Titan Medical Reports First Quarter 2019 Financial Results
15 May 2019 - 8:56AM
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 three months ended March 31, 2019.
All financial results are prepared in accordance with
International Financial Reporting Standards (“IFRS”) and are
reported in U.S. dollars, unless otherwise stated. The unaudited
condensed interim financial statements and management’s discussion
and analysis for the period ended March 31, 2019 may be viewed on
SEDAR at www.sedar.com.
David McNally, President and CEO of Titan Medical, said, “We
continued to make steady progress during the first quarter and
recent weeks, moving closer to pivotal milestones in the
development of our single-port robotic surgical system. Most
recently we announced hardware design freeze, which allows us to
complete verification and validation activities. We remain on track
to conduct preclinical studies this summer under Good Laboratory
Practices (GLP) and Summative Human Factors studies. These studies
are in preparation for submitting an Investigational Device
Exemption (IDE) application to the U.S. Food and Drug
Administration for human confirmatory studies, which we plan to
conduct during the fourth quarter. Based on this schedule and
anticipated approval of our IDE application, we expect to file by
year-end 2019 our 510(k) application with the FDA and our technical
file for the CE mark in Europe.
“During the first quarter we raised nearly $29 million in the
single-largest offering in Titan’s history, which included several
U.S. institutions as a result of our Nasdaq listing. We are now
capitalized through several of this year’s important milestones
ahead.
“We are taking the necessary steps to ensure a successful
launch, following regulatory clearance,” Mr. McNally added. “We
have bolstered our global patent position, which now stands at 35
issued and 73 patents pending. Our agreement with Teleflex for
ligation instruments will expand the types of procedures our system
will be able to perform in the future. We are also proud to have
welcomed our new chairman of the board earlier this month, Charles
Federico, a prominent medical technology executive who possesses
deep experience and a track record of success in strategic
planning, corporate governance, and successful
commercialization.”
Business highlights and milestones for the first quarter of 2019
and recent weeks include:
- Completed the system engineering
confidence build for all components of the Company’s single-port
robotic surgical system.
- Announced publication of a
peer-reviewed paper featuring its single-port robotic surgical
system in Surgical Endoscopy, which highlighted the feasibility,
safety and ease-of-use of the technology for general surgery
procedures.
- Expanded the global intellectual
property portfolio to 35 patents issued and 73 patents pending,
including the receipt of its first patent in China.
- Closed a public offering of units
consisting of one share of common stock and one warrant to purchase
one share of common stock, raising gross proceeds of $28.8
million.
- Announced a collaboration with Teleflex
Incorporated to integrate Teleflex’s market-leading Weck®
Hem-o-lok® polymer ligation technology into Titan’s single-port
robotic surgical system.
- Achieved hardware design freeze for its
single-port robotic surgical system.
- Appointed prominent medical technology
executive Charles Federico to chairman of the board of
directors.
Financial results for the first quarter of 2019 include:
- Research and development expenses for
the first quarter of 2019 were $14,408,612, compared with
$3,274,074 for the corresponding prior-year period, as the Company
accelerated advanced product development in preparation for planned
GLP and IDE studies.
- Net and comprehensive loss for the
first quarter of 2019 was $28,282,880, compared with a net and
comprehensive loss of $808,699 for the same period in 2018, which
in addition to increased research and development expenses,
includes the impact of changes in warrant valuation in 2019.
- Cash, cash equivalents and deposits
with product development service providers as of March 31, 2019
were $33,813,090, compared with $20,012,873 as of December 31,
2018.
- During the quarter 1,018,506 warrants
were exercised for total proceeds of $3,259,219.
About Titan Medical Inc.
Titan Medical Inc. is focused on computer-assisted robotic
surgical technologies for application in MIS. 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, 2019 (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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LHAKim Sutton Golodetz(212) 838-3777kgolodetz@lhai.comorBruce
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