Sam Brusco, Associate Editor11.22.23
Baird Medical Devices, a Chinese microwave ablation (MWA) device developer, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its portfolio of microwave ablation systems and disposable microwave ablation needles.
The minimally invasive, thermal energy-based procedure treats thyroid nodules, breast tumors, and other diseases where soft tissue ablation is indicated. The approach removes the need for surgery, mitigated associated complications, risks, and scarring.
Therapeutic microwave energy is administered with a device about the diameter of a pen. The treatment targets the nodule or tumor while preserving the surrounding healthy tissue. The company said precision is crucial because it safeguards the thyroid’s function and lowers the likelihood the patient will need expensive, lifelong thyroid hormone replacement therapy.
Haimei Wu, founder and CEO of Baird Medical, told the press, "Attaining FDA clearance represents a significant milestone in our geographical expansion. This clearance grants us the ability to market our portfolio of MWA systems and disposable needles in the United States. Based on our market research, we estimate that the U.S. presents a market opportunity of $1.6 billion for MWA systems alone. Because our follow-on sales of disposable MWA needles typically generate 36 times the revenue of our initial MWA system sales, we anticipate a total addressable market size of $1.6 billion in the U.S. alone. We are excited about our potential to capitalize on such a vast market opportunity. Our team of skilled professionals is ready to expand our market reach and deliver the much-needed benefits of our minimally invasive MWA procedure to patients across America."
The minimally invasive, thermal energy-based procedure treats thyroid nodules, breast tumors, and other diseases where soft tissue ablation is indicated. The approach removes the need for surgery, mitigated associated complications, risks, and scarring.
Therapeutic microwave energy is administered with a device about the diameter of a pen. The treatment targets the nodule or tumor while preserving the surrounding healthy tissue. The company said precision is crucial because it safeguards the thyroid’s function and lowers the likelihood the patient will need expensive, lifelong thyroid hormone replacement therapy.
Haimei Wu, founder and CEO of Baird Medical, told the press, "Attaining FDA clearance represents a significant milestone in our geographical expansion. This clearance grants us the ability to market our portfolio of MWA systems and disposable needles in the United States. Based on our market research, we estimate that the U.S. presents a market opportunity of $1.6 billion for MWA systems alone. Because our follow-on sales of disposable MWA needles typically generate 36 times the revenue of our initial MWA system sales, we anticipate a total addressable market size of $1.6 billion in the U.S. alone. We are excited about our potential to capitalize on such a vast market opportunity. Our team of skilled professionals is ready to expand our market reach and deliver the much-needed benefits of our minimally invasive MWA procedure to patients across America."