Peijia Medical Limited Achieves Key Milestone: First FDA Clearance for DCwire® Micro Guidewire

Summary of Announcement

• Peijia Medical Limited has announced that its subsidiary, Achieva Medical Limited, received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the DCwire® Micro Guidewire.
• This is the company’s first FDA-cleared product, marking a significant milestone in its globalization strategy.
• The announcement was made on a voluntary basis to keep shareholders and potential investors informed of new product development and business progress.

Key Details for Investors

• The DCwire® Micro Guidewire was independently designed and developed by Achieva Medical Limited, showcasing the Group’s R&D capabilities.
• FDA clearance opens up potential access to the lucrative U.S. medical device market, the world’s largest, and signals regulatory validation of the product.
• This milestone is a pivotal step in Peijia Medical’s globalization strategy, potentially setting the stage for further international expansion and product launches.
• However, the announcement includes a clear caution: There is no guarantee that the product will be successfully marketed outside China. Commercial success in the U.S. and other foreign markets is not assured.
• Shareholders and potential investors are explicitly advised to exercise due care when dealing in the shares of the Company, acknowledging the uncertainties around the commercialization of the DCwire® Micro Guidewire.

Potential Impact on Share Price

• The news is potentially price-sensitive, as regulatory approval in the U.S. can significantly enhance a medical device company’s valuation and investor confidence.
• The milestone signals Peijia Medical’s readiness to compete internationally and could attract institutional and retail investors seeking exposure to China’s emerging medtech sector.
• Despite the positive regulatory development, investors must factor in the risks associated with commercialization and market penetration outside China.

Corporate Information

• Board of Directors includes Dr. Yi Zhang (Chairman and Executive Director), Mrs. Ping Ye Zhang, Ms. Hong Ye (Executive Directors), Mr. Jifeng Guan, Mr. Fei Chen, Mr. Jun Yang (Non-Executive Directors), and independent non-executive directors Dr. Stephen Newman Oesterle, Mr. Robert Ralph Parks, Mr. Wai Ming Yip, and Mr. Huacheng Wei.
• Announcement dated March 17, 2026.

What Should Shareholders Watch For?

• Further updates on commercialization efforts, partnerships, or sales in the U.S. and other international markets.
• Potential follow-on regulatory approvals for other products.
• Any changes in strategy, management, or business development stemming from this milestone.

Disclaimer

This article is for informational purposes only and does not constitute investment advice. Investors should conduct their own research and consult financial professionals before making investment decisions. The Company has cautioned that there is no guarantee of successful commercialization of the DCwire® Micro Guidewire outside China, and shareholders should exercise due care when dealing in the shares of Peijia Medical Limited.

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