Following approval in China earlier this year, the US Food and Drug Administration (FDA) has cleared Baird Medical’s microwave ablation (MWA) system and disposable needles for use in the US.
The clearance, which is through Baird Medical subsidiary Betters Medical, means doctors in the US can now use the technology to ablate thyroid nodules, breast tumours and other diseases where soft tissue needs to be removed.
In July 2023, China’s National Medical Products Administration (NMPA) approved the system to treat benign thyroid nodules. Baird Medical says it occupies a 35% market share of microwave ablation devices in China.
The FDA following suit means that patients in the US will have access to another less invasive method to remove thyroid nodules – lumps in the thyroid that are estimated to be in around 40% of the population.
Baird Medical founder and CEO Haimei Wu said: “This clearance grants us the ability to market our portfolio of MWA systems and disposable needles in the United States.”
Radio-frequency ablation has become a common option to treat benign thyroid nodules. The non-invasive procedure uses an electric current to heat and destroy the nodules. MWA could offer several advantages over standard radiofrequency ablation such as its higher thermal efficiency, though this also comes at a cost of vulnerability to surrounding tissues. Baird Medical says its system precisely targets the nodule via a heated needle whilst preserving the surrounding tissue.
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In September 2023, the American Thyroid Association (ATA) issued new guidance on the safety, training, and adoption of thermal ablation techniques for the treatment of benign thyroid modules.
Baird Medical said it estimates a US market opportunity for microwave ablation systems of around $1.6bn.
Wu said: “Because our follow-on sales of disposable microwave ablation needles typically generate 36 times the revenue of our initial microwave ablation system sales, we anticipate a total addressable market size of $1.6bn in the US alone.”
In June 2023, Baird Medical signed a definitive business combination agreement with the publicly traded special purpose acquisition company (SPAC) Excel Fin Acquisition Corporation – with the aim of going public.
The deal will see the combined company operate under the name of Baird Medical Investment Holdings – it will have an estimated post-transaction enterprise value of $370m. It is expected to close in Q4 2023, upon which it will commence trading on Nasdaq.