Senzime's Next-Generation TetraGraph System Receives Regulatory Approval in Japan

UPPSALA, SE / ACCESS Newswire / December 17, 2025 / Senzime AB (publ.) (STO:SEZI)(OTCQX:SNZZF) today announced that its Next-generation TetraGraph^® system has received regulatory clearance for sale in Japan from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). The approval enables further commercialization of Senzimes products in one of the world's largest healthcare markets. In connection with the approval, Senzime received the first order for 80 Next-generation TetraGraph monitors for delivery to Japan in the fourth quarter of 2025.

Senzime entered the Japanese market in 2019 in partnership with Fukuda Denshi, a global leader in patient monitoring systems. Since then, hundreds of Japanese hospitals have adopted Senzime's TetraGraph technology to monitor patients' neuromuscular function during surgery.

The PMDA approval of the next-generation TetraGraph system represents a significant step in Senzime's strategy to drive continued revenue growth through broader market penetration, system upgrades, and expected higher utilization rates.

"This approval is a key milestone for us in Japan. Our partner Fukuda Denshi has extensive local market reach and a very strong platform to drive continued growth. Combined with recently updated Japanese clinical guidelines that reinforce the use of quantitative neuromuscular monitoring, we are excited to further expand our footprint in the large Japanese market," said Philip Siberg, CEO of Senzime.

Senzime has a long-standing partnership with Fukuda Denshi, which is responsible for commercializing the TetraGraph portfolio in the Japanese market, as well as the Fukuda HN-100 integrated NMT module based on TetraGraph technology. The Japanese market consists of approximately 15,000 operating rooms and nearly 3 million major surgical procedures performed annually, underscoring the revenue potential for Senzime's expanding product portfolio.

For further information, please contact:

Philip Siberg, CEO of Senzime AB
Phone: +46 (0) 707 90 67 34, e-mail: philip.siberg@senzime.com

About Senzime

Senzime is a leading medical device company at the forefront of a changing healthcare market, driven by new clinical guidelines and emerging technologies. Established in 1999, Senzime develops and markets precision-based monitoring systems that improve outcomes, reduce costs, and advance perioperative patient safety. The flagship solution is the TetraGraph^® system, proven best-in-class for accurate monitoring of neuromuscular transmission during surgery and used in thousands of operating rooms across the globe. The system helps to secure precise dosing of paralytic drugs and provides enhanced insights to safeguard every patient's journey, from anesthesia to recovery.

Headquartered in Uppsala, Sweden, Senzime is publicly traded on the Nasdaq Stockholm Main Market (SEZI), with cross-trading on the US OTCQX Market (SNZZF), and backed by long-term investors. More information is available at senzime.com.

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Senzime's Next-generation TetraGraph system receives regulatory approval in Japan

SOURCE: Senzime