Senzime receives approval for its pediatric sensor in Japan

The TetraSens® Pediatric sensor has received regulatory approval in Japan, further supporting the roll out of Senzime’s innovative patient monitoring systems

Uppsala, February 9, 2023. Senzime AB (publ) today announced that the TetraGraph® system and the TetraSens Pediatric sensor have been approved for use in Japan. Following this approval, Fukuda Denshi, which is Senzime’s licensing partner in Japan and a leading company within patient monitoring in Japan, has made its first order for TetraSens Pediatric. TetraGraph together with the flexible TetraSens Pediatric sensor enables accurate monitoring of infants and young children who are receiving muscle paralyzing drugs as part of anesthesia.

Fukuda Denshi has since 2016 exclusive right to license and commercialize Senzime's TetraGraph system in the Japanese market. Along with previous approvals of Senzime’s quantitative neuromuscular monitoring system, the approval of TetraSens Pediatric makes the entire TetraGraph offering available for use in Japan.

“Japan is an important market, and we are proud to work with such an established partner as Fukuda Denshi, helping us to drive a technology shift in neuromuscular monitoring. The approval of our pediatric sensor for use in Japan not only strengthens our offering, but more importantly; it is a step towards eliminating anesthesia-related complications and improving patient safety for pediatric patients,” said Pia Renaudin, CEO of Senzime.

About TetraGraph® and TetraSens® Pediatric
TetraGraph is a quantitative neuromuscular monitoring system, based on the gold standard electromyography (EMG) technology which provides accurate and versatile monitoring of neuromuscular blockade. The product is designed to meet the needs of monitoring physiological data during surgery of patients receiving general anesthesia and muscle relaxation using muscle paralyzing drugs. TetraGraph stimulates the patient's peripheral nerve using the TetraSens disposable sensors and measures, analyzes, and displays muscle function in real time. TetraSens Pediatric is a dedicated sensor for infants and up.

Thanks to its small size and versatile features, the TetraGraph system can be used in any type of surgery, anywhere in the hospital environment, and can be connected to external monitors and electronic hospital records.

For further information, please contact:

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Pia Renaudin, CEO of Senzime AB
Phone: [phone], e-mail: [e-mail]

Paula Treutiger, Head of Communication and IR
Phone: [phone], e-mail: [e-mail]

About Senzime

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Senzime is a Swedish medical device company that develops, manufactures, and markets CE- and FDA-cleared patient monitoring systems. Senzime’s employees worldwide are committed to the vision of a world without anesthesia- and respiratory-related complications. The company markets an innovative portfolio of solutions, including the TetraGraph® and ExSpiron® 2Xi for real-time monitoring of neuromuscular and respiratory functions, typically under and after surgery. The goal is to help eliminate in-hospital complications, and radically reduce health care costs related to surgical and high acuity procedures.

Senzime targets a market opportunity valued more than SEK 40 billion per year, and operates with sales teams in the world’s leading markets. The company’s shares are listed on Nasdaq Stockholm Main Market (SEZI). More information is available at senzime.com.

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Senzime receives approval for its pediatric sensor in Japan

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