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Chapel Hill office shutting down? TMDI heading back to Canada with tail between its legs? For years TMDI just hid info or flat out lied to us, IMO, but now we are supposed to be happy that they are communicating the continued screw ups (ie delays)? Let me find where my gold star stickers are...
Big Fan Of The Communication Process and Recent Patent Production…. $7.5 Billion this will sell for
“We continue to carefully monitor our project plan. With recent changes, we believe we have the right people, resources and partners in place to execute against our project delivery timeline. This team is committed, engaged and accountable, and we’re excited to bring our vision of single access robotic assisted surgery to the market,” concluded Paul Cataford.
About Titan Medical
Titan Medical Inc. (Nasdaq: TMDI; TSX: TMD), a medical device company headquartered in Toronto, Ontario and with operations in Chapel Hill, North Carolina, is focused on enhancing robotic assisted surgery using innovative technology through a single access point.
Didn’t Paul say on multiple occasions that they all were super focussed and had their head down working so hard towards IDE?
And now we learn they’ve had difficulties recording software engineering talent?
I bet ya Jazzy is banging on the interm CEOs door saying I want to re-price those $.53 RSUs that I was awarded back in April.
Surprise surprise, the work horses got stuck with a higher price while the interim CEO and a board member got the RSU’s in the 40s. Go figure!
Give me a CEO bump so I can take some money off the table!
.40’s before .70’s.
BelizeMe
Been at this science project for 10 years....last 5 of which have been nothing but lies / delays / fake cost estimates & timelines. YEP
* and they will likely get to kick the can for 6 more months. smh
#PAYem
It really is amazing to see the Titan shareholder base take yet another delay, which includes fundamental questions around the software function of the device, as a hugely bullish indicator.
Some of my favorite takes:
- Martha encouraged the PR to go out to prevent the stock going too high (LOL). All sorts of problems with this from an SEC standpoint and not to mention a guaranteed DOJ investigation with massive penalties to boot. This is the best of them all ...
- The timing indicating that a buyout is any day now - what?! Of course that's why McNally and Perry quit/resigned/were fired recently!
- That delays are just normal course for med devices (at least they are for Titan)
Titan Communication went from a D to a C+ IMO. WHHHHHEEEEEEEEE
Let's celebrate more delays - pretty sure 180 day extension is coming. smh
For starters, move everything out by 2 qtrs and then cross those fingers. Dilution City coming....AGAIN
I have to laugh - WHY on earth would he state that the team is accountable ? UMMM:
FDA submission in 2017 - Nope
FDA submission in 2018 - Nope
Design Freeze - Nope
FDA submission in 2020 - Nope
I give it about a 7.77% chance FDA submission finally comes on their 4x revised timeline.
Accountable - that's f'n funny !! Yep
Almost 7 months and no new CEO = Winning
#Nice
** Longer and longer things take, the Higher and higher the costs become
End of Q2, selection on new CEO. Lets go Stacey Abrams!
Further delays...yeah, go TMDI.
Read this PR closely - they mention delays driven by supply chain but most importantly software engineers.
This is a big flag if you are paying attention. This certainly means the Enos system is still being worked on at a fundamental level (that the imaging/displays and inputs are appropriately translating to outputs - the movement of the bot). Worse yet, it may mean they still haven’t figured out the interference and operability with other OR equipment issue that was cited in the prior launch delay PR from a few years ago.
This could very well be the “amuse-bouche” for a full course meal of disappointment and delays to come ….
And, these disclosures typically happen right before raising capital so a new investor knows that the market has fully priced in all the latest info.
Bad news….another delay/disruption in the timeline…
Titan Medical Provides Update to Enos Project TimelineDe Novo marketing authorization planned for early 2025 remains unchanged
TORONTO, June 28, 2022 (GLOBE NEWSWIRE) -- Titan Medical Inc. (Nasdaq:TMDI; TSX: TMD), a medical device company focused on the development and commercialization of innovative surgical technologies for single access robotic-assisted surgery (RAS), today announced that multiple disruptions have resulted in an updated Investigational Device Exemption (IDE) submission timeline for the Enos robotic single access surgery system. The company now expects the IDE submission to occur mid-year 2023 instead of the first quarter of 2023. Pending successful regulatory review and upon receipt of marketing authorization, the expected U.S. product launch for the Enos system remains on schedule for early 2025.
