London: Presentient Technologies has raised $3 million in funding, led by Wavemaker Three-Sixty Health, with Defined as co-lead and participation from Verve.
Presentient is modernising the decision infrastructure clinical trials have relied on since the 1980s. Its platform, BRAKES, enables autonomous interim analysis of unblinded trial data while preserving blinding for trial teams, removing a longstanding tradeoff between trial integrity and timely decision-making. Interim analyses are one of the highest-impact tools in drug development, yet greatly underused, costing the industry an estimated $15–20 billion a year in trials that run far longer than the data warrants. The company has now made its first formal submission to the U.S. Food and Drug Administration on BRAKES.
The company will use the funding to make clinical trials 10x better across three areas: earlier stopping for success/failure, AI-driven trial design efficiency, and earlier identification of subgroup and safety signals to enable more personalised medicine.
"Clinical trials still operate with unnecessary delay and friction," said Dr Tom Coates, Co-founder and CEO of Presentient. "We built BRAKES to give sponsors earlier, higher-quality answers without compromising the integrity of the trial. This funding, alongside our first formal FDA submission, puts us on the path to making BRAKES the gold standard for interim decision-making in clinical trials."
"Presentient is tackling one of the most persistent inefficiencies in clinical development," said Maxim Owen of Wavemaker Three-Sixty Health. "The team's deep understanding of trial operations and regulatory requirements positions them to deliver real impact."
"At Defined, we support founders solving fundamental problems with AI, and we're excited to support Presentient as BRAKES delivers a step-function change in clinical trials, cutting timelines in half, eliminating billions in wasted spend, and enabling a new class of decision-making in drug development," added Mark Trevitt, Founding Partner of Defined.
Presentient is already in discussions with major pharmaceutical companies as it advances commercial deployment alongside regulatory engagement.
About: Presentient Technologies is a London-based clinical trial technology company building software to improve the speed, efficiency, and precision of drug development. Its BRAKES platform enables autonomous interim analysis to support earlier, better-informed clinical trial decisions.
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