NEW YORK,Dec. 3, 2025/PRNewswire/ -- Baird Medical Investment Holdings Ltd. (NASDAQ:[BDMD](#financial-modal)) ("Baird Medical" or the "Company"), a market leader in minimally invasive Microwave Ablation (MWA) technology, today announced the appointment of Mark Saxton as Chief Executive Officer of its U.S. subsidiary.Mr. Saxton is a seasoned medical device executive with more than 25 years of commercial leadership experience, including a decade advancing intravascular RF ablation technologies. He will lead a ...

Core Insights - Baird Medical Investment Holdings Ltd. has officially launched its Microwave Ablation (MWA) technology in the Egyptian market with a successful procedure at Ain Shams Specialized Hospital [1][2][3] Company Overview - Baird Medical specializes in minimally invasive diagnostics and treatment, focusing on surgical robotic systems and innovative surgical instruments [3] - The company is FDA 510(k)-certified and has a presence in over 30 prestigious hospitals in the United States, including Johns Hopkins Hospital and Columbia University Medical Center [3] - Baird Medical is a market leader in China for thyroid microwave ablation devices and is expanding its commercial presence in over 20 countries worldwide [3] Recent Developments - The first procedure in Egypt involved a bone ablation for a 30-year-old male patient, successfully achieving full ablation and significant pain relief [2] - This procedure demonstrates the versatility of Baird's MWA system, extending its application from soft tissue to musculoskeletal treatments [2][3] - The company aims to enhance global access to advanced, non-surgical solutions through strategic partnerships with leading academic institutions [3]

Core Insights - Baird Medical Investment Holdings Ltd. has announced the clinical adoption of its Microwave Ablation (MWA) system at Elk Medical, a private endocrinology practice in Brooklyn, New York, marking a significant step in expanding access to minimally invasive thyroid treatments [1][3] Company Overview - Baird Medical specializes in minimally invasive diagnostics and treatment, focusing on surgical robotic systems and innovative surgical instruments, with a mission to enhance patient outcomes through precision technology [4] - The company is FDA 510(k)-certified and its solutions are utilized in over 30 prestigious hospitals and clinics across the United States, including Johns Hopkins Hospital and Columbia University Medical Center [4] - Baird Medical is a market leader in China for thyroid microwave ablation devices and consumables, and is expanding its commercial presence in over 20 countries worldwide [4] Clinical Adoption and Economic Viability - Dr. Kazeem, an experienced endocrinologist, has performed nine MWA procedures recently, focusing on large thyroid nodules as a non-surgical treatment option [2] - The initial MWA procedures have been successfully reimbursed by Medicare, indicating potential for broader patient access and economic viability of MWA therapy [3]

Core Insights - Baird Medical Investment Holdings Ltd. has successfully completed its first Microwave Ablation (MWA) procedure in Bangladesh, marking a significant advancement in non-surgical cancer therapies in the region [1][2][3] Company Overview - Baird Medical specializes in minimally invasive diagnostics and treatment, focusing on the research and development of surgical robotic systems and innovative surgical instruments [4] - The company is FDA 510(k)-certified and has its solutions utilized in over 30 prestigious hospitals and clinics across the United States, including Johns Hopkins Hospital and Weill Cornell Medicine [4] - Baird Medical is a market leader in China for thyroid microwave ablation devices and is expanding its commercial presence in over 20 countries worldwide [4] Recent Developments - The first MWA procedure in Bangladesh was led by Dr. Mofazzal Sharif Rasel, successfully treating a 65-year-old patient with a 6 cm liver tumor, who is reported to be recovering well [2][3] - The completion of this procedure signifies a new era of access to advanced treatment options for patients in South Asia, reflecting growing global confidence in Baird Medical's MWA technology [3] Strategic Goals - Baird Medical aims to strengthen its global presence through strategic collaborations with leading clinicians and medical institutions, enhancing access to innovative tumor treatment solutions [3]

Core Insights - Baird Medical Investment Holdings Ltd. is a global leader in minimally invasive Microwave Ablation (MWA) technology and has successfully participated in a workshop in Malaysia aimed at advancing MWA skills among local physicians [1][3]. Company Overview - Baird Medical specializes in minimally invasive diagnostics and treatment, focusing on surgical robotic systems and innovative surgical instruments [4]. - The company is FDA 510(k)-certified and its solutions are utilized in over 30 prestigious hospitals and clinics in the United States, including Johns Hopkins Hospital and Weill Cornell Medicine [4]. - Baird Medical is the market leader in China for thyroid microwave ablation devices and consumables, with a growing commercial presence in over 20 countries [4]. Workshop Details - The workshop held on October 1-2, 2025, featured leading surgeons and endocrinologists, providing hands-on training and complex case discussions [2]. - The program was led by distinguished faculty, including Dr. Shuhang Xu from Nanjing University and local surgeons from HCTM [2]. Commitment to Innovation - Baird Medical's participation in the workshop underscores its commitment to advancing medical technologies and ensuring their effective adoption globally [3]. - The company aims to empower physicians to deliver MWA treatments safely and effectively, marking a significant step in the global expansion of this therapy [3].

