Spanish healthtech company Biorce has secured $52.5m through a Series A funding round to support the global rollout of its artificial intelligence (AI) clinical trial programme.
The financing round, which includes investors TZR Capital, Endeavour Catalyst, Norrsken VC and Mustard Seed Maze, as well as angel investors like Revolut CEO Nik Storonsky and Mistral AI co-founder and CEO Paulo Rosado, will see the company expand from its roots in Barcelona to the US, while further developing the global scaling of its AI-powered technology.
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At the heart of this funding round is Aika, Biorce’s clinical trial platform. The company designed Aika to optimise trial design and operations – allowing study operators to create “regulator-ready protocols” in 90 seconds with 86% accuracy.
Built on a data pool of over one million clinical trials, the disease-agnostic technology functions through a multi-modality approach, Biorce’s CEO, Pedro Coelho, tells Clinical Trials Arena.
“Aika employs a mixture of task models. They are all trained to conduct a single task, while working together to create a protocol that is very likely to gain approval from regulators,” he said.
When generating a protocol, Coelho noted that Aika mirrors the way in which a human would approach the process. It achieves this by creating a best protocol first, which can then be tailored to a specific sponsor’s requirements before it is submitted to health authorities.
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By GlobalDataIt also helps to reduce the need for costly protocol amendments – which can add up to €1m ($1.2m) and six weeks in costs for an operator.
Biorce is also in a good financial position as it continues to roll out Aika, with the company ending 2025 at approximately 200% above its revenue target.
On top of Biorce’s Series A financing, the company raised a further €8.5m ($10m), consisting of a €3.5m raise in November 2024, as well as a €5m extension from Norrsken VC.
Regulators encourage AI’s use in clinical trials
As AI continues to reshape clinical trial design, regulators are increasingly looking to adapt to the technology’s presence by creating legislation that ensures patient safety and AI’s continued growth.
This led to the recent release of a collaborative framework from the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), which is built to advise industry members of how to use AI responsibly. The European Union also introduced the EU AI Act, which covers all facets of the technology, both in the consumer and business contexts.
While many global regulators are cracking down on the use of AI, Coelho noted that this is particularly true in the EU, so much so that he believes it’s stifling innovation.
“I think the AI Act has been painful for European companies to build from,” Coelho commented. “We’ve been part of the push to stop regulating so hard on AI – especially in Europe – just because we are clearly behind.”
As an example, Coelho notes that the average pre-seed round in Europe is between €500,000 and €800,000, while the EU predicts that it costs around €500,000 and €700,000 to get compliant with AI. “This means that a startup may end up selling a non-compliant product, or they’re not going to build one in the first place, as they can’t afford to make it compliant,” Coelho said.
“Europe will continue to trail the US and China if it tries to over-regulate, rather than unlocking the power of this technology like other countries,” Coelho concluded.
