Stereotaxis to Initiate First-in-Human Trial to Support CE Mark Application of MAGiC Catheter
15 Giugno 2023 - 10:10PM
Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical
robotics for minimally invasive endovascular intervention, today
announced that it intends to initiate a first-in-human trial to
support the CE Mark submission for its MAGiC™ catheter.
Stereotaxis’ MAGiC catheter is a
robotically-navigated magnetic ablation catheter designed to
perform minimally invasive cardiac ablation procedures. The
catheter’s CE Mark submission was made in July 2022 and included
substantial in vivo preclinical, lab and bench data. The submission
strategy was in-line with multiple historical precedents for
similar ablation catheters as well as verbal feedback provided by
the European Notified Body. Given evolving interpretation of recent
EU Medical Device Regulation, the Notified Body has now requested
clinical data to support the submission. Stereotaxis intends to
complete a first-in-human study to support the MAGiC submission
before the end of this year.
“We look forward to advancing the MAGiC catheter
into clinical use and are working expeditiously to ensure the
technology becomes available to patients and the electrophysiology
community as soon as possible,” said David Fischel, Stereotaxis
Chairman and CEO.
“Stereotaxis continues to experience demand for
its Genesis robotic system, and reiterates its expectation of
double-digit revenue growth in 2023. Our strong financial position
allows us to advance a robust innovation strategy through
commercialization without the need for additional financing. This
innovation strategy, including a highly-accessible robot with
proprietary interventional catheters for use in electrophysiology
and broadly across endovascular interventions, serves as the
foundational product ecosystem to transform endovascular surgery
with robotics.”
About StereotaxisStereotaxis
(NYSE: STXS) is a pioneer and global leader in innovative surgical
robotics for minimally invasive endovascular intervention. Its
mission is the discovery, development and delivery of robotic
systems, instruments, and information solutions for the
interventional laboratory. These innovations help physicians
provide unsurpassed patient care with robotic precision and safety,
expand access to minimally invasive therapy, and enhance the
productivity, connectivity, and intelligence in the operating room.
Stereotaxis technology has been used to treat over 100,000 patients
across the United States, Europe, Asia, and elsewhere. For more
information, please visit www.stereotaxis.com
This press release includes statements that may
constitute "forward-looking" statements, usually containing the
words "believe”, "estimate”, "project”, "expect" or similar
expressions. Forward-looking statements inherently involve risks
and uncertainties that could cause actual results to differ
materially. Factors that would cause or contribute to such
differences include, but are not limited to, the Company's ability
to manage expenses at sustainable levels, acceptance of the
Company's products in the marketplace, the effect of global
economic conditions on the ability and willingness of customers to
purchase its technology, competitive factors, changes resulting
from healthcare policy, dependence upon third-party vendors, timing
of regulatory approvals, the impact of pandemics or other
disasters, and other risks discussed in the Company's periodic and
other filings with the Securities and Exchange Commission. By
making these forward-looking statements, the Company undertakes no
obligation to update these statements for revisions or changes
after the date of this release. There can be no assurance that the
Company will recognize revenue related to its purchase orders and
other commitments because some of these purchase orders and other
commitments are subject to contingencies that are outside of the
Company's control and may be revised, modified, delayed, or
canceled.
Stereotaxis Contacts: David L.
FischelChairman and Chief Executive Officer
Kimberly PeeryChief Financial Officer
314-678-6100Investors@Stereotaxis.com
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