Industry News

ABILITY Neurotech reaches first-in-human at TUM Munich

Somewhere inside the University Hospital Rechts der Isar in Munich, over an unspecified handful of days sometime before Tuesday 21 July 2026, a neurosurgical team at the Technical University of Munich opened a patient’s skull to remove a brain tumour and, along the way, gave the surgical window over for twenty to thirty minutes to a Geneva-based company that had never before recorded from a human brain. The team was led by Arthur Wagner, Bernhard Meyer (director of the Department of Neurosurgery), and Simon Jacob (Professor of Translational Neurotechnology at TUM’s School of Medicine and Health). The company is ABILITY Neurotech, spun out of the Wyss Center for Bio and Neuroengineering in Geneva in March 2025 after eight years and roughly fifty million dollars of pre-spinout R&D. The device is a 128-channel sub-scalp electrocorticography array with the unusual feature of streaming its raw broadband neural data out through the intact scalp at fifty megabits per second by shining an infrared laser through the skin. The neural signals recorded during the tumour surgery are the first their fully-implantable brain-computer interface has ever produced from a human. To the patient, they are twenty to thirty minutes of borrowed time during an operation that had a different primary purpose. That gap between mission and moment is the tension in the 21 July 2026 announcement, and it is the one to hold in view.

What the announcement actually reports

The 21 July release is not a chronic implantation. Nothing was left inside a patient at end of surgery. The Munich cohort is an acute intraoperative validation study on up to five patients undergoing standard-of-care brain-tumour resection at TUM. Each participant contributes twenty to thirty minutes of intraoperative recording while ABILITY’s electrode array captures ECoG signals from the cortical surface exposed by the tumour operation. Initial patients were recorded under general anaesthesia to validate the full signal-acquisition system end to end. The next stage of the same protocol, per Rotem Kopel, ABILITY’s chief executive and co-founder, is to move to conscious patients performing speech and motor tasks: awake craniotomy work of the kind Precision Neuroscience is running through its parallel intraoperative protocol at Mount Sinai, WVU, and elsewhere.

Kopel’s on-record framing at the launch is worth reading in her own words: “This procedure, recording neural data from humans for the first time, is a key milestone for Ability and our mission to enable safe and ethical long-term BCI implantations. The real-world validation of our signal acquisition system to capture high-quality neural data in patients brings us another step closer to restoring communication, movement and autonomy for those living with paralysis and speech loss.” Simon Jacob’s framing from the Munich side matches the clinical caution: “This research allows us to capture known neural phenomena, including evoked potentials and high-gamma activity, and benchmark Ability’s signal quality against established clinical electrophysiology systems. Establishing this scientific basis is what will allow brain-computer interface technology to mature responsibly from research into a reliable clinical tool.” The Munich team’s institutional credential on this specific announcement is worth noting: in the summer of 2025 the same TUM department performed the first implantation of a microelectrode-based sensorimotor brain-computer interface in Europe, in a patient with a high-level spinal cord injury.

The second half of ABILITY’s clinical programme, which Inside BCI covered separately on 27 May 2026, is the chronic implantation study at UMC Utrecht in the Netherlands under the INTRECOM consortium (UMC Utrecht plus the Technical University of Graz plus ABILITY plus CorTec, the German electrode manufacturer). The Dutch medical ethics committee MREC NedMec approved the study through the IMDD pathway on 26 May 2026. The clinical lead is Mariska Vansteensel at UMC Utrecht, who has led the Utrecht ALS BCI programme for over a decade. That chronic surgery has not yet been performed and is the study where ABILITY is aiming its stated mission of communication restoration in locked-in ALS. The two studies together define ABILITY’s dual-track strategy: acute intra-op characterisation in Munich, chronic implantation in Utrecht.

What is genuinely new, and what is not

ABILITY’s device has three properties that its marketing bundles together: fully implantable, sub-scalp, and battery-free. Inside BCI is not going to write that this combination is a first, because it is not. Motif Neurotech reached first-in-human with its magnetoelectric-powered DOT device in September 2023, and DOT is fully implantable, sub-cranial (positioned in the skull vault above the dura, never contacting the brain), and battery-free. Neuracle NEO, which received Chinese NMPA commercial approval on 13 March 2026 and had its first commercial implant at Shanghai Huashan Hospital on 13 July 2026, is fully implantable, epidural, and battery-free (wireless power delivery through an external magnetic coil). StairMed’s WRS02, which has now reached eighteen cumulative implants at Huashan since March 2025, is fully implantable, penetrating, and battery-free. Synchron’s Stentrode plus BrainPort architecture is fully implantable and largely battery-free in its cortical component. The batteryless implantable BCI is, in 2026, a category with multiple predecessors in humans.

What is genuinely new in ABILITY’s device is the method used to stream neural data across the intact scalp. The transcutaneous optical link uses an infrared laser to modulate the raw broadband neural signal, and the receiving external unit demodulates the light on the other side of the skin. ABILITY’s public claim is that this delivers approximately fifty megabits per second of continuous lossless neural telemetry, which is roughly an order of magnitude beyond the radio-frequency wireless bandwidths that current implantable BCIs achieve. The wearable powers the implant transcutaneously by inductive coupling, per the Wyss Center’s public description of the platform. The signal type is raw broadband neural data, streaming continuously rather than pre-processed on the implant, which shifts the decoding computation to an external unit. Whether that architecture holds up in chronic implantation, in real-world scalp thickness variation, and against the safety envelope that continuous infrared through skin will need to prove is the open technical question the ALS chronic trial will start to answer once it begins.

