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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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tucker62
tucker62
February 2, 2016 12:40 pm

Serious volume in TRXC in the last few minutes.

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freedomwon
Guest
freedomwon
February 3, 2016 2:13 am
Reply to  tucker62

This article may explain why the heavy volume. There may be several companies looking to acquire TRXC. http://marketexclusive.com/johnson-johnson-jnj-opko-health-opk-linked-to-transenterix-nysemkttrxc-acquisition/2253/

p2tr1ck
Member
p2tr1ck
February 2, 2016 3:03 pm

I’m a newbi to this newsletter. I followed clues in the MoneyMapPress plug and came up with Titan Medical. It would appear that a number of companies are in this field.
What are the opinions on Titan Medical (Nasdaq TMD.TO)?

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modernrock
Irregular
February 9, 2016 12:29 pm
Reply to  p2tr1ck

It isn’t Titan

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Gui_
Gui_
February 9, 2016 2:53 pm
Reply to  p2tr1ck

Titan Medical TITXF?

At the expense of being attacked by the faithful, highly unlikely.

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sjanus11
sjanus11
April 2, 2016 5:24 am
Reply to  Gui_

Gui, in my humble opinion Titan has a long way to go before ever bringing a product to market. 2 years at minimum.

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Doug
Member
Doug
March 8, 2016 5:40 pm
Reply to  p2tr1ck

absolutely love it!!!

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EMWilson
Member
EMWilson
February 10, 2016 11:45 pm

Travis, this not only did really well for me since I heard about it but I’ve been reading about it and think it may very well have legs as a company. Their management team seems to be the real deal with very appropriate industry background. Are there other microcaps you know about in the robotic surgery space besides Titan, or Hansen. I’m not so keen on either of those right now. However, this one has really triggered a fascination of sorts for the industry, especially micros that may be successful.

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Mike
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Mike
February 5, 2016 3:13 pm

Does anyone know the ticker symbol for Gumshoe. Thanks Mike

Normally Dubious
Guest
Normally Dubious
February 9, 2016 7:34 pm
Reply to  Mike

You like Stock Gumshoe so much you want to buy stock in it?

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tucker62
tucker62
February 9, 2016 12:14 pm

Up 56% in 2 weeks. Thank you Travis!

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SoGiAm
February 9, 2016 12:17 pm
Reply to  tucker62

Thank you Dr. KSS, MD, PhD. and Travis 🙂 Best2ALL-Ben

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modernrock
Irregular
February 9, 2016 12:27 pm

let them have half at 4.35 ave from 1.87, kaboom!!

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Normally Dubious
Guest
Normally Dubious
February 9, 2016 3:22 pm

The stock is up since I purchased it after its name revealed on Stock Gumshoe, and this morning I purchased a 2 1/2 dollar call that’s already up a hundred bucks today… so for once it’s not all crap coming out of money map press

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Land16
Member
Land16
February 9, 2016 4:12 pm

If you look at the FDA site for clearances, you can read up on the submissions and the findings. Trxc submitted in 2010 but failed their clearance because a piece of the spider apparatus broke but was later recovered from the surgical bed.

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EMWilson
Member
EMWilson
February 10, 2016 11:47 pm
Reply to  Land16

Hopefully that issue has been addressed and improved.

Jim Sullivan
Guest
February 12, 2016 2:15 pm

So what is the take on TRXC. ATVI is the only Money Map recommendation I made money on…I lost my rear on FL. Is this another true teaser destined to bust. I didn’t subscribe to TRXC through Money Map but found it on Gumshoe. Do u recommend I take my small profit of .13 on 6,000 shs or continue the ride which is getting questionable by the day. Has anyone viewed the video of the machine. Not impressive at all. Looks like some kind of awkward piece of crap. I wouldn’t want it used on me. Too clumsy of an operation.

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burghoffer
Irregular
burghoffer
February 12, 2016 4:51 pm

I played this a little differently. On Feb 8 I bought 3000 shares of TRXC at 3.55 and sold the April 15 2.50 options for 1.60 for an entry cost of 1.92. If TRXC closes above 2.50 on April 15 I will net .55 for a 28% gain or annualized 153%. I’m nervous about the market and about a much hyped stock and this is a conservative way to get in on some gains. Admittedly, if the stock really takes off, I can’t make more than the 28% and I could lose if TRXC closes below 1.92 on April 15 , but I would probably buy back the option if the stock really tanks and sell the stock. The setup is not quite as lucrative now as it was on Feb 8 but a nice return can still be had with this trade.

