Freiburg, Germany, April 29, 2026 – CorTec GmbH today announced that the first participant in the University of Washington’s NIH-funded clinical trial of the Brain Interchange™ BCI system has successfully controlled a computer through thought alone — including a functional demonstration of the video game Pong — using the implanted device and cortical electrodes placed to support his motor recovery after stroke. This is the first reported instance worldwide in which a single fully implanted, wireless BCI system has demonstrated both brain stimulation for therapeutic stroke rehabilitation enhancement and thought-based computer control in the same patient using identical hardware.

During experimental brain-computer interface (BCI) sessions, the participant thinks of moving his arm, without any physical movement. The Brain Interchange™ implant records the corresponding cortical activity through its AirRay® electrodes placed on the brain surface and transmits it wirelessly to an external computer, where advanced algorithms decode the signals in real time and translate them into control commands. In a first demonstration, the participant was able to play the Pong video game through thought alone, within only about two hours after being introduced to the concept of controlling a computer with his mind.

A remarkable aspect of this study is that no modification to the implanted system was required. The Brain Interchange™ — the same fully implanted, wireless device delivering therapeutic cortical stimulation for stroke rehabilitation — performed the neural decoding using identical hardware and the same surgical placement.

“This is not a strategic pivot and not a new product,” said Dr. Frank Desiere, CEO of CorTec. “It is empirical proof of what we have been building for more than a decade. The same implant that helped the first participant regain motor function after stroke now also enables him to control a computer through thought alone. We know of no other fully implanted, wireless BCI platform technology worldwide that has demonstrated this dual clinical capability in a single patient.”

“Our wireless implant system delivers both therapeutic stimulation and real-time neural sensing and decoding using soft electrodes that are positioned on the brain surface,” said Dr. Martin Schuettler, CTO and Co-Founder of CorTec. “Without the need of penetrating brain tissue, our technology enables long-term safety to the patient.”

“For the first time, we are decoding real-time intent from a fully implanted BCI in an individual with stroke, and the signals are clear and consistent,” said Prof. Jeffrey Herron, Associate Professor of Neurological Surgery, University of Washington School of Medicine. “The same capability could ultimately serve patients with a wide range of neurological conditions.”

The demonstration took place after the first participant completed the rehabilitation program in an ongoing Early Feasibility Study (clinicaltrials.gov – ID NCT06506279), nine months post-device implantation. The study is co-led by Dr. Jeffrey G. Ojemann (University of Washington) and Dr. Steven C. Cramer (UCLA).

With this demonstration, Brain Interchange™ becomes the first fully implanted, wireless BCI system to deliver both therapeutic neuroplasticity induction and thought-based computer control in the same patient using identical hardware. As the clinical program continues to advance, CorTec is establishing Brain Interchange™ as a platform for a new generation of closed-loop neurotherapies, across stroke rehabilitation, BCI for paralysis, epilepsy, and treatment-resistant depression.

Go to the PDF download of this press release (English Version).

Go to the PDF download of this press release (German Version).

______________________________________________________________________________________

Contact:

CorTec GmbH
Carolina Remke – Head of Marketing
pr@cortec-neuro.com
www.cortec-neuro.com
Fon.: +49 (0)761 70 888 200

Media Support:

MC Services AG
Katja Arnold, Dr. Johanna Kobler, Kaja Skorka
cortec@mc-services.eu
Phone.: +49 (0)89- 210 228-0

______________________________________________________________________________________

Disclaimer: The research reported in this publication is supported by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health under Award Number UH3NS121565. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Forward-Looking Statements: This press release contains forward-looking statements regarding CorTec’s clinical development, regulatory strategy, and potential future applications of the Brain Interchange™ platform. Actual results may differ materially from those expressed or implied. The FDA Breakthrough Device Designation does not change the requirements for marketing authorization and does not guarantee approval.

Regulatory Disclaimer: The Brain Interchange™ is an investigational device and is not approved for commercial use in any indication. The computer control demonstration reported here illustrates platform versatility and does not fall within the scope of CorTec’s current FDA Breakthrough Device Designation, which covers therapeutic cortical stimulation for motor recovery after chronic ischemic stroke. CAUTION: Investigational device. Limited by Federal law to investigational use.

