Business Wire 13-Feb-2019 6:48 PM
Titan Medical Inc. (TSX:TMD) (NASDAQ:TMDI) ("Titan" or the "Company"), a medical device company focused on the design and development of a robotic surgical system for application in minimally invasive surgery ("MIS"), announces financial results for the year ended December 31, 2018.
All financial results are prepared under Canadian GAAP and are reported in U.S. dollars, unless otherwise stated. The audited financial statements and management's discussion and analysis for the year ended December 31, 2018 may be viewed on SEDAR at www.sedar.com.
David McNally, President and CEO, said, "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."
Mr. McNally continued, "In parallel with the development of the SPORT Surgical System in 2018, we continued our efforts toward achieving future commercial success. During the year, we filed several new U.S. and international patent applications, and received nine patent grants on various aspects of single-port robotic surgery. Surgeons presented results from the preclinical studies performed during the past two years at important medical conferences, and published a peer-reviewed manuscript with the goal of gaining awareness and support among the key opinion leaders who will be important to our success. To date, 12 experienced robotic surgeons from three continents have successfully performed 43 live animal studies and two human cadaver studies across a broad array of procedures.
"We completed two financings during the year, one where we welcomed new U.S. investors in conjunction with the cross-listing of our common stock on the Nasdaq Capital Market. During the year we effected a 1-for-30 reverse stock split in preparation for the cross-listing and U.S./Canadian financing. Additional funds will be required to see the SPORT system to commercialization, and we are currently evaluating financing alternatives while the exercise of warrants from our most recent financing continues to extend our cash runway," Mr. McNally concluded.
Key operational highlights for 2018 include:
Financial highlights for 2018 include:
Expectations for 2019
Titan Medical anticipates the completion of verification and validation testing, followed by design freeze and the initiation of animal and cadaver studies, in support of planned regulatory filings, during the first half of 2019. It also expects to submit an IDE study application to the FDA during the first half of 2019, to perform the IDE study at multiple hospitals during the fourth quarter of 2019, and to file a 510(k) premarket notification and submit its technical file to a European Notified body for CE mark by the end of the year.
Mr. McNally reiterated, "We remain confident in our highly experienced team to meet our aggressive timeline, just as they have been doing for the past two years."
Conference Call and Webcast
Titan Medical plans to hold a conference call and webcast to discuss its plans for 2019 by the end of March. A press release will be issued prior to the call with additional information.
About Titan Medical Inc.
Titan Medical Inc. is focused on computer-assisted robotic surgical technologies for application in minimally invasive surgery. The Company is developing the SPORT Surgical System, a single-port robotic surgical system comprised of a surgeon-controlled patient cart that includes a 3D high-definition vision system and multi-articulating instruments for performing MIS procedures, and a surgeon workstation that provides an advanced ergonomic interface to the patient cart and a 3D endoscopic view inside the patient's body. Titan intends initially to pursue focused surgical indications for the SPORT Surgical System, which may include one or more of gynecologic, urologic, colorectal or general abdominal procedures.
For more information, please visit the Company's website at www.titanmedicalinc.com.
This news release contains "forward-looking statements" which reflect the current expectations of management of the Company's future growth, results of operations, performance and business prospects and opportunities. Wherever possible, words such as "may", "would", "could", "will", "anticipate", "believe", "plan", "expect", "intend", "estimate", "potential for" and similar expressions have been used to identify these forward-looking statements. These statements reflect management's current beliefs with respect to future events and are based on information currently available to management. Forward-looking statements involve significant risks, uncertainties and assumptions. Many factors could cause the Company's actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements, including, without limitation, those listed in the "Risk Factors" section of the Company's Annual Information Form dated March 31, 2018 (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in the news release are based upon what management currently believes to be reasonable assumptions, the Company cannot assure prospective investors that actual results, performance or achievements will be consistent with these forward-looking statements.