Initial phase study marks the clinical evaluation of the Abreu BTT 700 TMS and its thermofebrile protocol, laying the foundation for future efficacy trials in the treatment of ALS and other neurodegenerative disorders
Dr. M. Marc Abreu, BTT Founder and Chief Medical Officer
MIAMI, Aug. 26, 2026 (GLOBE NEWSWIRE) — BTT Medical Institute, in collaboration with btt Corp. (Brain Tunnelgenix Technologies Corp.), a medical technology company pioneering brain thermodynamics-based solutions, announced the launch of the first-in-human clinical and biological safety trial (ClinicalTrials.gov Identifier: NCT07564440) evaluating thermal treatment with the investigational Abreu BTT 700 Temperature Management System (TMS), a fully noninvasive, computerized, brain-guided platform that gently and precisely raises body temperature into a controlled fever-range through cyclical thermal modulation.
This milestone represents the formal clinical translation of a scientific journey spanning more than a decade, initiated by M. Marc Abreu, M.D., with the discovery of the Brain Temperature Tunnel (BTT) at Yale University [1] and culminating in FDA clearance of the Abreu BTT 700 System in 2010.The trial advances the platform’s clinical development following the November 2025 publication of a peer-reviewed case report in Diseases [2]: “Total Reversal of ALS Confirmed by EMG Normalization, Structural Reconstitution, and Neuromuscular-Molecular Restoration Achieved Through Computerized Brain-Guided Reengineering of the 1927 Nobel Prize Fever Therapy: A Case Report”.
“Total Reversal of ALS Confirmed by EMG Normalization, Structural Reconstitution, and Neuromuscular-Molecular Restoration Achieved Through Computerized Brain-Guided Reengineering of the 1927 Nobel Prize Fever Therapy: A Case Report”
The launch of this trial builds upon the documented total reversal of ALS following digitally reengineered therapeutic fever designed to activate the brain’s heat shock response and the associated restoration of neurological functions. [2] The report described a 56-year-old woman with ALS whose diagnosis was confirmed at nationally ranked U.S. neurology centers. Consistent with standard counseling for ALS, she was informed by her neurologist that the disease carries an expected survival of approximately three to five years after symptom onset. Despite expert care and treatment with FDA-approved ALS medications, her disease continued to worsen. Following treatment with Dr Abreu’s brain-guided intelligent thermofebrile protocol, she no longer met the diagnostic criteria for ALS, discontinued all ALS-specific medications, and returned to activities including swimming, golf, and pickleball. More than a year later, she remains free of clinical relapses and with sustained neurological and functional recovery.
The published findings are supported by objective evidence generated independently by prominent third-party institutions with no involvement in the patient’s treatment. Before and after treatment, EMG studies were independently performed and interpreted at different nationally ranked U.S. neurology centers, neither of which was aware of the BTT treatment, as detailed in Diseases [2]. The pretreatment evaluation confirmed the diagnosis of ALS and documented electrophysiological evidence of active motor neuron degeneration, including denervation, fibrillation potentials, and fasciculations. Following Dr. Abreu’s programmed fever therapy, the post-treatment EMG demonstrated absence of denervation, fibrillations, and fasciculations, with no electrophysiological evidence of active motor neuron degeneration. Blood biomarker analyses were likewise performed independently by a major U.S. commercial reference laboratory, demonstrating normalization of biomarkers associated with disease progression and poor survival, providing additional objective corroboration of the reported neurological recovery.
The Unmet Need: A Global Brain Health Emergency
Neurological disorders affect more than one in three people worldwide and more than one in two Americans—over 180 million people—making them the leading cause of disability globally. [3,4] Alzheimer’s disease alone is projected to cost the United States $409 billion in 2026, rising to an estimated societal burden of $818 billion annually when unpaid caregiving and lost productivity are included. [5,6] ALS, the most treatment-resistant neurodegenerative disease, remains without a restorative therapy. [7,8] The 2025 G7 Summit highlighted that no country has yet identified a solution to the escalating global brain health crisis. [9] The investigational Abreu BTT 700 TMS is designed to address this unmet need through a noninvasive, digital platform employing individualized brain-guided thermodynamic control to target the underlying molecular pathology of protein misfolding.