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bill897
bill897
March 6, 2016 11:01 am
Reply to  burghoffer

I made a mistake with EGRX, Eagle Pharmaceuticals. I bought it at 40, 1000 shares and got rid of it for a loosing stock. In a couple months EGRX went to 80, maybe 90 than fell back in the 50s. I could have doubled my money if I was only patient and not jack out of shape by the day to day movements. Patients is King!!

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Jim
Guest
Jim
February 23, 2016 12:06 am

Anyone found out why TRXC is heading south faster than the Amazon river? Another Money Map disaster…

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modernrock
Irregular
March 2, 2016 4:24 pm
Reply to  Jim

Sub $2 to almost $5 is a disaster?

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modernrock
Irregular
March 2, 2016 4:27 pm

Promo round two started this afternoon. Great move of 2.80 with bottoming chart. Earnings tomorrow after close 3/3 so there is a small headline risk there and of course the stock sale previously announced. Also have the FDA risk/reward due any day.

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modernrock
Irregular
March 8, 2016 3:04 pm
Reply to  modernrock

all the way to $4 and change 3/8/16, KABOOM!! Let them have it all at 3.95 ave today.

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bill897
bill897
March 6, 2016 11:26 am

All Todd Pope has to do is submit this letter or one better to the FDA and ask, “If we do this will you approve it?” And they would get it done!

CEO Todd Pope and Chairman Paul LaViolette
TransEntrix Inc.
635 Davis Drive Suite 300
Morrisville, NC 27560
Phone: (248) 918-8721
Phone: (248) 918-8721
Email: Transentrix.com

Dear Honorable Chairman Paul La Violette and Honorable CEO Todd Pope,

Here are some more ideas:

1. You need to get off the shelf stuff that’s already been invented. All you need to do is get a license to use their software.

2. You need vision software and a lens that sees inside the body.

3. You need artificial recognition software. License it at a university. MIT should have everything you need.

4. You can outsource the total creation of this automated system.

5. This system would cost less than De Vinci.

6. What did Apple do to create the iPhone. They created the specs but outsourced everything from the supply chain to innovation, but Steve controlled every aspect. He had his in-house industrial designer.

7. You could use the off the shelf Android OS.

8. You would have the APP that controls the robot. Outsource the programming.

9. At every stage in the automated operation process, it would ask questions and provide information on the patient to make sure you first have the right patient, checked, and prepped, by your surgical nurse.

10. The proper program, x-ray, patient information would be loaded. The surgical nurse would send a message from the OR, that the patient is ready for the operation.

11. The surgeon would answer questions from the robot. It would say: “This is patient, such and such possibly read from the patients arm band, their name and other codes, etc.”

12. The surgeon would say “Yes, start the operation”. The surgeon has a kill switch to stop the robot at any time.

13. The robot would find the necessary organ and show the place to be operated upon. It will give a graphic picture of the organ and the surgeon would indicate where to make the incision. Possibly at the start of the operation, this method could be used also or the robot would know based upon the x-ray.

14. It would say: “We have found the appendix, where do you want to make the incision and gives a graphical picture of the appendix.” The surgeon would indicate where he wants the incision to cut off the appendix. The incision would be made and the robot would remove the appendix. It would then cauterize the wound.

15. The robot would report, “No bleeding seen”. Maybe if there was some blood it could be vacuumed out of the cavity. Antiseptic put on the wound.

16. Then the robot would report: “Wound ready for closing.” “Close now?” The surgeon replies “Yes” and the robot would sow the wound shut and apply a bandage over the wound and we are done with this appendix removal.

17. The cost to Medicare, a fraction of having all personnel in attendance for one simple operation. The equipment would cost less than De Vinci. Many ORs could be run by one surgeon.

18. Think of a bunch of hospitals like Humana pooling all of their surgery ORs to 500 ORs together and having only five surgeons running 500 robots. There is a tremendous cost savings here.

19. Let’s get this done!! The De Vinci has had this market all to themselves.

20. Otherwise, patients will get their operations in other countries for 1/5th the cost, e.g., India. The patient is always right. He is the King with the money. I would love robot surgery and go home the same day. I’m 69 and see real fast surgery on the horizon and the costs coming down. It’s a win-win for everyone, e.g., Obamacare, Medicare, the hospitals, the patients, etc.

