Titan Medical, Teleflx ink collab robotic ligation dev deal

Teleflex, Titan Medical

Titan Medical (NSDQ:TMDI) said today that it inked a collaborative development deal with Teleflex (NYSE:TFX) to integrate its polymer ligation technology into Titan’s Sport single-port robotic surgical platform.

Toronto-based Titan Medical said that Wayne, Penn.-based Teleflex’s polymer ligation system is intended for vessel sealing and includes an enhanced clip security feature that has been previously used in millions of cases.

“Our patented, multi-articulating instruments have been developed to facilitate the integration of advanced tools and technologies. This collaboration with Teleflex permits the expansion of our robotic instrument portfolio to offer market-leading, proven technology in a variety of surgical disciplines. Teleflex is a leading and innovative medical technology company with whom we share a common purpose of improving patient outcomes with clinically-inspired technology. We are proud to be working with them,” Titan Medical prez & CEO David McNally said in a press release.

“We continue to partner with leading robotic companies to allow surgeons globally to use our trusted Weck ligation solutions. We are excited about Titan Medical integrating our technology into its single-port robotic surgery system,” Teleflex surgical division GM James Ferguson said in a prepared statement.

Late last week, Titan Medical said that it closed a $25 million public offering.

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Titan Medical closes $25m offering

Robotic surgical platform developer Titan Medical (NSDQ:TMDI) said today it closed a $25 million public offering.

The Toronto-based company said that it floated approximately 7.4 million units in the offering at a price of $3.40 per unit. Each unit offered was comprised of a single common share of the company and a warrant for an additional common share at a price of $4, set to expire on March 20, 2024.

The offering included a fully-exercised over-allotment option through which the company floated an additional 1.1 million units for an additional approximate $3.8 million, Titan Medical said, bringing the total raised up to approximately $28.8 million.

Shares offered in the round were listed and posted for trading on both the Toronto Stock Exchange under the symbol “TMD” and on the Nasdaq Capital Market under the symbol “TMDI,” according to a press release.

Last month, Titan Medical said that it is hoping to launch an FDA investigational device exemption trial of its Sport robotic surgery platform by the fourth quarter of this year.

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Titan Medical prices offering of up to $25m

Titan Medical (TSX:TMD;OTC:TITFX) said today that it filed an overnight prospectus for a stock offering worth up to $25 million.

The Toronto-based surgical robotics developer said the flotation aims to raise between $20 million and $25 million from the sale of units consisting of a stock share and a warrant, plus a 30-day over-allotment option of up to 15% of the floated units.

Titan said it plans to issue the units at $3.40 apiece, with the warrants exercisable at $4.00 for five years following the close.

The proceeds are earmarked for further development of Titan’s single-port robot-assisted surgery platform, called Sport, plus working capital and other expenses.

Bloom Burton Securities is the agent for the offering, with Northland Securities as U.S. sub-agent, Titan said.

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Titan Medical hopeful for Q4 FDA IDE trial launch for Sport robotic platform

Robotic surgical platform developer Titan Medical (NSDQ:TMDI) said late yesterday that it is hoping to launch an FDA investigational device exemption trial of its Sport robotic surgery platform by the fourth quarter of this year.

The news came as part of the Toronto-based company’s 2018 earnings report, with the robotic surgical company saying that it is hopeful it will finish verification and validation testing followed by design freeze and animal and cadaver studies to support regulatory clearance filings during the first half of 2019.

Following that testing, Titan Medical said it hopes to submit an IDE study application to the FDA during the first half of this year, with a study launch following during the fourth quarter. The company added that it hopes to submit both a 510(k) premarket notification and technical files to support CE Mark approval in the European Union by the end of the year.

In its earnings report, Titan Medical saw losses shrink 32.6% from approximately $33.6 million in 2017 to approximately $22.6 million in 2018. Research and development expenses ballooned, however, rising 60.7% from approximately $12.9 million in 2017 to approximately $32.9 million in 2018.

“2018 was an exceptionally busy and productive year for Titan Medical as we achieved all milestones related to the development of our Sport single-port robotic surgery system. I want to congratulate the Titan Medical team and our business partners for their dedication as we continue our important work toward commercialization. By our internal estimates, we believe there is an opportunity for us to access an unaddressed U.S. market that potentially may include more than $12 billion in capital equipment revenue and more than $3 billion in associated annual recurring revenue, including smaller hospitals and the underserved ambulatory surgery center market segment. During the fourth quarter we completed the system engineering confidence build for our next-generation SPORT Surgical System, including a new camera system and design enhancements to the surgeon workstation and the patient cart, the two primary components of the system. The enhancements reflect our preclinical experience with expert robotic surgeons. We ended the year gaining clarity from the U.S. Food and Drug Administration on the regulatory pathway for the Sport system. During the second quarter, we expect to begin conducting the requisite animal studies that precede human studies. During the second half of 2019 we plan to complete the required human confirmatory studies under an Investigational Device Exemption, or IDE, in support of a 510(k) filing by the end of the year. We also expect to file for the CE mark by year-end 2019,” CEO David McNally said in a press release.