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About Brain Interchange™

Brain Interchange™ is CorTec’s proprietary brain-computer interface platform, a fully implantable, wireless, bidirectional closed-loop system designed for long-term neural sensing and adaptive cortical stimulation of the cortex and deep brain areas. The investigational device has demonstrated over 500 days of continuous, stable operation (Nature Scientific Data, 2025) and is currently the only BCI platform to hold an FDA Breakthrough Device Designation specifically for therapeutic motor rehabilitation after stroke. CorTec was granted TAP program participation by the US FDA for BCI-based stroke rehabilitation.

CorTec Clinical Program

The BCI demonstration of the Brain Interchange™ reported here is the first milestone towards advancing the Brain Interchange™ platform to the field of BCIs that help severely impaired patients to reintegrate into society by providing access to digital communication technology. It represents one of four pillars in CorTec’s clinical strategy, all built on the same Brain Interchange™ platform: stroke rehabilitation (ongoing UW Medicine study), epilepsy management (ongoing study with Mayo Clinic), BCI for paralysis and severe communication impairment, and treatment of depression (planned study with University Hospital Freiburg).
Learn more at www.brain-interchange.com or follow the Brain Interchange on LinkedIn.

About CorTec

CorTec GmbH is a clinical-stage neurotechnology company founded in 2010 in Freiburg, Germany. CorTec is developing Brain Interchange™, a fully implantable bidirectional BCI platform currently in FDA-authorized clinical evaluation in the United States. This makes CorTec the first and only European company to reach this stage. In April 2026, the device received both FDA Breakthrough Device Designation and admission to the FDA’s Total Product Life Cycle Advisory Program (TAP) for stroke motor rehabilitation.
Alongside its proprietary BCI platform, CorTec operates a revenue-generating contract development and manufacturing (CDMO) business for advanced implantable components, serving leading neurotechnology companies worldwide. This dual model supports CorTec’s platform development while scaling Europe’s most vertically integrated neurotechnology capability.
CorTec is backed by a syndicate of strategic investors including High-Tech Gründerfonds, KfW, K&SW Invest, LBBW Venture Capital, Mangold Invest, M-Invest and Santo Venture Capital GmbH.
Learn more at www.cortec-neuro.com or follow CorTec on LinkedIn.

Der Beitrag CorTec’s Brain Interchange™ BCI System Enables Stroke Patient to Control Computer with his Mind erschien zuerst auf CorTec | Thinking ahead – Innovation in Neurotechnology.

The FDA’s TAP Program is open to a limited number of breakthrough medical technologies. TAP provides companies with a dedicated FDA liaison, accelerated feedback on study design and regulatory strategy, and early engagement with payers and clinicians, including the Centers for Medicare & Medicaid Services (CMS). For CorTec, TAP acceptance means structured, end-to-end support from early clinical development through to market access and reimbursement. The program is designed to de-risk the path to approval and help establish reimbursement frameworks for entirely new therapy classes.

“TAP acceptance places CorTec at the forefront of a field dominated by U.S. players and confirms that European deep-tech innovation can compete at the highest level of global medtech development,” said Dr. Frank Desiere, CEO of CorTec. “Beyond the competitive significance, TAP as well as the recently received Breakthrough Device Designation highlight a strong regulatory momentum and mark the beginning of a structured path toward making Brain Interchange™ accessible to stroke patients worldwide. With closer FDA engagement and early interaction with payers, we can now build the clinical evidence and reimbursement framework for this entirely new therapy class.”

In parallel with these regulatory milestones, the Brain Interchange™ clinical study continues to advance. A further participant has been successfully implanted at Harborview Medical Center in Seattle, bringing the study cohort to three patients. The growing dataset will enable investigators to assess the system’s performance and therapeutic impact across a broader range of stroke profiles.

The potential of Brain Interchange™ was first demonstrated in the first study participant, who received the implant in July 2025. The system has since remained operational for nine months, with stable wireless performance and full functionality of both neural sensing and cortical stimulation maintained throughout.

“We now have three patients in the study, and each one adds a new dimension to what we can learn,” commented Jeffrey G. Ojemann, MD, Vice Chair and Professor of Neurological Surgery, University of Washington School of Medicine.

“Nine months of reliable, fully implanted brain sensing and stimulation without compromise in performance is far from a given in this field,” added Dr. Martin Schuettler, CTO and Co-Founder of CorTec. “We are now confident that the platform is ready for the demands of longer-term clinical use.”

