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About as much as I can trust advice from someone with a restraining order
largest OEMs in US, guess it has to be one of the top 5
http://www.mpo-mag.com/issues/2014-07-01/view_features/mpos-top-30-medical-device-oems
Here is my two cents (let's just hope that you can't get a share of Titan for that in a week):
Predicate Device for SPORT FDA Approval - this was the biggest piece of information that I took from the CC. They have assurances from the FDA of a Predicate device on which SPORT will be evaluated and approved (all you have to do is see what happened to TRXC to know how valuable this is for Titan going forward).
Randall mentioned strategic partnerships - they are not going alone on this
GLOBAL LEADER (Anonymous) new partnership and manufacturing handoff - how Hargrove handled that question was amazingly telling - easy answer about a parternship with VERB was NO - pretty simple, why the avoidance
Jurology anything in particular we should look at?
My guess/hope is that they will announce the completion of the Longtai deal, some information on cadaver studies and approval in Canada of SPORT. With approval in Canada of SPORT - it will allow them to control the rollout of SPORT (maybe 5-8 units across the country over the next 3-6 months) - sold thru Ningbo Longtai since it has Canadian Subsidiary.
This is only my thoughts and more likely what I am hoping for, unfortunately the time I've spent on this investment leads me to think that this won't happen - most likely a status quo update - no big news but no bad news either.
Jack Golden - the linebacker or the comedian?
Ximedica
Like I told LTG, One SPORT will be sold before One Surgibot
Like i said, One SPORT will be sold before One SURGIBOT
Thoughts on a R/S and could use clarification:
Say Titan has 150M shares outstanding at $1.50 PPS.
They do a 1:3 Reverse Split to get to 50M shares outstanding and $4.50 PPS.
If a company made an offer to buy Titan for $1.5B dollars.
PreSplit - I have 150 shares - I get $10/share = $1,500
After Split - I have 50 shares - I get $30/share = $1,500
If a R/S gets us uplifted and in front of more investors to help drive PPS, then that is good in my opinion. I can see how it can be bad after what we've seen with TRXC but to compare TRXC and Surgibot to TITXF and SPORT is not the right comparison. With SPORT, we are right on the doorstep and about to commercialize. TRXC did it about 2 years ago and still don't have approval and also had to go out and buy a completely different platform.
Classy
My experience in medical devices is that even after FDA approval, companies continue to collect data, information and do studies on these products to further market it. The after market information is often more valuable to convincing future adoption then the initial clinical trial info. During a clinical trial, the goal is to show the product is safe in a patient and can do the tasks it said it can do. I would imagine that if Titan does clinical trials, the procedures will be the most basic procedures you can do, the least complicated.
My point is that you will have SPORT in humans doing procedures that provides Data and information for those surgeons who need that. A clinical trial is not the only forum to collect that information.
Good thing for Titan is that they have their Surgeon Advisory Board who will adopt it without the clinical trials data. They also have the Mayo Clinic lined up to adopt it when it is available (APOLLO, OHIO STATE, CROUSE,SHANDS, ANNE ARUNDEL, ETC). If Clinical trials are not needed prior to approval, that is a bonus for Titan. I have a feeling you will have surgeons lining up to do cross center studies and individual studies based on their specialities for SPORT when it is available. I can't imagine Valvo or Swanstrom waiting to use a CE/FDA approved product that they are advising on b/c a clinical trial was not conducted
Did they give any reason? that is interesting.
Something to think about:
I believe there is something to this FDA approval process. After the FDA symposium regarding approval process for future robotic systems, I think Titan thought the FDA would move quick in making a decision about how they wanted to approve future devices (Meeting was in June). But since gov't entities never move quickly, Titan got caught and had to do that offering last winter b/c the FDA has not decided yet. It's possible that Bertner Advisers wasn't able to bring enough investors required to fill the offering. We also know they couldn't control the shorts (per Randall's comments). IMO, this could explain the decision to bring in ECV. After the last offering, which was required to get them through clinical trials from a money standpoint, they felt good about their product to unveil it at SAGES. This time around, they are capitalizing on the buzz from SAGES and interest in investors to go to the shelf in order to prevent getting caught if the FDA continues to drag their feet. If they can get the remaining $21M in this offering, this will get them through to FDA approval with some money to meet the initial PO's from international market.
IF the FDA comes back and rules that a surgical robotic platform like SPORT will be approved on the tasks in can perform rather than the customary procedural application, then we can expect SPORT to gain CE and FDA approval by year end.
This should all become clear over the next 3-6 months b/c we will hear back from the FDA on their Surgibot decision (TRXC's IR said it was expected by end of Q1 2016 - 8 more days unless their is a delay with the Surgibot product) - that should give us insight in how the plan to approach SPORT and any future surgical robotics platform.
Another interesting note about VERB, MEDTRONIC and anyone else getting into robotics, they would also have personnel that are in tune with the FDA process and they could be waiting to see what decision is made before they jump in and purchase a platform like SPORT. My belief is that if the FDA rules on task based, then SPORT will be acquired quickly. All of this of course is just an opinion.
Intuitive SP is a predicate device, already approved by FDA
Private Placement very good - agree that some entity wants in on Titan - would also indicate to me that it was initiated at SAGES and happened very quickly
This thing will continue to get manipulated until EVC sticks it to the shorters once or twice.