Last month, Titan Medical said that it completed an initial build of its Sport single-port robotic surgery system, paving the way for future development of the platform.

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Titan Medical completes initial Sport single-port robotic surgical system build

Titan Medical Sport

Titan Medical (NSDQ:TMDI) said last week that it completed an initial build of its Sport single-port robotic surgery system, paving the way for future development of the platform.

The Toronto-based company said that it completed a system engineering confidence build for all the components in the robotic platform, including a new camera system and design enhancements to its surgeon workstation and patient cart, which act as the two primary components of the system.

The Sport surgical system is a single-incision, advanced robotic surgical system featuring multi-articulated instruments with single-use replaceable tips. The platform uses 3D high-def visualization through a flat-screen monitor along with an open workstation and a single-arm mobile patient cart, according to the company’s website.

“I extend congratulations to Dr. Perry Genova, our senior vice president of research and development, and our engineering team for achieving this significant development milestone on an aggressive schedule during the fourth quarter of 2018. We are proud of their accomplishments and are thrilled with our substantial progress in 2018, and note that timely completion of this build is a critical step in preparation to file for regulatory clearances in the U.S. and the European Union. We are also grateful to the visionary surgeons who performed 45 preclinical studies with our earlier Sport system prototype, including 14 different procedures within four surgical disciplines, providing key input to our design team. As a result, our single-port robotic system now incorporates multiple important and patent-pending enhancements specifically intended to improve surgical performance and ease of use, which will better position us in the rapidly-expanding surgical robotics market,”prez & CEO David McNally said in a press release. “We welcome viewers to our website where we have posted video of the Sport system enhancements, which include a completely redesigned unique dual-camera system with a 3D high-definition steerable endoscopic camera for use during surgery, as well as a 2D high-definition wide-angle camera integrated into the camera insertion tube for visualization of instrument insertions, which also serves as a backup camera for safety. The engineering team has also designed a more compact and significantly lighter patient cart, with a reduced footprint designed to optimize portability, minimize set-up time and facilitate unencumbered assistance of surgical staff at the patient bedside. Further, we have improved the surgeon interface at the workstation with a more comfortable handle design, a new 4K monitor and upgraded haptic feedback with image overlays to assist the surgeon with the positioning of the instruments for optimal performance. We are excited to move into 2019 with this next-generation single-port robotic surgical system, with a focus on meeting our regulatory milestones.”

Yesterday, said that it expects to file for 510(k) clearance in the U.S. and CE Mark clearance in the E.U. by the end of 2019 for its Sport robotic surgical system.

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Titan Medical surges on NASDAQ listing bid, 30-1 reverse split

Titan Medical (TSX:TMD;OTC:TITFX) said it applied for a listing on the NASDAQ exchange and revealed plans for a 1-for-30 share split, sending share prices soaring today in New York and Toronto.

The robot-assisted surgery company, which lists its shares on the OTC exchange in the U.S. and on the Toronto Stock Exchange, said the reverse split is slated to go into effect June 19 when the markets open. The split is aimed at meeting the NASDAQ exchange’s listing requirements.

“We believe that dual-listing our common stock on both the TSX and NASDAQ presents the opportunity to expand awareness of the company among U.S.-based investors and potentially provides avenues for additional sources of funding as we work to complete the development of the Sport surgical system,” president & CEO David McNally said in prepared remarks. “The considerable progress we have made in product development, strengthening our intellectual property portfolio, the successful demonstration of the first simulation training modules with our collaborator Mimic Technologies, and most recently, surgeons presenting abstracts at renowned medical conferences, all underlie the timing of this decision. The consolidation of our shares is a necessary step to meet NASDAQ’s listing requirements and we anticipate that our stock will be listed by the end of June.”

Titan said the reverse split is expected to take the number of outstanding shares from 419,888,311 to 13,996,277.

TITFX shares were up 18.0% to 21¢ apiece today in late-morning trading in New York; TMD shares gained 10.2% to C27¢ (about 20.9¢) in Toronto.

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Titan Medical installs 3rd, final Sport system for validation & feasibility trials

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