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.
NO WARRANTS ATTACHED. $35M investment. Q4 - IDE SUBMISSION
Q4 - human clinic trials
JNJ/Titan/Verb/Auris
Great point flenderson. Are there posters saying this isn’t good? Well that should tell u all u need to know. No Warrants, terms are that ASPIRE CANT SELL the shares immediately, no doing them on the market tomorrow. I think it goes up tomorrow. Calling $2.20 end of day Friday. Hey HH777 was right, they raised funds BUT with complete control by Titan.
Aspire capital is all about M&A
JNJ/Titan/Verb/Auris
NO WARRANTS ATTACHED.
Titan can request an influx of cash at anytime.
Still left with $90M on the shelf!
Minimum dilution right now
Under 2% dilution on initial purchase
Great terms for Titan Medical
Titan has full control - no warrants- great news
I think you are mixing up the Endoscopic 3D Camera that is inserted thru the 2D CIT Camera (which is the patent you are referring too).
BTW that McNally/Genova patent means that NO OTHER COMPANY CAN PUT A CAMERA ON AN INSERTION TUBE without using that patent. They will need to either enter blindly or insert a camera thru another point, in essence not truly single port with visualization.
The 3D endoscopic camera is being made by someone else for Titan.BTW, this board is useless.
Have to say, this board is completely useless
Medtronic going to be submitting for IDE approval for their robot
All $125M is available to them
Here is a quote from Dr. Advincula - one of the world's foremost experts on robotic surgery when speaking about Titan Medical:
“During the summative studies, the procedural workflow that highlighted a simple yet sophisticated design approach of the system without reinventing the wheel, was easy to learn for myself and my surgical team. The streamlined design of the system made surgical assisting seamless and safe,” he added. “I was particularly impressed with innovative features like a dual-view camera system consisting of a flexible 3D high-definition camera
http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle&ID=2401031
Dennis Fowler
https://titanmedicalinc.com/titan-medical-inc-announces-dr-dennis-fowler-as-director-of-clinical-affairs-and-the-completion-of-a-regulatory-approval-process-plan-2/
He also became CHIEF MEDICAL OFFICE at KARL STORZ in Jan 2019
Oh..and Chad Zaring former VP of Robotics for Medtronic just signed up as CHIEF COMMERCIAL OFFICER for this apparent sinking ship in Titan Medical (if you believe some). If anyone can come up with a reasonable explanation for that, I and everyone on this board would like to hear about it. If not, the most likely explanation then is that Medtronic placed Zaring at Titan to commercialize SPORT.
I'm willing to bet there is a lot of weak hands out there tomorrow that will unload shares (obviously forgetting about the wash sales rules) and this will fall again, maybe to...i forget but HH777 probably has a number it will fall to....$1.70 he mentioned...
If I sold today, I would have to wait 30 days to buy back in (9/26/19) or else it is a wash sale....
Very interesting that Medtronic's announcement is 9/24/19...
The overlay was on top of that, the position of the end effectors is more navigational and position (or spatial as Dr Advincula refers to it)
My point was that the VC arm of BSCI had invested at some point during Corindus R&D - they eventually sold to Siemens
https://www.massdevice.com/boston-scientific-gets-45-private-placement-corindus-vascular-robotics/
Thanks for clarifying my point, I think JnJ had made some investments in Titan as did Medtronic and at the end Medtronic might have come in and sealed the deal.
So did BSCI as well as Phillips, just proves that Bigguns always do early investment in R&D and sometimes don't end up acquiring the company b/c another biggun came in and made a bigger offer. We all know that Medtronics acquired Mazor, check out the bigguns that invested in Mazor when they were R&D
Overlays are definitely Augmented Reality, nice pickup Samiam1862
https://internetofthingsagenda.techtarget.com/answer/What-are-examples-of-augmented-reality-overlays
One thing I have learned with this stock is never react emotionally, always digest the news first and process it. While I do still maintain that its:
JNJ/Titan/Verb/Auris
and will until the ink dries on the deal BUT I also am willing to admit that I might be wrong on this and it could be Medtronic. All the things Mcnally said in his statement is right out of a biggun playbook.
As for going it alone - non-starter - total horse poop.
