GenesisX was approved in Europe and is set to be approved in the US late this year. The new robot is a giant leap forward in accessibility. Stereotaxis should get MAGiC approved in Europe in October. I expect a US approval no later than Q2 2025. The firm has enough cash to reach breakeven. It won't hire a lot of people right away to sell GenesisX.
Stereotaxis (STXS) gets a CE mark in Europe for its GenesisX robotic system. Following this, the company also submits a 501(k) application for FDA clearance.
Stereotaxis (STXS) gains CE mark for GenesisX and plans to launch the system in 2025.
Stereotaxis, Inc. (NYSE:STXS ) Q2 2024 Earnings Conference Call August 12, 2024 4:30 PM ET Company Participants David Fischel - Chairman and CEO Kimberly Peery - CFO Conference Call Participants Adam Maeder - Piper Sandler Josh Jennings - TD Cowen Nelson Cox - Lake Street Capital Markets Operator Good afternoon, and welcome to the Stereotaxis, Inc. Second Quarter 2024 Earnings Conference Call. Certain statements during the call and question-and-answer period to follow may relate to future events, expectations and, as such, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.
Stereotaxis Inc. (STXS) came out with a quarterly loss of $0.07 per share versus the Zacks Consensus Estimate of a loss of $0.04. This compares to loss of $0.07 per share a year ago.
Stereotaxis' (STXS) receives updated EU Quality Management System Certificate, which demonstrates compliance with MDR.
Stereotaxis (STXS) announces the completion of treatment of first heart rhythm patients with its Genesis Robotic Magnetic Navigation system in Southern Italy.
Stereotaxis made a strategic acquisition of catheter company Access Point Technologies, which is expected to contribute $5 million in sales in the first 12 months after the acquisition. Access Point will help Stereotaxis release a robotically navigated guide catheter and a robotically navigated mapping catheter. Stereotaxis is working with regulators to get MAGiC approved. The CE Mark should be coming late this summer. PMA approval should come at year-end.