The Institutional Review Board has reviewed and approved this press release on August 7, 2026.
About the BTT 700 Technology Platform
The Abreu BTT 700 TMS digitally modernizes the Nobel Prize-recognized therapeutic principle of fever for treating neurological diseases through computerized individualized brain-guided thermodynamic control designed to induce therapeutic fever that activates the body’s natural heat shock response and production of protective heat shock proteins. The technology received early U.S. Federal Government recognition and development funding through the Qualifying Therapeutic Discovery Project for its potential to address critical unmet medical needs.
About btt Corp. (Brain Tunnelgenix Technologies, Corp.)
Headquartered in Miami, Florida, btt Corp. is a medical technology company with operations in the United States and The Bahamas, developing precision brain thermodynamics platforms for therapeutics, diagnostics, disease prevention, enhancing human performance, and longevity. The company has developed a proprietary technology portfolio protected by more than 100 issued and pending patents, and its pipeline includes investigational therapies for multiple disorders associated with protein misfolding.
The IRB attests that this submission has been approved by an IRB whose membership complies with the requirements defined in Health Canada regulations, ICH GCP guidelines, FDA regulations at 21 CFR part 56, and HHS regulations at 45 CFR part 46. The IRB carries out its functions in accordance with FDA regulations at 21 CFR parts 50, 56, 312, and 812; HHS regulations at 45 CFR part 46, subparts A-E; good clinical practices; Health Canada regulations; and the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, as appropriate to the research.
Media Contact:
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Sources:
- [1] Yale University. Yale researcher discovers “brain temperature tunnel” that for the first time allows external continuous measurement of brain
temperature [Internet]. New Haven (CT): Yale News; 2003 Jul 2 [cited 2026 Jul 23]. Available from: https://news.yale.edu/2003/07/02/yale-researcher-discovers-brain-temperature-tunnel-first-time-allows-external-continuou-0 - [2] Abreu MM, Hosseine-Farid M, Silverman DG. Total reversal of ALS confirmed by EMG normalization, structural reconstitution, and neuromuscular–molecular restoration achieved through computerized brain-guided reengineering of the 1927 Nobel Prize fever therapy: a case report. Diseases. 2025;13(11):371. doi: https://doi.org/10.3390/diseases13110371
- [3] World Health Organization. Over 1 in 3 people affected by neurological conditions, the leading cause of illness and disability worldwide [Internet].
Geneva: World Health Organization; 2024 Mar 14 [cited 2026 Jul 23]. Available from: https://www.who.int/news/item/14-03-2024-over-1-in-3-people-affected-by-neurological-conditions–the-leading-cause-of-illness-and-disability-worldwide - [4] Ney JP, Steinmetz JD, Anderson-Benge E et al. US Burden of Disorders Affecting the Nervous System: From the Global Burden of Disease 2021 Study. JAMA Neurol. 2026 Jan 1;83(1):20-34. doi: https://doi.org/10.1001/jamaneurol.2025.4470
- [5] Alzheimer’s Association. Alzheimer’s disease facts and figures [Internet]. Chicago (IL): Alzheimer’s Association; [cited 2026 Jul 23]. Available from: https://www.alz.org/alzheimers-dementia/facts-figures
- [6] Thunell J, Tysinger B, Baumgart M, et al. The cost of dementia in the United States in 2026. Alzheimer’s Dement. 2026; 22:e71480. https://doi.org/10.1002/alz.71480
- [7] Batulan Z, Shinder GA, Minotti S, et al. High threshold for induction of the stress response in motor neurons is associated with failure to activate HSF1. J Neurosci. 2003;23(13):5789-5798. doi: https://doi.org/10.1523/JNEUROSCI.23-13-05789.2003
- [8] Feldman EL, Goutman SA, Petri S, et al. Amyotrophic lateral sclerosis. Lancet. 2022;400(10360):1363-1380. doi: https://doi.org/10.1016/S0140-6736(22)01272-7
- [9] G7: Canada Brain Research Strategy. Canada Brain Economy Declaration. Available online: https://canadianbrain.ca/canada-brain-economy-declaration/ (accessed on 28 July 2026).
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/f3932b44-bfbb-4db7-94d9-146ece1a2c0f
