Stereotaxis, Inc. STXS and Shanghai MicroPort EP Medtech Co., Ltd. announced the receipt of regulatory approval from China’s National Medical Products Administration (“NMPA”) for the Magbot Magnetic Navigation Ablation Catheter last Monday. Stereotaxis had previously announced its collaboration with MicroPort EP in August 2021.

It is worthwhile to note that the Magbot Catheter is a single-use magnetic saline-irrigated radiofrequency ablation catheter designed and developed by MicroPort EP in collaboration with Stereotaxis. The catheter works exclusively and in conjunction with Stereotaxis’ robotic systems, including the recently NMPA-approved Genesis RMN and MicroPort EP’s Columbus 3D EP Mapping System.

MicroPort EP will initiate commercial launch of Magbot in China through its existing sales team focused on the electrophysiology community, while Stereotaxis will also benefit from the proceeds from Magbot adoption.

The latest regulatory clearance is a significant stepping stone for Stereotaxis to strengthen its foothold in the global cardiovascular care space.

Likely Trend of STXS Stock Following the News

Following the announcement on Dec. 9, shares of the company gained nearly 5.9% till Friday’s trading.

Historically, the company has gained a topline boost from its various regulatory clearances. We expect market sentiment on the stock to continue to remain positive around this announcement, too.

Stereotaxis currently has a market capitalization of $198.3 million. Its current cash flow growth of 13.4% is favorable against the industry’s negative growth. In the last reported quarter, STXS delivered a negative earnings surprise of 60%.

Significance of Stereotaxis’ NMPA Approval

According to Stereotaxis’ management, Magbot incorporates advanced design features that are expected to enhance the efficiency, effectiveness and safety of robotic magnetic catheter ablation. Robotically navigated using low-intensity magnetic fields, the Magbot catheter will likely be able to reach areas of the heart that are otherwise difficult to access with traditional methods and to maintain precise positioning and stability on cardiac anatomy with high accuracy.

Per MicroPort EP’s management, the approval of the Magbot Catheter signifies a major breakthrough for MicroPort EP in cardiac electrophysiology and a significant milestone for robotic navigation technology in China. Its recent technological advances with Stereotaxis are expected to offer a safer and more precise minimally-invasive treatment solution for complex arrhythmia patients.

Industry Prospects in Favor of STXS

Per a report by Grand View Research, the global cardiovascular devices market is valued at $53.67 billion in 2024 and is projected to witness a CAGR of 8.4% between 2025 and 2030. Factors like increasing cardiovascular disorders, an increase in the availability of affordable and effective devices, and rising demand for minimally-invasive procedures are likely to drive the market.

Given the market potential, the latest regulatory clearance is expected to provide a significant boost to Stereotaxis’ business.

Stereotaxis’ Notable Developments

Last month, Stereotaxis, along with MicroPort EP, received China’s NMPA approval for the Genesis Robotic Magnetic Navigation (RMN) System.

The same month, Stereotaxis announced that physicians at the Hospital da Luz in Lisbon, Portugal, had successfully treated the first patients using the advanced Genesis RMN System.

STXS’s Share Price Performance

Shares of the company have gained 45.4% in the past year compared with the industry’s 7.7% rise and the S&P 500's 28.6% growth.

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Stereotaxis’ Zacks Rank & Key Picks

Currently, STXS carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the broader medical space are Cardinal Health, Inc. CAH, Merit Medical Systems, Inc. MMSI and LeMaitre Vascular, Inc. LMAT.

Cardinal Health, carrying a Zacks Rank #2 (Buy) at present, has an estimated long-term growth rate of 10.2%. CAH’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 11.2%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Cardinal Health’s shares have gained 16.1% compared with the industry’s 4.9% rise in the past year.

Merit Medical, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 12%. MMSI’s earnings surpassed estimates in each of the trailing four quarters, with the average being 6.4%.

Merit Medical has gained 44.6% compared with the industry’s 4.9% rise in the past year.

LeMaitre Vascular, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 21%. LMAT’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 10.1%.

LeMaitre Vascular’s shares have rallied 68.2% compared with the industry’s 13.9% rise in the past year.

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