Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Thanks IITF. Glad someone else spoke up!
I cant prove Suckitup and Posilock are the same guy but they sure as hell post the same. Their / His claims are never backed up by sources either. I take everything I read on here with a grain of salt until I reaearch it for myself, then I make my own conclusions. I really dont care what Posilock/Suckitup posts but I agree with you, some people might act on what he says. We all can't be right everytime we post something but we all certainly should attempt to post credible information.
IMO!
I know, I just like bustn his chops!
Say what you want about Honeycomb but all I see is a guy who is very passionate about this company. Don't need to fault him for that. His passion leads him to pick everything apart and find what he likes to call "nuggets" of information. CUIN, Point, IITF and several others do the same... they put a significant amount of personal time in gathering information. I dont always agree with their analysis' BUT Im very much appreciative of the time, energy and input!
Okay, time to put the kibosh on this "love-fest!". Is Posilock out of iHub jail yet?
Yup, that's for sure! Strap on your helmets!
The last couple of days have been much more civil... and enjoyable. Just speaking for myself but when there's disagreement about Titan, I enjoy the discussion / debate format much better than the name-calling format. I can play that game too but really dont think this is the best place for that kind of discourse. I'm glad to see everyone bringing the topic back to the reason we are all here - our investment in Titan! At some point down the road we will most likely look back at this stage of the process and laugh. It will be quite satisfying to remember how our perseverance really paid off.
lol true!
lol... it's impressive what he digs up!
I eouldn't doubt it, It's a popular start-up business. Many people are generating income through 3D printing in the medical field.
It's not a guarantee he's right. He obviously used deductive reasoning to narrow it down. He knew it was a relative of an executive and by using the power of the internet and social networking sites, he came up with a pretty solid hypothesis. Private investigators, lawyers, employers, etc use this method all the time. It certainly has made for a lively discussion!
lol was thinking that too... She will see a bunch of profile hits from a dozen or so random dudes all in about a two-hour timeframe. lol
I agree with you guys. Not a great move if she could actually be replacing Talarico. But it sounds like she's just getting paid as a consultant. Let's hope they have others networking internationally as well.
Put it this way, the CEO hires his daughter... If true, not much anyone can do if she fails. This is all on the CEO. Does he have the ability to treat her like any other Titan employee? It could cause rumblings. Really, not a good decision at all.
Wasn't too impressed by his resume' either. So if you are right that she replaced him... not a huge difference in experience!
Yes, I was looking at her CV and just thinking the same thing... She and JT are of the same "mold" career-wise.
Great find IITF! Makes alot of sense!
lol, go to his personal posts. He is banned to The Jailhouse board until 8/20.
I noticed Posilock is in the iHub Jailhouse and cannot post. I didn't even know there was an iHub Jailhouse. Isn't he a Moderator?
Tourette's Syndrome?
This didnt have to be taken so literally...
First off, do we know if the computer in the device has or will have network integration built-in? If so, theoretically it could be hacked anyways. Also, we are talking about a potential advancement down the road. It is not being discussed as a selling point, it is being discussed as a possible future capability to make a point that surgical technology is advancing. In this instance, it was to explain a potential advancement that TRXC cannot offer in Surgibot. It's having a "Big Picture" of the direction of the industry. Of course u are correct, it could not work unless there were major advances in network security as well.
BTW, the government forced eMR on us knowing full well the systems could (and are) be hacked. Perhaps this is where the patchwork for prevention of infiltration should begin. HIPAA doesnt hold much water anymore!
It's not up to her to to decide whether or not to procure an M/A. We don't know the specifics of her agreement but if management decided right now they want to shop the company, Sherry Bertner will do whatever is expected of her to do under the current contract or she will end or re-negotiate her contract. The question isn't whether she would or wouldn't assist in a buyout play. The question is did she negotiate the best possible outcome for her company if there is a buyout? It doesn't appear that she did.
True, TRXC should be at least six months ahead of Titan in the market share race. It will be very interesting later this year and throughout 2015. I hope you do well with the investment. Hope you still have Titan in your portfolio as well! I plan to hold to a good chunk of Titan (or the acquiring company) for awhile. I think both the growth and the technology potential will allow its value to rise for several years. Take some of your profit from TRXC and buy more Titan if a M/A hasnt occurred at the time u sell TRXC!
Good point. I just think investors would be wise to look at how a company's new product will impact the marketplace both near and long-term. People often use the term "game-changer" to describe revolutionary developments. da Vinci was a revolutionary development and hence the company's value exploded (despite shitty customer service). SPORT is a "next logical step" forward. There will be a niche for SurgiBot I'm sure, but Ive put my $ in Titan because the SPORT design is open-ended advancement to the da Vinci system.
Again, you are not looking forward. Imagine an advanced technology and a potential for specialists 100s or 1000s of miles apart to confer and possibilty even work together on difficult cases in an OR. I'm hard-pressed to see how SurgiBot moves surgical robotics forward.
