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“Major Announcement Due by March 31” — What’s the “Bionic Surgeon” Looking for imminent FDA Approval?

Ernie Tremblay says this "Imminent Decision" will "unlock massive $18 billion market" and "spark a 224,00% sales surge for a $2 Microcap"

This ad first showed up in our inboxes under the “end surgery forever” headline in late January, and the following article first appeaered on January 26.

We have not gone through and updated the article, though the basic pitch is just about the same in the new version of the ad today as it was then. The “Major Announcement” is getting a bit closer, because the Company has consistently said they expect to hear a response from the FDA in the first quarter (and that ends on March 31).

Whether or not this widely-expected response from the FDA will have an immediate positive impact on the shares, I don’t know. The odds of approval seem quite high, I have not seen any analysts predict that they’ll fail to get approval this time … though there was also a sharply worded short attack on the shares from TheStreetSweeper a couple weeks ago. You can read the comments following the article for some of those updates and reactions along the way, but the rest of this article is unchanged from when it first appeared here six weeks ago:

“Intuitive Surgical’s stock price bolted from $3 all the way to $561 a share today.

“That’s a 19,000% return…

“Good enough to turn $10,000 into $1.9 million…

“And yet, it’s just a glimpse of the gains coming down the pike right now.

“You see, as innovative and groundbreaking as da Vinci is…

“Keep in mind, it’s not perfect.

“And the $2 company I’m recommending today has the patented technology to take robotic surgery to the next level…”

That’s what caught some of our readers’ eyes from a recent Ernie Tremblay ad — he’s looking for new subscribers to his Biotech Insider Alert, and in order to entice you he’s hinting about the “next Intuitive Surgical.”

That’s like waving a sausage in front of a dog, we can’t help but keep following — every investor is enchanted with the idea of finding the next mega-growth stock like Intuitive Surgical (ISRG) and their da Vinci machine. Even those of us dummies who sold the stock $400 ago (don’t ask).

So what’s this new technology? More from Tremblay:

“Their new technology isn’t just a tool used by a surgeon…

“It merges with the surgeon…

“Creating a whole new reality. Part man. Part machine.

“In short, a ‘bionic surgeon.'”

Cue the obligatory references to the Six Million Dollar Man (or, inflation adjusted, the $22 Million Man), but what Tremblay is touting here is a company with some sort of next-level surgical robot system, an improvement over Intuitive Surgica’s da Vinci.

More clues:

“… it’s moved through the FDA approval process while attracting some of the savviest technology investors on the planet, including a billionaire often referred to as the ‘Warren Buffet of biotech….’

“… you need to understand that in the coming weeks, this breakthrough bionic surgeon could hit every hospital and surgical center on the planet.”

“In the coming weeks?” Be serious. Even if this weren’t a half-million-dollar machine it would take time to roll out and build to critical scale.

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Some of the biotech-savvy among you have already guessed what stock this is, I imagine, but don’t ruin the surprise for everyone else…

let’s check out some more clues:

“Surgeons ‘wear’ the technology and are always in the same room conducting the surgery themselves.

“If there’s a problem, the surgeon is right there next to the patient – inside the sterile field – able to respond immediately.

“This is crucial. One surgeon puts it this way:

‘If you’re sitting on a console 10 feet away, you’re not scrubbed in. If there’s catastrophe on the field the first thing you have to do is: somebody has to undock the unit… Then you have to move the entire apparatus off the field while you run outside and scrub. If you think about the amount of time it takes to do that, it might be a few minutes, but it’s a lifetime literally to that patient.’

“Problems like these won’t happen with this new technology.”

I don’t know that this is a particularly big problem with the da Vinci, it’s not like the patient is alone in the room with the machine while the doctor’s across campus. But that’s beside the point, more clues:

“…. the Bionic Robot gives surgeons an intimate feel for what they are doing….

“It’s almost like they are wearing bionic surgical gloves.

“They can actually ‘feel’ what they are doing, adding human sensibilities that a robot alone could never deliver.

“Here’s how Dr. Juan-Carlos Verdeja – Director of Surgery at Baptist Health – describes this game-changing benefit…

‘It has the opportunity to revolutionize the robotic market. The platform allows me to scrub in and work at the patient’s side, and maintains a tactile feel that I want as a surgeon.'”

That has been a complaint, sometimes, about Intuitive Surgical — their robot doesn’t have the “haptic” touch feedback that surgeons would prefer.

