Another market-moving tweet

Nanox tweets that is going to change the world, and the stock jumps 15%.

The market is oblivious to the irony that it is investors who have been waiting for months for "FDA approval," whatever that is supposed to mean.  As of today, no Nanox x-ray system is legal anywhere in the world. 

Expect FDA approval in early 2020 (quoted November 2019 conversation with the CEO)

Note also that all my research so far indicates that it is not true that two-thirds of the world cannot reach medical imaging and that one-third of the world waits too long to get a scan.  The availability of low-cost x-ray systems (both stationary and portable/mobile) and ultrasound devices has solved this problem years ago.

 

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

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 mission

 Not to be confused with Nanox vision (announced in a press release with SKT in June 2019), Nanox mission is:

“to replace all legacy sources with our digital X-ray.” (November 2019 press release)

From/To in Nanox November 2019 press release 

Yes, that digital X-Ray source has a field of nano-gates (that is, holes) that emit pixie dust (because electrons are emitted by nano-cones, not nano-holes) in discrete streams instead of a Schrödinger cloud, according to the illustration above.  And cathodes, anodes, and years do not matter (based on the From half).

Unfortunately, Nanox own facilitator and option holder testifies that nobody wanted that non-existent digital X-ray source.  Not even when the current CEO, then the Chief Strategy Officer of Nanox predecessor, went to RSNA 2015 to show it around.  Now the title of his blog is IMAGING 3.0 which is remarkably similar to Imaging3.  Coincidence or Freudian slip?  No way he did not know about Imaging3.

  

Full-body scan vision

According to Nanox CEO, 

"Nanox.Arc could provide a full-body digital X-ray scan ... Most, if not all, cancers can be treated rather easily if found early enough through medical imaging. The World Health Organization says if every person had a full-body scan once a year, potentially millions could be saved by early detection." (Israel21c, March 23, 2020)

The problem is that the World Health Organization never said that.  In fact, it said exactly the opposite:

Whole body CT for IHA [individual health assessment] of asymptomatic individuals should cease.

Nanox vision is based on a lie.  

Nanox has backtracked since - now it is early detection of SYMPTOMATIC PATIENTS only!

Here is what the American Academy of Family Physicians says:

"Whole-body scanning is not recommended by medical professional societies for individuals without symptoms, nor is it a routinely practiced screening procedure in healthy populations."

Choosing Wisely, an initiative of the American Board of Internal Medicine, in cooperation with Consumer Reports and American and American College of Preventive Medicine has this to say about whole-body scans:

 "They don’t help find cancer—and may do more harm than good... No medical societies recommend whole-body scans. That’s because there is no evidence that the scans are a good screening tool.  Whole-body scans can lead to unnecessary follow-up tests."

Further reading:

Radiation Risk From CT: Implications for Cancer Screening, Jeffrey M. Albert

The available data suggest a small but real risk of radiation-induced malignancy from CT that could become significant at the population level with widespread use of CT-based screening. However, a growing body of literature suggests that the benefits of CT screening for lung cancer in high-risk patients and CT colonography for colorectal cancer may significantly outweigh the radiation risk. Future studies evaluating the benefits of CT screening should continue to consider potential radiation risks.

See also CT Radiation Dose and Risk: Fact vs Fiction 

 technologists also must consider the risks of reducing dose to the point that image quality falters or diagnoses are delayed or missed.

Average doses.

Pro mammo screening.

On mammograms and AI, rather than full-body, but article wrong about tomo for screening (note: Nanox.Arc can't do mammograms, compare to no squish, January 29, 2021):

More-aggressive screening strategies aim to maximize the benefits of early detection, whereas less-frequent screenings aim to reduce false positives, anxiety, and costs for those who will never even develop breast cancer.

“We know MRI can catch cancers earlier than mammography, and that earlier detection improves patient outcomes,” says Yala. “But for patients at low risk of cancer, the risk of false-positives can outweigh the benefits. With improved risk models, we can design more nuanced risk-screening guidelines that offer more sensitive screening, like MRI, to patients who will develop cancer, to get better outcomes while reducing unnecessary screening and over-treatment for the rest.”