It is a potential future enhancement of the current technology though. Surgibot doesn't offer up much room to advance the technology!
Way to go Suckitup - nice post!
Great to hear actual stories from real-world perspectives. Doesn't sound too promising for Intuitive unless they seriously consider a better pricing strategy. Sounds to me like they are banking on the "coolness factor" of the newly updated machine. That won't cut it with other products soon to be approved.
That's what it sounds like. The timeline makes more sense if that is the case. If SPORT was designated a Class III device, a PMA would take a hell of alot more time than the current forecast.
Actually, I may stand corrected. da Vinci was designated Class II when it was approved. I dont think that has changed. If that's the case then SPORT should have the same designation - Class II, so 510(k) clearance makes sense.
Well the point for me is that 510k clearance guarantees a much earlier product launch in the US than a PMA (which will require more data collection and $). Since Intuitive and Transenterix will most likely be launching their new single port devices possibly early to mid-2015, timing on Titan's approval becomes a bit more crucial. Yes there is plenty of market share to be had but once those two other devices are approved. But every day that SPORT remains in development stage is a day Titan loses in gaining a share of the market. It does matter.
This is from the 5/21 Presentation...
Program Projections - LONG TERM
• Design freeze
• Conduct human clinical trial
• Regulatory submission and FDA approval
• Manufacturing preparations
• Global limited launch
...and this from the May 8th Western U Alumni article referenced on the web site...
“Tissue testing will continue for probably the next eight or nine months. The testing can vary from simply testing instruments by passing a needle through real tissue to an intended procedure, gall bladder surgery,” says Rayman. “We are testing with robotic surgeons in the field using several key opinion leaders.” The goal is to get their machines into operating rooms by 2015.
“We expect in approximately one year to begin initial human pilot studies, human clinical trials, probably outside the United States first,” says Randall. “Europe and Canada are also prime areas for testing the device. All testing will be approved through the regional regulatory bodies that exist right down to the particular hospital and the surgeon.”
Are these studies being done per FDA PMA requirements or just for added assurance for 510(k) clearance?
...this is why Ive said over and over that if they are required to do a study (per a PMA) with a large sample, we aren't even close. It is a time-consuming endeavor.
Which is why I am confused about the fact they've stated numerous times (it is even in the May 21st Corporate Presentation) that they will be conducting clinical trials prior to FDA clearance. SPORT is a Class III device so maybe they've been advised to collect some safety data regardless. Does anybody know why they keep referring to clinical trials?
I think the confusion is arising from the Titan web site TBH. They refer to both clinical trials 510k clearance prior to FDA approval.
The PreMarket Application (PMA) and the 510(k) are two different standards the FDA uses for evaluating devices. The approval process for PMA devices is similar to that for pharmaceuticals in that the FDA requires the manufacturers of PMA devices to prove efficacy and safety by providing data showing the device’s performance in humans. The
regulation of 510(k) devices is different in that the FDA does not require human trials to prove efficacy and safety since these devices are considered to be at least as safe and effective as similar devices already on the market. 510(k) devices must demonstrate only that they have the same intended use and are substantially equivalent to similar devices that were on the market before May 28, 1976. So to tell you the truth, I'm confused at the contradictory language on the web site.
Here's another good, easy to read source for info on device trials...
http://www.experis.us/Website-File-Pile/Whitepapers/Experis/IT_Medicial-Device-Clinical-Trials_091912.pdf
...and as far as the sample size, I don't know exactly how it is determined other than they analyze current data available, determine what data is missing/needed and consult with the sponsor company on what should be incorporated in the study protocol (inclusion/exclusion criteria, sample size, study design, etc).
It will depend on the statistical analysis of the safety profile (number and types of adverse events that occur). Knowing what we know about SPORT, IMO I highly doubt there will be any questions regarding efficacy.
Im trying to find that out. As CUIN has said, it may be because the Spider platform has already been approved and, as I understand it, SurgiBot is an improvement on that platform, correct?
Sorry, i think I misunderstood what BKT was asking... There will be human trials as far as I am aware because SPORT is an entirely new platform. Randall even states this here...
http://www.titanmedicalinc.com/making-human-repairs-with-precision/
That is inaccurate. Human clinical trials are slated to begin in the middle of next year according to Stephen Randall. They have been doing cadaver testing already.
http://www.titanmedicalinc.com/making-human-repairs-with-precision/
Yes, also a concern I have. We all know how political healthcare / medicine has become. All I am doing is looking out for possible roadblocks. Like everyone here, I know Titan is on the right path. We all have to understand there are still outlying factors beyond Titan's control. The second the FDA notifies Titan that they've been approved, this thing goes to a whole different level. Im just being cautious because Ive worked for sponsor companies that assumed theyve had blockbusters in development and they were "under-cut" in some unforeseen fashion.