And yes, this is another kind of laparoscopic surgery — minimally invasive, like conventional laparoscopy or the da Vinci, the tools and camera go through a small incision (or incisions) and the surgeon performs his (or her) maneuvers under the skin. More from the ad:

“The surgeon makes a small, single incision – often hidden in the patient’s belly button.

“He then inserts a small tube which opens up like an umbrella, delicately positioning tiny surgical instruments inside the patient.

“The surgeon controls the instruments with his hands, all the while watching through a ‘bionic eye’ via a high definition camera.”

And more on that cost differential Tremblay noted:

“Intuitive Surgical’s da Vinci robot is priced as high as $2 million, putting it out of reach for most hospitals.

“You might expect this next-generation Bionic Surgeon to be even more expensive…

“I mean, it’s such a drastic improvement, a higher price – even as high as $3.5 million or more – would be justified.

“But it’s not more expensive…

“In fact, this tiny $2 company’s breakthrough Bionic Surgeon is 75% LESS than Intuitive Surgical’s da Vinci robot.

“That’s right. While the da Vinci robot can cost $2 million, the Bionic Surgeon will only cost around $500,000.”

Who is it? Here they’re teasing TransEnterix (TRXC), which is a very small company ($180 million market cap, looks like they have plenty of cash) that’s been acquiring other small robotic technology companies in recent years and developing what is, to some extent, a da Vinci competitor.

The machine Tremblay’s mostly referring to is the SurgiBot, which is a smaller, one-port laparoscopy machine, but they also did recently acquire the Italian company behind the Alf-X, which is a multi-port laparoscopy robot that seems more similar to the big da Vinci. The SurgiBot is currently with the FDA for review and TransEnterix expects clearance within the next few months (the general expectation is 6-9 months from submission, and they submitted the application for approval in June).

And our own Dr. KSS went into quite a bit of detail on TransEnterix over the Summer, so I’ll just let you go over and read his article for more background (the stock ha also been discussed pretty widely in the discussion sections of Dr. KSS’s other articles). I don’t have an opinion on this one, though the space seems more competitive now than it was when Intuitive Surgical was getting started — but I wanted to get this teaser solution out to you quickly instead of spending a few hours looking at the stock, but it has sure come down in price in these weeks leading up to possible (likely, most folks seem to think) approval.

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Wayne's Word
March 10, 2016 4:22 pm

Dr KSS commented here over a month ago (Jan 26). Has he anything else to add regarding a 1st Q deadline announcement?

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JR
Member
JR
March 10, 2016 9:17 pm

What stock is Dr.Moors talking about at Money Map today regarding the sand energy idea that is going to send oil to $1 a barrel . Love to hear your input on this one !!

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Harold Hansen
Member
March 11, 2016 4:35 am

Whooping Cough! It’s mentioned in Everyonee one
Of these replies. It’s TRXC ya got it now?
Has anyone heard anything new?
I wonder if I can buy in again?

youKendoit2
youKendoit2
March 13, 2016 1:10 pm

TRANSENTERIX, INC. (TRXC)
Article by Bleeker Street Research
Summary

A stock promotion sent TRXC up by over 150%; these same promoters have been involved in multiple other disastrous stock promotions.

TRXC is now preparing to issue equity via a dilutive stock sale even as insiders are preparing to cash out.

TRXC ALF-X robot has already been approved in Europe for 5 years, but has seen virtually no sales.

TRXC has been claiming that it is expanding its sales force in presentations, but LinkedIn and the company website show limited employees engaged in any sales capacity.

Authors note: The purpose of this article is to highlight a compelling short opportunity in shares of TransEnterix. There is currently limited stock borrow available for shorting shares. However, there are liquid calls and puts available at $2.50 and $5.00 strikes. Those who are interested in shorting TransEnterix can either buy puts or sell calls and be effectively short in a way very similar to shorting common stock.

Overview

TransEnterix (NYSEMKT:TRXC) is a $400 million market cap medical device manufacturer. The company manufactures the SurgiBot and the ALF-X surgical robot, which has been approved and on the market for 5 years in Europe. However, the company still generates zero revenues because the product simply doesn’t sell. Management and board members have multiple ties to past similar promotions which have imploded.

