ST. LOUIS - Stereotaxis (NYSE: NYSE:STXS), a global leader in robotic technologies for endovascular surgery, announced today the receipt of the CE mark in Europe for its new robotic system, GenesisX. The company has also filed for 510(k) clearance from the FDA in the United States, signaling a significant step in the system's global commercialization.
GenesisX represents an evolution in Robotic Magnetic Navigation (RMN) systems, designed to streamline the adoption process for hospitals. Traditional RMN systems required extensive modifications to operating rooms, including heavy magnetic shielding, floor reinforcement, and complex cabling. The innovative GenesisX system circumvents these barriers by integrating magnetic shielding into its own structure, eliminating the need for wall installations. It also operates on standard power outlets and requires minimal structural anchoring, substantially reducing installation complexity.
David Fischel, Chairman and CEO of Stereotaxis, emphasized the strategic importance of GenesisX, stating that it "supports broad adoption of robotics in electrophysiology and across endovascular interventions." He highlighted the clinical benefits of robotic technology and the need for broader accessibility to advance patient care.
The new system maintains the performance features of its predecessors, such as speed and responsiveness, while being lighter and more compact. Stereotaxis plans to utilize the coming months for regulatory approvals, real-world demonstrations, and preparations for a full launch in 2025.
Stereotaxis has a history of pioneering surgical robotics, with its technology having been used in over 100,000 patient procedures worldwide. The company continues to focus on innovations that enhance precision, safety, and efficiency in minimally invasive therapies.
The forward-looking statements in the press release reflect the company's aspirations but are subject to risks and uncertainties that could affect actual results. These include market acceptance, global economic conditions, competitive factors, regulatory timing, and other external contingencies.
This report is based on a press release statement from Stereotaxis, Inc.
In other recent news, Stereotaxis, Inc., a key player in the space of robotic technologies for the treatment of cardiac arrhythmias, has reported noteworthy developments. The company has finalized the acquisition of Access Point Technologies EP, Inc., a move aimed at enhancing Stereotaxis' product portfolio with Access Point Technologies' range of high-quality diagnostic catheters. The company has also introduced its Genesis Robotic Magnetic Navigation System at Penn Presbyterian Medical Center, marking the institution as the first in the Northeast United States to adopt the system.
Additionally, Stereotaxis has secured CE Mark recertification under the European Union's Medical Device Regulation, signifying compliance with enhanced standards for quality, clinical, and post-market surveillance. TD Cowen has maintained a 'buy' rating on Stereotaxis, acknowledging the company's strides in regulatory filings for the MAGiC catheter.
In terms of financials, Stereotaxis reported a 5% increase in revenue for the first quarter of 2024, reaching $6.9 million. However, it also faced an operating loss of $4.7 million and a net loss of $4.5 million for the same period. These are among the recent developments for Stereotaxis, reflecting its ongoing commitment to innovation and growth in the field of robotic cardiology.
InvestingPro Insights
As Stereotaxis (NYSE: STXS) makes headway with the CE mark for its GenesisX robotic system and pursues FDA clearance in the United States, a glance at the company's financial health and market performance offers additional context for investors considering the stock. According to InvestingPro data, Stereotaxis has a market capitalization of $152.17 million, which reflects the market's current valuation of the company.
InvestingPro Tips suggest that the company's stock price movements have been quite volatile, which may be indicative of market sentiment and could be crucial for investors looking for the right timing to enter or exit their positions. Moreover, while analysts do not anticipate Stereotaxis to be profitable this year, the company's liquid assets surpass its short-term obligations, suggesting a degree of financial stability in the near term. This could reassure investors of the company's ability to sustain operations and invest in strategic initiatives like the GenesisX system.
Additional metrics of interest include a Price / Book ratio of 10.39, signaling that the stock is trading at a premium relative to the company's book value. The Revenue Growth on a quarterly basis for Q1 2024 stands at 5.07%, indicating some positive momentum in the company's sales despite a slight decline of -2.01% in revenue over the last twelve months. With these insights, investors can better understand the financial backdrop against which Stereotaxis is launching its new robotic system.
For those looking for more detailed analysis and metrics, there are additional InvestingPro Tips available for Stereotaxis at https://www.investing.com/pro/STXS that can provide a more comprehensive financial perspective.
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