Titan Medical Announces Appointment of Tammy Carrea as Vice President of Quality and Regulatory Affairs
August 02 2021 - 7:30AM
Business Wire
Titan Medical Inc. (Nasdaq: TMDI; TSX: TMD), a medical device
company focused on the design and development of surgical
technologies for robotic single access surgery, today announced the
appointment of Tammy Carrea as Vice President of Quality and
Regulatory Affairs.
“We are delighted that Tammy has joined Titan Medical’s
leadership team as we advance our Enos™ robotic single access
surgery system toward human clinical studies,” said David McNally,
President and Chief Executive Officer. “Her proven track record in
developing and implementing clinical and regulatory strategies,
obtaining medical device regulatory clearances and successfully
managing FDA inspections will be invaluable assets for Titan. It is
my pleasure to welcome Tammy to Titan and I look forward to working
with her as we progress toward submitting our application for
Investigational Device Exemption for the Enos system to the
FDA.”
Ms. Carrea has more than 25 years of experience in managing
quality assurance and regulatory affairs activities in the medical
device industry, including robotic assisted surgery. Ms. Carrea has
been responsible for global submissions and registrations for Class
1, 2, and 3 medical devices including De Novo applications. Most
recently, she served as Vice President, Regulatory and Clinical
Affairs and Security Officer of Translational Imaging Innovations,
Inc., which produced software for ophthalmology medical imaging and
cloud data management to enable AI algorithm development. Ms.
Carrea holds a Bachelor of Science Degree in Materials Science and
Engineering from North Carolina State University, and a Master of
Science Degree in Quality and Regulatory Affairs from Temple
University, with a concentration in medical devices and clinical
research.
"I am thrilled to join Titan’s impressive leadership team during
such a pivotal time in the company's evolution. I look forward to
applying my background and experience to help the company to
realize its vision for commercializing its Enos robotic single
access surgical system for the benefit of patients, while enhancing
the surgical experience for surgeons and hospital staff," said Ms.
Carrea.
Curtis Jensen, Titan’s Vice
President of Quality and Regulatory Affairs since April 2017,
leaves the Company to pursue other opportunities in the medical
device industry. “We thank Curtis for his contributions to the
development program for the Enos system. Curtis commuted a long
distance to Chapel Hill while the Company established a team to
advance the development of the Enos system. We wish Curtis the best
in his future endeavors,” said David McNally.
About Titan Medical
Titan Medical Inc. (Nasdaq: TMDI; TSX: TMD), a medical device
company headquartered in Toronto, Ontario and with R&D
facilities in Chapel Hill, North Carolina, is focused on enhancing
robotic assisted surgery using innovative technology through a
single access point. The Enos™ robotic single access surgical
system is being developed with an ergonomic focus to provide a
surgical experience that imitates real-life movements that surgeons
demand and includes multi-articulating instruments designed to
allow surgeons an increased range of motion in a confined space,
with dexterity and the ability to exert the forces necessary to
complete common surgical tasks. With the Enos system, Titan intends
to initially pursue gynecologic surgical indications.
Certain aspects of Titan’s robotic assisted surgical
technologies and related intellectual property have been licensed
to Medtronic plc, while retaining world-wide rights to
commercialize the technologies for use with the Enos system.
Enos™ is a trademark of Titan Medical Inc.
For more information, visit www.titanmedicalinc.com.
Forward-Looking Statements
This news release contains “forward-looking statements” within
the meaning of applicable Canadian and U.S. securities laws, 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, including, without limitation, references to: the
Company’s progress toward submitting an application for
Investigational Device Exemption for the Enos system to the FDA;
the Company’s focus on the design and development of surgical
technologies for robotic single access surgery; the Enos system is
being developed with dual 3D and 2D high-definition vision systems,
multi-articulating instruments and an ergonomic surgeon
workstation; and that Titan intends to initially pursue gynecologic
surgical indications. These statements reflect management’s current
beliefs 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 and Form 40-F for the fiscal year ended December
31, 2020 (which may be viewed at www.sedar.com and at www.sec.gov).
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/20210802005169/en/
Kristen Galfetti Vice President, Investor Relations &
Corporate Communications +1-781-869-2553
investors@titanmedicalinc.com
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