Large market opportunity, strong corporate
foundation, innovative robotic-assisted technology
Clinical studies expected to commence in
2022
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, today announced a corporate update in conjunction with its
presentation at the H.C. Wainwright Global Life Sciences
Conference. David McNally, President, CEO and Chairman of Titan
Medical, will provide an overview of the Company and its Enos™
robotic single access surgical system at the conference, which is
available for on-demand access on Titan Medical’s website under the
“Investors” section.
“We are pleased to further detail our corporate strategy and the
market opportunity for our Enos surgical system. The achievements
to date position Titan for success in attaining our vision for
robotic-assisted surgery that may allow patients less trauma,
shorter hospitalization time, less scarring, faster recovery times
and reduced post-operative pain,” said David McNally. “With a
strong cash position and expert in-house technical talent, the
advanced development of the Enos surgical system is at full
intensity. We plan to continue executing on our corporate
milestones with the objectives of completing product development in
2021 and human clinical studies in 2022.”
Corporate highlights, including those found in the presentation
are included below.
Market Opportunity:
- Based on independent research, the total addressable US
surgical robotics market could reach $18 billion1 with up to six
million addressable procedures annually, and gynecologic surgery
representing about $1 billion in market potential, in the US
alone.2 Titan intends to initially pursue gynecologic surgical
indications with the Enos system.
- The current robotic surgery market appears to be
underpenetrated due in part to costs associated with existing
robotic surgical systems. The Enos surgical system is being
developed to allow hospitals to benefit from increased procedure
throughput and reduced post-operative hospitalization of
patients.
- Surgical procedures have evolved from open surgery with the
growth of minimally invasive surgery, and further with the
evolution in robotic assisted surgery. Current robotic assisted
surgical systems are primarily comprised of multi-port systems,
typically involving three instruments and a camera, and each
requiring a separate incision. With single port, or single access,
robotic surgery, the number and size of incisions, or access
points, is further reduced. The Enos surgical system is a robotic
surgical system designed for single access surgery.
- Reducing the number of incisions to a single access point may
potentially reduce the trauma, complications, scarring, healing
time, and use of post-operative pain medications associated with
surgery. This may especially be relevant in the context of a
post-COVID-19 environment.
Titan Medical’s Enos Surgical System:
- Through an aperture of approximately 25-millimeter diameter,
the Enos robotic single access surgical system is designed to
provide:
- Two multi-articulating instruments with fluid “snake-like”
movement engineered to generate the forces necessary for performing
complex surgical tasks, including suturing, and built with an open
architecture to accommodate a variety of end-effectors and to adapt
to future surgical tools and technologies.
- A dual-view 3D and 2D endoscopic high-definition vision system,
each supporting independent integrated illumination.
- An easy to maneuver ergonomic surgeon workstation has been
designed with embedded software for simulation training and surgeon
overlays for providing interoperative feedback.
- A compact single-arm patient cart provides for fast set-up and
unencumbered assistance by operating room staff.
- The complete surgical system of a surgeon workstation, patient
cart, instrument and accessories is designed to deliver operating
room efficiency and positive hospital economics.
- While the initial indication for use is expected to be benign
gynecologic surgery, preclinical evidence suggests that the system
may ultimately have application in other subspecialties, including
urologic, colorectal and general surgery.4
- An expanding intellectual property portfolio presently
comprises over 150 U.S. and international patents issued or
pending. Titan’s intellectual property stems from several years of
innovation in robotic assisted surgery covering technologies from
hand controllers, to multi-articulating instruments, to unique
software functionality including interoperative feedback. A select
portion of the intellectual property portfolio and associated
technologies have been licensed to global medical device leader
Medtronic plc in exchange for license fees, with the Company
retaining world-wide rights to commercialize the technologies for
use with the Enos surgical system. The Company continues to build
on and seek additional avenues for leveraging and/or expanding its
intellectual property portfolio.
Corporate Resources:
- As of January 31, 2021, the Company had pro forma cash and cash
equivalents of approximately $65.5 million when including proceeds
of over $30 million in equity financings and $10 million in warrant
exercises in January and February 2021.