We know Medtronic has their Einstein program. Titan made no mention of CE mark or rebranding being pushed back. Its not unusual for multiple competitive bigguns to invest in R&D companies as they go thru the development process and only one of them partners (Corindus was backed by Boston Sci VC, only to be acquired by siemens).
The Zaring hire screams of Medtronic coming in and making a big push for Titan. Certainly the announcement of the offering will clear that up BUT WE ARE STILL WAITING. Maybe this Friday, I am sure that is what HH777 will say.
The IDE process is no joke and in essence is the runway to FDA Approval - any partner who wants to acquire will want to get involved prior. AND THEY WILL WANT TO GET IT RIGHT. If a biggun was to have gotten involved at the doorstep of IDE appoval, they probably would want to take additional time to perfect the system and implement all planned system and sterile instrument interface components, software enhancements and training tools, in order not only to further de-risk the IDE studies, but also to introduce a more refined product in the marketplace. The partner will want a measured development schedule which will allow them to better manage workflow and ensure success.
To them 2-3 months is nothing when you talk about multiple tens of Billions in potential revenue in the surgical robotic space. They will want to make sure they control the IDE process and collect that data for studies and case reports for commercial launch.
I don't hear the noise anymore and it is quite quiet now. I have needed patients and a clear head during this investment, no doubt BUT SINGLE PORT was the right bet. And as Dr. Advincula said, SINGLE PORT is the FUTURE and Titan has the goods.
This is from one of the top Robotic Surgeons in the world - Dr. Arnold Advincula regarding Titan SPORT Platform
Commenting on the HFE, Arnold Advincula, M.D., Vice-Chair of Women’s Health & Chief of Gynecology at the Sloane Hospital for Women, Columbia University Medical Center/New York Presbyterian Hospital, and the Company’s Medical Advisor on Clinical Education and Hospital Economics, said, “It was exciting to see the latest improvements with the system during my recent participation in the summative human factors studies. For any novel surgical approach to gain a strong foothold in gynecology and other surgical specialties, the system must be user-friendly without compromising technical efficacy and surgical experience.
“During the summative studies, the procedural workflow that highlighted a simple yet sophisticated design approach of the system without reinventing the wheel, was easy to learn for myself and my surgical team. The streamlined design of the system made surgical assisting seamless and safe,” he added. “I was particularly impressed with innovative features like a dual-view camera system consisting of a flexible 3D high-definition camera along with an integrated 2D high-definition camera, and insightful overlays providing valuable spatial information for the multi-articulating instruments. These features are vital for simplifying single-port robotic surgery for the surgical community predominantly familiar with multi-port approaches. I remain enthusiastic with all the progress I am seeing toward making single-incision robotic surgery a reality that will become a standard part of our minimal access surgical armamentarium.”
Excellent due diligence and ability to string it together - keep it coming, it gets harder and harder as the pieces come together to refute the info in front of us all. And those that just say its bull or you are rehashing old info gives credence to the fact that they don't really understand everything that has and is taking place in this space.
Knobbe Martens.....where have we heard that before...oh that's right, they prosecuted the ENOS trademark for Titan. That's pretty obvious though b/c that is so recent.....where else have I heard of Knobbe Martens...of course, they also prosecute patents for Auris Health which was acquired by JNJ.
Just a coincidence, though, i think... maybe...well....uh.....
"In the year 2000, if Intuitive Surgical walked into a room and said 'we're going to be worth $60 billion in 20 years' nobody on the planet would have believed them. Nobody," said Leo Petrossian
Quote from this article
https://www.mddionline.com/do-you-have-what-it-takes-become-next-intuitive-surgical
AND THAT was before their was robotic surgery. Intuitive has paved the road meaning any viable competitor will get up and running much quicker, it would take a next generation surgical robotic platform done right maybe 1/4 of the time to reach ISRG's level.
"in the year 2019, if Titan Medical walked into a room and said 'we're going to worth $60B in 5 years' nobody on the planet would have believed them. Nobody" yet they are worth that in 2024.
Its a steal at $8 Billion. Intuitive better step up, they of all people know the potential that Single Port and the SPORT platform is capable of in 5 years - well over $8-10 Billion a year in revenue by 2024 with double digit growth YOY.
Gotta go right now, heading to white sandy beaches, then I play 9 holes of golf tomorrow and shoot 9 under.
