Tag: Stereotaxis

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

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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

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

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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

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First Heart Rhythm Patients in Southern Italy Treated with Advanced Robotic Technology

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ST. LOUIS, May 22, 2024 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), a pioneer in surgical robotics for minimally invasive endovascular intervention, today announced that Hospital Santa Maria della Pietà, in Nola in the Metropolitan City of Naples, has established the first robotic cardiac heart program in Southern Italy. Patients suffering from heart rhythm disorders are now being successfully treated with robotic ablation procedures using this advanced technology, and Hospital Santa Maria della Pietà is the first hospital in Italy to adopt the cutting-edge Genesis Robotic Magnetic Navigation (RMN) system. “As electrophysiologists, our primary goal is to improve the lives of our patients,” said Dr. Mario Volpicelli, Head of the Electrophysiology Unit of the hospital. “With the Genesis RMN system, we now have an unprecedented level of precision and control during cardiac ablation procedures, allowing us to target arrhythmias with unmatched accuracy while minimizing risk to our patients.” 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. “The adoption of the Genesis Robotic Magnetic Navigation system marks a significant milestone in our commitment to providing the highest standard of care to our patients.” added Giuseppe Russo, General Manager of the Hospital Santa Maria della Pietà. “We are proud to lead the way in Italy, revolutionizing cardiac treatment through innovative robotic technology.” added Luigi Caliendo, Chief of the Cardiology Department of the Hospital. “We are honored to partner with Hospital Santa Maria della Pietà in bringing the benefits of robotics to patients in Italy,” said David Fischel, Stereotaxis Chairman and CEO. “The adoption of the Genesis system reflects our shared commitment to advancing standard of care, innovation, and patient-focused solutions in electrophysiology.” 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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Stereotaxis Announces Definitive Agreement to Acquire Access Point Technologies

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ST. LOUIS, May 13, 2024 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that it has entered into a definitive share purchase agreement under which Stereotaxis will acquire Access Point Technologies EP (APT), a privately-held Minnesota-based developer of innovative electrophysiology catheters.

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