Stereotaxis has received US Food and Drug Administration (FDA) 510(k) clearance for its next-generation robotic system, GenesisX.
The GenesisX system is designed for minimally invasive endovascular procedures, particularly to treat heart rhythm disorders such as arrhythmias.
The US-based company noted that a primary challenge in adopting earlier robotic systems was their extensive infrastructure demands. The GenesisX model directly addresses this by featuring a compact, mobile-friendly design with an 80% smaller system cabinet that fits under an operating room table.
Unlike its predecessors, GenesisX incorporates magnetic shielding into the robot itself, eliminating the need for shielded room walls. It operates on standard power and requires no structural anchoring, enabling installation in existing catheterization labs without costly renovations.
“This is a landmark approval as we transform the accessibility and scalability of Robotic Magnetic Navigation,” said David Fischel, Chairman and CEO of Stereotaxis.
Path Forward
The company boasts of a well-established clinical value of Stereotaxis’ technology, with over 150,000 patients treated globally. The GenesisX system is expected to broaden access to robotic electrophysiology (EP) procedures, potentially benefiting tens of millions of patients suffering from arrhythmias who face risks of stroke and heart failure, as per the company.
“The GenesisX design changes that by dramatically simplifying installation,” said Dr. Francis Marchlinski, Director of Electrophysiology at the University of Pennsylvania Health System. “The GenesisX design changes that by dramatically simplifying installation. This helps to more readily bring the precision of robotic navigation and its ease of use for the operator to a broader patient population.”
The company’s also released its third-quarter financial report this week. Stereotaxis reported $7.5 million in revenue for the quarter. The company also highlighted a growing order backlog and a strong cash position, with $10.5 million in cash reserves and an additional $4 million as part of the registered direct financing announced in July.
Stereotaxis anticipates that its revenue in the fourth quarter will surpass $9 million, with around $3 million from system sales and over $6 million from recurring revenue. This outlook underpins an expected annual revenue growth exceeding 20%.
Management noted that the quarter reflected continued regulatory momentum, including the recent clearance of the MAGiC Sweep catheter, the first robotically navigated high-density EP mapping catheter.
Stereotaxis has initiated a limited launch of GenesisX in the United States and Europe. The company is concurrently expanding its portfolio of compatible catheters and refining its commercial processes for a full market rollout. The system’s flexibility will support various financing models, including sales, leases, and pay-per-use arrangements.
