On February 2, 2023 EXACT THERAPEUTICS AS ("EXACT-Tx", Euronext Growth: EXTX), a clinical stage precision health company utilising Acoustic Cluster Therapy (ACT) across multiple therapeutic areas, reported that the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has approved reopening of the clinical phase I ACTIVATE trial (Press release, Exact Therapeutics, FEB 2, 2023, View Source [SID1234626783]).

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As communicated in a press release of 8 March 2022, EXACT-Tx received a request from the MHRA for an additional submission and approval of medical device documentation associated to the protocol amendment filed with the ACTIVATE phase I clinical trial. EXACT-Tx responded to the request and has now received MHRA’s approval on both the medical device documentation and the amended protocol. The approvals were made without objections.

For EXACT-Tx, this mean that the ACTIVATE phase I trial will be reopened and additional patients will be recruited for the trial.

So far, there have been seven patients enrolled in the study with five patients’ data being evaluable for the study endpoints. Several valuable and encouraging insights have been gained from this first cohort of treated patients.