BETA
German medical device developer commercializing EASEE, an epicranial neurostimulation system for drug-resistant focal epilepsy.
PRECISIS is a Heidelberg medical device company developing bioelectronic therapies for neurological disorders. Led by CEO Karl Stoklosa and CTO Michael Tittelbach, it commercializes EASEE for selected patients with drug-resistant focal epilepsy.
EASEE places a thin electrode beneath the scalp and above the skull, connected by a subcutaneous lead to a pulse generator implanted near the chest. It delivers configurable high-frequency and DC-like stimulation patterns and permits patient-triggered stimulation. The epicranial approach avoids placing electrodes inside the brain.
The system received its first CE mark in September 2022 and has entered selected European markets. PRECISIS is also pursuing a U.S. clinical program through EASEE4US and secured a €20 million European Investment Bank venture-loan agreement in 2025 to support research, development and clinical evaluation.
The manufacturer’s Summary of Safety and Clinical Performance records initial CE marking in September 2022 and identifies DEKRA Certification B.V. as notified body 0344. The stated intended purpose is adjunctive neurostimulation for adults over 18 with focal-onset seizures refractory to two or more antiepileptic medications, subject to the labeling’s selection criteria and contraindications. [2][3][5][1]
The U.S. EASEE4US pivotal study (NCT07301346), sponsored by Precisis US, is registered as a randomized controlled investigation with estimated enrollment of 200. The August 28, 2026 registry update lists not-yet-recruiting status. An estimated start date is not confirmation that enrollment has begun, and European CE marking does not constitute FDA marketing authorization. [2][3][5][1]
Latest recorded source review: 2026-11-06.
Scope: selected product families.
Documented commercial product families.
Implantable system combining a subscalp electrode, lead and chest-area pulse generator. It provides configurable stimulation for adults with focal seizures refractory to at least two appropriate antiepileptic medications; the electrode lies outside the skull rather than inside the brain. [3]
CE-marked · Selected European commercializationEASEE4US lists planned enrollment of 200 and not-yet-recruiting status at this update. [1]
The EIB project record identifies a signed €20 million financing agreement supporting research, development and clinical evaluation. The amount is a loan facility rather than equity funding or a verified cash draw. [7]
The manufacturer’s safety and clinical-performance document dates initial CE marking to September 2022. [5]
The EIB’s company background records PRECISIS’ founding in 2004; development of the EASEE approach began later. [7]
Accessed 11/06/2026