Titan Medical Reports Second Quarter 2019 Financial Results
31 Julho 2019 - 6:57PM
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 and six months ended June 30, 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 June 30, 2019 may be viewed on
SEDAR at www.sedar.com and on EDGAR at www.sec.gov.
David McNally, President and CEO of Titan Medical, said, “We
continued to make steady progress during the second quarter of 2019
and in recent weeks, and moved closer to critical milestones
associated with anticipated regulatory filings for our single-port
robotic surgical system. Most recently we announced completion of
the surgeries associated with Good Laboratory Practices (“GLP”)
studies. These studies were undertaken in preparation for
submitting an Investigational Device Exemption (“IDE”) application
to the U.S. Food and Drug Administration (“FDA”) for human
confirmatory studies, which we plan to conduct during the fourth
quarter. Based on this schedule and the anticipated approval of our
IDE, we remain focused on filing our 510(k) application with the
FDA and our technical file for the CE mark by year-end 2019.
“Research and development expenses increased substantially
during the first half of 2019 compared to the same period of 2018
as we drove to hardware design freeze, accelerated system software
integration, made instrument improvements and developed surgical
accessories to support our GLP studies. It is noteworthy that costs
associated with the surgeon workstations, patient carts, camera
systems, instruments and accessories manufactured for the GLP
studies and human studies to be conducted under the IDE are
expensed and included in research and development costs. As noted
in the milestone table of our current MD&A, we expect these
expenses will peak during the third quarter as we prepare for human
confirmatory studies, but research and development expenses will
then decrease during the fourth quarter of 2019 and thereafter, as
we transition to manufacturing for commercialization.
“In parallel we are preparing for product launch, following
anticipated regulatory clearances. We named Chad Zaring as chief
commercial officer earlier this month. Mr. Zaring has deep
experience developing and executing commercial strategies and
driving sales for leading surgical robotics companies,” Mr. McNally
added. “During the second quarter we also welcomed Charles Federico
as our new chairman of the board. Charles is a prominent medical
technology executive with extensive experience and a track record
of success in strategic planning, corporate governance and product
commercialization, including surgical robotics.
“Titan recently became eligible to file a shelf registration
statement in the U.S. and soon thereafter we filed a Form F-3. Once
the registration statement is declared effective by the U.S.
Securities and Exchange Commission (“SEC”), we may access up to
$125 million of securities in aggregate over the next three years.
This new capital will finance the Company’s operations through a
transition from product development to manufacturing and planned
commercialization,” Mr. McNally added.
Business highlights and achievements for the second quarter of
2019 and recent weeks include:
- Expanded the Company’s global intellectual property portfolio
to 42 patents issued and 82 patents pending, including the receipt
of Titan’s first patent in China.
- Achieved hardware design freeze for the Company’s single-port
robotic surgical system.
- Appointed prominent medical technology executive Charles
Federico as chairman of the board of directors.
- Hired experienced industry executive Chad Zaring as chief
commercial officer.
- Completed the surgeries associated with GLP studies in
preparation for IDE submission to the FDA.
- Filed a shelf registration statement on Form F-3 to raise up to
$125 million over three years.
Financial results for the second quarter and first half of 2019
include:
- Research and development expenses for the three and six months
ended June 30, 2019 were $18,360,674 and 32,769,286, respectively,
compared with $6,246,275 and $9,520,349, respectively, for the
corresponding prior-year periods, as the Company accelerated
advanced product development in preparation for planned GLP and IDE
studies.
- Net and comprehensive loss for the three and six months ended
June 30, 2019 was $14,472,869 and $42,755,746, respectively,
compared with a net and comprehensive loss of $5,885,415 and
$6,694,114, respectively, for the same periods in 2018. In addition
to increased research and development expenses, the higher net loss
for both periods includes the impact of changes in warrant
valuation in 2019.
- Cash, cash equivalents and deposits with product development
service providers as of June 30, 2019 was $19,184,529, compared
with $20,012,873 as of December 31, 2018.
About Titan Medical Inc.
Titan Medical Inc. is focused on computer-assisted robotic
surgical technologies for application in MIS. The Company is
developing 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
gynecologic surgical indications for use of its single-port robotic
surgical system.
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, and
include, without limitation, statements regarding; the Company’s
capacity to complete the scheduled milestones on the path to
anticipated regulatory filings; the Company’s intention to complete
human confirmatory studies as part of its IDE application to the
FDA; the Company’s submission of its IDE application and
anticipated approval of such application; the Company’s expected
timeline for the submission of its 510(k) application with the FDA
and technical file for the CE mark; the Company’s expectations
regarding research and development costs in the future; the
Company’s timeline for its transition from product development to
manufacturing to product launch and planned commercialization and
the ability of its new employees and board members to assist with
this process; the SEC declaring the Company’s shelf registration
statement effective; the ability of the Company to access the up to
$125 million available under the shelf registration statement; the
sufficiency of the up to $125 million available under the shelf
registration statement in financing the transition from product
development to manufacturing and planned commercialization. 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 current or
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/20190731006073/en/
LHA Kim Sutton Golodetz (212) 838-3777 kgolodetz@lhai.com or
Bruce Voss (310) 691-7100 bvoss@lhai.com
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