It will be interesting if M3i Investment Group takes part in this offering from Titan. I would not be surprised if they did, considering robotic surgery is one of their priorities.
Maybe it's JJDC who will buy the offering
Thank you for posting, it was the only post that I read tonite and bypassed all the pumpers, dumpers and haters (LTG, Frank, etc). For those that are long, I am wondering if the feeling is the same that you showing back up here to post on SPORT and your thoughts is very encouraging. If you saw who you saw, that is great information - thanks for sharing and it very well could be a coincidence but for a long like me, I tend to lean towards the fact that it isn't. In fact, I think I am going to double my position in Titan. Thanks again.
At least they gave a damn about the product and have gotten us a next generation surgical robotics platform. Whereas TRXC didn't care about the shareholders ($14/share at one point) or the product (surgibot reviews are very poor and ALF-X hasn't been sold since approval 4 years ago).
Will say this, not too pleased with EVC telling some shareholders that financing wasn't imminent and then having an overnight. That is something I expected out of the other IR firm we had.
Anyone know how much is left in the shelf offering? I thought it was $20M left but if someone could verify, that would be helpful.
It could be that all the investors in TRXC told Titan to get uplifted so they could dump TRXC and move that money into an investment that has a future like TITXF
That's good info, it will be interesting to see if their message to us is consistent.
My theory: Shorters took on a big position, especially today and ECV is planning on dropping some big news that will cause the shorters some financial plan. Maybe that's my hope.
I suspect it will be a release of the MD&A report and last quarters financials.
I think you meant to say in the last 12-18 months TRXC was once trading at $14/share
Also, this isn't a Titan or Ximedica thing, this was discussed at length by the FDA and the experts they brought in for their symposium last Summer. That included world renowned physicians in robotics as well as representatives from ISRG and Titan.
I am not sure if the FDA has decided this route but it is completely plausible that it is an option for Titan and they would be considering this route for SPORT approval.
That guy said something about Titan being down 12% on the linkedin update regarding Valvo demonstrating SPORT
I didn't realize yesterday was August 22, 2014
http://investor.intuitivesurgical.com/phoenix.zhtml?c=122359&p=irol-newsArticle&ID=1920546
Come on Frank, you are better than that - this article is dated 8/22/2014 - you do realize today is March 18, 2016?
ISRG has had their single port approved by FDA for quite some time, this isn't new.
Looks like all the feedback from Surgeons at SAGES is that TRXC sucks.
Also, you are wrong about FDA approval for SPORT. it won't be 2039, you should do some research, it's right there on their website under milestones.
Or you could have done by SPORT in Asia in 6 months when it will be sold then
Prior to ECV coming on, the Shorts have had a field day and Bertner's Advisors couldn't control them. Based on some of the research on ECV, they are very, very good at controlling the shorts and I am curious to see how they are going to do it now. IMO, the shorts will increase and then ECV will drop something that makes them pay out big time for their short position.
I also found the news that ISRG did NOT have their SP at SAGES very interesting. There is something to that since it has been FDA approved for close to a year and this is the biggest medical conference of the year. Either it is total incompetence by ISRG or they have something else holding them back (patents?). Holding back b/c of pricing is not an argument that holds water, when has ISRG ever been worried about pricing of their system. Even if there was concern on their pricing, they would still have their FDA approved SP at the biggest surgeon conference of the year.
What's interesting about your dialogue on this topic is that it was brought up and discussed at length at the robotics symposium that the FDA had last summer. This was a strong recommendation by the robotics experts for the FDA to consider when approving devices in the future. Approve a surgical robotic platform on the task it can perform rather than on a specific procedure.
I find this info you shared to be extremely, extremely interesting and would leave me to believe that this is the route the FDA is considering in approving SPORT. Great news from my end
Is it true that ALf-x is so big that they could only have 3 of the 4 booms in the booth?
For intuitives SP, do you still have to stick you head into that giant console? Also, is the SP still counterintuitive movements (for uneducated - move your hand right if you want the arm to go left)?
ONe other thing that Titan has going for it when it hits the market and this is the biggest of all - hospitals and their administrator can't wait to stick it to Intuitive and will do so at the first chance they can. Intuitive has basically given the middle finger to any facility looking to work with them over the last 16 years. Titan can be priced the same as intuitive and customers will buy Titan over Intuitive SP. and since Titan will cost the same as a laprascopic procedure and the upfront capital cost will be lower and Titan SPORT will be a next generation surgical robotic platform, it seems to me to be a great situation for SPORT.
The short position might be ISRG - that stock could take a big hit over the next year, IMO
About a week ago, Titan was trading at .60 and ended today trading at .985. What i find interesting about this significant increase over the last week is that it wasn't artificial. What i mean by that is no significant news came out over the last week that was designed to "pump" titan. This increase in PPS was due to the fact that investors realize that SPORT is the next competitor to DaVinci. In fact, Sport is the next generation Surgical Robotic Platform. Can't wait to see what is next.
I thought TRXC was at $14 at one point, How can it be higher than $14 if it is at $4?
Surgibot is NOT a surgical robotic platform - that is one answer to your question. ALF-X is gargantuan, costly and hasn't sold one since it received CE Mark 4 years ago. ALF-X and Surgibot are not compatible with each other - meaning hospitals are not going to be buying two completely different platforms (with one of them not even a surgical robotic platform). Both SPORT and DaVinci will be able to handle single and multiport procedures off of their platform.