Core Insights - Baird Medical Investment Holdings Ltd. participated in the 3rd International Workshop on Thermal Ablation of Thyroid Tumor and Hyperparathyroidism, highlighting its leadership in minimally invasive Microwave Ablation (MWA) technology [1][3][4] - The workshop, chaired by Prof. Ming'an Yu, served as a platform for experts to share clinical experiences and advanced techniques in the field [2] - Baird Medical emphasizes the importance of collaboration in advancing MWA innovation and improving patient care [4] Company Overview - Baird Medical specializes in minimally invasive diagnostics and treatment, focusing on surgical robotic systems and innovative surgical instruments [6] - The company is FDA 510(k)-certified and has its solutions utilized in over 30 prestigious hospitals in the U.S., including Johns Hopkins Hospital and Columbia University Medical Center [6] - Baird Medical is the market leader in China for thyroid microwave ablation devices and is expanding its presence in over 20 countries [6]

Core Insights - Baird Medical Investment Holdings Ltd. is participating in the American College of Surgeons Clinical Congress 2025, showcasing its minimally invasive Microwave Ablation technology [1][4] - The ACS is the largest organization for surgeons globally, with over 90,000 members, providing a platform for discussing surgical advancements [2] - Baird Medical is conducting live demonstrations of its MWA devices, highlighting their precision in treating conditions like thyroid nodules and liver cancer [3][4] Company Overview - Baird Medical specializes in minimally invasive diagnostics and treatment, focusing on surgical robotic systems and innovative instruments [5] - The company is FDA 510(k)-certified and has its solutions used in over 30 prestigious hospitals in the U.S., including Johns Hopkins and Weill Cornell Medicine [5] - Baird Medical is a market leader in China for thyroid microwave ablation devices and is expanding its presence in over 20 countries [5]

Core Insights - Baird Medical Investment Holdings Ltd. is enhancing clinical proficiency in Microwave Ablation (MWA) technology through sponsored training programs at leading U.S. academic medical centers [1][2][3] Group 1: Training Initiatives - The company has conducted intensive training sessions at Tulane University and Columbia University, focusing on MWA for thyroid nodule treatment [1][2] - Notable training sessions included five live cases led by Dr. Emad Kandil at Tulane University and specialized courses at Columbia University by Dr. Jennifer Kuo, demonstrating the effectiveness of Baird's MWA system [2][3] Group 2: Commitment to Clinical Excellence - Baird Medical emphasizes its mission to ensure clinicians are well-trained to achieve optimal patient outcomes, collaborating with top institutions to set high standards in care [3] - The company is dedicated to expanding educational initiatives and partnerships with key opinion leaders to promote MWA as a primary treatment for thyroid disease [3] Group 3: Company Overview - Baird Medical specializes in minimally invasive diagnostics and treatments, focusing on surgical robotic systems and innovative surgical instruments [4] - The company is FDA 510(k)-certified and has its solutions utilized in over 30 prestigious hospitals across the U.S., including Johns Hopkins Hospital and Columbia University Medical Center [4] - Baird Medical is a market leader in China for thyroid microwave ablation devices and is expanding its presence in over 20 countries globally [4]

Core Insights - Baird Medical Investment Holdings Ltd. successfully participated in the 2025 American Thyroid Association Annual Meeting, showcasing its leadership in minimally invasive Microwave Ablation (MWA) technology and attracting significant global interest from medical professionals [1][5]. Company Overview - Baird Medical specializes in minimally invasive diagnostics and treatment, focusing on surgical robotic systems and innovative surgical instruments. The company aims to enhance patient outcomes through precision technology and advanced diagnostic solutions [6]. - The company is FDA 510(k)-certified and its solutions are utilized in over 30 prestigious hospitals and clinics across the United States, including Johns Hopkins Hospital and Columbia University Medical Center. Baird Medical is also the market leader in China for thyroid microwave ablation devices and consumables [6]. Conference Highlights - The company's exhibition booth at the ATA meeting served as a hub for leading endocrinologists, surgeons, and researchers, facilitating in-depth discussions and live demonstrations of MWA systems, emphasizing the technology's precision and clinical utility [2]. - A key session featured Dr. Emad Kandil, who presented data from over 200 MWA procedures, including a cohort of 19 patients where MWA was effective after failed Radiofrequency Ablation treatments, highlighting MWA's potential as a vital treatment alternative [3][4]. Clinical Evidence - Dr. Kandil concluded that Microwave Ablation is a novel, safe, and effective method for treating benign and malignant thyroid nodules in both adult and pediatric populations, offering advantages over other thermal ablation techniques [4].

