Baird Medical (BDMD) Stock Sinks 33% in After-Hours Trading

Baird Medical Investment Holdings Ltd (NASDAQ:BDMD) shares fell in after-hours trading Thursday after the company announced that its strategic partner, Alpmed, had submitted regulatory applications in the U.S. and European Union for an irreversible electroporation (IRE) system.

Baird Medical is a medical device company specializing in minimally invasive ablation technologies for solid tumors. Its lead product is a microwave ablation (MWA) system cleared by the U.S. Food and Drug Administration (FDA) for soft tissue ablation.

Baird Medical Announces FDA, EU Submissions

Baird Medical announced Thursday that Alpmed submitted a 510(k) premarket notification to the FDA and an application for CE conformity assessment in the European Union for its IRE system.

The system is designed for soft-tissue ablation and can treat various tumor types. IRE is a minimally invasive, non-thermal technology that uses high-voltage electrical pulses to disrupt cell membranes and induce cell death.

The company says the technology may offer advantages when treating tissue near sensitive anatomical structures.

Under its partnership with Alpmed, Baird Medical is leading global regulatory interactions and holds worldwide commercial rights for the IRE system.

The companies are targeting potential FDA 510(k) clearance and EU CE marking in 2027, subject to the respective regulatory reviews.

Baird Medical Expands Ablation Portfolio

Baird Medical said the submissions mark a step toward expanding its portfolio beyond microwave ablation technology.

"If cleared, adding IRE to our portfolio could create additional opportunities to address indications for which thermal ablation may not be the optimal solution," said Haimei Wu, Chairwoman and CEO of Baird Medical.

The company said the submissions were completed less than three months after the cooperation agreement with Alpmed was signed.

Baird Medical’s existing MWA system is being launched in the U.S., primarily for the treatment of benign thyroid nodules. The company is also developing IRE-based products and an AI-powered robotic ablation system.

Trading Metrics, Technical Analysis

Baird Medical has a market capitalization of approximately $5 million.

Baird Medical shares have traded between a 52-week high of $3.70 and a 52-week low of $0.07.

The stock has declined 85.42% over the past year.

Price Action: Baird Medical shares rose 47.47% to close at $0.16 during Thursday’s regular trading session.

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