With TAP acceptance and Breakthrough Device Designation secured within two weeks, and a growing patient cohort demonstrating long-term implant stability, CorTec’s Brain Interchange™ program is advancing on all fronts toward regulatory approval and broader clinical adoption in stroke motor rehabilitation.

Go to the PDF download of this press release (English Version).

Go to the PDF download of this press release (German Version).

______________________________________________________________________________________

Contact:

CorTec GmbH
Carolina Remke – Head of Marketing
pr@cortec-neuro.com
www.cortec-neuro.com
Fon.: +49 (0)761 70 888 200

Media Support:

MC Services AG
Katja Arnold, Dr. Johanna Kobler, Kaja Skorka
cortec@mc-services.eu
Phone.: +49 (0)89- 210 228-0

______________________________________________________________________________________

Disclaimer: The research reported in this publication is supported by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health under Award Number UH3NS121565. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

______________________________________________________________________________________

About Brain Interchange™

Brain Interchange™ is CorTec’s proprietary brain-computer interface platform, a fully implantable, wireless, bidirectional closed-loop system designed for long-term neural sensing and adaptive cortical stimulation of the cortex and deep brain areas. The investigational device has demonstrated over 500 days of continuous, stable operation (Nature Scientific Data, 2025) and is currently the only BCI platform to hold an FDA Breakthrough Device Designation specifically for therapeutic motor rehabilitation after stroke.
The platform’s closed-loop architecture enables an entirely new therapeutic category: real-time, adaptive neuromodulation tailored to each patient’s neural activity. Beyond stroke, Brain Interchange™ is being deployed in clinical and research programs addressing epilepsy (Mayo Clinic), treatment-resistant depression, and communication restoration for severely paralyzed patients (UMC Utrecht), establishing a multi-indication pipeline on a single, validated hardware platform.
Learn more at www.brain-interchange.com or follow the Brain Interchange on LinkedIn.

About CorTec

CorTec GmbH is a clinical stage neurotechnology company founded in 2010 in Freiburg, Germany. CorTec is developing Brain Interchange™, a fully implantable bidirectional BCI platform currently in FDA-authorized clinical evaluation in the United States. This makes CorTec the first and only European company to reach this stage. In April 2026, the device received both FDA Breakthrough Device Designation and admission to the FDA’s Total Product Life Cycle Advisory Program (TAP) for stroke motor rehabilitation.
Alongside its proprietary BCI platform, CorTec operates a revenue-generating contract development and manufacturing (CDMO) business for advanced implantable components, serving leading neurotechnology companies worldwide. This dual model supports CorTec’s platform development while scaling Europe’s most vertically integrated neurotechnology capability.
CorTec is backed by a syndicate of strategic investors including High-Tech Gründerfonds, KfW, K&SW Invest, LBBW Venture Capital, Mangold Invest, M-Invest and Santo Venture Capital GmbH.
Learn more at www.cortec-neuro.com or follow CorTec on LinkedIn.

Der Beitrag CorTec’s Brain Interchange Accepted into FDA Total Product Life Cycle Advisory Program (TAP) – Third patient successfully implanted at Harborview Medical Center as NIH-funded stroke trial advances erschien zuerst auf CorTec | Thinking ahead – Innovation in Neurotechnology.

The Breakthrough Device Designation is granted to medical technologies that have the potential to provide more effective treatment for life-threatening or irreversibly debilitating conditions. The program is designed to facilitate medical device development and review through prioritized and more interactive engagement with the FDA.

CorTec’s Brain Interchange system combines neural signal recording with adaptive stimulation in a closed-loop system. The platform is currently being evaluated in an FDA-approved IDE study at the University of Washington in Seattle, marking the first clinical investigation of a fully implantable, wireless BCI system for stroke rehabilitation in humans.

Stroke is the leading cause of acquired long-term disability in adults worldwide. Approximately 9 million ischemic strokes occur globally each year, with an estimated 1.7 million cases in the United States and Europe alone. Over 80% of stroke patients experience upper-limb impairment, and approximately 50% remain permanently disabled despite standard rehabilitation. For chronic stroke patients with moderate-to-severe motor deficits whose recovery has plateaued after conventional therapy, no approved implantable treatment exists today.

