Press release; Senzime receives CE mark approval for the OnZurf Probe
Uppsala, December 18, 2017. Senzime AB (publ) announces that the company has received CE mark approval for the OnZurf Probe, which means that the product now is approved for sale on the European market.
OnZurf Probe will now be launched in Europe, initially by direct sales in Scandinavia, while other distribution agreements are established in the rest of Europe. OnZurf Probe is intended to be used after various surgical procedures on the gastrointestinal tract.
"Continuous sampling in patients undergoing surgery may provide an opportunity to detect early complications. The clinical market seeks products that allow continuous sampling and monitoring of tissue substances to detect complications after surgery and control interventions. The CE mark of OnZurf Probe is an important milestone for Senzime and we will immediately initiate launch in Europe" says Lena Söderström, CEO of Senzime AB.
OnZurf Probe is unique in its ability to continuously collect samples from the surface of an organ. The OnZurf Probe collects micro samples, which can be analyzed either intermittently, by an external analyzer or continuously, using Senzime’s CliniSenz Analyzer. The OnZurf Probe is placed on the surface of a tissue or organ to monitor local metabolic changes before complications become systemic. OnZurf Probe is unique in its ability to monitor the patients’ healing process after surgery and provide early-warning signals of post-operative complications such as lack of oxygen (ischemia).
For example, for patients with esophageal cancer, the main treatment method is surgical excision, with attendant risk of multiple operations, morbidity, and even mortality. After esophageal surgery, the OnZurf Probe contributes vital and timely information to clinicians, facilitating optimal postoperative treatment. Currently, the OnZurf Probe is being trialed in several clinical studies -- both as a stand-alone sampler and through continuous monitoring with CliniSenz. The company’s analyzer CliniSenz is expected to receive CE approval in the second part of 2018.
For further information, please contact:
Lena Söderström, CEO of Senzime AB
Tel: +46 708-16 39 12, email: email@example.com
TO THE EDITORS
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 18 2017.