FDA authorization enables prospective BTSEE study in 45 pediatric and adult patients at up to 10 U.S. comprehensive epilepsy centers
REDMOND, Wash., Oct. 14, 2026 /PRNewswire-PRWeb/ -- Cadence Neuroscience, a clinical-stage company developing a biomarker-guided platform for personalized neuromodulation, announced today that the U.S. Food and Drug Administration (FDA) approved the company's Investigational Device Exemption (IDE), allowing the Biomarker Targeted Stimulation for Epileptiform Events (BTSEE) clinical study to proceed. The prospective, multicenter study will evaluate Cadence's investigational Biomarker Targeted Stimulation (BTS) therapy in 45 pediatric and adult patients with focal drug-resistant epilepsy at up to 10 comprehensive epilepsy centers across the United States. The BTSEE study is intended to generate clinical evidence to support a future Humanitarian Device Exemption (HDE) application and potential FDA approval.
The IDE approval marks an important transition for Cadence into prospective, multicenter clinical evaluation of its biomarker-guided approach. The investigational BTS system is designed to use patient-specific neural biomarkers to inform stimulation and measure the brain's response. This biomarker-guided approach is intended to provide clinicians and researchers with real-time physiological feedback that may support more personalized and adaptable neuromodulation.
Cadence is initially evaluating BTS in focal drug-resistant epilepsy, a serious condition in which many patients continue to experience seizures despite treatment with available anti-seizure medications. Focal drug-resistant epilepsy is the first indication for clinical evaluation of Cadence's platform, while the company builds the capabilities to develop the platform across additional neurological conditions.
Cadence's technology originated from research conducted by a Mayo Clinic Neurology and Neurosurgery team led by Gregory Worrell, M.D., Ph.D., a Mayo Clinic epileptologist and lead investigator. In a published retrospective analysis of 21 patients treated with chronic subthreshold cortical stimulation, researchers reported an 89% responder rate and that approximately 40% of patients were free of disabling seizures for at least 12 months.¹ BTSEE is designed to build on this scientific foundation by prospectively evaluating Cadence's investigational BTS system across multiple U.S. epilepsy centers.
"FDA approval of the IDE is an important milestone because it enables us to move from promising early clinical evidence¹ to prospective, multicenter evaluation of our biomarker-guided approach," said Chris Cronin, Chief Executive Officer of Cadence Neuroscience. "Our focus now is activating participating centers and beginning enrollment in the BTSEE study in patients with focal drug-resistant epilepsy."
"It is rewarding to see research that began in our laboratory advance to prospective clinical evaluation," said Gregory Worrell, M.D., Ph.D., Mayo Clinic epileptologist and lead investigator. "This milestone reflects years of scientific inquiry and collaboration focused on understanding patient-specific neural biomarkers and how they may inform new approaches to neuromodulation."
"From the beginning, our work has been grounded in the understanding that every person's epilepsy is different," said Kent Leyde, Founder and Chief Technology Officer of Cadence Neuroscience. "Reaching this stage reflects years of research and development exploring how patient-specific brain activity could inform a different approach to neuromodulation. BTSEE gives us the opportunity to rigorously evaluate that approach and build the clinical evidence needed to understand its potential for patients whose seizures remain uncontrolled despite available therapies."
Participation in the clinical study is voluntary, and not all individuals may be eligible. Information regarding study eligibility criteria, participating sites, and study contacts is available at ClinicalTrials.gov/study/NCT06424977 (Identifier: NCT06424977).
About Cadence Neuroscience
Cadence Neuroscience is a clinical-stage medical technology company developing a biomarker-guided platform for personalized neuromodulation. Its investigational Biomarker Targeted Stimulation (BTS) system is designed to use patient-specific neural biomarkers to inform stimulation and measure the brain's response in real time. Cadence is initially advancing BTS in focal drug-resistant epilepsy, with a long-term goal of developing the platform for additional neurological conditions. Founded in 2017 and headquartered in Redmond, Washington, Cadence is building on technology originating from Mayo Clinic research. Cadence is backed by leading healthcare and technology investors, including F-Prime Capital, Jazz Venture Partners, LivaNova, Angelini Lumira Biosciences Fund, and Mayo Clinic. For more information, visit cadenceneuro.com.
Mayo Clinic and Dr. Worrell have a financial interest in the technology referenced in this news release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education, and research.
Cadence Neuroscience is developing investigational medical technologies that have not been approved or cleared by the U.S. Food and Drug Administration (FDA) or other health authorities.
Any forward-looking statements reflect current expectations and are subject to risks and uncertainties. Actual results may differ materially. Patients should consult qualified healthcare providers regarding diagnosis and treatment options.
Currently, these investigational technologies are only accessible through participation in a clinical trial. For information about the BTSEE study, including eligibility and study contacts, visit ClinicalTrials.gov/study/NCT06424977.
Reference:
- Lundstrom BN, Van Gompel J, Khadjevand F, Worrell G, Stead M. Chronic subthreshold cortical stimulation and stimulation-related EEG biomarkers for focal epilepsy. Brain Communications. 2019.
Related Links:
https://clinicaltrials.gov/
https://www.cadenceneuro.com/
Media Contact:
Alysa Wood
(425) 298-3184
[email protected]
Media Contact
Alysa Wood, Cadence Neuroscience, 1 (425) 298-3184, [email protected], https://www.cadenceneuro.com/
SOURCE Cadence Neuroscience
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