Titan Medical Achieves all Third Quarter Milestones Related to the Development of the SPORT Surgical System
October 04 2018 - 8:43AM
Titan Medical Inc. (“Titan” or the “Company”) (TSX: TMD)
(Nasdaq: TMDI), a medical device company focused on the
design, development and commercialization of a robotic surgical
system for application in single-port minimally invasive surgery
(“MIS”), announces that the Company has achieved all of its
publicly stated third quarter 2018 development milestones for the
SPORT Surgical System, as follows:
- Completed the improved camera insertion tube engineering
confidence build (functional prototype)
- Completed design enhancements of both the surgeon workstation
and patient cart in anticipation of system engineering confidence
build by year-end 2018
- Completed and demonstrated full suite of simulation training
software for beta testing
- Filed three Q-submissions containing detailed protocols for
animal, cadaver and human confirmatory studies for review by the
U.S. Food and Drug Administration (“FDA”), approximately one year
ahead of plan
“The pace of development of our single-port
robotic SPORT Surgical System has been moving rapidly, and we are
pleased to have met multiple significant milestones for design and
engineering, training and regulatory affairs,” stated David
McNally, Titan’s chief executive officer. “We are particularly
pleased to have filed three Q-submissions with the FDA that we
believe will help us to clarify requirements well in advance of
collecting evidence for our planned 510(k) submission. Having
successfully achieved all of our projected milestones on or ahead
of schedule for the third quarter, our team is confident we will
remain on track to meet our fourth quarter milestones with
continued strong execution in 2019.”
The Company notes that key milestones expected
to be achieved during the balance of 2018 include:
- Completion of the engineering confidence build of the improved
SPORT Surgical System, based on surgeon feedback from previous
preclinical studies
- Peer-reviewed publications and presentations at important
medical conferences, including a presentation about the assessment
of technical skills with the SPORT system at the American
Association of Gynecologic Laparoscopists 2018 Global Congress in
November
“We affirm expectations that during 2019 we will
conduct preclinical and confirmatory human studies to support the
submission of our technical file for CE Mark and of our 510(k) with
the FDA by the end of the year,” Mr. McNally added.
About Titan MedicalTitan
Medical Inc. is focused on research and development through to the
planned commercialization of 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. The SPORT Surgical System is 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 www.titanmedicalinc.com.
Forward-Looking StatementsThis
news release contains “forward-looking statements” within the
meaning of applicable Canadian and U.S. securities laws. Such
statements 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. Except as
required by law, the Company expressly disclaims any intention or
obligation to update or revise any forward-looking statements
whether as a result of new information, future events or
otherwise.
Contacts:
LHA Investor Relations Kim Sutton Golodetz(212)
838-3777kgolodetz@lhai.com orBruce Voss(310) 691-7100
bvoss@lhai.com
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