Arnau Espinosa Manzanal, MSc

Co-Founder, ABILITY Neurotech | Implantable BCI · Class III · EU MDR · FDA | Gene Therapy & ATMP | Co-Founder, Save Sight Now Europe

Geneva, Geneva, Switzerland

About

15 years building neural interfaces — from EEG-based BCI research to a fully implantable 128-channel cortical recording system now entering clinical trials. At the Wyss Center for Bio and Neuroengineering and now ABILITY Neurotech, I have been the link between engineering and the real world: regulatory strategy, clinical translation, and getting a Class III implantable device from a research prototype to human use. My work has spanned preclinical programs in NHP and sheep, clinical trials in stroke rehabilitation and locked-in syndrome (including the first locked-in ALS patient to communicate using intracortical signals, published in Nature Communications 2022), and the regulatory pathway for an implantable broadband cortical recording system under EU MDR and FDA frameworks. In parallel, my daughter Bruna was diagnosed with Usher syndrome type 1B at nine months old — a rare inherited condition causing congenital deafness and progressive blindness from retinitis pigmentosa. I co-founded Save Sight Now Europe to accelerate treatments for USH1B, and that pulled me deep into a second world: AAV gene therapy, ATMP regulation, rare disease clinical trial design. Four consecutive years at ARVO. Euretina. Conversations with the researchers and companies running the most important programmes. Understanding — from the inside, as a father — what it takes to move a gene therapy from a lab to a patient who actually needs it, and why so many have failed not on science but on access, pricing, and design. I work at the intersection of implantable neurotechnology and biological therapies. I believe the most important medical device companies of the next decade will live in that intersection — combining precise neural interfaces with cell-type-specific biological interventions to treat conditions that neither approach can address alone.

Experience

  • Co-Founder & Director of Hardware at ABILITY Neurotech at ABILITY Neurotech
    Mar 2025 - Present · 1 yr 5 mos

    Co-founded ABILITY Neurotech SA following 7 years of R&D at the Wyss Center for Bio and Neuroengineering, Geneva. ABILITY is a fully implantable 128-channel broadband ECoG brain-computer interface for people with severe paralysis (ALS, spinal cord injury, brainstem stroke) — a hermetically sealed, battery-free implant paired with a body-worn external unit for wireless power and data. Spun out of the Wyss Center in 2025 after $50M+ in R&D investment and 8 years of development. As Director of Hardware, I lead hardware development of the implantable and wearable system: - Implant hardware architecture and integration: 128-ch ECoG recording front-end, optical data uplink (50 Mbit/s), inductive wireless power (6.78 MHz), hermetic titanium housing with cermet feedthrough (140+ conductors) - Hardware engineering team leadership across electronics, mechanical, packaging, and system integration - Hardware design under medical device standards: IEC 60601, ISO 14971 hardware risk analysis, ISO 13485 design controls; hardware interfaces to IEC 62304-controlled software - Verification and validation strategy for hardware subsystems on the Class III qualification path - Cross-functional collaboration with regulatory, clinical, software, and quality teams; technical input into investor and partner communications

  • Co-Founder and Board of Directors at Save Sight Now Europe
    Oct 2022 - Present · 3 yrs 10 mos

    Co-founded Save Sight Now Europe following my daughter Bruna's diagnosis with Usher syndrome type 1B — a rare inherited condition causing congenital deafness and progressive blindness from retinitis pigmentosa. The association funds and advocates for research to accelerate treatments for USH1B. Affiliated with Pro Raris (Swiss rare disease network) and EURORDIS. My involvement goes beyond advocacy — through this work I have built genuine professional expertise in: - AAV gene therapy pipeline and clinical development for inherited retinal disease - ATMP (Advanced Therapy Medicinal Product) regulatory framework under EMA/CAT - Rare disease clinical trial design, patient registry development, and biomarker identification - Gene therapy commercial landscape: what has worked, what has failed, and why Four consecutive years at ARVO (Association for Research in Vision and Ophthalmology). Euretina. Active engagement with Biotech/ pharma, Foundation Fighting Blindness, RARE-X, and leading academic groups in gene and cell therapy for retinal dystrophy.

  • Wyss Center for Bio and Neuroengineering ()
    • Senior Engineering Manager
      Jan 2024 - May 2025 · 1 yr 5 mos

      7 years as a core member of the AVANCER and ABILITY project — the Wyss Center's flagship programme to develop a fully implantable, wireless, broadband brain-computer interface for clinical use in severe paralysis (ALS, stroke). ABILITY device development Systems engineering for the ABILITY system — implant + body-worn external unit, 128-ch ECoG, inductive wireless power (6.78 MHz), 50 Mbit/s optical data uplink, hermetic titanium housing with cermet feedthrough. KIAP — Communication for completely locked-in patients Enabled verbal communication in completely locked-in ALS patients using intracortical Utah array signals and auditory neurofeedback. Nature Communications, 2022 — first demonstration of reliable communication in a completely locked-in patient. AVANCER — Stroke upper-limb rehabilitation Co-investigator on the AVANCER trial: personalised, cumulative neurotechnology therapy for severe chronic stroke. Published in Med (Cell Press, 2023) and Frontiers in Human Neuroscience. Preclinical programmes Chronic implant experience in NHP(Utah array) and sheep (Utah array + ECoG). Multi-species track record. Regulatory and quality IEC 62304, ISO 14971, ISO 13485 compliance for ABILITY. Investigational device submissions under EU MDR Article 62 and FDA regulatory engagement.

    • Project Manager
      May 2019 - Feb 2024 · 4 yrs 10 mos

    • Project Lead
      Jun 2022 - May 2023 · 1 yr

  • Business Office Manager at g.tec medical engineering Spain S.L.
    Jul 2013 - May 2018 · 4 yrs 11 mos

    As founding manager of g.tec's Barcelona office my responsibilities included but were not limited to: - Developing strategic operating plans to implement the brand in Barcelona and accomplish board objectives - Wrote and managed EU FP7/H2020 research grants (BackHome, DeNeCor, ComaWare, NeuroGraphene, Astonish) - Representing the company to major customer and professional associations - Directing strategy of the brand towards profitable growth and operation of the company. - Planning financial operations, writing research grants and developing necessary financial control systems - Developing and ensuring that company policy is implemented - Building and maintaining an effective team - Assuming full accountability to the board for all company operations - Creating a Neurotechnology center for stroke and disorders of consciousness patients - In charge of Good Manufacturing Practice regulations - Business Process Management implementation

  • g.tec - GUGER TECHNOLOGIES (6 yrs 4 mos)
    • Area Sales Representative
      Mar 2012 - May 2018 · 6 yrs 3 mos

      My responsibilities included: - Identifying sales opportunities in Spain, Portugal and South of France - Creating and executing marketing strategic plans - Providing direct customer service - Establishing, developing and maintaining positive business and customer relationships

    • Software developer
      Feb 2012 - May 2018 · 6 yrs 4 mos

      - Programmer: Brain Computer Interfaces and real-time biosignal processing - Stroke and minimum consciousness therapies development

    • Project Manager
      Feb 2012 - May 2018 · 6 yrs 4 mos

      For the last 5 year I´ve been in charge of development and management of several national and international projects: As BackHome, DeNeCor, ComaWare, NeuroGraphene or Astonish among others. My responsibilities included: - Writing project proposals and DOWs for the grant calls - Project activity and resources planning - Developing schedules and time estimating to reach the project goals with excellency and on time - Monitoring and reporting the project progress, when necessary to the European Commission - Analyzing and managing risk and project issues