Titan Medical Reports 2018 Financial Results
February 13 2019 - 6:48PM
Business Wire
Titan Medical Inc. (TSX:TMD) (Nasdaq:TMDI) (“Titan” or the
“Company”), a medical device company focused on the design and
development of a robotic surgical system for application in
minimally invasive surgery (“MIS”), announces financial results for
the year ended December 31, 2018.
All financial results are prepared under Canadian GAAP and are
reported in U.S. dollars, unless otherwise stated. The audited
financial statements and management’s discussion and analysis for
the year ended December 31, 2018 may be viewed on SEDAR at
www.sedar.com.
David McNally, President and CEO, said, “2018 was an
exceptionally busy and productive year for Titan Medical as we
achieved all milestones related to the development of our SPORT
single-port robotic surgery system. I want to congratulate the
Titan Medical team and our business partners for their dedication
as we continue our important work toward commercialization. By our
internal estimates, we believe there is an opportunity for us to
access an unaddressed U.S. market that potentially may include more
than $12 billion in capital equipment revenue and more than $3
billion in associated annual recurring revenue, including smaller
hospitals and the underserved ambulatory surgery center market
segment.
“During the fourth quarter we completed the system engineering
confidence build for our next-generation SPORT Surgical System,
including a new camera system and design enhancements to the
surgeon workstation and the patient cart, the two primary
components of the system. The enhancements reflect our preclinical
experience with expert robotic surgeons. We ended the year gaining
clarity from the U.S. Food and Drug Administration on the
regulatory pathway for the SPORT system. During the second quarter,
we expect to begin conducting the requisite animal studies that
precede human studies. During the second half of 2019 we plan to
complete the required human confirmatory studies under an
Investigational Device Exemption, or IDE, in support of a 510(k)
filing by the end of the year. We also expect to file for the CE
mark by year-end 2019.”
Mr. McNally continued, “In parallel with the development of the
SPORT Surgical System in 2018, we continued our efforts toward
achieving future commercial success. During the year, we filed
several new U.S. and international patent applications, and
received nine patent grants on various aspects of single-port
robotic surgery. Surgeons presented results from the preclinical
studies performed during the past two years at important medical
conferences, and published a peer-reviewed manuscript with the goal
of gaining awareness and support among the key opinion leaders who
will be important to our success. To date, 12 experienced robotic
surgeons from three continents have successfully performed 43 live
animal studies and two human cadaver studies across a broad array
of procedures.
“We completed two financings during the year, one where we
welcomed new U.S. investors in conjunction with the cross-listing
of our common stock on the Nasdaq Capital Market. During the year
we effected a 1-for-30 reverse stock split in preparation for the
cross-listing and U.S./Canadian financing. Additional funds will be
required to see the SPORT system to commercialization, and we are
currently evaluating financing alternatives while the exercise of
warrants from our most recent financing continues to extend our
cash runway,” Mr. McNally concluded.
Key operational highlights for 2018 include:
- On February 6, 2018, the Company
reported the successful completion of a single-port prostatectomy
procedure using the SPORT Surgical System in a preclinical
setting.
- On March 29, 2018, the Company
announced, in conjunction with Mimic Technologies, a market leader
in robotic simulation, the collaboration and successful
demonstration of a first set of simulation modules for use with
Titan’s SPORT Surgical System surgeon workstation.
- On April 16, 2018, the Company
announced the presentation of an abstract highlighting the early
physician experience with the SPORT Surgical System at the Society
of American Gastrointestinal and Endoscopic Surgeons Annual
Meeting.
- On June 18, 2018, David McNally
presented the SPORT Surgical System in the plenary session at the
Society of Robotic Surgery 2018 Annual Meeting.
- On June 20, 2018, the Company announced
that Jasminder Brar, Titan’s Director of Strategic Development and
Intellectual Property, was recognized by Intellectual Asset
Management as a global IP strategy leader.
- On June 27, 2018, the Company’s common
stock commenced trading on the Nasdaq Capital Market under the
symbol TMDI.
- On June 28, 2018, the Company announced
the appointment of medical device veteran Domenic Serafino to its
board of directors.
- On August 2, 2018, the Company
announced an expanded advisory role for Arnold Advincula, M.D., a
world-renowned expert in robotic gynecologic surgery.
- On September 5, 2018, an abstract of a
pilot study featuring the SPORT Surgical System in partial
nephrectomy and heminephrectomy procedures was presented at the
European Association of Urology Robotic Urology Section Annual
Meeting.
- On September 18, 2018, the Company, in
conjunction with Mimic Technologies, announced the successful
completion of the core surgical skills simulation modules for use
with the SPORT Surgical System surgeon workstation.
- On November 14, 2018, an abstract
titled “Reverse Objective Structured Assessment of Technical Skills
(Reverse-OSATS) as a means of measuring the capability of the Titan
Medical SPORT Surgical System on core surgical principles” was
presented at the American Association of Gynecologic Laparoscopists
2018 Global Congress.
- On January 3, 2019, the Company
announced that it had completed the system engineering confidence
build for all components of the SPORT Surgical System.
- Throughout 2018, the Company enhanced
its intellectual property position with the receipt of important
global patents and the continued filing of patents. It currently
has 29 issued patents and 76 pending patent applications including
in the U.S., Europe, Canada and China.
Financial highlights for 2018 include:
- Research and development expenses for
2018 were $32,858,339, compared with $12,900,855 in 2017.
- Net and comprehensive loss for 2018 was
$22,639,272, compared with $33,586,984 in 2017. The 2018 net loss
includes adjustment for warrant liability gain on the change in
fair value of warrants of $17,095,220.
- The Company raised gross proceeds of
$28,424,732 through two separate public offerings of common stock
and warrants.
- Cash, cash equivalents and deposits
with product development service providers as of December 31, 2018
were $20,012,873, compared with $28,668,927 as of December 31,
2017.
- As of February 8, 2019, a total of
619,606 warrants issued as part of the August 2018 offering were
exercised at the conversion price of $3.20 per warrant, for
proceeds to date of $1,982,739.
Expectations for 2019
Titan Medical anticipates the completion of verification and
validation testing, followed by design freeze and the initiation of
animal and cadaver studies, in support of planned regulatory
filings, during the first half of 2019. It also expects to submit
an IDE study application to the FDA during the first half of 2019,
to perform the IDE study at multiple hospitals during the fourth
quarter of 2019, and to file a 510(k) premarket notification and
submit its technical file to a European Notified body for CE mark
by the end of the year.
Mr. McNally reiterated, “We remain confident in our highly
experienced team to meet our aggressive timeline, just as they have
been doing for the past two years.”
Conference Call and Webcast
Titan Medical plans to hold a conference call and webcast to
discuss its plans for 2019 by the end of March. A press release
will be issued prior to the call with additional information.
About Titan Medical Inc.
Titan Medical Inc. is focused on computer-assisted robotic
surgical technologies for application in minimally invasive
surgery. 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
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, 2018 (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/20190213005890/en/
LHA Investor RelationsKim Sutton Golodetz(212)
838-3777kgolodetz@lhai.comorBruce Voss(310)
691-7100bvoss@lhai.com
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