Med sommaren runt hörnet tittar BioStock närmare på vad Fluicell åstadkommit under det gångna halvåret. Bland höjdpunkterna kan man notera lanseringen av bolagets senaste produkt, Biozone 6, samt bolagets entré på området för regenerativ medicin genom sitt BioRej Advance-program. BioStock pratade med Fluicells vd Victoire Viannay om hennes tankar kring bolagets nya riktning och vilka milstolpar Fluicell siktar mot under resten av 2021. 

De utmaningar som pandemin inneburit under det första halvåret 2021 har inte stoppat svenska encellsbolaget Fluicell i arbetet med att ge forskare möjlighet att förbättra människors hälsa genom att utveckla de verktyg som behövs för läkemedelsupptäckt och utveckling.

Teknologisk expertis

I mars, 16 månader efter lanseringen av 3D-bioprintern Biopixlar, som har lett till både nya distributionsavtal, ökad försäljning och initiering av CRO-tjänster, släppte Fluicell sin fjärde produkt baserad på avancerad mikrofluidik för encellsbiologi – Biozone 6. Läs mer om den nya produkten här.

Lanseringen av Biozone 6, precis som lanseringen av Biopixlar, är ännu ett exempel på hur Fluicell gör verklighet av innovativa idéer baserade på mikrofluidikens principer, något som demonstrerar den höga kompetens och det engagemanget som finns i bolaget. Lanseringen sker under en period av tillväxt och expansion för Fluicell, inte bara när det gäller nya investeringar i produktutveckling och FoU utan också i nyrekryteringar till teamet. Hittills i år har bolaget anställt två applikationsforskare och en utvecklingsingenjör.

I juni uppnådde Fluicell en viktig milstolpe i form av försäljningen av en Biopixlar-plattform till National Institute of Diabetes and Digestive and Kidney Diseases, en del av National Institutes of Health. Fluicells expansion i USA fortsatte i juni, först genom ett avtal med det amerikanska life science-bolaget Nexus Scientific för marknadsföring och för att hitta nya kunder för Biozone 6 och BioPen på den amerikanska marknaden. Avtalet ger Fluicell möjlighet till starkare närvaro på en av världens största marknader. Avtalet med Nexus Scientific följdes snabbt av ett samarbetsavtal med IonOptix där Fluicell, baserat på sin expertis, IP och know-how, kommer att vidareutveckla IonOptixs plattform för hjärtcellanalys.

Fluicell äntrar området för regenerativ medicin

Årets andra höjdpunkt har varit bolagets engagemang inom det mycket lovande området för regenerativ medicin där man utnyttjar Biopixlars högupplösta bioprintningsfunktioner. Målet är att fokusera på att utveckla läkemedel för avancerad terapi (ATMP) baserat på transplanterbara mikrovävnader, och därmed sikta in sig på viktiga sjukdomsområden som typ 1-diabetes, hjärtsvikt eller åldersrelaterad makuladegeneration (AMD). För en närmare beskrivning av detta initiativ, läs här.

För att uppnå detta har Fluicell introducerat ett nytt partnerskapsprogram för ATMP-forskning och utveckling kallat BioRej Advance. Programmet fungerar som en teknisk ram för utveckling av avancerade terapier inriktade på sjukdomar som har stor inverkan på människors hälsa och som idag saknar adekvata behandlingar och där konstruerade vävnader har potential att ge fördelar. Detta innebär att Fluicell kan rikta sig mot nästan alla typer av sjukdomsområden, inte bara de indikationer som nämns ovan. Med det nya programmet utvecklas Fluicell också från att enbart vara en utvecklare av forskningsinstrument till att gå mot att bli en drivkraft för terapeutisk utveckling.

»Based on scientific advances in high precision tissue printing using Biopixlar, Fluicell is now entering the rapidly growing regenerative medicine market. We have developed strong product concepts in three therapeutic areas where small-scale precision tissues can restore organ function and offer treatment alternatives. Because of this recent development, we now see a great opportunity to enter this new phase in the evolution of Fluicell that we believe will greatly benefit the future growth of the company« — Victoire Viannay, vd Fluicell

BIRDIE-projektet

En nyckelfaktor för att skapa nya partnerskap för BioRej Advance-programmet har varit Fluicells engagemang i BIRDIE-projektet – ett initiativ för att utveckla modeller för att undersöka virusinfektion och nefrotoxicitet samt bygga relevanta plattformar för att bidra till framtida behandlingar för patienter med njursjukdom.

Projektet, som initierades i mars och finansierades av ett bidrag på 3 miljoner euro från EUs ramprogram för forskning och innovation, Horizon 2020, för samman ett konsortium av partners som inkluderar projektets samordnare, Maastricht University och Université de Nantes, som båda kommer att använda Fluicells Biopixlar för att utveckla tillförlitliga och relevanta bioprintade modeller av mänsklig njurvävnad. Den andra samarbetspartnern från branschen är TissUse GmbH, som kommer att tillhandahålla sin egen Multi-Organ-Chip för att möjliggöra en samodling av fysiologiskt relevanta vävnadsmodeller i en sluten mikrofluidkrets.

Vd blickar framåt

BioStock talade med Fluicells vd Victoire Viannay för att höra hennes tankar om det arbete bolaget gjort hittills i år och vad vi kan förvänta oss av resten av 2021.

Victoire Viannay, Fluicell has continued to grow this year, despite the pandemic. What has been the key to affronting this difficult challenge, both for you as leader of the company and for the team as a whole?

