design being 100% finalized (per investor Zoom event following the RSNA 2020 demo, about 55 minutes into it).  However, the device lacks a built-in high-voltage generator necessary to produce any x-rays.  

The CEO says (about 53 minutes into the Zoom) when asked about the location of he high-voltage receptacl: "inside the gantry we have connecting [sic] one by one the tubes into the high-power voltage and all the way to a PCB card that is then connecting to the high-power supply." 

This snapshot from Nanox video titled "The making of Nanox ARC" (about 1:03 into video) shows the black high-voltage cable leading away from the device to a generator that is not visible (and may not even exist).  

Revised: December 21, 2020