Press release; Senzime receives CE mark approval for the TetraGraph
Uppsala, December 12, 2017. Senzime AB (publ) announced today that it has received CE mark approval to enable the commercialization of the TetraGraph Neuromuscular Monitoring System.
Lena Söderström, CEO of Senzime states, "The CE mark is a major milestone for Senzime, we will immediately commence the market roll-out of the TetraGraph system initially in Europe followed by the US and rest of the world. The TetraGraph will allow physicians to monitor the effects of neuromuscular blocking drugs perioperatively and ensure that patients can breathe spontaneously which will prevent complications and hence lower healthcare costs”.
The TetraGraph neuromuscular monitor is a unique system designed to address the needs of perioperative monitoring of physiologic data in surgical patients receiving general anesthesia and muscle relaxation using neuromuscular blocking drugs (NMBAs). The TetraGraph stimulates a peripheral nerve and measures, analyzes and displays the muscle function in surgical patients who receive NMBAs as part of their general anesthetic.
“We look forward to use the TetraGraph routinely, since the device is very easy to use, saves us time with the quick set-up and provides invaluable clinical information,” says Prof. Bela Fulesdi, Chairman of the Department of Anesthesiology and Intensive Care, Debrecen University Hospital, Debrecen, Hungary.
Every year, over 70 million surgical patients undergo general anesthesia and receive neuromuscular blocking drugs. Without objective monitoring (the ability to measure and analyze the evoked muscle responses) over 30 percent of these patients experience postoperative complications. The TetraGraph system will enable physicians to assure sufficient return of neuromuscular function of patients, and avoid these postoperative complications.
Senzime has previously entered distribution agreements for TetraGraph in the UK, Ireland, Switzerland, Australia and New Zealand, and licensing agreements in Japan. Discussions are ongoing with distributors for additional markets and additional agreements are expected during the following quarter.
Senzime develops unique patient-oriented monitoring systems that make it possible to assess patients' biochemical and physiological processes before, during and after surgery. The portfolio of technologies includes bedside systems that enable automated and continuous monitoring of life-critical substances such as glucose and lactate in both blood and tissues, as well as systems to monitor patients’ neuromuscular function perioperatively and in the intensive care medicine setting. The solutions are designed to ensure maximum patient benefit, reduce complications associated with surgery and anesthesia, and decrease health care costs. Senzime operates in growing markets that in Europe and the United States are valued in excess of SEK 10 billion. The company's shares are listed on Nasdaq First North (ticker SEZI). FNCA is Certified Adviser for Senzime. www.senzime.com
This information is insider information that Senzime AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication through the agency of the contact person set out above, on December 12 2017.
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