– As a small sized company with around 20 employees, we are used to thinking outside the box and to quickly adapt to rapidly changing conditions. The difficulty is being able to do that, and at the same time continue to give some level of continuity and stability to the employees. The pandemic has been a shock to everyone, not only last year but this year as well as we were hit with the 3^rd wave. At Fluicell, we have met this challenge by being a tight-nit team with smart co-workers that are quick to adapt and not afraid of challenges. In addition, we are backed by a very supportive board of directors. As leader, the challenge has been to be able to make fast and intuitive decisions, always in concert with the chairman of the board on one hand and the senior management on the other. It is also about guiding and trusting the sales team, which is at the forefront of the difficulties induced by the Covid-19 pandemic.

You recently announced the sale of a Biopixlar system to the NIH. Can you comment on the importance of that specific deal for Fluicell?– 

– We are extremely pleased about this Biopixlar order by the NIH, which we received very recently. The National Institutes of Health is one of the foremost research institutes in the world, with outstanding internal research capacities and a large influence over biomedical research overall. The Biopixlar system has been purchased by the department of diabetes and digestive and kidney diseases, which is an ideal fit for the Biopixlar technological capabilities. The core research focus of this group at the NIH is to study how cells sense and integrate mechanical and chemical information from their environment to control cell state and behavior. That a world renowned actor such as the NIH invests in Biopixlar is a strong signifier for the quality of our technologies and that our products are able to provide unique values for researchers in this field.

– The deal with the NIH is also part of Fluicell’s expansion on the important US market, which, together with Europe, is the largest market for our products. The Biopixlar sold to the NIH is the second system in the US, with the Biopixlar platform that we delivered to OHSU early this year being the first. Together, these two systems will provide a substantially increased exposure for Biopixlar on the US market. In addition to this, our recent sales agent agreement with Nexus means that also BioPen and Biozone 6 are covered in the US, providing a platform for future sales growth.

Specifically, how does the BioRej Advance partnership programme generate value for Fluicell?

– Based on scientific advances in high precision tissue printing using Biopixlar, Fluicell is now entering the rapidly growing regenerative medicine market. We have developed strong product concepts in three therapeutic areas where small-scale precision tissues can restore organ function and offer treatment alternatives. Because of this recent development, we now see a great opportunity to enter this new phase in the evolution of Fluicell that we believe will greatly benefit the future growth of the company.

– We will be conducting preclinical research in the areas of diabetes, cardiovascular disease and eye disease, with the goal to have at least one program going to clinical trial.

– While the challenges associated with therapeutic development should not be downplayed, the economic benefits from a therapeutic product resulting from this program would be considerable, on a scale that is substantially larger than the current scale of the company. Through this programme, we also see an important opportunity to add value to society by focusing on developing therapies for diseases that currently lack adequate treatment options. Deciding to follow the path toward therapeutics is therefore creating different types of long terms value for Fluicell and provides a strong foundation for future growth.

»We see many exciting opportunities for Fluicell for the remainder of 2021. First of all, our core focus is to continue to increase our revenue, both through instrument sales and through research commissions. As we have previously stated, our sales pipeline continuous to be strong, which allows me to see the future for Fluicell in this regard in a very positive light«

The Horizon 2020 grant funding the BIRDIE project has given Fluicell substantial funds directed towards research. What is the benefit for Fluicell in research collaborations such as BIRDIE?

– Fluicell benefits in many ways from research grants such as BIRDIE. First of all, being awarded large grants such as H2020-FETOPEN-2018-2019-2020-01 is a major quality stamp for our scientific acumen as well as our technology platform. Research grants also enable us to fund development work and allow us to explore new trajectories that can lead to new products and increased sales down the line.

– In the BIRDIE project, we are also part of advancing bioprinting research and development towards improved in vitro models for disease understanding that combines high-resolution bioprinting with organ-on-chip technologies. This contributes to advancing the bioprinting market in general, which benefits Fluicell going forward. The project also includes placing two Biopixlar systems in research laboratories in Nantes and Maastricht, something that further advances the position of the platform among core customer groups.

Finally, what milestones are you hoping to achieve during the rest of 2021?

– We see many exciting opportunities for Fluicell for the remainder of 2021. First of all, our core focus is to continue to increase our revenue, both through instrument sales and through research commissions. As we have previously stated, our sales pipeline continuous to be strong, which allows me to see the future for Fluicell in this regard in a very positive light.

– Another important milestone this year will be to develop proof-of-concept for regenerative medicine applications that will create a foundation that will allow us to advance development towards in vivo research in 2022.

– In conjunction with this, we will also focus on establishing partnerships with important R&D players, either towards regenerative medicine or for drug development purposes. Partnering with industry leaders across different areas of biomedical research is an important part of Fluicell’s innovation agenda and will also play an increasingly important role in the advancement of the BioRej Advance program.

– Finally, as we announced at the AGM, we also plan to release a new product during Q4 this year/Q1 next year. Releasing this new product on time will also be one of our core focus points this year.

–Taken as a whole, we can say that there is a lot to look forward to for the remainder of the year. We strongly believe that there is true value in being an innovation company such as Fluicell. This is highlighted in the report The Bio Revolution published by McKinsey & Co. describing a future development where biotechnologies will have far-reaching impact on society as a whole, not least in the area of healthcare. According to this report, “The main capabilities enabling impact are the increased precision and personalisation in the delivery of treatment and the accelerated pace and scope of R&D. In the longer term, innovations are likely to spread to more therapeutic areas such as cardiovascular and neurodegenerative diseases.” According to Mc Kinsey again, “Companies will need to adapt their business strategies focusing on scientific advances and technologies that are likely to have the most impact, investing in them, partnering with innovative startups, reinventing their own organisations where appropriate, and managing risks.”

– Fluicell, as a small, science-based startup currently at the forefront of innovation, is well situated to meet these requirements and attract collaborations. We see Fluicell as an important part of this development, and we will use our capacity to innovate to strive towards a leadership role.

The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.

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