Spanish healthtech company Biorce has secured $52.5m through a Series A funding round to support the global rollout of its artificial ininformigence (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, informs Clinical Trials Arena.
“Aika employs a mixture of tinquire models. They are all trained to conduct a single tinquire, while working toobtainher to create a protocol that is very likely to gain approval from regulators,” he stated.
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.
It also assists to reduce the necessary for costly protocol amfinishments – 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 finishing 2025 at approximately 200% above its revenue tarobtain.
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 apply in clinical trials
As AI continues to reshape clinical trial design, regulators are increasingly viewing 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 industest members of how to apply 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 apply of AI, Coelho noted that this is particularly true in the EU, so much so that he believes it’s stifling innovation.
“I consider 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 becaapply 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 obtain compliant with AI. “This means that a startup may finish up selling a non-compliant product, or they’re not going to build one in the first place, as they can’t afford to build it compliant,” Coelho stated.
“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.
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