Titan Medical Provides Update to Enos Project Timeline
June 28 2022 - 07:30AM
Titan Medical Inc. (Nasdaq
: TMDI; TSX: TMD),
a medical device company focused on the development and
commercialization of innovative surgical technologies for single
access robotic-assisted surgery (RAS), today announced that
multiple disruptions have resulted in an updated Investigational
Device Exemption (IDE) submission timeline for the Enos™ robotic
single access surgery system. The company now expects the IDE
submission to occur mid-year 2023 instead of the first quarter of
2023. Pending successful regulatory review and upon receipt of
marketing authorization, the expected U.S. product launch for the
Enos system remains on schedule for early 2025.
“We have been fortunate to have avoided and mitigated against
many of the issues facing almost all other technology companies
over the last few months. However, we now expect our targeted IDE
application date to be pushed out to the summer of 2023. Human
clinical trials are still planned to start in 2023 and we expect to
receive marketing authorization in the U.S. in early 2025,” said
Paul Cataford, Interim President and CEO.
The Enos project timeline has been impacted by several factors
including:
- Supply of certain key components and materials has affected the
production of instruments and camera systems and the delivery of
capital equipment resulting in delays for verification and
validation testing.
- Recruitment and resourcing of software engineers and developers
has resulted in delays in unit testing procedures and certain
documentation activities.
- Delayed procurement of disposable and consumable components
resulted in delays in cleaning and disinfection testing and the GLP
study required for the IDE submission.
“We continue to carefully monitor our project plan. With recent
changes, we believe we have the right people, resources and
partners in place to execute against our project delivery timeline.
This team is committed, engaged and accountable, and we’re excited
to bring our vision of single access robotic assisted surgery to
the market,” concluded Paul Cataford.
About Titan Medical
Titan Medical Inc. (Nasdaq: TMDI; TSX: TMD), a medical device
company headquartered in Toronto, Ontario and with operations in
Chapel Hill, North Carolina, is focused on enhancing robotic
assisted surgery using innovative technology through a single
access point. The Enos™ robotic single access surgical system is
being developed with an ergonomic focus to provide a surgical
experience that imitates real-life movements that surgeons demand
and includes multi-articulating instruments designed to allow
surgeons an increased range of motion in a confined space, with
dexterity and the ability to exert the forces necessary to complete
common surgical tasks. With the Enos system, Titan intends to
initially pursue gynecologic surgical indications.
Enos™ is a trademark of Titan Medical Inc.
For more information,
visit www.titanmedicalinc.com and
follow @TitanMedical on Twitter and LinkedIn.
Forward-Looking Statements
This news release contains “forward-looking statements” within
the meaning of applicable Canadian and U.S. securities laws, 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, including, without limitation, references to: the
company’s focus on the design and development of surgical
technologies for robotic single access surgery; the timelines
related to the development of the Enos system, including the
expectation of the Company for IDE submission to occur mid-year
2023, clinical trials in 2023, and upon receipt of marketing
authorization, the expected U.S. product launch for the Enos system
in early 2025; the Enos system providing a surgical experience that
imitates real-life movements; and the company’s intention to
initially pursue gynecologic surgical indications with the Enos
system. These statements reflect management’s current beliefs 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 Report for the fiscal year ended December 31,
2021, which may be viewed at www.sedar.com and at www.sec.gov.
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.
ContactKristen GalfettiVice President, Investor
Relations & Corporate
Communications+1-781-869-2553investors@titanmedicalinc.com
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