Regulatory Compliance - Baird Medical obtained five registration certificates for microwave ablation therapeutic apparatus and multiple models of microwave ablation needles, all classified as Class III, on February 6, 2023[67]. - The company is subject to the Holding Foreign Companies Accountable Act (HFCAA), which could lead to delisting if the PCAOB cannot inspect its auditors in China for two consecutive years[72]. - The regulatory framework for the microwave medical device industry in China is evolving, which may lead to increased compliance costs and affect product commercialization[90]. - The company may face fines ranging from RMB5,000 to RMB30,000 for non-compliance with PRC safety facility regulations[135]. - The company is subject to evolving PRC regulatory requirements regarding cybersecurity, which may result in fines or penalties for non-compliance[228]. - The implementation of the Cybersecurity Review Measures requires operators of critical information infrastructure to pass a cybersecurity review when purchasing network products and services[227]. - The company faces regulatory uncertainties that could restrict its ability to adopt additional share incentive plans for its directors and employees under PRC law[246]. - The company must ensure compliance with Circular 37, which requires PRC residents to complete foreign exchange registrations for offshore investments, to avoid potential fines and legal penalties[241]. - Current PRC regulations restrict PRC subsidiaries from paying dividends except from accumulated after-tax profits, and they must set aside at least 10% of profits for reserve funds until reaching 50% of registered capital[259]. Financial Performance and Risks - The company has not paid any dividends or made distributions to shareholders since 2022, and there are no current plans to do so in the foreseeable future[71]. - Baird Medical's historical operating results may not be indicative of future performance, making it difficult to predict future growth[80]. - The company has a high gross profit margin, but it may not be sustainable in the future due to various operational risks[80]. - The company may face delays in obtaining Class III medical device registration certificates for its microwave ablation products, which could negatively impact sales revenue[101]. - The company may require significant capital for operations and growth, which may not be available on acceptable terms[159]. - The company may face penalties ranging from RMB 1,000,000 to RMB 10,000,000 for non-compliance with regulatory requirements, which could hinder its ability to raise funds overseas[225]. - The company faces intense competition in the medical technology industry, which may adversely affect market share and profitability[145]. - Future revenue may be impacted by regulatory changes in the medical device industry, including potential price reductions due to centralized procurement[152]. Market and Operational Strategy - The company has developed a strategically managed network with hospitals and medical device distributors, gradually expanding its market share in microwave ablation medical devices in China[81]. - The microwave ablation medical devices industry in China is in an early stage of development, and there is no guarantee that hospitals or distributors will accept the products at acceptable price points[82]. - The company relies on distributors for product delivery, and any failure to maintain these relationships could adversely affect revenue and growth[93]. - The availability of medical insurance reimbursement for the company's products varies by region and is subject to change, impacting demand and sales[95]. - The national medical insurance program in China generally reimburses a higher percentage for domestic products compared to imported ones, which may affect pricing strategies[96]. - The company relies on marketing service providers for product development and marketing, which is critical for understanding clinical needs and trends[120]. Intellectual Property and R&D - The company has a total of 54 registered patents in China and has applied for 18 additional patents as of December 31, 2024[175]. - The company faces risks related to potential patent infringement claims, which could lead to significant legal costs and operational disruptions[178]. - The company’s ability to maintain patent protection is contingent on compliance with various procedural requirements imposed by patent agencies[179]. - The company’s R&D personnel must account for at least 10% of total employees to qualify as a High and New Technology Enterprise[164]. - The Super Deduction ratio for R&D expenses is currently 100% since October 1, 2022, with 80% for outsourced R&D expenses[164]. Management and Operational Challenges - The company relies on key management personnel, particularly CEO Haimei Wu, whose loss could adversely affect business growth[141]. - Labor shortages and increased labor costs may significantly impact the company's operating costs and financial results[143]. - The company has identified material weaknesses in its internal control over financial reporting, including insufficient personnel knowledgeable in U.S. GAAP and SEC reporting requirements[190]. - The company engaged an external consulting firm to perform U.S. GAAP conversion of its PRC financial statements as a remedial measure for identified weaknesses[191]. - The company is increasingly dependent on information technology, and failures in data protection could lead to significant operational disruptions[122]. Supply Chain and Production - The company procured all raw materials in China in 2022, 2023, and 2024, relying on three, four, and three suppliers that contributed more than 10% of total cost of revenues, respectively[121]. - The company is exposed to risks of raw material shortages and price increases, which could adversely affect profitability if costs cannot be passed on to customers[121]. - Manufacturing operations could be interrupted by various factors, including natural disasters and regulatory changes, impacting the ability to meet customer demand[136]. External Economic Factors - The company’s operations are significantly influenced by the political, economic, and social conditions in China, which may lead to material changes in operations and the value of securities[200]. - The PRC government has significant control over economic growth, including resource allocation and monetary policy, which could adversely affect the company’s business and financial condition[201]. - The uneven economic growth in China could lead to fluctuations in demand for the company’s products, adversely affecting its competitive position[202]. - The COVID-19 pandemic has had a limited impact on the company’s operations in 2021 and 2022, but future external events could lead to material disruptions[202].