We have been fortunate to have avoided and mitigated against many of the issues facing almost all other technology companies over the last few months. However, we now expect our targeted IDE application date to be pushed out to the summer of 2023. Human clinical trials are still planned to start in 2023 and we expect to receive marketing authorization in the U.S. in early 2025, said Paul Cataford, Interim President and CEO.
The Enos project timeline has been impacted by several factors including:
Supply of certain key components and materials has affected the production of instruments and camera systems and the delivery of capital equipment resulting in delays for verification and validation testing.
Recruitment and resourcing of software engineers and developers has resulted in delays in unit testing procedures and certain documentation activities.
Delayed procurement of disposable and consumable components resulted in delays in cleaning and disinfection testing and the GLP study required for the IDE submission.
We continue to carefully monitor our project plan. With recent changes, we believe we have the right people, resources and partners in place to execute against our project delivery timeline. This team is committed, engaged and accountable, and were excited to bring our vision of single access robotic assisted surgery to the market, concluded Paul Cataford.
About Titan Medical
Titan Medical Inc. (Nasdaq: TMDI; TSX: TMD), a medical device company headquartered in Toronto, Ontario and with operations in Chapel Hill, North Carolina, is focused on enhancing robotic assisted surgery using innovative technology through a single access point. The Enos robotic single access surgical system is being developed with an ergonomic focus to provide a surgical experience that imitates real-life movements that surgeons demand and includes multi-articulating instruments designed to allow surgeons an increased range of motion in a confined space, with dexterity and the ability to exert the forces necessary to complete common surgical tasks. With the Enos system, Titan intends to initially pursue gynecologic surgical indications.
Enos is a trademark of Titan Medical Inc.
For more information, visitwww.titanmedicalinc.comand follow@TitanMedicalon Twitter andLinkedIn.
Transparency is always a good thing. There was no transparency or truthfulness from McNally.
Interesting indeed. I believe this is the “we’ve been on holidays for the last quarter’ presser.
Whoever would have seen this coming?
https://ca.finance.yahoo.com/news/titan-medical-provides-enos-project-113000867.html
what do you think of the change in communication?
With McNully we would have known in the second half of 2023
Nice and thanks.....still adding
https://pdfpiw.uspto.gov/.piw?PageNum=14&docid=11369353&IDKey=8D79D6161BC4&HomeUrl=http%3A%2F%2Fpatft.uspto.gov%2Fnetacgi%2Fnph-Parser%3FSect1%3DPTO2%2526Sect2%3DHITOFF%2526p%3D1%2526u%3D%25252Fnetahtml%25252FPTO%25252Fsearch-bool.html%2526r%3D1%2526f%3DG%2526l%3D50%2526co1%3DAND%2526d%3DPTXT%2526s1%3D%252522titan%252Bmedical%252522%2526OS%3D%252522titan%252Bmedical%252522%2526RS%3D%252522titan%252Bmedical%252522
https://pdfpiw.uspto.gov/.piw?PageNum=16&docid=11369353&IDKey=8D79D6161BC4&HomeUrl=http%3A%2F%2Fpatft.uspto.gov%2Fnetacgi%2Fnph-Parser%3FSect1%3DPTO2%2526Sect2%3DHITOFF%2526p%3D1%2526u%3D%25252Fnetahtml%25252FPTO%25252Fsearch-bool.html%2526r%3D1%2526f%3DG%2526l%3D50%2526co1%3DAND%2526d%3DPTXT%2526s1%3D%252522titan%252Bmedical%252522%2526OS%3D%252522titan%252Bmedical%252522%2526RS%3D%252522titan%252Bmedical%252522
https://pdfpiw.uspto.gov/.piw?PageNum=20&docid=11369353&IDKey=8D79D6161BC4&HomeUrl=http%3A%2F%2Fpatft.uspto.gov%2Fnetacgi%2Fnph-Parser%3FSect1%3DPTO2%2526Sect2%3DHITOFF%2526p%3D1%2526u%3D%25252Fnetahtml%25252FPTO%25252Fsearch-bool.html%2526r%3D1%2526f%3DG%2526l%3D50%2526co1%3DAND%2526d%3DPTXT%2526s1%3D%252522titan%252Bmedical%252522%2526OS%3D%252522titan%252Bmedical%252522%2526RS%3D%252522titan%252Bmedical%252522
Nice to see Andrea Bajo is still pump’n out the IP for Titan. Dude is money!!!!!!
BOOM
https://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=1&f=G&l=50&co1=AND&d=PTXT&s1=%22titan+medical%22&OS=%22titan+medical%22&RS=%22titan+medical%22
Articulated tool positioner and system employing same
Well they will need to do a raise just to finance her eating habits!
