Stereotaxis STXS recently received a CE mark in Europe for GenesisX — a next-generation robotic system. The company also submitted a 510(k) application to the FDA in the United States for the same.
The latest development is in line with Stereotaxis’ focus on broadening the adoption of robotics in electrophysiology and across endovascular interventions.
About GenesisX
Built upon the established benefits and performance of Robotic Magnetic Navigation (RMN) systems, GenesisX helps reduce the complexities and barriers to hospital adoption of the technology.
Smaller and lighter than any previous generation system, GenesisX maintains the speed, responsiveness and efficient workflow of Genesis. It uses comparatively smaller magnets to incorporate magnetic shielding into its structure. The system requires no structural anchoring through the floor and operates using standard 120/230V power outlets. A single fiber is routed from each robot to the system cabinet, which is 80% smaller than that of Genesis and can fit under a table in the operating room.
More on the News
In the coming months, the company is planning to gain regulatory approval for compatible catheters, demonstrate real-world use of the system, enhance compatibility with various x-rays, and prepare supply-chain, manufacturing, installation and commercial processes for a full launch of GenesisX in 2025.
Other Recent Developments
In May 2024, Stereotaxis successfully treated its first heart rhythm patients from Penn Presbyterian Medical Center (PPMC) using the advanced Genesis Robotic Magnetic Navigation System.
The same month, the company entered into a definitive share purchase agreement to acquire Access Point Technologies EP, a Minnesota-based developer of innovative electrophysiology catheters. With the acquisition, Stereotaxis will have high-quality catheter development and manufacturing capabilities. This, in turn, will increase and accelerate Stereotaxis’ efforts to advance the treatment of complex arrhythmias and the adoption of robotics within endovascular surgery.
Market Prospects
Per a report from Mordor Intelligence, the Robotic Assisted Surgery Systems market size is valued at $9.5 billion in 2024, and is expected to reach $7.87 billion by 2029, at a CAGR of 13.48%. The primary factors responsible for the market surge include the advantages of robotic-assisted surgery and the rise in research studies using robotic-assisted surgeries.
The increase in cases of chronic disease and the rise in preference for minimally invasive surgeries due to their success and benefits over open surgeries are also contributing to the market growth.
Comparison With Peers
Another renowned player in the broader MedTech space that is solidifying its foothold in the robotic system arena is Intuitive Surgical ISRG. In recent times, the company has made significant progress for its da Vinci surgical system. Intuitive Surgical’s da Vinci surgical systems, designed to help surgeons perform minimally invasive surgeries, offer high-definition 3D vision, a magnified view, and robotic and computer assistance. In June, the company received FDA clearance for the revised da Vinci Xi and X labeling on Radical Prostatectomy. FDA review of historic data showed that patients who received robotic prostatectomies have overall cancer survival rates, on par with open surgery.
Earlier this year, Intuitive Surgical received FDA 510(k) clearance for da Vinci 5 — a next-generation multiport robotic system. Da Vinci 5 is the latest addition to the da Vinci family, which includes multiport systems da Vinci X and da Vinci Xi, and the single-port system da Vinci SP.
Another notable player is Zimmer Biomet ZBH, which announced a limited distribution agreement with THINK Surgical, Inc. regarding its wireless, handheld, TMINI — a miniature robotic system for total knee arthroplasty. TMINI system complements Zimmer Biomet’s flagship ROSA Robotics portfolio. With this, Zimmer Biomet will become the first medtech company to offer two complementary robotic systems for surgeons looking to use robotic assistance while performing a knee replacement.
Earlier this year, the company expanded its ROSA Robotics portfolio with ROSA Shoulder, the world's first robotic surgery system for shoulder replacement.
Asensus Surgical ASXC collaborated with various hospitals across the globe for its Senhance Surgical System. These include St. Marianna University School of Medicine Yokohama City Seibu Hospital in Japan, The Rocky Mountain Hospital for Children in Denver, CO, and LKH-Universitätsklinikum Graz in Austria. The Senhance Surgical System reduces surgery time and cost-per-procedure (in contrast to traditional laparoscopy), bringing the benefits of advanced robotically assisted technology to more patients and surgeons around the world.
Last month, the company received 510(k) clearance from the FDA for an expanded indication to treat adult and pediatric Urology patients with the Senhance Surgical System.
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