“Only a few BCI companies worldwide – including Neuralink, Synchron, or Blackrock Neurotech – have received Breakthrough Device Designation to date. Achieving this designation is a defining milestone for CorTec and underscores the potential of our Brain Interchange system to address the significant unmet need in stroke rehabilitation,” said Dr. Frank Desiere, CEO of CorTec. “Together with promising initial results from our first-in-human study in Seattle as well as additional long-term data published in Nature Scientific Data¹ demonstrating signal stability over 500 days, this designation provides strong momentum as we advance toward larger clinical trials. We believe CorTec occupies a unique position in the global BCI landscape, combining a fully implantable, bidirectional closed-loop platform with a therapeutic approach focused on restoring motor function after stroke.”

CorTec’s approach represents a distinct direction within the global BCI field. While a number of BCI systems have received Breakthrough Device Designation and are restricted to enable patient communication by controlling digital devices through thought, the Brain Interchange™ platform is being developed as a fully implantable, bidirectional device, enabling brain-based communication but also therapeutic neurostimulation, e.g. allowing to restore motor function after stroke. At present, no other BCI company worldwide holds a Breakthrough Device Designation for this indication.

“The Breakthrough Device Designation enables more frequent and structured engagement with the FDA as we advance our development program,” said Mara Assis, Head of Regulatory Affairs & Quality Management at CorTec. “Our regulatory strategy has followed a stepwise approach, from prior device clearance to IDE approval and successful human implantations. This designation will help accelerate planning of clinical trials and support the next regulatory milestones.”

CorTec continues to advance the Brain Interchange System as a flexible, adaptive platform with potential applications across multiple neurological conditions. In addition to the ongoing stroke rehabilitation study, the Brain Interchange platform is being evaluated for epilepsy, with further indications including paralysis and depression under development.

Go to the PDF download of this press release (English Version).

Go to the PDF download of this press release (German Version).

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[1] https://www.nature.com/articles/s41597-025-06359-w

Contact:

CorTec GmbH
Carolina Remke – Head of Marketing
pr@cortec-neuro.com
www.cortec-neuro.com
Fon.: +49 (0)761 70 888 200

Media Support:

MC Services AG
Katja Arnold, Dr. Johanna Kobler, Kaja Skorka
cortec@mc-services.eu
Phone.: +49 (0)89- 210 228-0

______________________________________________________________________________________

Disclaimer: The research reported in this publication is supported by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health under Award Number UH3NS121565. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Forward-Looking Statements: This press release contains forward-looking statements regarding CorTec’s regulatory strategy and clinical development plans. Actual results may differ materially. The FDA Breakthrough Device Designation does not change the requirements for marketing authorisation and does not guarantee approval.

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About Brain Interchange™

Brain Interchange™ is a proprietary brain-computer interface platform developed and owned by CorTec GmbH. The fully implantable, wireless investigational system is designed for long-term neural recording and adaptive stimulation, allowing bi-directional brain-based communication for the severely paralyzed, and also enabling the discovery and development of next-generation closed-loop neuromodulation therapies across a range of neurological and psychiatric conditions.

Learn more at www.brain-interchange.com or follow the Brain Interchange on LinkedIn.

Clinical Evidence Underpinning the Designation

The Breakthrough Device Designation is supported by a robust regulatory and clinical development pathway. Following FDA 510(k) clearance for cortical mapping electrodes in 2019, CorTec demonstrated the first successful beta-phase–locked closed-loop stimulation in a 2023 feasibility study at the University of Washington, Seattle, USA.

After Investigational Device Exemption (IDE) approval in 2024, the first two patients were implanted at Harborview Medical Center in Seattle in July 2025 and February 2026, with the first patient showing meaningful neurological improvement, including recovery of upper-limb motor function that had previously plateaued with conventional therapy.

The Brain Interchange system has demonstrated more than 500 days of continuous stability, as reported in a peer-reviewed publication in Nature Scientific Data1, and is also being evaluated in an FDA-registered epilepsy study at Mayo Clinic, supporting its multi-indication platform design.

Der Beitrag CorTec Receives FDA Breakthrough Device Designation for Its Brain Interchange System in Stroke Rehabilitation — the First BCI Worldwide Designated for Stroke Motor Rehabilitation erschien zuerst auf CorTec | Thinking ahead – Innovation in Neurotechnology.

Second implantation at Harborview Medical Center in Seattle marks continued progress in the FDA-approved study informed by promising results from the first participant.