Who ABILITY Neurotech is

The company was formally spun out of the Wyss Center for Bio and Neuroengineering in Geneva in March 2025 with Rotem Kopel as chief executive and Craig Cook, formerly head of business development and licensing at the Wyss Center, appointed as chief business officer and co-founder in June 2025. Kopel has an electrical engineering background from Tel Aviv University with early telecommunications work at Texas Instruments before she transitioned into neuroscience, neuromonitoring device development, and technology-evaluation and investment roles that led into the Wyss Center technology translation programme. Craig Cook came in from the Wyss Center itself, where he had built the business-development function that has spun six neurotechnology companies out of the Geneva ecosystem. The company operates from Campus Biotech in Geneva, the multi-tenant research and translation cluster that also houses the Wyss Center, EPFL’s neurotech programmes, and Neurosoft Bioelectronics.

John Donoghue, one of the founding figures of the modern clinical brain-computer interface field through his role as a founding investigator of the BrainGate consortium at Brown University, was the Wyss Center’s inaugural director from 2015 to 2019, a role announced by Brown and EPFL in July 2014. The ABILITY architecture was conceived under his tenure. The Center was directed subsequently by Mary Tolikas and Erwin Böttinger, and is currently directed by Tracy Laabs, who took the role on 1 July 2026. Donoghue is not a founder of ABILITY; he is the institutional parent of the technology. The Wyss Center itself was founded in 2014 by the Swiss-American medical-device philanthropist Hansjörg Wyss, formerly chief executive of Synthes. The roughly fifty million dollars that were invested in the platform before the March 2025 spinout came from Wyss Center research capital, not from a traditional venture round. ABILITY’s post-spinout venture funding history has not been publicly disclosed in verifiable sources as of publication.

ABILITY’s regulatory posture is described by the company as a dual EU/US pathway. In the Netherlands, MREC NedMec’s IMDD approval of the Utrecht chronic ALS trial on 26 May 2026 is the European clearance in hand. In the United States, ABILITY has submitted for FDA Breakthrough Device Designation but has not yet received it as of publication. The German regulatory instrument governing the Munich intraoperative study is not named in ABILITY’s release. The company’s stated commercial arc is chronic home use for locked-in ALS, spinal cord injury, and stroke patients, on the same broad clinical thesis as Synchron, Neuralink, Paradromics, Precision Neuroscience, StairMed, and Neuracle, with the technical differentiator sitting in the optical telemetry layer rather than the electrode or the decoding software.

Where this sits in the European BCI cluster

Inside BCI has been tracking the European invasive brain-computer interface cohort as a market segment distinct from the US commercial cluster (Neuralink, Paradromics, Precision, Synchron) and the Chinese commercial cluster (Neuracle, NeuroXess, StairMed, plus BrainCo’s non-invasive positioning). The European cluster now includes ABILITY (Geneva), CorTec (Freiburg, Germany, INTRECOM partner and a supplier to ABILITY’s Utrecht chronic study), Onward Medical (Eindhoven, Netherlands, focused on spinal-cord stimulation for SCI rather than cortical BCI), and the academic-clinical BCI programmes at UMC Utrecht (Vansteensel), TU Graz (Müller-Putz), TUM (Meyer, Jacob), and EPFL/CHUV (Courtine, Bloch). The 21 July 2026 Munich first-in-human is the ABILITY entry into the same clinical-milestone cohort that Neuralink, Paradromics, Neuracle, StairMed, and Precision have been racing through 2026. Its regulatory pathway sits squarely inside the horizontal-regulator posture Inside BCI has identified as the European market’s frame: EU MDR plus GDPR governing at the classification and data-privacy level, national-level regulators (BfArM in Germany, Swissmedic in Switzerland, Dutch competent authority in the Netherlands) governing trial approvals per site.

What to watch

Watch when the Utrecht chronic ALS surgery actually happens. IMDD approval was granted on 26 May 2026 and Inside BCI covered it then. Two months later ABILITY has hit its intraoperative first-in-human at Munich but has not yet performed the chronic surgery that the entire commercial thesis rests on. Whether the chronic implantation lands in September 2026 as some reporting has suggested, or slips further, is the operational milestone that determines whether ABILITY moves from a proof-of-signal-quality company to a proof-of-clinical-utility company.

Watch how the fifty-megabit optical link performs against real scalp. Every claim in the 21 July release about ABILITY’s genuine novelty rests on the optical telemetry layer working at scale under chronic conditions. Whether a fifty-megabit continuous infrared beam sustains through the natural variation in skin thickness, hair density, sweat, movement, and daily wear across months of use is an engineering question the Utrecht chronic cohort will start to answer as it begins.

Watch the FDA Breakthrough Device Designation decision. ABILITY has submitted; a decision is pending. Whether the designation lands in the second half of 2026 or slips into 2027 is the US regulatory signal that would determine whether the company can pursue Early Feasibility Study filings in the American market on any parallel-track timeline with the Utrecht chronic work.

Watch whether the batteryless implantable BCI category consolidates on a shared technical vocabulary. Motif Neurotech’s DOT uses magnetoelectric wireless power. Neuracle NEO uses inductive coupling. StairMed’s WRS02 uses a wireless power supply integrated with communications. ABILITY uses inductive wireless power paired with optical data telemetry. Different companies making batteryless claims on structurally different architectures leaves the market vulnerable to loose superlative language and to genuine engineering distinctions being lost in press-release standardisation. Inside BCI will keep drawing the distinctions.

Sources

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