Titan Medical Announces Successful Completion of Survival Phase of GLP Chronic Procedures with its Single-Port Robotic Surgic...
06 Agosto 2019 - 9:50AM
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 the
successful completion of the chronic procedures performed under
Good Laboratory Practice (“GLP”) principles using its single-port
robotic surgery system, noting that all animals survived through
the follow-up period. Ricardo Estape, M.D., a robotic gynecologic
oncology surgeon specializing in robotic single incision surgeries
from South Miami Gynecology Oncology Group, led the completion of
the GLP studies.
The Company now intends to complete the full GLP studies report
and required Summative Human Factors studies, followed by the full
Human Factors Evaluation (“HFE”) report to facilitate filing of the
Investigational Device Exemption (“IDE”) submission by the end of
September.
“We are pleased to have successfully completed the survival
phase of the chronic studies performed under the expert guidance of
Dr. Estape for our IDE application to the U.S. Food and Drug
Administration (“FDA”),” said David McNally, Titan’s chief
executive officer. “All of the chronic study animals survived the
required time following benign hysterectomy procedures using our
single-port robotic surgery system. The demonstration of multi-week
survival is a significant achievement for Titan. We are encouraged
by the results and our team is now focused on completing the
remaining milestones to support a 510(k) filing by year-end
2019.”
Dr. Estape said, “It was a privilege to lead these important
studies with Titan’s single-port robotic surgery system and I am
pleased that the post-surgery period has elapsed without
complications. The survival of the chronic animals, along with the
successful completion of other GLP acute animal and cadaver
studies, demonstrates that I was able to complete the essential
surgical tasks to achieve the desired results using the system. I
remain very excited about the potential of Titan’s single-port
robotic surgical system. Once cleared for clinical use, it may
deliver single-incision surgery performance that could result in
reduced trauma and faster healing for my 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 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190806005560/en/
LHA Investor Relations Kim Sutton Golodetz (212) 838-3777
kgolodetz@lhai.com or Bruce Voss (310) 691-7100 bvoss@lhai.com
Titan Medical (NASDAQ:TMDI)
Gráfico Histórico do Ativo
De Mar 2024 até Abr 2024
Titan Medical (NASDAQ:TMDI)
Gráfico Histórico do Ativo
De Abr 2023 até Abr 2024