 

WHIS-RAD, WHO's alternative to Nanox Vision

Nanox Vision is a cancer-inducing initiative contradicting the ALARA principle and ImageWisely, as proclaimed in the joint June 2019 press release with SK Telecom: 

nanox.vision is the global initiative led by nanox and world-leading healthcare players to drive the 1x1x1 vision of at least one medical screening for each person on the planet each year. The 1x1x1 Initiative is based on nanox's revolutionary MEMs X-ray source and encompassing ecosystem of partners to provide affordable, early detection for all. 

Note that early detection has actually two separate components: 1) early diagnosis and 2) screening.

Nanox falsely claims in its prospectus:

We believe [heat and complexity] key factors leading[sic] to the high cost and complexity of existing medical imaging systems, which in turn significantly limits the availability of medical imaging for early detection globally. According to a report from the Pan-American Health Organization and the World Health Organization (“WHO”) in 2012, approximately two-thirds of the world population did not have access to medical imaging, while many people with access to medical imaging face substantial wait times for scanning.

What the WHO report actually says is:

The use of X-rays and other physical waves such as ultrasound can resolve between 70% and 80% of diagnostic problems, but nearly two-thirds of the world's population has no access to diagnostic imaging [not the same as medical imaging, see above]

Nanox fails to mention WHIS-RAD, WHO's proposed solution.  WHIS-RAD system was developed by the WHO in collaboration with radiographer experts.  It was designed to provide high-quality images and to be safe to use, reliable, easy and simple to learn. Additionally, it is designed to operate where power is unreliable or unavailable for extended periods of time.  So much for Nanox Vision!

WHIS-RAD (source:  Red Cross, see link below)

"Providing low-cost, high-quality x-ray units was the goal behind development of the WHO's basic radiology system" (Alternatives to WHIS-RAD units fall short.)

WHO's purchasing guide states that the first imaging unit any hospital should buy is a general-radiography x-ray system like WHIS-RAD, which automatically eliminates both single-source and multiple-source Nanox.Arc, due to their low power and inability to do standard chest x-ray.  So much for Nanox conquering the world!

Recent assessment notes that the equipment works well and easily satisfies the requirements of the original design, and is adapted to the digital age, but notes some reasons for the low number of installations.  Cost is about $45,000-$50,000 (Radiology for the People: A Basic Radiological System for Health Care inDeveloping Nations, 2019)

Resources:

WHIS-RAD technical specifications.

Copy of presentation slides covering WHIS-RAD (original link no longer available).

WHIS-RAD tech background (Chapter 10 from The WHO manual of diagnostic imaging. Radiographic technique and projections by Staffan Sandström)

Rotary WHIS-RAD project.

Red cross example ($46,000 is an undated "budget" cost) 

Benefits of U-arm and straight arm systems.

Useful WHO docs:

Repair.

2016 RAD-AID Conference overview.

Update March 26, 2021:  Arsakaan @ Twitter reminded me again why Nanox should not be allowed to market/promote ANY medical device.  Nanox is not just some investment fraud - with its incompetence, it endangers lives, even if it has no intention to ever shipping any working device.  The snapshot from the current Nanox webpage still shows this overlay:

Of course, anyone remotely familiar with cancer screening should know that "cancer screening is looking for cancer BEFORE a person HAS ANY symptoms."   That is, screening SYMPTOMATIC patients is non-sense.  Moreover,  the U.S. Preventive Services Task Force does not recommend any plain X-ray, fluoroscopy, or tomosynthesis (what Nanox claims will be offering with the Nanox.Arc it intends to commercialize) as a screening tool today - only mammograms for breast cancer (only for women aged 50 to 74 years) and low-dose CT for lung cancer (only for adults aged 50 to 80 years who have a 20 pack-year smoking history and currently smoke or have quit within the past 15 years; screening should be discontinued once a person has not smoked for 15 years or develops a health problem that substantially limits life expectancy or the ability or willingness to have curative lung surgery).  Nanox.Arc, as designed today, cannot do either mammograms or CT, of course.  That is, Nanox.Arc is useless for screening purposes.

Update May 20, 2021:  added a link to screening definition from the U.S. Department of Health and Human Services.