What a tremendous opportunity to get back in, this is heading to $10 let’s go Titan!!! Long and Strong
I can tell you one thing for sure I wouldn’t want to be short from .42 cents!
My friend Jerry is a big investor in Titan and gets all the inside scoop!!
Rumor has it Stacey Abrams is slated to be the next CEO;)
Who wants to bet this hits the .40’s again before .80’s ??
I’ll take the .40’s. Going low on this stock is always the smart bet.
BelizeMe
has design been refrozen ? smh
Wish I could but it’s never certain until it’s disclosed.
Wish I could but it’s never certain until it’s disclosed.
Very interesting news coming soon!
Let's amp up those scoopems, tic tocs, booms, we're waitings, smiles, and all the rest for the weekend!
They can’t regain compliance…hey listen this company was worth A LOT MORE on the OTC and before the Medtronic deal….
and THAT’s a true story bro…
Probably half a million in RSU’s.
When is that NASDAQ compliance notification coming out? Nothing like going to major investor conferences from a position of strength!
Titan Medical
January 10, 2022 Titan Medical Corporate Presentation
https://d1io3yog0oux5.cloudfront.net/_101e2d94c73b26bc133246c537736f29/titanmedicalinc/db/1086/9873/pdf/Titan+-+IR+Presentation+-+Q1+2022+FINAL.pdf
*200+ patents issued or pending
Surgeon Feedback From Initial Clinical Testing:
Ricardo Estape, M.D., a robotic gynecologic oncology surgeon from South Miami Gynecology Oncology Group who specializes in robotic single port surgeries, said, “The SPORT Surgical System performed beyond my expectations and I was able to complete a variety of critical surgical tasks with the necessary dexterity and precision through a single incision. The robotic instruments provided the necessary articulation, range of motion and rigidity along with 3D high-definition video on the flat panel monitor that allowed me to complete the surgery in a comfortable posture. This could be a game changer in gynecological surgery.” SEE VIDEO
Eduardo Parra-Davila, M.D., a robotic colorectal surgeon at Florida Hospital who has trained thousands of surgeons worldwide on robotic surgery, commented, “Single port surgery without robotic assistance is not easy and yet it remains highly beneficial because of the desire to have fewer ports. It’s all about robotic articulation delivered through a single incision that allows for the reach, necessary angles and multi-quadrant access to treat diseases in colorectal surgeries. The SPORT Surgical System has the promise to become a valuable tool for all robotic surgeons looking to do single port surgery in the future.” SEE VIDEO
Arnold Advincula, M.D., Chief of Gynecologic Specialty Surgery at Columbia University and an expert in robotic surgery, said, “After using the SPORT system, I am more convinced that single-port robotic surgery could become a reality for many patients. Previous approaches to single-incision surgery have been limiting and ineffective. The SPORT system demonstrated that it can not only address those limitations, but it may also provide some unique capabilities for enabling a variety of gynecologic surgeries through a single incision. The future of single-port robotic surgery is bright and I am excited to actively participate in this journey with Titan Medical.”
Vipul Patel, M.D., a world-renowned robotic urology surgeon from the Global Robotics Institute at Florida Hospital and the only surgeon in the world to have completed 10,000 robotic prostatectomies, said, “Although multi-port robotic prostatectomy is currently the standard of care in urology, single port robotic surgery could be the next frontier in urology and other surgical disciplines. It was exciting for me to use Titan Medical’s SPORT system at Florida Hospital Nicholson Center. The technological capabilities of the SPORT system are very encouraging and the early success in establishing feasibility is an important step in the right direction.”
William Burke, M.D., a gynecologic oncologist at Stony Brook University Hospital with extensive robotic surgery experience, commented, “Having completed thousands of multi-port robotic surgeries over several years of practice, I was pleased with the capabilities of the SPORT system that eased my transition from a multi-port approach to single-port robotic surgery. The workspace, access and ease of use while maintaining critical multi-port robotic features such as multi-articulated instruments and high-definition 3D visualization through a single incision, are important factors in transitioning from multi-port to single-port robotic surgery. I must say that the SPORT system, with its sophistication, makes a highly compelling case for single-port robotic surgery.”
