The testimony at RSNA 2020 that disappeared

This testimony was removed after briefly appearing in a longer video on Nanox' RSNA 2020 virtual booth on November 29, 2020 (days ahead of the live presentation). Per Nanox prospectus:

In addition, we signed an agreement with a President of SK Telecom, Dr. Ilung Kim, dated December 16, 2019, for the provision of consulting services to us. Under the agreement, we granted Dr. Kim options to purchase 1,206,290 of our ordinary shares at an exercise price of $2.21 per ordinary share. 301,572 of the options vested as of the grant date and the remaining 904,718 options will vest in equal monthly installments over a period of three years from the vesting commencement date. In case of an initial public offering or certain other events, all unvested options will fully accelerate immediately prior to the closing of the initial public offering. The vested options are exercisable until the earlier of (a) the second anniversary of termination of the engagement between us and Dr. Kim or (b) the tenth anniversary from the date of grant.

So why did it disappear?  High-cost of tubes, not ready for mass production, anything else?

Update March 30,2021:  

Well, turns out Dr. Kim was a marketing SVP and GM of Samsung Memory from 1999 to 2008, according to a recent press release announcing his joining MCE's advisory board.  Turns out, a Dr. Kim, vice president of marketing for the memory division at Samsung, agreed to plead guilty to a single count of price fixing in 2007. Dr. Kim was later sentenced to pay a fine of $250,000 and to "a period of incarceration of fourteen months."  And who claims to be working as a Marketing Managers for MCE?  Eli Reifman, the convicted felon.  Both Lydia Edwards, who is President, USA at Nanox, and Bruce Edwards, who is Nanox’s VP of Business Development used to work with Mr. Reifman.  

And one more thing:  He was on the list of Nanox representatives at the November 2020 Berenberg "CEO" conference.  

Thanks to Steve @ Yahoo and MuddyWaters' report for the hints.

Update March 31, 2021:  The draft registration statement filed on January 14, 2021 had the date of Dr. Kim agreement as October 28, 2019.  Apparently, Nanox had forgotten that the agreement with Dr. Kim had been modified on December 16, 2019 to allow for full vesting of the options prior to the IPO...

Update August 1, 2021:  Dr. Kim, a convicted felon who swindled SK Telecom into investing in Nanox and therefore received the most generous consulting fee from Nanox, has "left" SK Telecom two months ago, and joined Nano-X Korea Ltd. full-time in July ("Responsible for Korean Fab Operation, X ray Tube R & D and AP area sales and marketing", per his linkedin profile).  I first learned it from a June 30 MCE "article", which refers to him as a "former President SK Telecom."  The promotional piece appears authored by Eli Reifman, a convicted felon who claims to be Marketing Manager at MCE.  Reifman may still have an email address at Nanox (according to an email verification service), and may be affiliated with A-Labs (A-Labs supposedly denies it), which provided "consulting services" in connection "with various transactions, such as a private placement [and] ... initial public offering."  For example, A-Labs touted nine months ago the Monolith, the "world's first full-screen smartphone designed by Eli Reifman, founder of Emblaze Ltd. in 2001 with R&D initiated in 2004 which is 3 years before Apple's steve jobs introduced the first iPhone in 2007." 

Here is an August 2020 Israeli article explaining (google translate):

The Emblaze consulting firm cuts millions of dollars in coupons in Nanox and INX offerings

Eli Reifman is not officially affiliated with A-Labs, one of the biggest beneficiaries in the Nanox IPO • The company is owned by Doron Cohen, former vice president of technology company Emblaze, along with Roni Lieberman, who briefly served as VP of product at Emblaze

Gali Weinreb 23.08.2020

Eli Reifman.  Affair that began with his conviction in 2011 / Photo: Tamar Mitzpi, Globes  

A-Labs, which served as a consultant for the Nanox IPO , is one of the biggest beneficiaries of the move. As recently revealed in "Globes", this is a company founded by the graduates of the technology company Emblaze by Eli Reifman , and according to market estimates, Reifman is significantly involved in it. A-Labs itself admittedly denied that Reifman was officially associated with her, but the company's CEO and founder, Doron Cohen, noted that Reifman is a friend and sometimes advises him in a friendly manner.

