Baird Medical secures FDA certificate for Egypt entry

Published 09/04/2025, 13:46
Baird Medical secures FDA certificate for Egypt entry

NEW YORK - Baird Medical Investment Holdings Ltd. (NASDAQ: BDMD), a developer of AI-powered surgical robotic systems and minimally invasive surgical instruments with a market capitalization of $197.5 million, has received a Certificate to Foreign Government (CFG) from the U.S. Food and Drug Administration (FDA), paving the way for its entry into the Egyptian market. The company has also submitted regulatory registration applications in multiple Asian countries, following its recent approval in Indonesia on March 2025.

The CFG confirms Baird Medical's compliance with U.S. medical device standards, which is a critical step in the company's strategy to expand its global footprint. This certification assists in the company's efforts to introduce its microwave ablation (MWA) technology, used in the treatment of thyroid nodules and tumors, into new international markets.

Baird Medical has initiated partnerships with leading healthcare institutions to create distribution networks and training programs for MWA procedures in anticipation of regulatory approvals in Egypt, Hong Kong, Thailand, Malaysia, Kazakhstan, Sri Lanka, and India. These efforts are aimed at ensuring that the company's advanced medical solutions are readily available to patients upon approval.

The company's MWA technology is noted for its precision, efficiency, and the ability to minimize damage to healthy tissues, which is significant in the treatment of tumors. Baird Medical's commitment to patient outcomes is underscored by its focus on providing minimally invasive treatments that leverage cutting-edge technology, including the integration of open-source AI innovations. This innovative approach has helped the company achieve an impressive gross profit margin of 88.4%. According to InvestingPro, the company maintains strong financial health metrics, with 8 additional exclusive insights available to subscribers.

Baird Medical's products are already in use in over 30 hospitals and clinics across the United States and hold a leading position in the Chinese market for thyroid microwave ablation devices and consumables. Trading at a P/E ratio of 15.7 and showing a strong 40.1% return over the past six months, the company's expansion into new markets is part of its ongoing strategy to increase its commercial presence worldwide. For detailed analysis and real-time valuations, investors can access comprehensive metrics through InvestingPro.

The press release also contains forward-looking statements regarding Baird Medical's future financial and operating performance. With a beta of -0.74, indicating movement often contrary to broader market trends, and trading at $5.52 per share, these statements are based on current expectations and involve risks and uncertainties that could cause actual results to differ materially. Baird Medical cautions readers not to place undue reliance on these forward-looking statements, which are subject to change based on various factors, including regulatory developments and economic conditions.

This news is based on a press release statement from Baird Medical Investment Holdings Ltd. and does not constitute an endorsement of the company or its products.

In other recent news, Baird Medical Investment Holdings Ltd. has received regulatory approval from the Indonesian Ministry of Health for its Great Wall Microwave Therapeutic Instrument and the Great Wall Disposable Microwave Ablation Needle. This approval allows Baird Medical to introduce its minimally invasive treatment solutions in Indonesia, marking a significant step in its global strategic expansion. Additionally, Baird Medical has expanded its footprint in the United States by opening a clinic in San Francisco. This expansion follows the FDA 510(k) clearance of its Microwave Ablation (MWA) system, which has been adopted by numerous physicians, including notable practitioners in San Francisco and at Tulane University. The company is committed to improving access to minimally invasive treatment options and aims to support healthcare providers with advanced solutions. These recent developments reflect Baird Medical's dedication to enhancing patient care and its ongoing efforts to broaden its distribution network globally. The company has also participated in the J.P. Morgan Health Conference, highlighting its commitment to medical innovation.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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