Many of Intuitives patents are set to expire, nice article from one of the top Intellectual Property law firms in the world
http://legacymedsearch.com/dominant-robotic-surgery-patents-expiring-this-year-whats-coming-next/
It’s going to be a Medtronic/Mazor type deal. Meaning the biggun will come in and sign a deal that will help them finish regulatory and help w sales/marketing and distribution upon approval. With eventual buyout. I don’t think we will see a biggun come in and outright buy Titan in overnight deal. A lot of advantages to partnering and letting Titan operate nimbly and quickly to complete this.
As for who, as I’ve always said:
JnJ/Titan/Verb/Auris
And if it is Medtronic at $8 Billion, I’ll have plenty of money to eat crow and celebrate that I invested in the right surgical robotic platform.
Some timeline that will help increase the value of Titan - for investors to keep in mind.
First off, TRXC has a market cap of $250M and Titan is at $70M - so once the financing is announced we should see a run up to $250M MC at a minimum. Then the value will continue to go up based on the following milestones:
IDE approval in 30 days or so - Value goes up
Human Factors completion - Value Goes up
IRB approval at 4 major worldwide institutions - Value goes up
Successful Human clinical trials - Value goes up
Regulatory submission for CE Mark in Q4 - Value goes up
510k submittal in Q4 - Value goes up
FDA submittal in Q4 - Value goes up
CE MARK - VALUE GOES WAY UP
FDA Approval, H1 2020 - VALUE GOES WAY, WAY, WAY up.
PO's for systems from the 4 facilities doing the human clinical trials AND POs for multiple system after approval - Value is north of $10B
Oh and another reminder about the IDE - Titan will need a US Sponsor to submit for them
Foreign companies/studies
Can a foreign company submit an IDE/Is a U.S. Sponsor required?
A foreign company cannot sponsor an IDE; the company must have a U.S. agent who acts as the sponsor (see 21 CFR 812.18(a)). The U.S. agent must fulfill all the responsibilities of a sponsor identified in the IDE regulations.
Do clinical studies have to be conducted in the U.S. / Will foreign studies be accepted?
The FDA continues to promote global harmonization in many aspects of medical device development and regulation, including our commitment to recognize the value of and accept, where appropriate, data from multiple sources and countries.
Who Must Apply for an IDE
The sponsor of the clinical trial is responsible for submitting the IDE application to the FDA (§812.40) and obtaining Institutional Review Board (IRB) approval before the study can begin. Foreign companies wanting to conduct a clinical study in the U.S. MUST have a U.S. sponsor (§812.18).
For more information regarding the FDA’s acceptance of clinical data refer to our page on Acceptance of Data from Clinical Investigations for Medical Devices and the FDA guidance entitled “FDA Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions.”.
.... wonder who it will be..........
Why 60 days? The FDA can approve an it within a couple of days of submittal. The MAX TIME it can go unapproved is 30 days. How do you know that Titan hasn't already submitted the IDE application? How do you know it won't be submitted this week? OR Even next week. All of that would indicate that approval will be granted within 30 days, AT THE MAX. So I believe that my statement is well within the timeline.
https://www.fda.gov/medical-devices/device-advice-investigational-device-exemption-ide/ide-approval-process
Do please provide evidence that Titan hasn't submitted IDE application?
If you can provide, then I will revise based off that evidence and put the exact date a MAX TIME OF 30 DAYS from that date.
Every Major Medical Device company wants a robot:
https://www.medicaldesignandoutsourcing.com/these-7-trends-matter-the-most-for-medtech-in-2019/2/
BUT Titan will be either JnJ or Medtronic. Hard to believe that Intuitive won't offer up cash and stock to lock up Single Port over the next decade or so. They better step up and make a substantial offer or they will be in serious trouble 3 years from now. I'm sure they thought Titan would go the way of Computer motion and they could get it cheap but that time has passed. Intuitive will have to make an offer of $10B or more earlier then they should just to keep it from going to JnJ or Medtronic.
IDE approval in 30 days or so - Value goes up
Human Factors completion - Value Goes up
IRB approval at 4 major worldwide institutions - Value goes up
Successful Human clinical trials - Value goes up
Regulatory submission for CE Mark in Q4 - Value goes up
510k submittal in Q4 - Value goes up
FDA submittal in Q4 - Value goes up
CE MARK - VALUE GOES WAY UP
FDA Approval, H1 2020 - VALUE GOES WAY, WAY, WAY up.
