BTT Medical Institute, in collaboration with BTT Corp., has initiated a first-in-human clinical and biological safety trial (ClinicalTrials.gov Identifier: NCT07564440) to evaluate induced hyperthermia delivered by the Abreu BTT 700 Temperature Management System, a noninvasive computerized, brain-guided platform that raises body temperature into a controlled fever range through cyclical thermal modulation.
The trial, approved by an Institutional Review Board on 7 August, is described as an initial phase study intended to support future efficacy trials in amyotrophic lateral sclerosis and other neurodegenerative disorders.
The announcement links the clinical program to more than a decade of preclinical and clinical development, including an FDA clearance for the Abreu BTT 700 in 2010 and a November 2025 peer-reviewed case report that the company claims documented a total reversal of ALS in a single patient after treatment with a brain-guided thermofebrile protocol.
BTT Corp. is identified as a Miami-headquartered medical technology company developing precision brain thermodynamics platforms, and the company states the technology is protected by more than 100 issued and pending patents.
