Manufacturing Team and Capabilities Continue to
Expand
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 financial results for the three
months ended March 31, 2022.
“The entire team is focused on driving performance and progress
supporting our IDE application submission milestone. We are also
starting to prepare for the forthcoming commercialization of the
Enos single-access RAS platform for gynecological surgery, our
initial target indication for use,” stated Paul Cataford, Interim
President, CEO and Board Chair. “We are working closely with
Benchmark on the capital equipment build of six Enos systems and
have expanded our team and capability for our in-house production
of instruments and cameras at our Chapel Hill facility. These
capital units, instruments and cameras will go into validation and
verification testing in late summer,” concluded Mr. Cataford.
The company remains on track with the De Novo regulatory process
for marketing authorization with the U.S. Food and Drug
Administration (FDA). Utilizing the Q-Submission Program, the
company has engaged in ongoing dialogue with the FDA clarifying
requirements in an effort to mitigate against timeline risks. The
company plans to file the IDE application with the FDA in the first
quarter of 2023 and anticipates receiving a response on the IDE
from the FDA in the first half of 2023. Following IDE approval,
Titan expects the IDE clinical study to proceed and be completed in
time for submission of a De Novo classification request in 2024.
Commercial launch of the Enos system is scheduled to begin upon
receipt of marketing authorization from the FDA, anticipated in
early 2025.
Recent Company Activities and Progress
- Announced Purchase Order with Medtronic plc
- Purchase order covers the purchase of instruments and cameras
that will be used in preclinical activities and the evaluation of
Titan Medical as a potential manufacturing and supply partner for
Medtronic.
- Completed additional animal lab
- Additional surgeon validation was gained during a recent animal
lab where Titan received positive feedback on improvements on the
vision system and on electrical energy instrumentation. New
insights on laparoscopic surgeon ease of adoption to robotic
surgery were also noted, which the company intends to address in
training programs.
- Continued communications with the FDA via Q-submission process
- The company submitted a Q-submission and completed a conference
call with the FDA, as part of its ongoing communications plan to
obtain additional guidance from the FDA. The company anticipates
another Q-submission before the end of the second quarter.
- Ongoing product development and transfer to manufacturing
- The company completed the design transfer of capital equipment
and is working to finalize the selection for contract manufacturers
for draping and consumables.
- CEO search progress
- The board’s ad hoc CEO selection committee has met with a
number of qualified candidates in its search for a permanent CEO to
replace Interim President and CEO Mr. Cataford.
- Evaluating options to address Nasdaq notification regarding
minimum bid price deficiency
- In addition to reviewing its options, the company continues to
try to regain compliance with Nasdaq Rule 5550(a)(2) prior to the
June 28, 2022 deadline.
- Paul Cataford presented and participated in the Bloom Burton
& Co Healthcare Investor Conference in Toronto on May 2,
2022
Financial Highlights
As of March 31, 2022, Titan had cash and cash equivalents of
$30.1 million, compared to $32.3 million at December 31, 2021.
For the three months ended March 31, 2022, R&D expenses
increased to $9.4 million compared to $7.6 million for the for the
three months ended March 31, 2021. In the quarter, the Company’s
R&D expenses were focused on finishing product development and
transferring key components on the Enos System to manufacturing. In
the comparative period, R&D expenses related to the development
of the Enos System and the development work required to achieve the
milestones under the Development Agreement with Medtronic.
G&A expenses decreased to $2.5 million for the three months
ended March 31, 2022 compared to $4.1 million for the three months
ended March 31, 2021. The decrease in G&A expenses in the
quarter is related to a decrease in professional and consulting
fees of $0.9 million and a decrease in stock-based compensation of
$0.2 million.
The company’s interim financial statements and MD&A are
available at www.sedar.com and/or at www.sec.gov.
Investor Audio Webcast Information
Titan Medical will host an investor audio webcast at 8:30 a.m.
ET today (May 12, 2022) to discuss the company’s financial results
for the three months ended March 31, 2022, and recent business
highlights. The webcast can be accessed via the Investor Relations
section of the company’s website www.titanmedicalinc.com.
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. Forward-looking statements are
frequently, but not always, identified by words such as “may”,
“would”, “could”, “will”, “anticipate”, “believe”, “plan”,
“expect”, “intend”, “estimate”, “potential for” and similar
expressions, although these words may not be present in all
forward-looking statements. Forward-looking statements that appear
in this release may include, without limitation, references to: the
company’s focus on the development and commercialization of its
innovative surgical technologies for single access robotic-assisted
surgery; the company’s plans and estimation of completing product
and software development, testing and verification of the Enos
system; the company’s preparation for commercialization of the Enos
system; the company’s work with Benchmark on the capital equipment
build; the validation and verification testing in late summer of
the capital units, instruments and cameras; the company remaining
on track with the De Novo regulatory process for marketing
authorization with the U.S. FDA; the company’s ongoing dialogue
with the FDA and plans with respect to regulatory submissions,
including for an IDE and De Novo application; the company’s
utilization of the Q-Submission program to mitigate against
timeline risks, including filing a Q-Submission before the end of
the second quarter; the company’s plans for clinical studies; the
company’s expectations with respect to timing for the commercial
launch of the Enos system; the company’s potential as a
manufacturing and/or supply partner for Medtronic; the company’s
evaluation and selection of a contract manufacturers for draping
and consumables; the company’s intention to host an upcoming
investor audio webcast; the Enos robotic single access surgical
system being developed with an ergonomic focus to provide a
surgical experience that imitates real-life movements that surgeons
demand; and that Titan intends to initially pursue gynecologic
surgical indications. 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
on Form 20-F 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220512005294/en/
Kristen Galfetti Vice President, Investor Relations &
Corporate Communications +1-781-869-2553
investors@titanmedicalinc.com
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