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.

The Bernstein-CorTec Prize honors outstanding scientific achievements in doctoral and master’s theses in the field of computational neuroscience and neurotechnology. The prize is awarded annually, alternating between doctoral and master’s theses. In the year 2024, the prize is awarded to doctoral theses.

The two award-winning doctoral theses deal with the following topics:

1. Enya Paschen: Mesial temporal lobe epilepsy (MTLE) is the most common focal epilepsy in adults. Despite advances in pharmacological, surgical and neuromodulatory treatment strategies, many patients do not achieve adequate control of their epileptic seizures. Enya Paschen’s dissertation focussed on the development of new neuromodulation techniques and their effects on seizure activity and cognitive functions in MTLE. She found that low-frequency stimulation (LFS, optogeneric or electrical) in the hippocampus suppresses seizure onset and does not impair core hippocampal functions such as learning, spatial navigation and memory. She was thus able to present LFS as an effective stimulation protocol and an alternative therapeutic approach for treatment-resistant MTLE patients.

2. Eric Klein: His thesis describes the first functional optical cochlear implant (oCI) based on integrated μLEDs successfully applied in vivo. In order to integrate the highest possible number of individually addressable μLEDs, he evaluated different routing schemes, implementing single- and multi-layer metallization. Based on conclusions drawn during the intense evaluation of the first oCI generation (oCI-1), a new single layer interconnection approach was developed, characterized, and found to be more efficient than the commonly used multi-layer based multiplexing scheme for LED arrays. Based on in vivo tests performed in cooperation with project partners, he concluded that a single μLED is capable of efficiently stimulating optogenetically modified nerve cells in the cochlea. It was further demonstrated that the μLED arrays of the oCIs reduce the spectral spread, compared to a clinical style electrical cochlear implant, by up to 5 octaves, thereby providing much higher frequency resolution to the cochlear implant patients.

Enya Paschen works now as Behavioural Pharmacology & EEG Team Leader with Ulysses Neuroscience Limited, a private Irish Research and Development Organisation. Eric Klein is now pursuing his scientific interests as a postdoc in the Inst. for Microystems Engineering (IMTEK) at the University of Freiburg.

Award Lectures

Both awardees will present their research in an Extra Bernstein Seminar on January 14 at 17:15 hours in the Bernstein Center Freiburg. Make sure to already mark your calendars for the upcoming event.

For more information please visit the Bernstein-Center Website

Der Beitrag Bernstein-CorTec Award 2024 goes to two young researchers erschien zuerst auf CorTec | Thinking ahead – Innovation in Neurotechnology.

IRB approval is a critical step in the clinical research process, especially for studies involving human subjects. While FDA approval ensures the safety and technical readiness of the device being studied, the IRB provides an essential layer of oversight to safeguard the ethical conduct of the research. The IRB’s review takes into account the specific local context of the research site, including the population being studied and the resources available, to ensure participant safety. This local oversight is crucial, as it tailors the ethical review process to the unique circumstances of each study, beyond the federal standards.

“Securing FDA approval for our IDE study(1) was a thorough process that involved the submission of extensive documentation from both our team at the University of Washington and the device manufacturer, CorTec,” said Dr. Jeffrey Herron, Assistant Professor at the University of Washington and co-investigator on the NIH-funded study(2). “The FDA’s evaluation focused on the study protocol, hazard analysis, and the device design to ensure readiness for human implantation. Achieving this IDE approval was a critical milestone, and with the following IRB approval, we are now prepared to move forward with participant recruitment.”

According to Dr. Martin Schuettler, CorTec’s CTO, the Brain Interchange System‘s closed-loop functionality is a groundbreaking achievement that opens new avenues for highly individualized treatments. “I am incredibly proud of this milestone,” Dr. Schuettler expressed. “Our system enables a seamless exchange of information between biology and technology, which is why we named it the CorTec Brain Interchange. With this system, we are not only providing the critical technological tools needed to advance new therapies but also shaping the future of brain-computer interfaces and paving the way for future therapy discoveries.”

CorTec is collaborating with leading experts in the U.S. to further the development of innovative therapies using the Brain Interchange System. The first Investigational Device Exemption (IDE) study will be conducted in collaboration with Professor Jeffrey G. Ojemann from the University of Washington School of Medicine in Seattle and Professor Steven C. Cramer from the University of California, Los Angeles. Funded by the U.S. National Institutes of Health (NIH), this consortium aims to gather initial safety data and develop novel therapeutic rehabilitation approaches for upper limb impairment in stroke patients through direct cortical electrical stimulation delivered by the Brain Interchange System(2).

Patient enrollment and the first implantation of the neural interfacing system are scheduled for the fourth quarter of 2024, marking the beginning of a new chapter in stroke rehabilitation research.

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

______________________________________________________________________________________
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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References:
[1] IDE Application reference G230003/A001
[2] NIH Project 1UH3NS121565-01A1: ” Motor Recovery through Plasticity-Inducing Cortical Stimulation”, in response to RFA-NS-18-023: https://reporter.nih.gov/search/-xvTvG85Ukm-KXyunAWaJw/project-details/10357993

Der Beitrag Next Important Milestone Reached for First-in-Human Implantation of the CorTec Brain Interchange System as a Therapeutic Brain-Computer Interface erschien zuerst auf CorTec | Thinking ahead – Innovation in Neurotechnology.