GUANGZHOU, China, Aug. 10, 2023 /PRNewswire/ -- Baird Medical Investment Holdings Limited ("Baird Medical" or the "Company"), a leading microwave ablation ("MWA") medical device developer and provider in China, today announced the 510(k) premarket notification submission of the Company's Disposable Microwave Ablation ("MWA") Needle and the Company's MWA System to the U.S. Food and Drug Administration (FDA) for the treatment of soft tissue microwave ablation.
Baird Medical believes MWA technology offers compelling advantages over other treatment options, including shorter operation times, faster patient recovery, reduced procedure costs, and fewer post-surgery complications. Compared to traditional approaches such as open surgery, radiofrequency ablation, and cryoablation, these advantages make it an attractive choice for patients seeking a minimally invasive and efficient treatment approach that yields improved outcomes.
Ms. Haimei Wu, Founder and CEO of Baird Medical, said, "Minimally invasive and more affordable treatment solutions represent the future. We are pleased to move forward in this as a key part of our global growth and will collaborate closely with the FDA to ensure a smooth and successful submission."
The Center for Devices and Radiologic Health (CDRH) of the FDA accepted the submission for the Company's Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018) and the Company's Microwave Ablation System (BD-GT) on July 28, 2023.
The Company received recent approval from China's National Medical Products Administration for its Class III disposable MWA needle on July 13, 2023.
About Baird Medical
Established in 2012 and headquartered in Guangzhou, China, Baird Medical is a leading MWA medical device developer and provider in China. Baird Medical's proprietary MWA medical devices are used for treatment of benign and malignant tumors including thyroid nodules, liver cancer, lung cancer and breast lumps. Baird Medical is the first company to obtain Class III medical devices registration certificate for MWA medical devices specifically indicated for thyroid nodules in China. For more information, please visit http://baidesz.com/.
Forward-Looking Statements
This communication contains "forward-looking statements." Such statements include statements concerning anticipated future events and expectations that are not historical facts. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are typically identified by words such as "believe", "expect", "anticipate", "intend", "target", "estimate", "continue", "positions", "plan", "predict", "project", "forecast", "guidance", "goal", "objective", "prospects", "possible" or "potential" by future conditional verbs such as "assume", "will", "would", "should", "could" or "may" or by variations of such words or by similar expressions or the negative thereof. Actual results may vary materially from those expressed or implied by forward-looking statements based on a number of factors. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made. Baird Medical does not assume any obligation to publicly update any forward-looking statement after it is made, whether as a result of new information, future events or otherwise, except as required by law.
Contacts
Investor Relations
Robin Yang, Partner
ICR, LLC
Phone: +1 (646) 308-1475
Email: BairdMedical.IR@icrinc.com
Public Relations
Brad Burgess, Senior Vice President
ICR, LLC
Phone: +1 (646) 588-0383
Email: BairdMedical.PR@icrinc.com