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Enter Symbol
or Name
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CA



Titan Medical Inc
Symbol TMD
Shares Issued 187,978,646
Close 2017-03-22 C$ 0.33
Market Cap C$ 62,032,953
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Titan Med finalizes user requirements for SPORT system

2017-03-23 10:09 ET - News Release

Mr. David McNally reports

TITAN MEDICAL FINALIZES USER REQUIREMENTS FOR 1ST GENERATION ROBOTIC SURGICAL SYSTEM; REITERATES 2017 AND 2018 DEVELOPMENT MILESTONES LEADING TO FDA 510(K) SUBMISSION

Titan Medical Inc. has provided the following update. The first milestone for 2017, finalizing user requirements for the single-port robotic surgical system, has been achieved slightly ahead of schedule. The company has also reiterated the development milestones it is pursuing for its single-port robotic surgical system for application in minimally invasive surgery (MIS). The milestones and timeline are designed to lead to Titan's 510(k) submission to the United States Food and Drug Administration (FDA) for clearance to market.

The remaining 2017 milestones are as follow:

  • Select and confirm two U.S. and one European strategic facilities for preclinical studies;
  • Test and evaluate performance of subsystems of existing engineering verification (EV) units;
  • Complete initial formative human factors studies that follow previous heuristic studies;
  • Initiate design changes based on subsystem performance and human factors evaluation;
  • Implement design changes and retest system and subsystems;
  • Update design history file and documentation for relevant modules of the company's quality management system (QMS);
  • Complete initial requirements and architecture for simulation software and training program design;
  • Complete and report on preclinical studies at strategic facilities in the U.S. and Europe;
  • Confirm FDA and CE Mark pathways in co-ordination with regulatory authorities.

2018 milestones:

  • Complete software development, system design and update design history file for regulatory filings;
  • Complete summative human factors evaluation;
  • Complete simulation software development and training program design;
  • Complete and document preclinical studies for FDA submittal;
  • Prepare and submit 510(k) application to the FDA, and prepare technical file for CE Mark and submit to European notified body;
  • Publish white papers on preclinical studies.

David McNally, president and chief executive officer, stated: "During the past few weeks, Dr. Perry Genova, our vice-president of research and development, and our team have carefully reviewed our plan to submit our single-port robotic surgical system to the FDA for clearance to market, and apply for the CE Mark with a European notified body by the end of 2018. While the execution of the original road map was delayed during last year due to funding issues, we believe that the team's experience in advancing innovative and complex medical technologies through the design, development and regulatory review processes will enable Titan to submit its applications in 2018. We still need to raise additional funding of approximately $70-million to meet the 2018 filing objective. However, we believe with the multibillion-dollar opportunity ahead of us, sufficient financing and successful execution by our team, we can create substantial shareholder value.

"Achieving the user requirements milestone slightly ahead of our updated schedule is a positive step for Titan's trajectory toward commercialization and illustrates our team's ability to focus on the most important requirements for our platform, so that execution can be simplified. We will leverage the momentum gained by achieving this milestone to execute on the remaining objectives as we advance toward commercialization."

Management led by Mr. McNally will host a conference call to discuss the financial results and management's discussion and analysis for the fourth quarter ended Dec. 31, 2016, and recent corporate developments at 4:30 p.m. ET on March 23. Investors within Canada and the U.S. interested in participating are invited to call 800-274-0251. All other international participants can use the dial-in number 1-416-642-5209. During the call, management will offer remarks and take live questions from analysts and professional investors. Others are encouraged to submit questions prior to or during the call via e-mail.

A replay of the event will be available for two weeks following the conclusion of the call. To access the replay, callers in Canada and the U.S. can call 888-203-1112 and reference the replay access code 5784933. All callers outside Canada and the U.S. can dial 1-647-436-0148, using the same replay access code. To access the webcast, please visit the company website and select investors.

About Titan Medical Inc.

Titan is a Canadian public company focused on research and development through to the planned commercialization of computer-assisted robotic surgical technologies for application in MIS. The company is currently developing the SPORT surgical system, a single-port robotic surgical system. The SPORT surgical system comprises a surgeon-controlled patient cart that includes a 3-D high-definition vision system and multiarticulating instruments for performing MIS procedures, and a surgeon workstation that provides the surgeon with an advanced ergonomic interface to the patient cart and a 3-D endoscopic view inside the patient's body during MIS procedures. With the SPORT surgical system, the company aims to pursue a broad set of surgical indications, including general abdominal, gynecologic and urologic procedures.

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