21. No overnight stay in the hospital. No complications. Perfect operation every time.

22. No need to worry about a Friday operation where the doctor isn’t too sharp and may nick here and there causing internal bleeding.

23. No sponges left inside the patient. No lawsuits for malpractice.

24. The Medicare charge would be a lot less than a full host of surgeons, surgery nurses, anesthesiologists, etc.

25. Picture this: You have one doctor, one anesthesiologist, one surgery nurse working while 100 robots do 100 operations all at the same time.

26. Get approval for the simple stuff first.

27. This robot would be ideal for an emergency room where time is of the essence. The doctor doesn’t need to be present. A nurse that preps the patient could be there. You have people coming in for wounds that need immediate attention. Let the robots do it.

28. The robot could do everything a nurse does when you first are admitted, e.g., checks the weight, checks the pulse, and surveys the body, possible triage the patient if they need immediate attention.

29. I’ve been in emergency with a circular saw cut by my knee and they had to sow two layers of skin and I’ve had a concrete piece fall on my left big toe. It was broke in 5 places. It took the doctor 5 hours to show up. Probably he needed his sleep more at Beaumont Hospital in the Detroit Area.

30. Because of Obama Care, these hospitals are banding together to save costs, but because there will be less doctors and we need more doctors and we have 70 million baby boomers retiring; they will inundate our hospitals, errors will be made; patients will sue for those errors. Chaos and hell will inundate these hospitals with patients not able to pay for various reasons.

31. With total automation, we will need less doctors. Currently, there are 1 million surgery centers in the United States. Because of the costs, people will go to India for medical care; because it’s 1/5th the price of medical care in our hospitals.

32. Our hospitals need to compete. They need automation, e.g., perfect operations every time.

33. This is where TransEntrix comes in.

34. Your job is not to be another De Vinci, an expensive, slow, mechanical robot that takes forever to schedule an operation that takes a surgeon with steady hands and not some Friday thinking going on about what he’s going to be doing on the weekend. You need perfection 24/7 because accidents happen 24/7.

35. You do not need to be another De Vinci. That’s already been done. You need total automation on the simple operations and some intervention on the more complex operations. The hole jest of this matter is lower the costs to Medicare, less doctors and nurses needed to do more.

36. The 3 biggies in the auto industry are: COST, QUALITY, & TIMING TO THE CUSTOMER. If you can do this, you will get the sale and reputation that goes with it.

37. If you let these hospitals fall behind, the patient will go elsewhere and with this world travel; they will go where they perceive value for their hard earned money.

Truly yours,

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Miceal
Miceal
March 7, 2016 4:47 pm

Is this Peter Lynch quote relevant at this time: “The real key to making money in stocks is not to get scared out of them.”

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sjanus11
sjanus11
April 2, 2016 5:30 am

Travis, FDA has told TRXC it is not finished and will be Mid-April. Not a delay, just not finished. Pope came out with statement to such effect. So now we watch paint dry. LOL
Anyway it still looks like approval as FDA could have asked for more docs, yet did not. Also probably would have rejected now , but did not.
Steve

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Anonymous Questions
Irregular
March 8, 2016 1:58 pm

Thank you.

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who noze
Member
March 9, 2016 12:09 am

i had the davinci do n opeaion on my lung recuperation was fast veryt little paini

Harold Hansen
Member
March 9, 2016 12:55 am

You guys were scaring me to death! You’re talking about The stock, and it’s the 8th today! Here you are replicating conversations that have been had on the 3rd! OMG! I’ve been watching it all day and it’s up to its usual tricks. Up 200, down 200.! Yikes!
But they still are on track for FDA approval eom
March, right? I can’t hang if it goes down 200$ everyday? Pope knows what he’s doing ive heard,
But if they were offered a lot of cash, at least we’ve got them! I was thinking how stupid to insert
Something else into this, and moving the FDA to
June,? I’d have to kill!! Couldn’t the FDA approval
Come at anytime, doesn’t have to be at the end of
March, right? To much man… Good luck gang!

