WP 1 and WP4 Base unit update. The existing Base Unit HW, SW, and User Interface were updated. The updated HW and SW designs were approved in design reviews and functional tests, The finalized Base Unit will be handed over to Flowsion during early January 2019. After verification testing the Base Unit will be sent to EMC testing and electrical safety testing according to EN60601-1 and usability testing according to EN 62366.
WP 2 Front End Sensor update. The existing Front End Sensor (Optical Sensor) was retested and reviewed. The documentation was updated. Some updating was performed regarding cables and software interface to the Base Unit. Also the dynamic range was characterized, and a test- and calibration procedure was developed. With these updates the Front End Sensor can be used in the CE marked system
WP 3 Consumable update. The consumable was updated, including updating the probe, the existing moulds, and developing an insertion mechanism making placement of the Glycostat probe into the central venous catheter very easy for the doctor. All parts of the updated consumable were available during December 2018.
WP 5 Tests. Testing that Glycostat conforms to basic safety according to EN60601-1 and usability according to EN 62366 are key activitisy of the last 12 months of the GLUCOSTAT project.
WP 6 Manufacturing. The existing rented clean room facility was not available to Flowsion anymore. Thus, we decided to use the budget for the rented the clean room for building a temporary clean room for this project. The temporary clean room was finalized, and the first successful bioburden analysis was available in October 2018. The key manufacturing process that needed upgrade was gluing the reagent cassette. The glue connections on the previous design of the reagent cassette were degraded by sterilization and had too often to be re-glued. This problem was solved by replacing the glue connections by luer lock connections, thus getting rid of these gluing processes all together.
WP 7 Regulatory. The objective of WP 7 is to achieve CE certification for our quality management system and the Glycostat system. This work are key activities during the last 12 months of the GLUCOSTAT project
WP 8 Clinical study. This work package comprises preparation of documentation for ethics committee approval of the clinical study, and completing the clinical study showing that Glycostat is able to semi automatically to control the blood glucose level of ICU patients in the normal range, 4-6 mM. This work are key activities during the last 12 months of the GLUCOSTAT project
WP 9 Dissemination. We have updated our www.flowsion.dk website, identical to www.glycostat.com including the GLUCOSTAT project. We have sent out a press release via Businesswire regarding the EU grant for the GLUCOSTAT project. We have been very active participating in investor dating conferences in EU and USA organized by the EU and others in trying to attract investors to help funding in the marketing stage and the approval stage for the USA. Furthermore we have been in dialogue with FDA to verify the regulatory pathway in the USA and to verify that our strategy is still aligned with their policies. We have also been in dialogue with the NIH to explore the possibilities to attract support from them for the clinical studies needed for FDA approval.
WP 10 Project management. Project management has been and will be a key effort in securing the success of the GLUCOSTAT project. Frequent meetings of the Flowsion Management team, employees, third parties, and suppliers have been and will be key focus areas and activities in the GLUCOSTAT project.