Freiburg, Germany, February 10, 2026 – CorTec GmbH, a pioneer in active implantable medical technologies, today announced the successful second implantation of its proprietary BrainComputer Interface (BCI) system, the Brain Interchange™, in an FDA-approved clinical trial involving stroke patients at Harborview Medical Center, a major site of UW Medicine. The implantation follows encouraging neurological gains observed in the study’s first participant, whose rehabilitation progress has strengthened confidence in CorTec’s fully implantable platform for stroke recovery. This represents another key milestone in the joint effort to evaluate CorTec’s fully implantable closed-loop BCI platform, developed and manufactured entirely in Germany, for  therapeutic applications in neurological disorders.

This second procedure took place in early February at Harborview Medical Center (Seattle) under an  FDA Investigational Device Exemption (IDE). Led by Principal Investigator Jeffrey G. Ojemann, MD, from the University of Washington School of Medicine in Seattle and Co PI Professor Steven C. Cramer  from the University of California, Los Angeles, the trial gathers initial safety data and evaluates whether direct cortical electrical stimulation can enhance upper-limb motor recovery in stroke patients. The study is funded by the National Institutes of Health (NIH).

“The procedure went smoothly, and the participant is recovering as expected,” said Dr. Martin Schuettler, CTO of CorTec. “Having supported the implantation of our BCI system on site for a second  time, it is inspiring to see how seamlessly our teams at CorTec and UW Medicine work together. This kind of clinical and technical research collaboration is essential to deliver these procedures safely. With each step, we gain important insights that strengthen our confidence in the future of this technology.”

Jeffrey G. Ojemann, MD, Vice Chair and Professor of Neurological Surgery, University of  Washington School of Medicine, commented: “We are very encouraged by the outcome of this second implantation and pleased with the participant’s steady recovery. The notable rehabilitation progress and meaningful neurological gains observed in our first study participant using CorTec’s BCI system has led us to this next phase. Each procedure helps us refine safe clinical practices for this emerging neurotechnology and explore its potential to improve outcomes for patients in the future.”

With two successful surgeries completed at Harborview Medical Center, the study will enroll further participants and continue to gather neural and behavioral data. CorTec’s implantable closed-loop BCI platform is designed to continuously record and interpret neural activity with high fidelity and deliver targeted electrical stimulation in real time. This novel approach enables highly precise and personalized neurotherapeutic interventions by enhancing neuroplasticity – the brain’s ability to reorganize neural networks – and explores whether lost functions can be relearned, potentially accelerating and improving patient rehabilitation through the integration of engineering, neurophysiology, and machine learning.

“This second implantation is a milestone for our technology and the progress of our clinical program,” said Dr. Frank Desiere, CEO of CorTec. “More importantly, it brings us closer to realizing the potential of a new class of neurotherapeutic solutions that could meaningfully improve outcomes for patients with neurological conditions and lays the groundwork for the next phase of clinical and technology development.”

CorTec will continue to share updates as the study progresses, and additional insights emerge.

Go to the PDF download of this press release (English Version).

Go to the PDF download of this press release (German Version).

 

Contact:

CorTec GmbH
Carolina Remke – Head of Marketing
pr@cortec-neuro.com
www.cortec-neuro.com
Fon.: +49 (0)761 70 888 200

Media Support:

MC Services AG
Katja Arnold, Dr. Johanna Kobler, Kaja Skorka
cortec@mc-services.eu
Phone.: +49 (0)89- 210 228-0

______________________________________________________________________________________
Disclaimer: The research reported in this publication is supported by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health under Award Number UH3NS121565. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
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Der Beitrag CorTec Announces Successful Second Human Implantation of Its Brain-Computer Interface (BCI) System erschien zuerst auf CorTec | Thinking ahead – Innovation in Neurotechnology.

Early in the year, we entered into a strategic partnership with Heraeus Medevio. Together combine our strengths in development, prototyping, small series production and large series production.  This way both companies create scalable, high-quality solutions, ensure seamless transition from development to production and bring more innovations to our customer.

Another important step was welcoming Frank Desiere as our new CEO, who together with our leadership team is shaping the next chapter of CorTec. Looking ahead, this leadership team is laying the groundwork for scaling our impact and advancing bold ambitions in neurotechnology.