Lee Swanstrom, MD, FACS, Chief Innovation Officer of IHU Strasbourg, said, “I was pleased with my first experience with the SPORT system for applications in abdominal procedures. There are many patients undergoing general surgical procedures who could greatly benefit from a reduced number of incisions. Single-port robotic surgery can be a truly enabling solution for patients and surgeons alike, and it is exciting to see that the SPORT system takes us much closer to that possibility.”
Jelle Ruurda, MD, a gastrointestinal and oncologic surgeon at University Medical Center Utrecht, who has several years of robotic surgery experience, commented, “Many oncologic general surgery procedures require specimen retrieval at the end of the procedure. These procedures are natural applications for single-port robotic surgery. My first operation of the SPORT system in a preclinical environment was very exciting, and the system shows great promise for future clinical use. I look forward to the opportunity to work together with Titan Medical to evolve a single-port robotic surgery option for my oncology patients. Based on this first experience, I am confident that single-port robotic surgery has a bright future”.
Eric Barret, MD, a world-renowned robotic urologic surgeon at Institut Mutualiste Montsouris, said, “Having performed many single-incision robotic surgeries with flexible, non-wristed and crossed-over instruments, my first experience with the SPORT system was exceptional. The SPORT system addresses many limitations of previous laparoscopic and robotic single-incision surgery approaches, and holds significant promise for meaningful use in urologic applications.”
The SPORT Surgical System is a versatile single incision advanced robotic surgical system that features state-of the-art multi-articulated instruments with single-use replaceable tips, 3D high definition visualization on a flat-screen monitor, ergonomic open workstation and a single-arm mobile patient cart for ease of set up while enabling broad applications of single and multi-quadrant surgeries previously not possible with current robotic solutions.
Titan Medical Inc. is a Canadian public company, headquartered in Toronto, Ontario, that trades on the Toronto Stock Exchange (TMD) and the OTCQX in the United States (TITXF). Titan is developing the SPORT™ (Single Port Orifice Robotic Technology) Surgical System for use in minimally invasive surgery (“MIS”) that is expected to be commercially available in 2019. Titan’s robotic surgical system is being designed to expand robotic surgery into areas that are currently underserviced. This will allow surgeons to perform procedures within small to medium size surgical spaces such as general surgery and cholecystectomy. Currently, the most common medical procedures for which robotic systems are used are hysterectomies and prostatectomies. Titan plans to expand the scope and obtain approval for various surgical procedures as outlined in their Corporate Presentation. http://www.titanmedicalinc.com/
Interim President & CEO
In his over 10 years at Zephyr, Mr. Cataford was able to grow the team to over 65 people, clear class II medical devices through both 510 (k) and De Novo FDA approval paths and build a 13485: 2016 certified manufacturing facility. Zephyr successfully closed on two joint ventures with established dental technology companies raising over $20 million from a combination of strategic and private investors. He brings significant high technology and medical device company experience and is a key contributor to strategy, M&A, corporate finance, governance, team building and empowerment and scale. Over the last 25 years, Mr. Cataford has also served as independent corporate director on a number of TSX, TSXV and NASDAQ company boards including: Sierra Wireless, Inc., Trakopolis IoT Corp., SemiBioSys Genetics Inc., and AGJunction Inc. Mr. Cataford has a Bachelor of Science degree in Mechanical Engineering from Queen’s University, an MBA specializing in Finance and International Strategy from Schulich School of Business at York University, and is a graduate of the Institute of Corporate Directors – Directors College, Rotman School of Business at the University of Toronto.
Dr. Advincula is Vice-Chair of Women’s Health & Chief of Gynecology at the Sloane Hospital for Women, Columbia University Medical Center/New York Presbyterian Hospital. Formerly, he was Professor of Obstetrics and Gynecology, Director of the Minimally Invasive Surgery Division and Fellowship, and Director of the Endometriosis Center at the University of Michigan. More recently, he was Director of the Center for Specialized Gynecology and Director of the Education Institute at the Nicholson Center, an advanced medical and surgical simulation training facility at Florida Health. He is currently Vice President of the American Association of Gynecologic Laparoscopy and a Member-at-Large for the Society of Gynecologic Surgeons. He is a leader in minimally invasive surgical techniques and one of the world’s most experienced gynecologic robotic surgeons, who has published and taught extensively in the area of minimally invasive surgery, as well as developed surgical instruments that are in use worldwide.
