ST. LOUIS and SHANGHAI - Stereotaxis (NYSE: NYSE:STXS) and Shanghai MicroPort EP Medtech Co., Ltd. (688351.SH, MicroPort EP), announced today that the Genesis RMN® System has received regulatory approval from China's National Medical (TASE:PMCN) Products Administration (NMPA). This clearance marks a significant step in bringing the latest robotic technology in minimally-invasive procedures to the Chinese market.
The Genesis RMN System, which has already obtained FDA clearance and CE marking, is recognized for its robotic precision and safety in endovascular procedures. Stereotaxis, a pioneer in robotic magnetic navigation technology, has reported that the system has been utilized in treating thousands of patients in the United States and Europe.
MicroPort EP, a leading Chinese medical device company specializing in the diagnosis and treatment of arrhythmias, is set to commence the full commercial launch of Genesis, leveraging its established sales teams within the electrophysiology community.
The approval of Genesis plays a crucial role in the broader collaboration between Stereotaxis and MicroPort EP, which began in August 2021. Their partnership focuses on the development, integration, and commercialization of Stereotaxis' robotic systems, robotically-navigated catheters, and MicroPort EP's Columbus™ 3D mapping system.
Dr. Yiyong Sun, President of MicroPort EP, expressed enthusiasm about introducing the Genesis system to China and the continued partnership with Stereotaxis aimed at providing cutting-edge solutions to the electrophysiology community.
David Fischel, Chairman and CEO of Stereotaxis, highlighted the NMPA clearance as a key milestone in the company's strategy to expand its presence in important geographic markets. He reiterated Stereotaxis' commitment to advancing medical technology to improve patient outcomes for those with cardiovascular disease globally.
Stereotaxis' mission includes the development and delivery of robotic systems and solutions that enhance the precision, safety, and efficiency of interventional laboratory procedures. The company's technology has been used to treat over 150,000 patients worldwide.
This announcement is based on a press release statement and includes forward-looking statements which involve risks and uncertainties that could cause actual results to differ. These statements are not guarantees of future performance, and Stereotaxis does not undertake any obligation to update them.
In other recent news, Stereotaxis, Inc. has experienced significant developments, with Piper Sandler maintaining an Overweight rating on the company, following its third-quarter sales report. The company reported an 18% increase in revenue to $9.2 million, surpassing the $7.1 million projection by analysts. This growth was driven by strong sales in both the system and disposable revenue streams, particularly the delivery of three Genesis systems to European hospitals.
However, operating losses rose to $6.3 million due to higher operating expenses, including costs associated with the recent acquisition of APT. Stereotaxis has also confirmed its full-year 2024 guidance, anticipating revenues to remain consistent with the prior year. The company has identified several catalysts expected to enhance shareholder value and potentially accelerate revenue growth into 2025, including the revamping of its Robotic Magnetic Navigation (RMN) portfolio and the upcoming regulatory approval for the MAGiC catheter in Europe.
Piper Sandler's analysis suggests continued confidence in Stereotaxis' strategic initiatives and market position. The firm highlighted the company's ongoing efforts to update its RMN portfolio and believes that these improvements, along with upcoming catalysts, will play a crucial role in propelling Stereotaxis forward and generating increased revenue in 2025. Despite the challenges, Stereotaxis remains committed to investing in growth technologies and maintaining prudent financial management.
InvestingPro Insights
The recent regulatory approval of Stereotaxis' (NYSE: STXS) Genesis RMN® System in China marks a significant milestone for the company, potentially opening up new revenue streams in a major market. However, investors should consider several key factors when evaluating the company's prospects.
According to InvestingPro data, Stereotaxis currently has a market capitalization of $173.7 million USD, reflecting its position as a smaller player in the medical device industry. The company's revenue for the last twelve months as of Q3 2023 stood at $25.14 million USD, with a notable quarterly revenue growth of 17.91% in Q3 2023. This recent growth could be an early indicator of the positive impact of the Genesis RMN® System's expanding global reach.
Despite these developments, InvestingPro Tips highlight some challenges. The company is not currently profitable, with a negative P/E ratio of -7.92 for the last twelve months. Additionally, analysts do not anticipate the company will be profitable this year. This aligns with the company's focus on expansion and market penetration, which often requires significant investment before profitability is achieved.
It's worth noting that Stereotaxis operates with a moderate level of debt, which could provide financial flexibility as it pursues growth opportunities in China and other markets. However, investors should be aware that the stock price movements are quite volatile, which is not uncommon for smaller medical technology companies with developing product lines.
For those interested in a more comprehensive analysis, InvestingPro offers additional tips and insights on Stereotaxis. There are 7 more InvestingPro Tips available, which could provide valuable context for understanding the company's financial health and market position as it embarks on this new phase of expansion in China.
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