Cystotech raises €1 million in capital - and achieves CE approval in record time
Claus Hansen, Co-CEO and winner of the INCUBA Award 2023 as Investor of the Year, has together with the rest of the Cystotech team led the successful effort. He is known for his courage to invest in a capital-intensive, high-risk life science industry and his dedication to Aarhus' startup community.
‘We are extremely proud that the team completed the entire application process in just eight months - far faster than the industry average,’ he says. Cystotech is now entering a commercial phase just four years after its founding - a milestone that Claus Hansen calls ‘transformative’.
With the CE mark, Cystotech can now market and sell the product in all EU countries without additional national approvals. This significantly accelerates the company's go-to-market opportunities.
Claus Hansen, Co-CEO of Cystotech and winner of the INCUBA Award 2023 as Investor of the Year presented at the Aarhus Investor Summit.
Investment paves the way for scaling and new markets
The newly injected capital will boost Cystotech on both the technical and regulatory fronts. With a core team of nine full-time employees - supplemented by several part-time specialists - the company is now expanding its competencies to ensure the organisation is in a strong position for the next commercial milestones. The funds will also finance a focused entry into the US market, where Cystotech is aiming for an FDA application in 2026. This requires both more internal resources and external experts, such as advisors with specialised knowledge of regulations, law and go-to-market strategies.
Co-founder Anna Munk, Cystotech, with Efstathios Vassiliadis, Evnia. Evnia has helped Cystotech with ISO 13485 certification and made the solution ready for both EU/MDR and FDA requirements. Read more.
Cystotech founder team. From left: Thomas Grønning Knudsen, Jacob Elmose Jensen, Anna Munk, Claus Hansen & Philip Butenko
Four rounds - without traditional venture capital
Cystotech has completed four capital rounds with support from 15 business angels, a local fund, management and the board - without traditional venture funds.
‘The management and the entire board also participated in this round, and our first private investors have now co-invested for the fourth time,’ says Claus Hansen. ‘The broad support both humbles us and raises our ambitions.’
Since 2021, the company has raised around DKK 23 million in hard funding and just under DKK 5 million in soft funding; the new capital will last approximately 12 months.
Focus on commercial execution and continued product development
Cystotech expects that additional growth capital may be needed - especially to expand the product portfolio, which already includes the now approved AI solutions for detection, but also includes a vision of tumour categorisation and digital 3D mapping of the bladder.
‘Our goal is positive cash flow and a strong European customer base within 4-5 years, which will put us in the black on the bottom line,’ states Claus Hansen.
With the CE mark, fresh capital and a robust investor base, Cystotech is well positioned to become the first player in the market with software AI-based bladder cancer diagnostics - initially in Europe and then globally.
- Established: 2021 as a spin-out from Aarhus University Hospital with the mission to develop products to benefit patients with bladder cancer
- Team: Medical professionals, IT specialists and commercial forces. Professional board of directors
- Technology: AI-based software that can accurately identify malignant changes in the bladder in both outpatient and surgical procedures
- Product portfolio: Currently three products in the pipeline: bladder cancer detection, bladder cancer categorisation and later digital 3D mapping of the bladder
- Market potential: Approximately 40 million bladder cancer screenings are performed annually globally, a figure that is increasing by 5-6% annually
- First to market: The company expects to be the first to introduce AI technology for bladder cancer detection in both the EU and the US
- Customers: Urology departments in close co-operation with buyers and other stakeholders
- Expansion: Denmark, Germany and France
- Cystotech has been part of INCUBA since 2022.