- In 2020, the Company generated $20 million in license revenue
from its development and license agreements with Medtronic.
Future Company Milestones:
- Under an ongoing development and license agreement with
Medtronic and with the satisfaction of certain milestones
thereunder, the Company expects to generate $21 million in
additional license revenue in 2021.
- With its Enos surgical system, over the next two years the
Company plans to complete product development and tooling for
initial manufacturing, apply for an Investigational Device
Exemption from the U.S. FDA, and once approved, conduct human
clinical studies compiling data to prepare for FDA marketing
authorization application.
For full financial information, including a detailed milestone
table, please see the Company’s consolidated financial statements
and annual management’s discussion and analysis for the year ended
December 31, 2020 and December 31, 2019, which may be viewed at
www.sedar.com and at www.sec.gov.
Sources:
1. Bank of America Merrill Lynch: Intuitive Surgical: Tide still
rising…a fresh, detailed look at the US TAM for surgical robotics,
published 12 August 2019 2. Life Science Intelligence Report
LSI-PV-US1753SU, published 2017 3. A Fact Sheet from the Office on
Women’s Health, Depart of Health & Human Services, USA,
www.womenshealth.gov 4. See preclinical studies, peer-reviewed
abstracts and published manuscript referenced on pages 12-14 of
Titan Medical Overview dated March 9, 2021, which can be accessed
on the Company’s website, www.titanmedicalinc.com.
About Titan
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
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 references to: the Company being focused on
the design and development of surgical technologies for robotic
single access surgery; the large market opportunity for the
Company; that clinical studies are expected to commence in 2022;
that David McNally will provide an overview of the Company and its
Enos robotic single access surgical system at the H.C. Wainwright
Global Life Sciences Conference; that the achievements to date
position Titan for success in attaining its vision for
robotic-assisted surgery that may allow patients less trauma,
shorter hospitalization time, less scarring, faster recovery times
and reduced post-operative pain; that the Company continues
executing on its corporate milestones with the objectives of
completing product development in 2021 and human clinical studies
in 2022; that the total addressable US surgical robotics market
could reach $18 billion with up to six million addressable
procedures annually; that gynecologic surgery represents about $1
billion in market potential; that the Enos surgical system is being
developed to allow hospitals to benefit from increased procedure
throughput and reduced post-operative hospitalization of patients;
that reducing the number of incisions to a single access point may
potentially reduce the trauma, complications, scarring, healing
time, and use of post-operative pain medications associated with
surgery, which may especially be relevant in the context of a
post-COVID-19 environment; that preclinical evidence suggests that
the system may ultimately have application in other subspecialties,
including urologic, colorectal and general surgery; that the
Company expects to generate $21 million in additional license
revenue in 2021; the Company continues to build on and seek
additional avenues for leveraging and/or expanding its intellectual
property portfolio; that the Company plans to complete product
development and tooling for initial manufacturing, apply for an
Investigational Device Exemption from the U.S. FDA, and once
approved, conduct human clinical studies compiling data to prepare
for FDA marketing authorization application; that the Enos system
is being developed with dual 3D and 2D high-definition vision
systems, multi-articulating instruments, and an ergonomic surgeon
workstation; Titan’s intention to initially pursue gynecologic
surgical indications with the Enos system; the license of certain
of Titan’s robotic assisted surgical technologies and related
intellectual property to Medtronic plc, while retaining world-wide
rights to commercialize the technologies for use 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 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, 2019 and the Company’s 2020 annual management’s
discussion and analysis (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.
Market Research Reporting
The data from the sources referenced in the footnotes speak as
of their original publication dates (and not as of the date of this
news release) and the opinions and market data expressed in those
reports are subject to change without notice (including without
limitation from the intervening impacts of the COVID-19 pandemic).
The reports referenced are third party sources and have not been
independently verified by Titan Medical Inc. and their accuracy and
completeness and any underlying assumptions for the market estimate
and projections contained therein have not been independently
verified.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210309005360/en/
Monique L. Delorme Chief Financial Officer +1-416-548-7522
investors@titanmedicalinc.com
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