Titan Medical Announces Hardware Design Freeze for its Single-port Robotic Surgery System
30 Abril 2019 - 8:00AM
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 single-port minimally invasive surgery (“MIS”),
announces it has achieved hardware design freeze for its
single-port robotic surgery system. This design freeze is the
culmination of engineering work based on product feedback gathered
from extensive preclinical feasibility studies at three Centers of
Excellence and ongoing Formative Human Factors studies.
Hardware design freeze is an essential milestone in the system
design process as it allows Titan to complete various design
verification and validation activities such as preclinical studies
conducted under Good Laboratory Practices (“GLP”) and Summative
Human Factors studies, in preparation for submitting an
Investigational Device Exemption (“IDE”) to the U.S. Food and Drug
Administration (“FDA”) for human confirmatory studies. The assembly
of systems for the GLP studies is well underway, and Titan has
begun procuring hardware for the production of systems for the IDE
studies.
“Design freeze is a significant achievement for us, and we are
delighted to reach this important inflection point within our
stated timeframe,” said David McNally, Chief Executive Officer of
Titan Medical. “Thanks to the tremendous effort by our development
team including our product development partners and valuable
feedback by our surgeon KOLs, we now have what we consider to be a
world-class, differentiated surgical robot. We look forward to
conducting GLP and IDE studies this year, as we continue on track
to file by year-end 2019 our 510(k) application with the FDA and
our technical file for the CE mark in Europe.”
The Company notes that software integration and advanced
Graphical User Interface features will continue to be implemented
on a rolling basis.
About Titan Medical
Titan Medical Inc. is focused on computer-assisted robotic
surgical technologies for application in MIS. 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.
Forward-looking statements of Titan medical Inc.
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, 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/20190430005097/en/
LHA Investor RelationsKim Sutton Golodetz(212)
838-3777kgolodetz@lhai.comorBruce Voss(310)
691-7100bvoss@lhai.com
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