Titan Medical Provides Regulatory Update
December 30 2020 - 7:30AM
Business Wire
Titan Medical Inc. (“Titan” or the “Company”) (TSX: TMD)
(Nasdaq: TMDI), a medical device company focused on the design
and development of surgical technologies for robotic single access
surgery, announces that the Company has received a written response
from the U.S. Food & Drug Administration (“FDA”) to its Request
for Information in accordance with Section 513(g) of the U.S.
Federal Food, Drug and Cosmetic Act (“FD&C Act”), regarding the
regulatory requirements applicable to its robotically assisted
surgical device (“RASD”), the Enos™ Robotic Single Access System.
While the FDA's response to a 513(g) request does not constitute a
classification decision, the FDA has indicated that, based on
information provided to the agency, the Enos system is appropriate
for classification through the De Novo pathway.
“The timely response from the FDA provides additional
information regarding the agency’s position on potential predicate
RASD systems along with the intended use and the technology
embodied in the Enos system. These insights will help guide our
regulatory strategy so that we can most efficiently allocate our
resources to achieve U.S. market clearance,” said David McNally,
President and Chief Executive Officer of Titan. “At this time,
given the information available to us, we do not anticipate our
likely pursuit of the De Novo pathway would materially affect our
previously stated milestones or budgets for 2021. During the first
quarter of 2021, we plan on further communications with the FDA,
including filing a Pre-Submission, with the intent of clarifying
any requirements for our planned Investigational Device Exemption
studies and any potential impact on previously established
timelines and forecasted costs.”
Requests for Information made pursuant to Section 513(g) of the
FD&C Act require the FDA to provide information about the
classification and the regulatory requirements that may be
applicable to a particular device. FDA responses to such requests
represent the FDA's best judgment about how a device would be
regulated, based upon review of information provided by a
requester, including the description of the device and its intended
use. The FDA's response to a 513(g) request is not a classification
decision for a device and does not constitute FDA clearance or
approval for commercial distribution. Classification decisions and
clearance or approval for marketing require submissions under
different sections of the FD&C Act, such as a classification
obtained in response to a premarket notification submitted in
accordance with Section 510(k) of the FD&C Act, commonly known
as a 510(k) submission, or a classification obtained for novel
devices under section 513(f)(2) of the FD&C Act, also known as
a De Novo submission.
In view of the FDA’s written response and other information
available to the Company at this time, the Company would likely
proceed with a De Novo classification request for its Enos system
in place of a 510(k) submission. Should the FDA grant the De Novo
classification request, the Class II device would be cleared to be
marketed. In addition, a new classification regulation will be
established, and the new device may then serve as a predicate
device for 510(k) submissions of future devices of the same type.
Should the De Novo classification request be declined, the device,
as a Class III device, would require pursuit of a premarket
approval under Section 515 of the FD&C Act, also known as a
PMA, requiring additional time and expense.
About Titan Medical
Titan Medical Inc., a medical device company headquartered in
Toronto, is focused on developing robotic assisted technologies for
application in single access surgery. The Enos system, by Titan
Medical, is being developed with dual 3D and 2D high-definition
vision systems, multi-articulating instruments, and an ergonomic
surgeon workstation. With the Enos system, Titan intends to
initially pursue gynecologic surgical indications.
Certain of Titan’s robotic assisted surgical technologies and
related intellectual property have been licensed to Medtronic plc,
while retaining world-wide rights to commercialize the technologies
for use with the Enos system.
Enos™ is a trademark of Titan Medical Inc.
For more information, visit www.titanmedicalinc.com.
Forward-Looking Statements of Titan Medical
This 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, including references to: the Company’s focus on the
design and development of surgical technologies for robotic single
access surgery; the Company being focused on developing robotic
assisted technologies for application in single access surgery; the
Enos system being developed to become the new standard of care in
robotic single access surgery with dual 3D and 2D high-definition
vision systems, multi-articulating instruments, and an ergonomic
surgeon workstation; the FDA’s response to the Company’s 513(g)
request indicating that the Enos system is appropriate for
classification through the De Novo pathway; the FDA guidance will
help guide the Company’s regulatory strategy so that it can
allocate resources to achieve U.S. market clearance; pursuit of the
De Novo pathway will not materially affect the Company’s previously
stated milestones or budgets for 2021; during the first quarter of
2021 the Company plans on further communications with the FDA,
including filing a Pre-Submission; the Company will likely proceed
with a De Novo classification request for its Enos system in place
of a 510(k) submission; were the FDA to grant the De Novo
classification request, the Class II device would be cleared to be
marketed; the Enos system may serve as a predicate device for
510(k) submissions of future devices of the same type; were the De
Novo classification request declined, as a Class III device, the
device would require pursuit of a premarket approval under Section
515 of the FD&C Act, requiring additional time and expense; and
the Company’s intention to initially pursue gynecologic surgical
indications. 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
Report on Form 20-F dated April 2, 2020 (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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201230005089/en/
Monique L. Delorme Chief Financial Officer +1-416-548-7522
investors@titanmedicalinc.com
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