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whoopingcough
Guest
whoopingcough
March 9, 2016 1:06 pm

Still need to hear the ticker symbol for the tiny $2 robotic surgery stock

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who noze
Member
March 9, 2016 2:23 pm
Reply to  whoopingcough

trxc

A.M. Deist
Member
A.M. Deist
March 9, 2016 4:35 pm

I have been in and out of TRXC twice in the past couple of months. The first time, I bought it at $2.50 a share and sold at $4.40 a share. Then after hours they announced a dilution of the stock and I purchased a bunch back at $3.50. Since then, I have been buying 400 shares every time it drops. My basis was $378 and today, I sold all shares at $4.55 a share. My take is that if the FDA approves their system, the best you might hope for is someone to buy them out. If the FDA asks for more information before approval, the stock will likely tank. I consider it very high risk, but since I already have made enough to buy back half the shares with profits already made, I might dip back if the stock price drops back again. This, however, is not on to buy and hold, hoping that the FDA will approve it and a large premium buyout will occur right after.

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SoGiAm
March 9, 2016 4:40 pm
Reply to  A.M. Deist

Soothe moves A.M. Deist 🙂 Welcome to the Gummunity 🙂 Best2You-Ben

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Harold Hansen
Member
March 9, 2016 9:38 pm

Whooping Cough it’s TRXC. Help?
OK. I’ve been snooping around today and they’re talking about how hard it’s been to sell in Eur, I saw
This Bleecker Street Research, and they said
“Watch for 60% decline after stock promotion and
Then disappointing sales after.” They go on and on about puts and shorts, and to be quite frank, it’s scaring me. It went up nice today but does anybody have anything to add to this? They haven’t sold anything, but I don’t know if they can with that
Clearance they have. And Mar. 31st is a long ways
Away! I could use this, I’m so broke! Anybody want
To share what they think? They’re really putting down the market today too. Like what if you can’t
Cash your checks, stuff like that. It sounds pretty
serious today. What if this guy is a ” Pump n Dumper? I’m asking for help here friends. Any thoughts? Does anyone know of a better one?
Thanks you guys& gals!!! This is it, tonight for me.

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bill897
bill897
March 10, 2016 3:41 pm
Reply to  Harold Hansen

I’m in this stock for 5 years. I’ve sent them 3 letters. I posted a letter previously about what I call Surgbot 2 – a total automation robot. Why can’t TRXC say to the FDA, if we create this automated robot with these checks and balances, will you approve it? It’s possible they could get immediate Surgbot 1 approved and the go ahead to do Surgbot 2 and go to Humana and show this initial Surgbot 2 approval and get 1000 advanced orders and quietly sell the rest of the hospitals to create these surgical centers for hospitals consolidating there surgical centers into on large center and all of a sudden they’ve got 12,000 advanced orders and money to do Surgbot 2. Whouldn’t that be where this is all hearded? Do you want our 70 million retired baby boomers going to India for their surgery or in the good old USA?

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SoGiAm
March 11, 2016 5:22 am
Reply to  Harold Hansen

$TRXC- http://www.stockgumshoe.com/2015/07/the-second-coming-of-transenterix/ Join Irregulars for 13 1/2 Cents per day 🙂 #Best #investment #Bar #None

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sjanus11
sjanus11
March 30, 2016 5:44 am
Reply to  Harold Hansen

Harold, It’s not that they had trouble selling the ALF-X in Europe, it’s that the prior owners never really tried. Here’s a good link on The evolution of TRXC, and it explains their acquisition of the ALF-X system and why it never was really put in to a sales cycle. Instead they went for more of a documentation route.
http://www.thewallstreetfox.com/2016/02/the-evolution-of-transenterix.html

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sjanus11
sjanus11
April 2, 2016 5:42 am
Reply to  Harold Hansen

Harold, The reason ALF-X never sold in Europe is because the prior owner never tried. They were busy building up clinical data. Here is a good link on the history of
Tranenterix.
http://www.thewallstreetfox.com/2016/02/the-evolution-of-transenterix.html
It explains the ALF-X story. Chill, This will make you gobs of money in the long term. I have spent about 1 month now researching TRXC, and can find no flaw. They have built a better mouse trap Period. My only concern is how well the can sell it. They have an “All Star ” Management team, and 2 new sales hires from Intuitive. Why would they come here if they did not believe. 1 in particular ( Paul Ziegler ) was Western regional VP. Had like 150 people, and 3 other VP’s reporting to him.
Hang tight and buckle up.
PS, do your self a favor and Google this combo for all the “Warm and fuzzy”info on co.
Wall Street Fox and TRXC there will be about 10 articles. This guy has done a bunch of research over 2 years. Plus go to TRXC website and read the last earnings call transcripts. Then you will have a real good feel for your investment.

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