Titan Medical Receives ISO 13485 Certification, Provides Update on Fourth Quarter Milestones
January 27 2020 - 8:28AM
Business Wire
Titan Medical Inc. (“Titan” or the “Company”) (TSX: TMD)
(Nasdaq: TMDI), a medical device company focused on the design
and development of a single-port robotic surgical system for
application in minimally invasive surgery (“MIS”), today announced
receipt of ISO 13485 Certification from a European Notified Body
following completion of audits of the Company’s quality system and
related documentation. This certification represents that Titan’s
quality management system (“QMS”) maintains standards that meet
international requirements specific to medical device design and
development.
ISO 13485 certification is the most common path to meet the QMS
medical device requirements in the European Union, Canada and
Australia, and serves as the basis for QMS compliance in other
countries including Japan, Korea and Brazil.
Titan also announced the achievement of its two other previously
stated milestones during the fourth quarter of 2019:
- The Company obtained the final independent report from its
validation testing of system safety and usability for the intended
users and use environments under simulated robotic manipulation
exercises, which are intended to replicate essential surgical
tasks.
- The Company completed the robotic system setup user manual for
operating room staff and surgeon operation of the surgeon
workstation, patient cart, instruments and accessories.
“We are pleased to have achieved these previously stated
milestones during the fourth quarter of 2019, especially given the
financial challenges we have recently faced,” said David McNally,
president and chief executive officer of Titan Medical. “In recent
weeks we exercised our $35 million common stock purchase facility
with Aspire Capital to fund our work while we continue to seek
additional financing.”
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 dual-view camera
system with 3D and 2D high-definition vision options 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 to initially 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” within
the meaning of applicable Canadian and U.S. securities laws. Such
statements 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 29, 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. 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20200127005355/en/
LHA Investor Relations Kim Sutton Golodetz (212) 838-3777
kgolodetz@lhai.com or Bruce Voss (310) 691-7100 bvoss@lhai.com
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