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Stereotaxis (STXS) Receives European Approval for GenesisX
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Stereotaxis (STXS - Free Report) recently announced the achievement of the CE mark approval of its next-generation robotic system, GenesisX, in Europe. Simultaneously, the company has submitted a 510(k) application for the system to the FDA.
These developments mark a significant step forward for Stereotaxis, paving the way for enhanced accessibility and adoption of robotic systems in various medical disciplines.
Innovative Design and Strategic Impact
GenesisX is the latest iteration of Stereotaxis' Robotic Magnetic Navigation (“RMN”) technology, which has been praised for its precision and efficiency in surgical procedures. However, previous iterations of RMN systems required extensive structural modifications for operating rooms, including heavy magnetic shielding and high electrical power requirements, making it a complex and costly endeavor for many hospitals. GenesisX addresses these challenges with a more compact and user-friendly design.
The system employs smaller magnets, incorporates magnetic shielding within its structure and operates using standard power outlets, eliminating the need for extensive structural modifications. Additionally, GenesisX’ cabinet has been reduced in size by 80%, making it more adaptable to existing surgical environments.
This design evolution is strategically transformative for Stereotaxis. By simplifying the installation and operational requirements, GenesisX significantly lowers the barriers to adoption, allowing more hospitals and physicians to adopt robotic-assisted surgery. This is particularly crucial in the field of electrophysiology and other endovascular interventions, where precision and control are paramount. The GenesisX system positions Stereotaxis to expand its market presence and influence by maintaining the speed and responsiveness of its predecessor while enhancing accessibility.
Regulatory Pathway and Prospects
The approval of GenesisX in Europe and the subsequent FDA submission represent only the initial steps in a broader regulatory strategy for Stereotaxis. The company is poised to pursue additional approvals for compatible catheters. It also aims to generate real-world usage data to further validate the system's efficacy and safety. Stereotaxis also plans to enhance the system's compatibility with various X-ray technologies, which will further integrate GenesisX into a wide range of clinical settings.
Looking ahead, Stereotaxis anticipates a full-scale commercial launch of GenesisX in 2025. The company is currently preparing its supply-chain, manufacturing and installation processes to meet the expected demand. If successful, the widespread adoption of GenesisX could mark a new era in robotic-assisted surgery, making advanced surgical technologies more accessible and improving patient outcomes across the globe.
Per a report by MarketsandMarkets, the global surgical robots market size was valued at $8.5 billion in 2022 and is expected to reach $18.4 billion by 2027, at a growth rate of 16.6%.
The benefits of laparoscopic or minimally invasive surgery to patients and surgeons, including improved screening, increased precision, shorter hospital stays, and less pain and suffering, are driving the demand for and acceptance of this procedure, thereby leading to the expansion of the market.
With the given market potential, CE mark for GenesisX can provide a great boost to Stereotaxis’ business and generate additional revenues.
Zacks Rank and Stocks to Consider
Stereotaxis currently carries a Zacks Rank #3 (Hold).
DaVita has an estimated long-term growth rate of 17.5%. DVA’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 24.2%.
DaVita’s shares have risen 39.2% year to date compared with the industry’s 11% growth.
Aspen Technology has an estimated long-term growth rate of 13.1%. AZPN’s earnings surpassed estimates in two of the trailing four quarters and missed the same twice, the average surprise being 4.24%.
Shares of Aspen Technology have lost 3.1% year to date against the industry’s 9.2% growth.
Universal Health Services has an estimated long-term growth rate of 19%. UHS' earnings surpassed estimates in each of the trailing four quarters, the average surprise being 14.58%.
The company’s shares have risen 44.7% year to date compared with the industry’s 34.9% growth.
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Stereotaxis (STXS) Receives European Approval for GenesisX
Stereotaxis (STXS - Free Report) recently announced the achievement of the CE mark approval of its next-generation robotic system, GenesisX, in Europe. Simultaneously, the company has submitted a 510(k) application for the system to the FDA.
These developments mark a significant step forward for Stereotaxis, paving the way for enhanced accessibility and adoption of robotic systems in various medical disciplines.
Innovative Design and Strategic Impact
GenesisX is the latest iteration of Stereotaxis' Robotic Magnetic Navigation (“RMN”) technology, which has been praised for its precision and efficiency in surgical procedures. However, previous iterations of RMN systems required extensive structural modifications for operating rooms, including heavy magnetic shielding and high electrical power requirements, making it a complex and costly endeavor for many hospitals. GenesisX addresses these challenges with a more compact and user-friendly design.
The system employs smaller magnets, incorporates magnetic shielding within its structure and operates using standard power outlets, eliminating the need for extensive structural modifications. Additionally, GenesisX’ cabinet has been reduced in size by 80%, making it more adaptable to existing surgical environments.
This design evolution is strategically transformative for Stereotaxis. By simplifying the installation and operational requirements, GenesisX significantly lowers the barriers to adoption, allowing more hospitals and physicians to adopt robotic-assisted surgery. This is particularly crucial in the field of electrophysiology and other endovascular interventions, where precision and control are paramount. The GenesisX system positions Stereotaxis to expand its market presence and influence by maintaining the speed and responsiveness of its predecessor while enhancing accessibility.
Regulatory Pathway and Prospects
The approval of GenesisX in Europe and the subsequent FDA submission represent only the initial steps in a broader regulatory strategy for Stereotaxis. The company is poised to pursue additional approvals for compatible catheters. It also aims to generate real-world usage data to further validate the system's efficacy and safety. Stereotaxis also plans to enhance the system's compatibility with various X-ray technologies, which will further integrate GenesisX into a wide range of clinical settings.
Looking ahead, Stereotaxis anticipates a full-scale commercial launch of GenesisX in 2025. The company is currently preparing its supply-chain, manufacturing and installation processes to meet the expected demand. If successful, the widespread adoption of GenesisX could mark a new era in robotic-assisted surgery, making advanced surgical technologies more accessible and improving patient outcomes across the globe.
Stereotaxis Inc. Price
Stereotaxis Inc. price | Stereotaxis Inc. Quote
Industry Prospects
Per a report by MarketsandMarkets, the global surgical robots market size was valued at $8.5 billion in 2022 and is expected to reach $18.4 billion by 2027, at a growth rate of 16.6%.
The benefits of laparoscopic or minimally invasive surgery to patients and surgeons, including improved screening, increased precision, shorter hospital stays, and less pain and suffering, are driving the demand for and acceptance of this procedure, thereby leading to the expansion of the market.
With the given market potential, CE mark for GenesisX can provide a great boost to Stereotaxis’ business and generate additional revenues.
Zacks Rank and Stocks to Consider
Stereotaxis currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space that have announced quarterly results are DaVita (DVA - Free Report) , Aspen Technology (AZPN - Free Report) and Universal Health Services (UHS - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
DaVita has an estimated long-term growth rate of 17.5%. DVA’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 24.2%.
DaVita’s shares have risen 39.2% year to date compared with the industry’s 11% growth.
Aspen Technology has an estimated long-term growth rate of 13.1%. AZPN’s earnings surpassed estimates in two of the trailing four quarters and missed the same twice, the average surprise being 4.24%.
Shares of Aspen Technology have lost 3.1% year to date against the industry’s 9.2% growth.
Universal Health Services has an estimated long-term growth rate of 19%. UHS' earnings surpassed estimates in each of the trailing four quarters, the average surprise being 14.58%.
The company’s shares have risen 44.7% year to date compared with the industry’s 34.9% growth.