Market Overview

Titan Medical Affirms Timeline for U.S. and EU Regulatory Submissions by Year-End 2019 for Its Sport Surgical System


Titan Medical Inc. (TSX:TMD) (NASDAQ:TMDI) ("Titan" or the
, a medical device company focused on the design and
development of a robotic surgical system for application in minimally
invasive surgery ("MIS"), affirms its regulatory filing timeline with a
510(k) submission expected by the end of 2019 as a result of discussions
with the U.S. Food and Drug Administration ("FDA"). The Company plans to
complete the required human confirmatory studies under an
Investigational Device Exemption ("IDE") during the second half of 2019
in support of its 510(k) filing. Additionally, the Company confirms that
it also expects to file for the CE mark by year-end 2019. Based on the
timing of anticipated approvals, Titan plans to commence
commercialization of its single-port robotic system in the U.S. and
Europe in 2020, as previously announced.

"We are encouraged by the collaborative nature of our correspondence and
conversations with the FDA, and are confident that with their guidance,
our confirmatory studies will be designed and executed to meet their
standards. Under the leadership of Curtis Jensen, our Vice President of
Quality and Regulatory Affairs, and with expert guidance from trusted
surgeon advisors, planning meetings have already been held with
qualified hospitals in preparation for our IDE study," said David
McNally, president and chief executive officer of Titan Medical. "Based
on our close interaction with regulatory bodies in the U.S. and the EU
during 2018, we believe we have a clear understanding of the
requirements to support our respective regulatory submissions. In
parallel with planning for our IDE study in the U.S., we are preparing
to complete the necessary audit and required documentation for the CE
mark. We are well positioned to execute on a sound regulatory plan for
our initial target markets."

Mr. McNally added, "During the past year, we have significantly improved
the capabilities and performance of our product platform. The focus in
the first half of 2019 will be on completing verification and validation
testing along with meeting ISO 13485 requirements for certification in
support of the regulatory filings. Our efforts in the second half of
2019 will be directed toward preparing and implementing the IDE study
and filing our 510(k) submission by the end of the year. We remain
confident in our highly experienced team to meet our aggressive
timeline, just as they have been doing during the past two years."

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 to initially 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

Forward-Looking Statements

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
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.

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