Senzime submits 510 (k) application to the FDA
Uppsala, September 25, 2017. Senzime AB (publ) announced today that the company has submitted a 510 (k) application to the US Food and Drug Administration (FDA) for approval of the TetraGraph in the United States.
Senzime signs distribution agreement for the Swiss market
Uppsala, September 18, 2017. Senzime AB (publ) today announced an exclusive distribution agreement with Leuag AG regarding the Swiss market.
RESOLUTIONS AT SENZIME AB’S (PUBL) EXTRAORDINARY GENERAL MEETING
Senzime AB (publ) (the “Company”) held its Extraordinary General Meeting on September 15, 2017 in the premises of Advokatfirman Lindahl on Vaksalagatan 10 in Uppsala.
Notice of Extraordinary General Meeting of Senzime for the introduction of an employee stock option program
Uppsala, August 31, 2017. Senzime AB (publ) calls for an Extraordinary General Meeting for the introduction of an employee stock option program. The Board proposes that the General Meeting approve resolutions to issue no more than 1,300,000 warrants and to introduce an employee stock option plan.
Senzime’s Interim report January – June 2017
Uppsala, August 31, 2017. Senzime AB’s (publ) Interim report for January – June 2017 is now available on the company’s webbsite www.senzime.com.
Senzime obtains US patent
Uppsala, August 9, 2017. Senzime AB (publ) is awarded a U.S. patent for its TetraSens disposable electrodes. With its unique design, the TetraSens enables fast application and effective function. The electrodes are used in conjunction with Senzime's neuromuscular monitoring system, the TetraGraph, which contributes to effective, continuous monitoring of patients undergoing anesthesia and surgical muscle relaxation. The TetraGraph, via the interfaced TetraSens electrodes, makes it possible to easily and objectively determine the optimal dose of neuromuscular blocking drugs administered during the procedure, and to establish the appropriate time when it is safe to wake the patient after surgery and allow spontaneous breathing without the help of a ventilator.
TetraGraph clinical use and comparison presented in ASA abstract
Uppsala, 21 June 2017. Senzime AB (publ) in partnership with Dr Réka Nemes at the University of Debrecen, Department of Anesthesiology and Intensive Care, Debrecen, Hungary, reports results from the Comparative Investigation of TOF-Watch SX and the TetraGraph.
Senzime receives ISO 13485 certification
Uppsala, June 12, 2017. Senzime AB (publ) has received ISO 13485 certification, which is an important milestone in the CE labeling process for the company's first monitoring products.
Senzime initiates clinical study with CliniSenz System
Uppsala, May 31, 2017. Senzime AB (publ) initiates a clinical trial with CliniSenz for monitoring of tissue lactate levels after surgery in patients with esophageal cancer, a disease that affects approximately 500,000 patients worldwide annually. The current treatment is mostly surgical with risk of multiple operations and increased mortality. With CliniSenz System, it is possible to monitor the healing process after surgery and detect complications at an early stage. The study has been approved by the Ethics Committee and is expected to start in the beginning of June 2017.
Senzime is granted additional patent for OnZurf Probe
Uppsala, 24 May 2017. Senzime AB’s (publ) application regarding a new Swedish patent for OnZurf Probe has been approved, strengthening Senzime’s existing patent portfolio. The Onzurf Probe is a new generation of microdialysis probes that enable organ-specific biological monitoring of various organs such and the bowel, liver and kidney after surgery. The technology makes it possible to monitor the organs’ healing process and to provide early warning signs of complications such as ischemia and anastomotic failure.