Stereotaxis Genesis Robotic System Achieves Regulatory Approval in China
November 25 2024 - 7:21AM
Stereotaxis (NYSE: STXS) and Shanghai MicroPort EP Medtech Co.,
Ltd. (688351.SH, “MicroPort EP”), today announced regulatory
approval of the Genesis RMN® System by China’s National Medical
Products Administration (NMPA).
This approval is a significant milestone, making
available the latest advances in minimally-invasive robotic
technology to physicians and patients in China. MicroPort EP is
initiating full commercial launch of Genesis through its existing
sales teams focused on the electrophysiology community. Approval of
Genesis is a key element in a broader collaboration between
Stereotaxis and MicroPort EP which entails the development,
integration and commercialization of Stereotaxis’ robotic system,
robotically-navigated catheters, and MicroPort EP’s Columbus™ 3D
mapping system. MicroPort EP is one of China’s leading medical
device companies with a portfolio of cardiovascular medical devices
designed to diagnose and treat arrythmias. Stereotaxis and
MicroPort EP previously announced their collaboration in August
2021.
“We are proud to partner with Stereotaxis to
bring the benefits of the Genesis system to China,” said Dr. Yiyong
Sun, President of MicroPort EP. “We look forward to launching this
significant technology and continuing our partnership to provide
China’s electrophysiology community with the most advanced
innovations.”
"We are delighted to receive NMPA clearance for
the Genesis System in China," said David Fischel, Stereotaxis
Chairman and CEO. "This approval represents another key milestone
as we establish the foundations for significant growth across key
focus geographies. Our investment to advance the substantial
innovations underscores our commitment to pioneering the frontiers
of medical technology to improve the lives of patients with
cardiovascular disease around the world.”
Genesis is the latest innovation in Robotic
Magnetic Navigation technology. Robotic Magnetic Navigation
introduces the benefits of robotic precision and safety to
minimally-invasive endovascular procedures. The Genesis RMN System
has FDA clearance and is CE marked, with systems across the United
States and Europe having been used to treat thousands of
patients.
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 150,000 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
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