Titan Medical (NASDAQ:TMDI)
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1 Ano : De Mar 2019 até Mar 2020
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
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
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.
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190514006108/en/
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