Shares of TransEnterix have risen by more than 150% in recent weeks due to a promotion from “Small Cap IR”, which has spread rumors that the company could be an attractive buyout target. Small Cap IR has been extremely effective in boosting the share prices of its clients just in time for the companies to complete equity offerings. After the offering is completed, the share prices inevitably come crashing back down. It should be seen as no coincidence that TransEnterix just filed an ATM registration to raise money via stock sales. This was done just in time for the stock promotion. Shortly after the price spiked, TransEnterix filed for the sale of 43 million shares for certain institutional investors.

Background on exposing stock promotions

Over the past several years, I have exposed numerous companies whose share prices have been propped up only by paid stock promotion. There is always an underlying business, with some catalyst to sell investors on. The promoters take the basic underlying story and create a powerful new spin on it. Maybe there is a buyout in the works. A new FDA approval. A new strategic investor. The list of hypothetical catalysts for promoting a stock is nearly endless.

But in general, this promotion only exists as a way for the company to sell shares into the market, using inflated stock prices and volumes to raise money at an artificial premium. Typically, it is retail shareholders who are left holding the bag, having bought in on the basis of the new hype in the promotion.

In the past year, I have exposed DS Healthcare (NASDAQ:DSKX), Chanticleer Holdings (NASDAQ:HOTR), and Cellceutix (OTCPK:CTIX) as having been the subject of stock promotion. In each of these cases, the stock price had risen by more than 100% due to inappropriate and unsustainable stock promotion. I highlighted each of these examples as a compelling opportunity on the short side.

Since my publications, CTIX has fallen almost 70%, HOTR has fallen 73%, and DSKX has fallen 60%. The promotion behind TransEnterix is virtually identical to what we saw in those cases above. As with the others, watch for shares of Transenterix to quickly fall by at least 60%. There is minimal underlying business and the recent share price strength is simply the result of unsustainable promotion.

Recent Stock Promotion

TRXC has been the subject of recent stock promotion. Those promoting the stock have numerous ties to other cases of stock promotion in which shares have plunged substantially, and many instances where the SEC halted the stock outright.

On February 1st, a report from Broad Street Alerts speculated about the possibility of TRXC being acquired by Johnson and Johnson (NYSE:JNJ). The title read “TransEnterix Inc. Rumors of Johnson & Johnson Considering Acquiring the Company.” You can view the full report here. The report only provides extremely vague speculation about the acquisition:

“Because Johnson & Johnson has a large medical device division that’s seen its sales flat-line, its management has indicated plans to restructure and conduct M&A, and it’s already announced a collaboration to work with Alphabet (NASDAQ: GOOG) on robotic surgical devices, investors are speculating that TransEnterix could be on the company’s wish list. The company did recently hire former Intuitive Surgical sales leaders to spearhead their commercialization efforts, and the market is big and growing. For example, Intuitive Surgical sales increased 12% to $2.38 billion in 2015.”

Broad Street Alerts suggests that Johnson and Johnson would be interested in acquiring TRXC because sales in its medical device division have been flatlining, pointing to a collaboration with Google (Alphabet) as an indicator that J&J would acquire TRXC.

Yet why would J&J, a $290 billion company, acquire a pre-revenue company, when it is already in a partnership with Google? Furthermore, why would J&J seek to acquire a company whose product has been approved and on the market for 5 full years without generating any meaningful sales?

Despite the nonsensical nature of the rumor, the speculation quickly spread and was repeated in 5 separate articles on the Motley Fool, helping to fuel the share price even higher.

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bill897
bill897
March 15, 2016 3:09 pm
Reply to  youKendoit2

I believe TRXC has used some of the technology from the TRXC ALF-X to create the Surgibot. The market in Europe is depressed for investment due to this terrible currency union that tries to combine socialist counties with the capitalist and the extreme greed country of Germany. I believe England will leave the EU and regain its financial sovereignty. You’ve got insane materialistic leaders running Germany. They think they can control every aspect of EU life. I don’t buy German Junk. They are taking over Europe for the third time. I’m not a EU lover. Extreme Greed destroys capitalism as it did in 2008 and in WWII with Hitler, Mussolini, Tojo who headed poor countries tried to grab what was not theirs. The health care in Europe is mostly government run. They don’t have any money to spend. I’m trying to get this company to come out with a Surgibot 2. A totally automated robot whereby a surgeon can control 100 robots all at the same time. It would be like a big circle with the surgery people in the middle with the ORs surrounding the center. All ORs would be easily accessible. If we can totally, semi-automate surgery, the medical costs will go down. We will have 70 million baby booms that will inundate our hospitals. We will not have enough surgeons. These patients will go elsewhere, e.g., India at 1/5th the cost. There will be worldwide competition for these patients. Do we want the U.S. to be the leader in surgery or the follower?

