Fluisense has strengthened the team further by hiring experienced employees within project management, regulatory affairs and production. In February, co-founder Malene Schrøder was appointed CEO and in the end of the year the organisation had grown from 11 to 16 employees. Preparing for ISO 13485 certification of Fluisense and CE certification of Fluispotter has been the focus throughout the year.
Fluisense moved into new head quarters in February to establish clean room - and EPA production facilities and to expand office space for the growing team of engineers and consultants all working to obtain ISO 13485 certification and CE certification in due time for the clinical investigation study funded by Innovation Fund Denmark. Throughout the year the team grew from 7 to 11 employees and three part time consultants. Fluisense was granted patents on the full system and on the multi lumen catheter in Europe.
Fluisense presented the Fluispotter to medical doctors in Capital Region Denmark and decided, together with a team of three doctors, to apply for funding of a grand solution project from Innovation Fund Denmark to test the device in patients who suffer from endocrine diseases. Funding was granted in the autumn of 2015. The team grew from 5 to 7 employees and two part time consultants. Fluisense was granted a patent in Japan.
In April, Fluisense exhibited at ScandLAS 2014 with an eye-catching 3D presentation of the Fluispotter on a rat, in Stockholm, Sweden. In May, Fluisense moved into our own facilities in Allerød with more room for development and production. Goal was to finish the design of a functional prototype and start assembly, and this led to the first hirings in 3 years: Divya was hired as our first operator producing parts and assembling the disposable unit together with Martin. Fanny was hired as mechanical design engineer responsible for the first assembly instructions. Animal trials on minipigs were performed at CiToxLAB in collaboration with Ellegaard Göttingen Minipigs.
The portable automated sampling system was named Fluispotter and made its first public appearance as a concept prototype at ScandLAS 2013 in Tallinn, Estonia.
Fluisense successfully completed the first proof-of-concept study in a goat with a fully portable early prototype that could keep the catheter patent for 24 hours.
Fluisense was selected to attend the Symbion Accelerace Programme as one of 15 of the most promising and innovative start-up companies in Denmark. Martin Toft Madsen joined Fluisense as development engineer. The strategy of developing a device wearable by dogs and larger laboratory animals was changed to developing a device small enough to be wearable by rats. Attention Design was hired to support and ensure the design and engineering of a technical solution suitable for mass production and designed to meet customers’ needs.
In February 2010 Fluisense ApS was founded by Sten Velschow and a group of private investors. Co-founders Malene Schrøder and Christian Mellentin were employed to support business administration and product development.
Sten Velschow moved into the inspiring environment of another engineering company, Unisensor A/S, in Allerød, where he worked on the first prototypes of a table top blood tape recorder.
In the late fall of 2008 Sten Velschow decided to leave his job as head of the animal facilities at the Danish pharmaceutical company H.Lundbeck A/S to focus on developing a technical solution to a portable automated blood sampling system. This led to the idea that forms the basis of the technology behind the Fluispotter. In the winter of 2008 Sten Velschow filed the first main patent application about the Fluispotter technology.