PO's for systems from the 4 facilities doing the human clinical trials AND POs for multiple system after approval - Value is north of $10B
ALL OF THIS WITHIN 12 MONTHS.
Great Point on Frederico - guy is not in this for any extended period of time, he is here for one reason and that is to get the best deal done for Titan. That is why I am not surprised their is a bidding war going on right now for Titan.
Titan has had a ton of conversations with the FDA and have been told exactly what the need to do and document for approval. I believe Titan has already delivered on 80-85% of the info that the FDA requires for approval and the final 15-20% will be completed upon human clinical trials.
The FDA approval process will be shorter then most b/c of all the documentation and discussions that have taken place. In the past, companies would do all this work and then submit all at once to the FDA which in turn they would have to take 6-9 months to review and then make a decision. In Titan's case, they have been discussing with the FDA over the last 12 months and submitting info that is reviewed by FDA that they would normally review after regulatory submittal. I am expecting quick 510k approval after submittal and FDA process to be shorter than people are expecting it to be.
Randall being the guy that said all the warrants will be in the money - don’t believe it, ask cptsjd how that turned out for him.
I believe it will go the route of a Medtronic/Mazor deal Or The jnj/Auris route. Basically the eventual partner takes a public position thru an investment and based upon milestone achievements they will increase their investment/stake in the company and will eventual buyout the remainder of the company at a set milestone. During that time PPS will continuously and consistently rise.
I would like to see the partner reveal themselves when the clinical trials start which would be in early Q4. I think definitely after regulatory approval (CE mark in late Q4, early Q1) the partner will surface if they haven’t by that time.
great post, make note of those that say "so what".
Every Major Medical Device company wants a robot:
https://www.medicaldesignandoutsourcing.com/these-7-trends-matter-the-most-for-medtech-in-2019/2/
BUT Titan will be either JnJ or Medtronic. Hard to believe that Intuitive won't offer up cash and stock to lock up Single Port over the next decade or so. They better step up and make a substantial offer or they will be in serious trouble 3 years from now. I'm sure they thought Titan would go the way of Computer motion and they could get it cheap but that time has passed. Intuitive will have to make an offer of $10B or more earlier then they should just to keep it from going to JnJ or Medtronic.
IDE approval in 30 days or so - Value goes up
Human Factors completion - Value Goes up
IRB approval at 4 major worldwide institutions - Value goes up
Successful Human clinical trials - Value goes up
Regulatory submission for CE Mark in Q4 - Value goes up
510k submittal in Q4 - Value goes up
FDA submittal in Q4 - Value goes up
CE MARK - VALUE GOES WAY UP
FDA Approval, H1 2020 - VALUE GOES WAY, WAY, WAY up.
PO's for systems from the 4 facilities doing the human clinical trials AND POs for multiple system after approval - Value is north of $10B
ALL OF THIS WITHIN 12 MONTHS.
U do know Pinocchio was a fake made up story and not real. So u are saying that I am a wooden doll and a biggun is Geppetto. Someone behind the scenes pulling the strings.
Ok, yes I agree with you that their is a biggun behind the scenes of Titan pulling the strings. Been saying that from day one:
JnJ/Titan/Verb/Auris
JNJ/Titan/Verb/Auris
Don’t get worked up, he thinks Titan Spine is a r&d start up soft tissue surgical robotic system.
Good look at Intuitive's Endoluminal platform:
https://www.intuitive.com/en-us/products-and-services/ion?utm_medium=sm&utm_source=linkedin&utm_campaign=fy19q3%20ionbyintuitive&utm_content=post6li&utm_audience=surgeon&utm_product=ion&utm_vertical=thoracic#ionprecision
To recap, the market creator and industry leader in surgical robotics - Intuitive has the following platform:
Multi-Port, Single-Port and Endoluminal
Any biggun or someone who wants to be a biggun in robotic surgery will need the following:
Multi-Port, Single-Port and Endoluminal
So what does the playing field look like:
Multi-Port - just too many companies to list but we all know them (i.e.Intuitive, CMR, Senhance, Medtronic, JnJ, etc....)
Single Port - Titan Medical, Intuitive, virtual incision
Endoluminal - Intuitive, JnJ(Auris), medrobotics
Things are getting interesting. IDE approval in about 30 days.