Tag: Stereotaxis

Stereotaxis Genesis Robotic System Achieves Regulatory Approval in China

ST. LOUIS and SHANGHAI, Nov. 25, 2024 (GLOBE NEWSWIRE) — 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

Hospital Da Luz is the First in Portugal to Adopt Genesis Robotic System

ST. LOUIS, Nov. 20, 2024 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that physicians at the Hospital da Luz in Lisbon, Portugal have successfully treated the first patients using the advanced Genesis Robotic Magnetic Navigation (RMN) System.

Stereotaxis to Report Third Quarter 2024 Financial Results on November 11, 2024

ST. LOUIS, Oct. 23, 2024 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that it will release financial results for its 2024 third quarter on Monday, November 11, 2024 at the close of the U.S. financial markets. The Company will host a conference call and webcast at 4:30 p.m. ET that day to discuss the Company’s results and corporate developments.

Stereotaxis Technology to be Featured at Annual Meeting of the Society for Cardiac Robotic Navigation

ST. LOUIS, Oct. 21, 2024 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that it will participate in the Society for Cardiac Robotic Navigation’s Annual Meeting taking place October 28-29 in Lisbon, Portugal.

Stereotaxis Robotic Technology to be Featured during Heart Rhythm Society’s HRX Congress

ST. LOUIS, Sept. 03, 2024 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that its technology will be prominently featured during the upcoming HRX digital health conference taking place September 5-7, 2024, in Atlanta, Georgia.

Stereotaxis to Report Second Quarter 2024 Financial Results on August 12, 2024

ST. LOUIS, July 22, 2024 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that it will release financial results for its 2024 second quarter on Monday, August 12, 2024 at the close of the U.S. financial markets. The Company will host a conference call and webcast at 4:30 p.m. EST that day to discuss the Company’s results and corporate developments.

Penn Presbyterian Medical Center Becomes First Hospital in the Northeast to Adopt Advanced Robotic Technology for Heart Treatment

ST. LOUIS, May 29, 2024 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), a pioneer in surgical robotics for minimally invasive endovascular intervention, today announces the successful treatment of the first heart rhythm patients by Penn Presbyterian Medical Center (PPMC) utilizing the advanced Genesis Robotic Magnetic Navigation System. PPMC, part of the University of Pennsylvania Health System, renowned for advanced clinical research, innovation, and compassionate patient care, stands at the forefront as the first in the Northeast United States to offer the Genesis System. Genesis is the latest advancement in Robotic Magnetic Navigation technology. Robotic Magnetic Navigation introduces the benefits of robotic precision and safety to cardiac ablation, a common minimally invasive procedure to treat arrhythmias. Tens of millions of individuals worldwide suffer from arrhythmias – abnormal heart rhythms that result when the heart beats too quickly, too slowly, or with an irregular pattern. When left untreated, arrhythmias may significantly increase the risk of stroke, heart failure, and sudden cardiac arrest. “Our adoption of advanced robotic technology significant enhances our ability to precisely diagnose and treat patients suffering from complex cardiac arrhythmias,” said Dr. Benjamin D’Souza, Cardiac Electrophysiologist at Penn Presbyterian Medical Center. “We are committed to leveraging cutting-edge innovations to provide patients with the best care. Our team has leveraged the precision and safety of robotics to treat patients that often have few other options for care. With unmatched accuracy, we can tailor treatments to each patient’s unique anatomy, enhancing safety and efficacy.” “We are excited to partner with Penn Presbyterian to pioneer the Genesis Robotic System in the Northeast,” said David Fischel, Chairman and CEO of Stereotaxis. “We look forward to supporting Penn Presbyterian in growing a highly successful and impactful robotic heart care program that advances patient care, clinical research and technology advancement.” 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

Stereotaxis Receives CE Mark Recertification Under EU’s MDR Regulatory Framework

ST. LOUIS, May 24, 2024 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that it has received CE Mark recertification under the European Union’s new Medical Device Regulation (MDR) regulatory framework. The recertification under MDR covers all Stereotaxis devices currently available in Europe. MDR (Regulation (EU) 2017/745) replaces the former European Medical Device Directive, which had governed the approval and marketing of medical devices in the EU. The new regulation includes more stringent standards and requirements across quality, clinical and post-market surveillance areas. It is intended to create a robust regulatory framework for improved clinical safety and market access for medical devices. Stereotaxis has now received its updated EU Quality Management System Certificate. This certificate shows that the Stereotaxis Quality System is in accordance with MDR and that Stereotaxis’ products now have a valid CE Mark under MDR. This MDR certification will support regulatory clearances of upcoming innovations. “This final step in the certification of our products and quality systems under MDR is the culmination of several years of diligent work by the Stereotaxis team,” said Matthew Stepanek, Sr. Director of Regulatory Affairs, Quality & Technical Writing. “We appreciate the collaboration with our Notified Body in this entire process.” “This is a reflection of Stereotaxis’ commitment to high-quality devices, systems, and processes to ensure the best possible experience for the patients and physicians that rely on our technology,” said David Fischel, Chairman and CEO. “Congratulations to all those at Stereotaxis who made this possible.” 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. Company Contacts:                                                        David L. FischelChairman and Chief Executive Officer Kimberly R. Peery                                                        Chief Financial Officer 314-678-6100Investors@Stereotaxis.com