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Jim
Guest
Jim
March 21, 2016 6:56 am

Zacks rating on TRXC
3-Hold 3
Value: F | Growth: F | Momentum: F | VGM: F
Be careful with TRXC. Like others I have been in and out of TRXC hoping something good is going to come of it. There are quite a few other companies into robotic surgery and one made a promising sale the other day. Problem I have with TRXC as
youKendoit2 says, they have no sales staff to mention of and I think evidently don’t have much confidence in the FDA because they continue to cut there small staff instead of increasing it in light of awaiting FDA approval. I don’t get it. Does anyone have any other news. They haven’t made a dollar…I would compare them with another hype company..in another sector BLKG..Black Stallion Oil & Gas…haven’t made a cent and never will.

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sjanus11
sjanus11
March 22, 2016 12:25 pm
Reply to  Jim

Here is the History of Trans, and why no sales were made on Alph X

http://www.thewallstreetfox.com/2016/02/the-evolution-of-transenterix.html

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sjanus11
sjanus11
March 30, 2016 6:03 am
Reply to  Jim

Jim, you really have to do you’re own D&D and not rely on the post above.
I really don’t know what he is talking about. No sales staff? You must go
http://ir.transenterix.com/ and start digging around OK. Why don’t you start by reading the transcript from last earnings call.
1 st) 2 new hires in sales coming from Intuitive. Rock stars. Why would they come here.?
2) ALF-X was never ever put in sales cycle in Europe. Used to create more docu.
see here
http://www.thewallstreetfox.com/2016/02/the-evolution-of-transenterix.html
as of call 23 dedicated to ALF team.
FDA just announced Mid April. Not delayed, FDA said not finished. I take that as a big positive. FDA prob would have either asked for more now, or out rigt rejected.
Says insiders selling. Go to Nasdaq and look at Insider trades. No they are buying.
In fact 93% Institutional/insider owned. That is pretty high.
Dr. Jack Frost big investor. Look him up.
I could keep going on. The water here has been muddled by Money map with the pump and dump. I believe they actually got one right.
I’ve spent weeks doing D&D, and I’m convinced this is the real deal.
Steve
PS. It’s as simple as they have built a better mouse trap. And I’ve come to see this Surgibot is not a direct competitor to Da Vinci. It is a market unto it’s own.
Surgibot’s predecessor, was the “Spider” which Trans made. Which was very good. This is just a big upgrade. Surgeons love it. Will sell great.

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sjanus11
sjanus11
March 22, 2016 12:34 pm

Her are some good links on TRXC.

http://www.thewallstreetfox.com/2015/03/the-risks-behind-transenterix.html
http://www.thewallstreetfox.com/2016/02/the-evolution-of-transenterix.html
http://www.thewallstreetfox.com/2015/03/transenterix-how-big-can-it-become_31.html
Read the bios on these members. Pretty impressive for a pump and dump if you ask me.
http://www.transenterix.com/company/leadership/
Some new hires from Intuitive, J&J , Becton Dickson
Do your own D&D. I’m long and in for the long haul. I can’t find anything bad, other than just how well will they be able to sell the darned things.
The market is to grow from 2 Billion to 10 in 4-5 yrs. They need to capture like maybe 5 % to become very successful.
We shall see shan’t we. LOL Good luck all.

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osgo
March 23, 2016 2:10 pm

Can anyone elucidate me or tell me what I am missing when I view the FDA Calendar?
http://tinyurl.com/TRXC-FDA
When you search for Transenterix on the FDA’s site, it shows an “Maude Adverse Event” dated 2016-03-18 — but the so called “Event” happened in 2009-2011?? The listing is disingenuous…if someone didn’t delve further they might think it applied to the current year.

With all the date anticipation lately, I can see how this might be construed incorrectly in the pre/post anticipation froth that’s all the rage on quite a few media outlets/boards….

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SoGiAm
March 23, 2016 2:16 pm
Reply to  osgo

osgo, I sure wish you would join us on ZKSS’s biotech threads. The current one is: http://www.stockgumshoe.com/2016/02/special-commentary-turbulence-for-esperion/ and previous articles can be found here: http://www.stockgumshoe.com/author/dr-kss-md-phd/ Best2You-Ben

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tommy thompson
Guest
tommy thompson
April 2, 2016 2:41 pm

TransEnterix, Inc. announced consolidated unaudited earnings results for the fourth quarter and full year ended December 31, 2015. For the quarter, the company reported operating loss of $13,900,000 compared with $7,800,000 for the same period a year ago.

