Stereotaxis Achieves CE Mark in Europe and Submits 510(k) in the US for Next Generation Robotic System GenesisX
August 12 2024 - 4:03PM
Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical
robotics for minimally invasive endovascular intervention, today
announced it obtained CE mark in Europe and submitted a 510(k)
application to the FDA in the US for a next generation robotic
system, GenesisX.
“We are excited to introduce GenesisX and share
the achievement of these significant milestones,” said David
Fischel, Chairman and CEO. “Medical innovation only realizes its
full potential to advance and improve patient care if it is
designed to be broadly accessible. The clinical value of
Stereotaxis’ robotic technology has been extensively demonstrated
yet difficult to access for the vast majority of interested
physicians and hospitals. GenesisX is strategically transformative
as it supports broad adoption of robotics in electrophysiology and
across endovascular interventions.”
GenesisX builds upon the established benefits
and performance of Robotic Magnetic Navigation (RMN) systems, while
reducing the complexities and barriers to hospital adoption of the
technology. Preparing an operating room to accommodate a RMN system
has typically required significant structural modification,
including the installation of thousands of pounds of magnetic
shielding in the walls, reinforcement of the floor, high electrical
power, and extensive cabling through conduits between the operating
room and a dedicated cabinet room. This entailed months of planning
and coordination between site planners, architects, and
contractors. GenesisX utilizes smaller magnets and incorporates
magnetic shielding into its structure in place of the shielding
otherwise installed in the walls of the operating room. It requires
no structural anchoring through the floor and operates using
standard 120/230V power outlets. A single fiber is routed from each
robot to the system cabinet, which is 80% smaller than the cabinet
of Genesis and can fit under a table in the operating room.
GenesisX is smaller and lighter than any previous generation
system, and maintains the speed, responsiveness, and efficient
workflow of Genesis. GenesisX will serve as a platform for
additional innovations in the future.
GenesisX has obtained CE mark in Europe and has
been submitted to the FDA for 510(k) clearance in the United
States. Stereotaxis plans to use the coming months to gain
regulatory approval for compatible catheters, demonstrate
real-world use of the system, enhance compatibility with various
x-rays, and prepare supply chain, manufacturing, installation and
commercial processes for a full launch and significant adoption of
GenesisX in 2025.
GenesisX Robotic Magnetic Navigation System
Magnetic shielding built into the structure of the GenesisX
Robotic Navigation System
About Stereotaxis
Stereotaxis (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 statements relating to our recent acquisition of
APT, including any benefits expected from the acquisition, 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
Photos accompanying this announcement are available at
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https://www.globenewswire.com/NewsRoom/AttachmentNg/739addac-9797-49cf-b274-3c1eae48bda2
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