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Stereotaxis Announces First Patients Successfully Treated Using MAGiC Ablation Catheter

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Stereotaxis (STXS) announced the successful treatment of the first patients using its Magnetic Interventional Ablation Catheter, MAGiC™, designed for minimally invasive cardiac ablation procedures. The first human procedures using the MAGiC catheter were performed at Vilnius University Hospital Santaros Klinikos in Lithuania, with eight patients treated in the first week of January. Data from the clinical trial will support the CE Mark submission of MAGiC, marking a significant milestone for Stereotaxis as they advance their comprehensive innovation strategy.
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The initiation of clinical trials for Stereotaxis' MAGiC catheter represents a pivotal moment in the field of robotically assisted minimally invasive surgery, particularly in cardiac ablation procedures. The successful treatment of the first patients is an encouraging sign for the technology's efficacy and safety profile. From a research perspective, the data collected from these trials will be crucial in determining the clinical benefits and potential market penetration of the MAGiC catheter. A key factor to consider is the comparative effectiveness of this new technology against existing standards of care in cardiology, which could significantly influence adoption rates.

Furthermore, the trial outcomes will have implications for regulatory approval processes, notably the CE Mark in Europe. A positive trial could streamline the pathway to market and facilitate quicker adoption by healthcare providers. Conversely, any setbacks could delay market entry and impact Stereotaxis' financial projections. The long-term success of the MAGiC catheter will depend on the balance of cost, clinical outcomes and ease of integration into existing medical practices.

The announcement from Stereotaxis concerning their MAGiC catheter has potential implications for the company's financial health and stock valuation. The commencement of patient treatment within the clinical trial phase is a critical step towards commercialization, which can attract investor interest due to the high growth potential of the medical robotics market. The success of these initial procedures may lead to positive sentiment among investors, potentially impacting the stock's performance in the short term.

In the long term, the successful commercialization of MAGiC could lead to increased revenue streams for Stereotaxis. It is important to monitor the progress of the clinical trials and subsequent regulatory approvals, as they will be significant drivers of the company's future earnings. Moreover, the market's response to this innovation, in terms of adoption rate by healthcare providers, will be a key determinant of the financial impact. Stakeholders should also be aware of the competitive landscape and how Stereotaxis positions the MAGiC catheter within it.

The introduction of Stereotaxis' MAGiC catheter into clinical trials is a noteworthy event within the healthcare industry, particularly in the niche of surgical robotics. The successful application of this technology in cardiac ablation procedures could signal a shift towards increased reliance on robotic assistance in surgeries, offering precision and stability that may surpass manual techniques. The industry-wide implications of such technological advancements include potential shifts in training requirements for medical professionals, changes in procedural workflows and the evolution of patient care standards.

It is essential to consider the broader impact on the healthcare system, including how such technologies can drive efficiency, reduce procedure times and potentially lower complication rates. These factors can contribute to overall healthcare cost savings and improved patient outcomes. However, the adoption curve for new medical technologies can be steep and the rate at which the MAGiC catheter is embraced by the medical community will be influenced by factors such as cost, clinical trial results and the robustness of the evidence supporting its use over traditional methods.

ST. LOUIS, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer in surgical robotics for minimally invasive endovascular intervention, today announced that the first patients have been successfully treated using its Magnetic Interventional Ablation Catheter, MAGiC™.

Stereotaxis’ MAGiC catheter is a robotically navigated magnetic ablation catheter designed to perform minimally invasive cardiac ablation procedures. The first human procedures using the MAGiC catheter were successfully performed by Prof. Germanas Marinskis and Assoc. Prof. Gediminas Račkauskas at Vilnius University Hospital Santaros Klinikos in Lithuania. Eight patients were treated in the first week of January, following receipt of approvals to begin enrollment in the prospective clinical trial. Data from the clinical trial will support the CE Mark submission of MAGiC.

“We were delighted to perform the first procedures using the MAGiC catheter, and were pleased with the performance,” said. Assoc. Prof. Račkauskas. “The catheter was very stable, effective and safe. We look forward to continued enrollment in the coming weeks. The electrophysiology community has long awaited innovation in robotic catheter technology, and we are excited to support this progress.”

“This is a significant milestone for Stereotaxis as we advance our comprehensive innovation strategy,” said David Fischel, Stereotaxis Chairman and CEO. “We look forward to the impact MAGiC, a key pillar in our new product ecosystem, will have on patients, physicians, and the advancement of medicine.”

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 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. Fischel
Chairman and Chief Executive Officer

Kimberly Peery
Chief Financial Officer

314-678-6100
Investors@Stereotaxis.com


FAQ

What is the name of the company mentioned in the press release about the Magnetic Interventional Ablation Catheter, MAGiC™?

The company mentioned in the press release is Stereotaxis, with the ticker symbol STXS.

Where were the first human procedures using the MAGiC catheter performed?

The first human procedures using the MAGiC catheter were successfully performed at Vilnius University Hospital Santaros Klinikos in Lithuania.

How many patients were treated in the first week of January using the MAGiC catheter?

Eight patients were treated in the first week of January using the MAGiC catheter.

What will the data from the clinical trial support?

The data from the clinical trial will support the CE Mark submission of MAGiC.

Who is the Chairman and CEO of Stereotaxis?

The Chairman and CEO of Stereotaxis is David Fischel.

Stereotaxis, Inc.

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About STXS

stereotaxis 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. over 100 issued patents support the stereotaxis platform. 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.