Hard to believe that a company that doubles its operating loss in less then a year would be a good investment. Perhaps i could get more information from someone who knows more about what a good investment might be

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jcaldwell
Guest
April 5, 2016 4:19 pm

They are still discussing a $2 stock (in new pumps) that is pending FDA approval in April.
Seeing that this stock has not been @ $2 for 2 months now. are we absolutely sure its TRXC (currently trading at 5.20)?

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sjanus11
sjanus11
April 11, 2016 7:13 am

Travis, I even called the boneheads. LOL at MM and told them they need to update their Ad Copy. The price is now in the 5’s. Has touched 6 briefly.
So you’re saying even though they look dopey with the 2.00 pitch , because it works they stay with it?
Well even 5.00 won’t last as we expect FDA approval this week. Have to thank you again for helping me figure out TRXC instead of listing to another nightmare inducing pitch. LOL
Hope the little Gumshoes are well,
Steve

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Harry
Guest
Harry
April 7, 2016 7:19 am

What are you thinking about Ekso bionics Holding? Now trading at $ 0,85.

Greetz from Holland

sjanus11
sjanus11
April 11, 2016 7:18 am

Harry, about EKSO. are you aware of their latest news?
http://finance.yahoo.com/news/ekso-gt-robotic-exoskeleton-cleared-110000008.html
FDA just gave them approval for their devices to be used in treating Stroke victims.
Price back up to .99.
I like EKSO, what with their Med/Industrial/Military/Darpa connections
I’ve been slowly adding. Cheap enough..

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bill897
bill897
April 20, 2016 8:48 am
Reply to  sjanus11

What I saw on one website was the new revised reporting date is May 4th.

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bill897
bill897
April 12, 2016 11:34 am

Here’s the competition for surgical patients worldwide:
Which are the leading research centres/labs for surgical robotics in the world?
Alina Popescu
Technology is becoming more and more integrated into the medical system and as we saw, robots do not actually replace humans but rather improve their ability to operate through the small incisions.
Although still in its infancy, robotic surgery has already proven itself to be of great value and is set to revolutionize surgery by improving and expanding laparoscopic procedures, advancing surgical technology, and bringing surgery into the digital age.
Robotic Surgery Medical Centers
•Polisano Group, Romania
•Istituto Auxologico Italiano, Italy
•Istituto Europeo di Oncologia IEO, Italy
•PlacidWay Medical Tourism,
•Policlinico Abano Terme, Italy
•Placid Greece, Greece
•PlacidWay Moongate Alliance, Bermuda
•Manor Medical Center, Israel
•Manipal Hospital, India
•Asian Bariatrics, India

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Doc
Guest
Doc
April 12, 2016 12:48 pm

So much for the March 30 deadline. Now April 15 is being pushed … Hard.
Stock has pushed up in anticipation. Don’t hold your breath

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Aman
Guest
Aman
April 21, 2016 2:09 am

TRXC Lost FDA approval on 04/19

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Aman
Guest
Aman
April 21, 2016 2:11 am

They stated it dropped to 1.74 in late trading!

jimppc
Guest
jimppc
April 30, 2016 3:46 pm

what is the ticker of this company that’s supposed to make a large announcement it Italy on Monday may 2. Does anyone know? I thought it was alf-x but I read they can’t sell in the u.s.

Eric
Member
Eric
September 7, 2016 12:39 pm
Reply to  jimppc

I’m not sure about what you may be referring to but TRXC will be applying for FDA approval of the ALF-X in the U.S. probably before the end of 2017, based on the last conference call. Also they sold an ALF in Europe during the last quarter. Things appear to be looking up. I’ve been out of the stock for a while now but hope to get back in within a couple of months. I think they have a good chance of approval and it it comes, stock may rebound to five dollar level overnight.

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Lisette
Guest
August 20, 2016 10:29 pm

These are my HOT ROBOTICS stocks: TITXF .55 sports robotics, ISSM .69, TRXC 1.40, and NUSMF .13 — BUY A TON OF ALL THESE!

Uncle Albert
Member
Uncle Albert
October 12, 2016 6:03 pm

Today it closed up . 22 cents or 11.22% with some cat advising a buy:
* Transenterix Inc: B.Riley starts with buy; $3 target price

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