Titan Medical Completes Preclinical Good Laboratory Practice Procedures With Its Single-Port Robotic Surgical System
18 Julho 2019 - 9:43AM
Business Wire
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 minimally invasive surgery (“MIS”), announces that
all procedures under Good Laboratory Practice (“GLP”) principles
associated with the acute and chronic animal studies and human
cadaver studies using its single-port robotic surgery system have
been completed. The Company intends to announce the results of
required follow-up to the chronic procedures by the end of
August.
“We are pleased to have completed all of the planned GLP
procedures necessary for our Investigational Device Exemption
(“IDE”) application to the U.S. Food and Drug Administration
(“FDA”),” said David McNally, Titan’s chief executive officer.
“Anticipating positive results from the chronic study, we
subsequently plan to submit the IDE application to the FDA during
the current quarter. Meanwhile, we are proceeding with human
factors studies that were previously planned for the second quarter
and moved to the third quarter in order to accommodate the GLP
procedures, which from a timing perspective, were our priority. All
of this data, along with the confirmatory human data to be
collected from studies under the IDE, is intended to support our
planned 510(k) application for U.S. marketing clearance of our
single-port robotic surgery system, and a concurrent application
for the CE mark planned by year-end 2019.”
About Titan Medical Inc.
Titan Medical Inc. is focused on computer-assisted robotic
surgical technologies for application in MIS. The Company is
developing 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
gynecologic surgical indications for use of its single-port robotic
surgical system.
For more information, please visit the Company’s website at
www.titanmedicalinc.com.
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 29, 2019 (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.
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version on businesswire.com: https://www.businesswire.com/news/home/20190718005427/en/
LHA Investor Relations Kim Sutton Golodetz (212) 838-3777
kgolodetz@lhai.com or Bruce Voss (310) 691-7100 bvoss@lhai.com
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