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Press release: Uppsala, February 15, 2019. Senzime AB (publ) today announces the
intent to re-submit the existing 510(k) application to the US Food and Drug
Administration (FDA). Based on an updated version of the TetraGraph, the
existing 510(k) application will be re-submitted and Senzime thereby seeks to
decrease the overall time to FDA approval.
The FDA application is part of Senzime''s strategic launch plan for the
TetraGraph system, with primary focus of launching in Europe, Japan, Korea and
the United States – central markets for monitoring patients undergoing surgery
with general anesthesia and muscle relaxants.
For further information, please contact:
Pia Renaudin, CEO of Senzime
AB
Tel: +46 (0)70-813 34 17, email: pia.renaudin@senzime.com
TO THE EDITORS
About Senzime
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 Sweden AB, +46 (0)8-528 00 399,
info@fnca.se, 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
February 15th, 2019 13:40 |