Under the consulting agreement between the companies, A-Labs received a 2.5% success fee from the issue amount - approximately $ 4 million, an additional payment of $ 1 million due to the issue itself, and another 160,457 options at an exercise price of $ 16 (compared to $ 18 per issue), equivalent to At the time of the IPO, another $ 300,000. A-Labs advises in a similar format to other Israeli companies, and it was recently announced that it is expected to pocket millions of additional dollars from the issuance of the crypto company INX in the USA ( see separate article ).

Reifman is not officially affiliated with A-Labs. The company is owned by Doron Cohen, formerly vice president of the technology company Emblaze, together with Roni Lieberman, who briefly served as VP of product at Emblaze. Its vice president of operations, Raviv Pablo, also previously worked at Emblaze. 

Clues to the fact that Reifman is involved in the company can be found, for example, in the fact that Scratch Alter, who was defined in the court document as "Reifman's relative" in the matter of providing a guarantee for him, is the head of the life sciences department in the company. In addition, the company's offices are located in Kadima, where Reifman also lives.

Recent issues involving A-Labs have included issues of Israeli companies in Canada: Zoomd, which provides website search engine technology, and Else, which has developed a vegan baby food compound.

Eli Reifman is the founder of the technology company Emblaze, which has developed technology in the field of digital video. In the past, Reifman was considered a "child prodigy" in Israeli high-tech, however, he became involved in crime and accumulated debts in the gray market.

In 2011, Reifman was convicted of forgery and fraud and sentenced to four years in prison and compensation to the complainants against him. Following an appeal he filed, the Supreme Court dismissed his appeal and he went to jail, from which he was finally released a year and a half before the end of his full sentence.

Reifman founded Emblaze in 1994. The company was issued in London in 1996, and its value rose from $ 160 million at the time of the IPO to about $ 8 billion at its peak. Reifman sold tens of millions of dollars worth of shares in the company, and became one of the most prominent high-tech rich in the economy before the dot.com bubble burst.

Facts and Distortion

"Personally I never care for fiction or story-books. What I like to read about are facts and statistics of any kind. If they are only facts about the raising of radishes, they interest me. Just now, for instance, before you came in"—he pointed to an encyclopedia on the shelves—"I was reading an article about 'Mathematics.' Perfectly pure mathematics.

"My own knowledge of mathematics stops at 'twelve times twelve,' but I enjoyed that article immensely. I didn't understand a word of it: but facts, or what a man believes to be facts, are always delightful. That mathematical fellow believed in his facts. So do I. Get your facts first, and"—the voice dies away to an almost inaudible drone—"then you can distort 'em as much as you please." (Mark Twain, according to Rudyard Kipling)

First digital source

 In its "first" press release issued in November 2019,  Nanox says:

Nanox, founded by the serial entrepreneur Ran Poliakine, is an Israeli/Japanese cooperation that has created the world’s first commercial-grade digital X-ray source for real-world medical imaging applications

How do you define digital? Roentgen used a cold-cathode (gas discharge) tube when he discovered X-rays, and so did all commercial X-ray sources until 1913.  Carestream/Micro-X/XinRay got clearance for the mobile x-ray unit that uses CNT tubes in February 2018. 

Crookes tube, source:  https://www.emory.edu/X-RAYS/century_02.htm

 

Update March 31, 2021:  Vatech got clearance for its dental x-ray system that uses a CNT tube (V1-650304) in September 2016.

Why Nanox source is digital

Because it is digitally switched with low voltage (30V+), according to this patent.  But so is any hot-cathode source, with filament voltage as low as 3V, and possibly an extra grid or Wehnelt cup electrode.

Wehnelt cup (source:  Lambtron at Wikipedia)

Update March 24, 2021:  A good slide from a IAEA on grid-controlled tubes use in pulsed fluoroscopy:

How fast can you switch?  A 1984 paper says pulse width down to 19 microseconds (says that at the time, fluoroscopy and CT did not requires pulse widths less than 1 millisecond).  The 120kVp is switched with 3.7kVp at the grid, tube current is 125mA

Update April 6, 2021:  The switching grid, or focusing cup, is negatively biased toward the cathode (filament), at about 1kV (while in a conventional tube, the cup is connected to the filament)

Nanox uncertainty principle

Per Nanox tech page, the temperature of a (filament in a) hot cathode can never be measured, because

Hot cathode temperature is ‎over 2000 degrees Celsius

, but it is

operating at temperatures of up to 2000°C.