Dr. Juliane Bingener is Professor of Surgery, Mayo Clinic College of Medicine, and Vice Chair for Quality, Safety and Service in the Mayo Clinic Department of Surgery. She has a joint appointment in the Division of Gastroenterology and Hepatology, which supports her clinical interests in minimally invasive surgery, endoscopy, and gastrointestinal disease. Her research focuses on patient reported outcomes and novel technology in the diagnosis and treatment of these diseases. Dr. Bingener’s previous work included the development of a Natural Orifice Translumenal Endoscopic Surgery (NOTES) technique for using an omental patch to close perforated ulcers. Her ongoing interests focus on the development, study, and implementation of innovative endoscopic and laparoscopic approaches for gastrointestinal diseases.
Dr. Boyd is a Professor of Surgery and Director of Robotics and Biosurgery at the University of California Davis. He is Head of Adult Cardiac Surgery and Surgical Director of the Transcatheter Valve Program. He is recognized for his pioneering work in cardiothoracic surgery and for his use of robotic-assisted surgical systems. He specializes in minimally invasive cardiac and robotic-assisted heart surgery. Dr. Boyd completed the world’s first closed-chest, beating-heart coronary artery bypass surgery using a robotic system in 1999. Prior to his appointment as a professor of surgery at UC Davis Health System, Dr. Boyd served as chair of the Department of Cardiothoracic Surgery at the Cleveland Clinic in Florida. As the author of more than 70 peer-reviewed, journal articles, Dr. Boyd’s research interests include cardiac tissue regeneration using extracellular matrix/stem cells, new techniques for robot-assisted minimally invasive coronary artery revascularization, valve surgery and tele-surgery. He is a graduate of Carleton University in Ottawa, Canada and obtained his medical degree from the University of Ottawa, Canada.
Dr. Litwin trained in General Surgery at the University of Saskatchewan, and completed a hepatobiliary fellowship at the University of Toronto. He was an early pioneer in laparoscopic surgery, having performed the first laparoscopic cholecystectomy in Western Canada in 1990 and the first laparoscopic colectomy in Canada in 1991. He was a leader in educating a large number of surgeons across Canada in basic and advanced laparoscopic techniques. During the early advent of minimally invasive surgery, he innovated new laparoscopic approaches to the spine and aorta, and he participated in the development of HandPortTM, a hand assist device for laparoscopic surgery. In 1993, Dr. Litwin became the Director of Minimally Invasive Surgery at the University of Toronto. In 1997, he moved to the University of Massachusetts as Chief of Minimally Invasive Surgery. Since 2004, he has been Chairman of Surgery at the University of Massachusetts Medical School and UMass Memorial Medical Center, one of the largest Academic Health Sciences Centers in Massachusetts. There, he continues to practice minimally invasive surgery of the abdomen in addition to his administrative role.
Dr. Swanstrom heads the Division of GI and Minimally Invasive Surgery at the Oregon Clinic and is Director of the Providence Health System’s Complex GI and Foregut Surgery Postgraduate Fellowship Program. In addition, he is Clinical Professor in the Department of Surgery at OHSU, a Director of the American Board of Surgery, and Past President of both the Society of American Gastrointestinal Endoscopic Surgeons (SAGES) and the Fellowship Council (FC). Most recently, he became the Chief Innovations Officer and Director of the Innovations Fellowship at the Institutes des Hôpitalo Universitaires of the University of Strasbourg, France. He is the editor of Surgical Innovation and the author of over 300 scientific papers and 50 book chapters. This has resulted in 13 patents and a successful medical device startup company. He is and has been an investigator on numerous outcomes research studies for new procedures such as Natural Orifice Translumenal Endoscopic Surgery (NOTES) to determine their safety and efficacy for establishing new standards of care. He remains focused on developing innovative approaches to the minimally invasive treatment of foregut and other gastrointestinal disorders.
Dr. Valvo, a practicing surgeon, is the Executive Director of Robotic and Minimally Invasive Surgery at Rochester General Hospital in Rochester, New York, where he formerly was the Chief of Urology. Following a 20-year career performing open surgery, Dr. Valvo founded the robotic surgery program at Rochester General Hospital in early 2004, which currently ranks in the top two percent of robotic surgery volume in the United States. The program has trained over 30 robotic surgeons and enabled the completion of more than 7,000 robotic urology, gynecology, general and colorectal surgeries to date. Dr. Valvo has authored more than 100 scientific articles and helped start many robotic programs in the northeast. His focus on robotic surgery credentialing led to a notable published paper on policy guidelines for robotic surgery. He is a fellow of the American College of Surgeons and American Urological Association, and a member of the Society for Laparoscopic Surgeons.
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