Peijia Medical Advances Global Strategy with CE Mark Application for GeminiOne® TEER System
On February 9, 2026, Peijia Medical Limited (HKEX: 9996), a prominent player in the medical device sector, announced a significant milestone in its mission to broaden its global footprint. The company has officially submitted its CE Mark registration application for the GeminiOne Transcatheter Edge-to-Edge Repair (TEER) System, aimed at treating mitral regurgitation. This submission stands as a pivotal step in Peijia's ambitious international expansion strategy, with HighLife SAS serving as a strategic partner for European operations.
The GeminiOne device showcases innovative engineering and design. It features a distinctive sliding groove mechanism that enhances coaptation length while maintaining a compact implant size and delivery system. The system is designed to simplify procedures with an independent leaflet grasping technology that minimizes complexity and incorporates a convenient auto-locking mechanism to prevent errors during operation. Moreover, it possesses a multi-angular detachment capability, enabling adaptability to various anatomical structures, a critical factor in interventional cardiology. The design has been patented globally following rigorous freedom-to-operate analyses, ensuring its viability in diverse markets.
Besides the ongoing CE Mark application, Peijia Medical is also progressing in China, where the National Medical Products Administration (NMPA) has accepted its registration application. Furthermore, the GeminiOne system has received Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration to conduct an Early Feasibility Study in the United States, validating its potential in the competitive cardiac device landscape.
Peijia Medical's ongoing commitment to addressing mitral regurgitation is critical, considering the condition's prevalence and its associated risks. As an organization rooted in innovation, Peijia continuously strives to enhance patient outcomes by introducing advanced medical solutions. CEO of Peijia Medical, noted, “Our focus remains on delivering safe and effective treatment options to patients globally. We are committed to advancing our regulatory registrations to ensure that our innovative products are accessible as soon as possible.”
Peijia Medical was founded in 2012 and is headquartered in Suzhou, China. The company is dedicated to the burgeoning interventional procedural medical device market in China, aiming to develop a comprehensive suite of treatment solutions for structural heart and neurovascular disorders. The company has already launched several successful products, including four TAVR systems and numerous neurointerventional devices, which are currently registered in China. This diverse portfolio exemplifies Peijia’s ambitious drive and commitment to innovation.
The recent announcements reflect Peijia's strategy to capitalize on the opportunities within the cardiac treatment market, particularly for conditions like mitral regurgitation, which affect a significant portion of the population. The company's focus on effectiveness and safety establishes a solid foundation for patient trust and regulatory acceptance in international markets.
As Peijia Medical continues to progress through the regulatory landscape, it stands poised for growth and advancements that could redefine treatment protocols for cardiac patients worldwide. Investors and customers alike are eager to see how this innovative device will perform in clinical trials and its eventual commercial launch in the various markets where Peijia is focusing its efforts. In light of these developments, the medical community and stakeholders alike are invited to follow Peijia Medical’s journey as it seeks to transform cardiac care on a global scale.
The GeminiOne device showcases innovative engineering and design. It features a distinctive sliding groove mechanism that enhances coaptation length while maintaining a compact implant size and delivery system. The system is designed to simplify procedures with an independent leaflet grasping technology that minimizes complexity and incorporates a convenient auto-locking mechanism to prevent errors during operation. Moreover, it possesses a multi-angular detachment capability, enabling adaptability to various anatomical structures, a critical factor in interventional cardiology. The design has been patented globally following rigorous freedom-to-operate analyses, ensuring its viability in diverse markets.
Besides the ongoing CE Mark application, Peijia Medical is also progressing in China, where the National Medical Products Administration (NMPA) has accepted its registration application. Furthermore, the GeminiOne system has received Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration to conduct an Early Feasibility Study in the United States, validating its potential in the competitive cardiac device landscape.
Peijia Medical's ongoing commitment to addressing mitral regurgitation is critical, considering the condition's prevalence and its associated risks. As an organization rooted in innovation, Peijia continuously strives to enhance patient outcomes by introducing advanced medical solutions. CEO of Peijia Medical, noted, “Our focus remains on delivering safe and effective treatment options to patients globally. We are committed to advancing our regulatory registrations to ensure that our innovative products are accessible as soon as possible.”
Peijia Medical was founded in 2012 and is headquartered in Suzhou, China. The company is dedicated to the burgeoning interventional procedural medical device market in China, aiming to develop a comprehensive suite of treatment solutions for structural heart and neurovascular disorders. The company has already launched several successful products, including four TAVR systems and numerous neurointerventional devices, which are currently registered in China. This diverse portfolio exemplifies Peijia’s ambitious drive and commitment to innovation.
The recent announcements reflect Peijia's strategy to capitalize on the opportunities within the cardiac treatment market, particularly for conditions like mitral regurgitation, which affect a significant portion of the population. The company's focus on effectiveness and safety establishes a solid foundation for patient trust and regulatory acceptance in international markets.
As Peijia Medical continues to progress through the regulatory landscape, it stands poised for growth and advancements that could redefine treatment protocols for cardiac patients worldwide. Investors and customers alike are eager to see how this innovative device will perform in clinical trials and its eventual commercial launch in the various markets where Peijia is focusing its efforts. In light of these developments, the medical community and stakeholders alike are invited to follow Peijia Medical’s journey as it seeks to transform cardiac care on a global scale.
Topics Health）
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