Stereotaxis Earns FDA Clearance and Announces U.S. Launch of Genesis Robotic Magnetic Navigation System
March 06 2020 - 8:05AM
Stereotaxis (NYSE: STXS), the global leader in innovative robotic
technologies for the treatment of cardiac arrhythmias, announced
today it has received U.S. Food and Drug Administration (FDA)
510(k) clearance of the Genesis RMN® System for the robotic
navigation of magnetic ablation catheters to treat heart rhythm
disorders.
“Genesis is a leap forward in Robotic Magnetic
Navigation technology,” said David Fischel, Chairman and CEO. “We
are confident Genesis will have a meaningful impact on patients,
physicians, and providers in Electrophysiology. Genesis is a
reflection of our commitment to positively transform interventional
medicine with robotics.”
Tens of millions of individuals worldwide suffer
from arrhythmias. When left untreated, certain arrhythmias can
significantly increase the risk of stroke, heart failure, and
sudden cardiac arrest. Robotic Magnetic Navigation (RMN) introduces
the benefits of robotic precision and safety to cardiac ablation, a
common minimally invasive procedure to treat arrhythmias. More than
100,000 patients have been treated using Stereotaxis’ RMN
technology in more than 100 hospitals around the world. Over 350
scientific publications have documented the technology’s clinical
value.
The Genesis RMN System builds upon the
established benefits and reliability of RMN in an innovative
architecture that is faster, smaller, lighter and more flexible. It
utilizes smaller magnets rotated along their center-of-mass for
increased speed and control. Across a broad range of navigational
routines, the Genesis System is 70% to 80% faster than its
predecessor. The system’s significant size reduction is designed to
improve the patient experience while on the operating table,
provide physicians and nurses with greater access to the patient
during the procedure, and increase space in the labs for an
enhanced work environment. The magnets are held on flexible and
rugged robotic arms, increasing the potential range of motion of
the system and serving as a platform from which future innovations
in other clinical specialties may be possible. The Genesis RMN
System has FDA clearance to navigate an array of compatible
interventional devices broadly within all chambers of the heart and
coronary vasculature, and throughout the neuro and peripheral
vascular system.
Genesis is integrated and available with
Stereotaxis Imaging Model S, an x-ray system designed for
electrophysiology with modern, digital flat-panel detector
technology to support radiation reduction and clear image quality.
The combined systems are designed to reduce the cost of
acquisition, the ongoing cost of ownership, and the complexity of
installation of a robotic electrophysiology practice. Stereotaxis
will serve as the single source for architectural planning,
installation, and ongoing servicing and maintenance of the combined
technologies, providing a more efficient, responsive, and
cost-effective solution.
About StereotaxisStereotaxis is
the global leader in innovative robotic technologies designed to
enhance the treatment of arrhythmias and perform endovascular
procedures. 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,
improved lab efficiency and productivity, and enhanced integration
of procedural information. The core components of Stereotaxis’
systems have received regulatory clearance in the United States,
European Union, Japan, Canada, China, 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 from the forward-looking statements. Factors that would
cause or contribute to such differences include, but are not
limited to, the Company's ability to raise additional capital on a
timely basis and on terms that are acceptable, its ability to
continue to manage expenses and cash burn rate at sustainable
levels, continued 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 systems and
the timing of such purchases, competitive factors, changes
resulting from healthcare reform in the United States, including
changes in government reimbursement procedures, dependence upon
third-party vendors, timing of regulatory approvals, 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 in any particular period or at all because some of
these purchase orders and other commitments are subject to
contingencies that are outside of the Company's control. In
addition, these orders and commitments may be revised, modified,
delayed or canceled, either by their express terms, as a result of
negotiations, or by overall project changes or delays.
Company Contacts:David L.
FischelChairman and Chief Executive Officer
Kimberly R. PeeryChief Financial Officer
314-678-6100investors@stereotaxis.com
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