Titan Medical Announces Successful Completion of Human Factors Evaluation for Its Single-Port Robotic Surgical System, Provid...
August 26 2019 - 8:45AM
Business Wire
Titan Medical Inc. (“Titan” or the “Company”) (TSX: TMD)
(Nasdaq: TMDI), a medical device company focused on the design,
development and commercialization of a robotic surgical system for
application in minimally invasive surgery (“MIS”), announces that
the human factors evaluation (“HFE”) required to support its
planned Investigational Device Exemption (“IDE”) filing with the
U.S. Food and Drug Administration (“FDA”) was completed
successfully and received a highly favorable assessment from the
surgeon investigators.
Commenting on the HFE, Arnold Advincula, M.D., Vice-Chair of
Women’s Health & Chief of Gynecology at the Sloane Hospital for
Women, Columbia University Medical Center/New York Presbyterian
Hospital, and the Company’s Medical Advisor on Clinical Education
and Hospital Economics, said, “It was exciting to see the latest
improvements with the system during my recent participation in the
summative human factors studies. For any novel surgical approach to
gain a strong foothold in gynecology and other surgical
specialties, the system must be user-friendly without compromising
technical efficacy and surgical experience.
“During the summative studies, the procedural workflow that
highlighted a simple yet sophisticated design approach of the
system without reinventing the wheel, was easy to learn for myself
and my surgical team. The streamlined design of the system made
surgical assisting seamless and safe,” he added. “I was
particularly impressed with innovative features like a dual-view
camera system consisting of a flexible 3D high-definition camera
along with an integrated 2D high-definition camera, and insightful
overlays providing valuable spatial information for the
multi-articulating instruments. These features are vital for
simplifying single-port robotic surgery for the surgical community
predominantly familiar with multi-port approaches. I remain
enthusiastic with all the progress I am seeing toward making
single-incision robotic surgery a reality that will become a
standard part of our minimal access surgical armamentarium.”
In addition, based on a reassessment of ongoing preparations for
the IDE filing and planned human confirmatory studies, and to
optimize resources while maintaining its goal for best-in-class
product quality and reliability, the Company is in the process of
revising its product development and regulatory timeline. Titan now
expects to file and receive FDA approval for its IDE submission
during the fourth quarter of 2019, and to file its 510(k)
application with the FDA during the first half of 2020, compared
with previous published projections which included filing the
application by year-end 2019.
David McNally, Titan’s chief executive officer, added, “We have
now successfully completed all GLP and HFE studies, which have
further demonstrated our single-port system’s best in-class
potential. Having achieved the expected results, we are compiling
the associated reports from independent experts in preparation for
our IDE submission with the FDA to begin human studies. In
addition, we have engaged a top contract research organization to
manage our human studies. We will now take additional time to
perfect our system and implement all planned system and sterile
instrument interface components, software enhancements and training
tools, in order not only to further de-risk our IDE studies, but
also to introduce a more refined product in the marketplace. This
more measured development schedule will allow us to better manage
workflow and associated payments to our contractors, resulting in a
reduction of our anticipated third quarter cash burn and a smoother
overall quarterly cash burn through to the filing of our 510(k). By
extending our resources and milestones, we can ensure the highest
likelihood of success for our single-port robotic system from
clinical, regulatory and commercial perspectives, and enable a
robust and careful examination of our future funding options, which
may include strategic sources.”
Chad Zaring, Titan’s chief commercial officer, commented, “In
the short time I have worked at Titan Medical I have become ever
more excited about the potential for our single-port robotic
surgical system, once it is fully developed, to compete
successfully in a very large market. I have already met with a
number of experienced robotic surgeons and hospital administrators,
and based on their feedback I believe the single-port market has
the potential to develop rapidly. I also believe Titan Medical can
deliver a product with differentiated features of value to the
surgeons who utilize it, ultimately benefitting their
patients.”
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 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 and on EDGAR at www.sec.gov.
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. 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 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 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/20190826005342/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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