STXS - Major Regulatory Approvals Coming For Stereotaxis In The Next 10 Months

2024-03-09 00:58:23 ET

Summary

• The Magic catheter human trial was successful. All 20 patients had acute success and there were 0 adverse events.
• Stereotaxis submitted the Magic catheter to EU and US regulators, with expectations of CE Mark approval in May or June.
• The company reported $4.56 million in sales in Q4, missing estimates due to installation timing.
• Stereotaxis plans to submit the semi-mobile robot to regulators in Q2. The firm expects it to be approved in Europe in mid-2024 and in the US in Q3.
• The $20.6 million cash position is enough to get the company to breakeven and launch its new products without additional financing.

Closer Stereotaxis Coverage Coming

In this article I will review the “Open EP Robotic Lab” presentation Stereotaxis ( STXS ) gave on March 1 ^st in which it revealed the results from the EU Magic human trial and the March 4 ^th Q4 earnings report. I will continue covering Stereotaxis on a quarter-by-quarter basis since the company is on the brink of numerous regulatory submissions and approvals in 2024.

As a reminder, management said it would start the Magic catheter human trial, which is needed for CE Mark, late in 2023. They said they would submit a PMA supplement to the FDA for Magic, which would potentially have enhanced data, by year end. The data is from the CE Mark human trial. Stereotaxis planned to submit the semi-mobile robot to regulators in Q1 right after the catheter submissions. The Synchrony system, which is the display computer system used to complete the procedures in another room, was projected to be submitted to regulators soon after the semi-mobile robot. Synx, the app doctors can use to collaborate, has been in internal testing and was projected to launch in the intermediate term, with no exact timing given....

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