Hot cathode (source: Nanox website, "Understanding Nanox technology & vision" video) 

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.

The other Nanox

The stationary CT by NanoVision, not to be confused with Nanox.Vision, demoed (illegally, I think) at RSNA2019.  Claims:

"FDA 510(k) in the process of applying."

The device actually appears feasible, but it does not make sense, as the image quality will not match that of regular CT while the manufacturing cost will be higher due to the performance demand on the detectors. 

Update November 17, 2021:  NanoVision will be presenting the same video and same disclaimer "FDA 510(k) in the process of applying" virtually at RSNA 2021.  Sure.

A glimpse of Nanox headquarters?

One of Nanox "sister" companies (source: adam lia/GooogleMaps, December 2018)

3D view

No comment

From the Korean press in September 2020:

Nanox CEO presenting (source: Pulse, Sept 9, 2020, by By Kim Ki-cheol, et al.)

Existing X-ray and CT machines cost over billions of dollars to set up, with one-time imaging over $100. Nanox device costs about $10,000 with one-time imaging about $1.

Here is a comment anyway:  Anything is possible in Korea.

Hypothetical predicate

Hypothetically, if someone were to submit for 510(k) clearance a single-source device like the one demoed by Nanox at RSNA2020, what would be the proper predicate (ignoring the DR detector)? 

There are 71 product codes for x-ray, of which only two appear relevant:

1. IZL is "mobile" (which includes portables, some even using dental tubes, and devices on wheels, list, annotations, 3rd party: 8):

"A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories."

2.  KPR is "stationary." (list, 3rd party: 18):

"A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories."

Note:  Code MWP is not appropriate, since it is an enclosed "cabinet" system not for imaging humans directly, but has a redacted 510(k) submission by Hologic which may be potentially useful)

An interesting clearance under JAK product code (uses K160857 as KPR reference, just for hands and feet: old manual).

WHO apparently required (requires?) 11kW tube for stationary (so Nanox is out, I believe) and says mobile is not essential in many small hospitals but may be needed for orthopedic surgery.

Screenshots from Nanox RSNA2020 demo (vimeo 487071020/487132636) showing views of the single-source device "pending clearance:"

Other notes:  Two portables, Micro C (fluoro) and Fuji's Xair are waiting for years for 510(k) clearance and haven't gotten it yet.  The operator will probably need lead apron.  Fuji is supposedly doing trials in 2020. Micro C/Oxos looks like a scam (based on the hype in some local press articles and in a NASA presentation ; claims testing at Intertek for IEC 60601-1). Note: Jan 18/Feb13, 2021:  Wow, Micro-C got cleared (summary, through a 3rd party within 30 days, initially expected December 2018, but turns out submitted again November 16, 2019, and delayed).  Note Mar 30, 2021:  But Micro-C was initially promoted as a fluoroscopic device (product code JAA), instead it got cleared as a portable x-ray device only (product code IZL) for extremities (static and "serial") 

Further notes added on Jan 5, 2021:  A review of possible x-ray systems (including tomo, fluoro, C-arm, CT, etc) shows only 10 clearances in the past 5 years that involved a Third Party Review, by only two Organizations that are still active in the Program.  Here is the list:  K203216, K203187, K202564, K201053, K180727, K170789, K170716, K170221, K161920, K160315.  Time from recommendation to clearance ranged from 2 to 52 days.  Nanox is in trouble (if it ever submitted anything for clearance, of course). 

Note (Jan 15, 2021):  A potential predicate for the multi-source device (video), but not a good one, as the Shimadzu unit has a powerful x-ray tube (added Mar 11, 2011).

Update June 22, 2021:  The predicate (which Nanox could not get right in its 510K Summary) is described in this blog post.

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