The biggest highlight of the year was undoubtedly the First in Human implantation of our Brain Interchange System, a historic achievement not only for our company but also for the field of neurotechnology. This milestone demonstrates how close we are to bringing our technology into clinical application and how impactful it can be for the future of medicine. In December 2025 the University of Washington shared the inspiring journey of the patient Matt, who received our Brain Interchange System in July. Movements that were restricted by a stroke are returning thanks to our technology.

Beyond this breakthrough, we experienced many other memorable moments: our CTO Martin Schuettler delivered an inspiring TEDx Talk in Freiburg, sharing the possibility of our technology. Under the Titel “Brain Implants – Blessing for Patients – Superpower for all?” he demonstrated that these implants not only help people with neurological disorders, but also can have applications outside the field of medicine.

We showcased our innovations at major international conferences and trade fairs such as SfN, MD&M, and Compamed, where we connected with partners, experts, and visionaries from around the world. Under the leadership of our COO Oliver Bärtl, numerous exciting projects took shape, laying the foundation for what is to come in 2026.

Yet above all, the greatest highlight remains our amazing team. With passion, creativity, and dedication, you made 2025 a year we will never forget. A huge THANK YOU also goes out to our customers and partners – with your trust, collaboration, and support, we reached one of the most important milestones in company history. Without you, none of this would have been possible. 🙌

Here’s to a 2026 full of smart solutions, exciting collaborations, and perhaps a surprise or two that we already have in mind. Together, we are shaping the future of neurotechnology.

Thank you for an unforgettable year and cheers to a successful 2026! 🎉

Link to Press Releases:

Strategic Partnership Medevio: https://cortec-neuro.com/marking-a-new-era-in-medical-device-development-cortec-announces-strategic-partnership-with-us-based-heraeus-medevio/

Frank joins leadership Team at CorTec: https://cortec-neuro.com/cortec-welcomes-dr-frank-desiere-as-chief-executive-officer/

First in Human Implantation: https://cortec-neuro.com/first-human-implantation-of-a-bci-made-in-germany/

TedXTalk by Martin: https://cortec-neuro.com/a-breakthrough-after-a-stroke/

UW Update on Patient Matt: https://cortec-neuro.com/a-breakthrough-after-a-stroke/

Der Beitrag 2025 in Review erschien zuerst auf CorTec | Thinking ahead – Innovation in Neurotechnology.

After two strokes, Matt Kidd’s left side was almost completely paralyzed.

Years of therapy brought little progress, until he became part of a clinical trial at the University of Washington (UW).

In this study, researchers are focusing on a novel brain implant developed in close collaboration with CorTec. Two thin silicone foils with electrodes were placed directly on the affected region of the brain. During rehabilitation, they emitted targeted electrical impulses designed to stimulate nerve cells to work together again and create new connections in the brain.

After just a few weeks, Matt was able to perform simple movements again – holding a cup, unscrewing a nut, closing the shower curtain. “I’m finding myself not even realizing I’m doing things [I couldn’t before],” he says in interview with UW.

For the doctors at UW, this progress is an encouraging sign. For CorTec, it is also proof that our technology can make a decisive contribution to opening up new perspectives for people after a stroke.

Visit the University Washington Newsroom to read the full article here: https://newsroom.uw.edu/blog/in-brain-implant-study-patient-breaks-through-dead-end 

Or go directly to the YouTube video: https://www.youtube.com/watch?v=P9sVMHyq3-E

Der Beitrag A Breakthrough after a Stroke erschien zuerst auf CorTec | Thinking ahead – Innovation in Neurotechnology.

Freiburg, Germany, July 29, 2025 – CorTec GmbH, a pioneer in active implantable medical technologies, today announced the first human implantation of its proprietary BCI system, Brain  Interchange™, marking a pivotal advance in translating laboratory research into real-world clinical applications.

The procedure took place in late July at Harborview Medical Center (Seattle) under an FDA  Investigational Device Exemption (IDE). Led by Principal Investigator Jeffrey G. Ojemann, MD, from the University of Washington School of Medicine in Seattle and Co PI Professor Steven C. Cramer from the University of California, Los Angeles, this trial will gather initial safety data and evaluate whether direct cortical electrical stimulation can enhance upper-limb motor recovery in stroke patients. The study is funded by the National Institutes of Health (NIH).

“We’re thrilled to share that the implantation procedure was a success and, most importantly, the patient is in good condition and recovering well from the surgery. We’re incredibly grateful for this initial outcome in our first study participant. Both the therapeutic strategy and the technology we are using are entirely novel. While we proceed with careful optimism, the potential benefits for patients are promising,” commented Jeffrey G. Ojemann, MD, Vice Chair and Professor of Neurological Surgery, University of Washington School of Medicine.

This novel approach offers highly precise and personalized treatment for neurological conditions. The implant system continuously records brain activity, instantly interpreting signals and delivering targeted electrical stimulation in real time to enhance neuroplasticity, the brain’s ability to reorganize neural networks. The study explores whether this can help the brain relearn lost functions, thereby accelerating and improving rehabilitation of patients.

“The first implantation of our BCI marks a milestone for European medical neurotechnology and underscores CorTec’s emergence as Germany’s first implantable BCI developer, ready to compete on the global stage,” said Dr. Frank Desiere, CEO of CorTec. “Building on our extensive experience in developing advanced components and active implantable systems, our proprietary cutting-edge BCI system is now entering human clinical testing, aiming to help people affected by neurological diseases recover lost function and enhance their quality of life. We are proud of this new era of innovation and are committed to expanding the possibilities of neurotechnology to improve outcomes for patients.”

Today in the US and Europe alone, 1.7 million people annually have a stroke that frequently involves loss of upper limb function. While physical therapy alone can help many patients regain function, it is sometimes not sufficient. Patients with a BCI may benefit from neuroplasticity-inducing stimulation during their rehabilitation. Regaining control of their upper limbs would enable patients to be more independent and have a better quality of life.

“This breakthrough opens the door to therapies that were once unimaginable,” added Dr. Martin Schuettler, CTO of CorTec. “For the first time, our BCI system connects wirelessly to external hardware – no cables, no physical links. This approach is part of the transformation of neurological therapies worldwide, built on a technology platform that can be tailored to multiple neurological conditions, delivering real-time, patient-specific treatment. I’m incredibly proud of our team and our partners, in particular Jeffrey G. Ojemann and Jeffrey Herron of UW Medicine, who turned years of research into real hope for patients.

Go to the PDF download of this press release (English Version).

Go to the PDF download of this press release (German Version).

Contact:

CorTec GmbH
Carolina Remke – Head of Marketing
pr@cortec-neuro.com
www.cortec-neuro.com
Fon.: +49 (0)761 70 888 200

Media Support:

MC Services AG
Katja Arnold, Dr. Johanna Kobler, Kaja Skorka
cortec@mc-services.eu
Phone.: +49 (0)89- 210 228-0

______________________________________________________________________________________
Disclaimer: The research reported in this publication is supported by the National Institute Of Neurological Disorders And Stroke of the National Institutes of Health under Award Number UH3NS121565. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
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Der Beitrag CorTec Announces Neurotech Milestone: First Human Implantation of a Brain-Computer Interface made in Germany erschien zuerst auf CorTec | Thinking ahead – Innovation in Neurotechnology.

Der Beitrag Bernstein-CorTec-Award 2025: Call for Nominations is open erschien zuerst auf CorTec | Thinking ahead – Innovation in Neurotechnology.

CorTec GmbH, a pioneer in active implantable technologies and Brain-Computer Interface (BCI) systems, is pleased to announce the appointment of Dr. Frank Desiere as its new Chief Executive Officer (CEO). This significant leadership milestone highlights CorTec’s commitment to driving innovation and growth in the rapidly evolving Neurotechnology sector.

The appointment of Dr. Frank Desiere as new CEO marks a pivotal moment for CorTec, leveraging his vast experience to expand its impact in the rapidly growing Neurotech industry. Dr. Oliver Baertl, in the role of COO, will be focusing on leading the component business for active implantable technologies and ensuring operational excellence. CTO Dr. Martin Schuettler, will continue to lead technological advancements and sustained innovation. The strengthened leadership team displays CorTec’s dedication to addressing the dynamic needs of the medical device sector while unlocking new opportunities within the field of Brain-Computer Interfaces.

Introducing Dr. Frank Desiere: A Visionary Leader

Dr. Frank Desiere brings a wealth of experience and a proven track record in the Medical Device and Life Science industry. Holding a PhD in Life Sciences from ETH Zuerich and an MBA from IMD Lausanne, Dr. Desiere has held senior leadership roles at global organizations, including Roche, where he spearheaded business development initiatives and introduced groundbreaking MedTech innovations and digital health solutions. His expertise spans fostering strategic partnerships, driving technology transfer, and leading digital transformation – all central capabilities that align perfectly with CorTec’s vision for shaping the future of Neurotechnology.

“I am thrilled to join CorTec at such an exciting time,” said Dr. Frank Desiere. “The company is at the forefront of active implantable technologies and systems and has a bold vision for the future.
Together with this talented team, we will achieve remarkable breakthroughs, strengthen our position as a technology leader, and unlock new growth opportunities.”

A Unified Vision for the Future

Dr. Oliver Baertl expressed his enthusiasm: “We will be able to further advance our active implantable technologies within the strategic partnership with Heraeus Medevio, while at the same time positioning CorTec in the rapidly growing BCI segment. I am excited to work with Frank, Martin, and the team to drive CorTec’s strategy forward and to empower our partners and customers to realize medical device innovations.”

Commenting on the new leadership structure, Chairman of the Board, Dr. Christoph Mangold adds: “The onboarding of Dr. Frank Desiere as CEO and the composition of a strong leadership team is a clear statement about CorTec’s ambitious plans in the market. This will unlock new strategic opportunities and drive groundbreaking innovation in both the component and BCI segments.”

CorTec is now well positioned to become the Development and Manufacturing partner of choice for implantable technologies and to drive exceptional growth.

Go to the PDF download of this press release (English Version).

Go to the PDF download of this press release (German Version).

Media Contact:

Carolina Remke – Head of Marketing
pr@cortec-neuro.com
www.cortec-neuro.com

Fon.: +49 (0)761 70 888 200

Der Beitrag CorTec Welcomes Dr. Frank Desiere as Chief Executive Officer erschien zuerst auf CorTec | Thinking ahead – Innovation in Neurotechnology.

The partnership between Medevio and CorTec combines Medevio’s advanced production capabilities with CorTec’s expertise in the development, prototyping and small series production for nerve cuff and paddle electrodes, capable of sensing and stimulation. Together, they will address the neuromodulation market’s growing demand for innovative, high-quality implantable components. Medevio will refer early-phase complex prototype development projects for cuff and paddle electrodes to CorTec, while CorTec will leverage Medevio’s exclusive capabilities to scale production efficiently for high-volume manufacturing of such electrodes.

This unique synergy reinforces both companies’ commitment to providing unparalleled quality, expertise, and customer support in advancing medical innovation.

“We are thrilled to partner with a company as innovative and driven as CorTec,” said Toiné Warren, Executive Vice President, Commercial at Heraeus Medevio. “It is an opportunity to leverage each other’s expertise to provide a wider breadth of offerings to meet our customers’ needs in the neuromodulation space. This partnership with CorTec to exclusively manufacture their products positions us to bring forth the future of implantable technologies for our customers, driving our vision to improve 100 million lives every year forward.”

CorTec’s CEO, Dr. Oliver Baertl, shared the enthusiasm: “Partnering with Heraeus Medevio marks a decisive step in our mission to make the impossible possible for our customers. This cooperation allows Heraeus Medevio and us to combine our strengths. We can now ensure that our customers, regardless of size and location, have access to a complete suite of implantable solutions from prototype to large-scale production, all backed by the highest standards of quality and support.”

CTO Dr. Martin Schuettler adds, “This collaboration allows us to extend our engineering expertise across oceans, enhancing our offering with Heraeus Medevio’s large-scale production capabilities. Together, we’re not only bridging continents but also advancing the field of implantable technology as we will be able to deliver next-generation implantable components from the initial start of engineering up to the final series production. Our partnership and the cross-integration of technologies minimizes product development risks for our customers!”

Looking ahead, Medevio is expected to begin high-volume manufacturing of nerve cuff and paddle electrodes based on CorTec’s proprietary laser-micromachining technology by the end of 2025.

Go to the PDF download of this press release (English Version).

Go to the PDF download of this press release (German Version).

Media Contact:

Carolina Remke – Head of Marketing
pr@cortec-neuro.com
www.cortec-neuro.com

Fon.: +49 (0)761 70 888 200

Der Beitrag Marking a New Era in Medical Device Development – CorTec Announces Strategic Partnership with US-based Heraeus Medevio erschien zuerst auf CorTec | Thinking ahead – Innovation in Neurotechnology.