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.

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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).

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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.

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.

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).

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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).

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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.

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).

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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.

With the Brain Interchange System, CorTec aims to provide a fully implantable closed-loop Brain-Computer Interface (BCI) to clinicians for the investigation of therapies. According to CorTec CTO Dr. Martin Schuettler, this closed-loop functionality provides new possibilities for highly individualized treatments. He states, “The system is capable of interchanging information between biology and technology, between brain and computer. That’s why we call it CorTec Brain Interchange. With our system, we are providing the technological tools that are needed to develop new therapies and brain-computer interface applications.”

With FDA clearance secured, CorTec joins forces with partners in the USA to continue the development of novel therapies. The first IDE study¹ involving the Brain Interchange System will be conducted in collaboration with one of the world’s leaders in the field, principle investigator professor Jeffrey G. Ojemann from the University of Washington School of Medicine in Seattle as well as Prof. Steven C. Cramer from the University of California Los Angeles and their respective teams. With funding by the US-American National Institutes of Health (NIH)², the consortium aims at obtaining initial first-in-human safety data and at the development and evaluation of novel therapeutical rehabilitation approaches for upper limb impairment in stroke patients via direct cortical electrical stimulation delivered by the Brain Interchange System. Enrollment of patients and the first implantation of the neural interfacing system are schedule for the third quarter of 2024.

Assistant Professor Dr. Jeffrey Herron from University of Washington is a co-investigator of the NIH funded study and the engineering lead on the project. He explains the importance of the FDA approval for the upcoming IDE study: “In the United States, all studies involving devices which pose a significant risk require the approval by both the FDA and institutional review board prior to participant recruitment. The FDA review of Investigational Device Exemptions for significant risk device studies is a rigorous process involving the submission of extensive documentation by both UW, the research site, and CorTec, the device manufacturer. The FDA makes their determination for a specific study based upon the details of the study protocol, an extensive hazard analysis, and an in-depth evaluation of the manufacturer’s documents pertaining to the design and testing of the device to ensure that it will perform as needed for the study. The fact that UW and CorTec have now received this IDE approval from FDA is an absolutely critical milestone demonstrating a readiness to proceed towards participant recruitment for this study, pending local UW IRB approval.”

CorTec’s CEO, Dr. Oliver Baertl adds, “We are very excited about the feedback from the FDA! This was an important first step for CorTec to support clinical research in the fast growing neuromodulation and Brain Computer Interface space. We foresee many more studies with our device. The first in human use will be the next milestone for our technology and our company.”

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 FDA approves Investigational Device Exemption for Early Feasibility Study for rehabilitation of stroke patients using CorTec’s Closed-Loop Brain Interchange implant system. erschien zuerst auf CorTec | Thinking ahead – Innovation in Neurotechnology.

As it prepares for the next stage of its groundbreaking device for the treatment of stroke, CorTec GmbH, a pioneering German medical technology company, is poised to make significant strides in the field of neurotechnology.

CorTec is eager to highlight its own advancements in the field, following Neuralink’s recent announcement of the first human implantation of its implantable chip. The company is proud to announce that its cutting-edge Brain Interchange System will enter the first phase of human testing in the coming months. With this significant milestone, CorTec aims to demonstrate its commitment to innovation and improvement of existing therapies.

The Brain Interchange System represents a major leap forward in implanted neurotechnology. By continuously monitoring the brain´s state, it accurately assesses each patient’s individual therapeutic needs before precisely delivering optimal electrical stimulation therapy. The system is designed for the treatment of neural network disorders, such as epilepsy, schizophrenia, and Parkinson’s disease. The company invites journalists and members of the press to follow the progress of the Brain Interchange and witness the transformative impact it promises to have on the field of neuromodulation.

In addition, CorTec GmbH is offering exclusive interview opportunities with its Chief Technology Officer, Dr. Martin Schüttler, to provide in-depth insight into the technology behind the Brain Interchange System and the company’s vision for the future of neuromodulation.

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

Der Beitrag Press Release: CorTec ready for next phase with Brain Interchange System erschien zuerst auf CorTec | Thinking ahead – Innovation in Neurotechnology.

CorTec GmbH, a Medical Device innovation leader located in Freiburg, Germany, announced that Dr. Oliver Bärtl has been appointed Chief Executive Officer. He complements the existing executive leadership team alongside Dr. Jörn Rickert and Dr. Martin Schüttler, who led the company during its start-up phase.

Bärtl is an experienced medical device executive with expertise in different market segments and geographies. Most recently, Oliver served as co-CEO of Henke-Sass, Wolf, a hidden champion in the Medical Device market operating in the fields of Endoscopy and Veterinary. Prior to Henke-Sass, Wolf, Bärtl worked 13 years in different executive management roles for Stryker, one of the world’s leading medical technology companies. He received his PhD on value-based management from the University of Zürich, Switzerland.

“We are pleased to welcome Oliver as CorTec’s CEO”, comments Dr. Martin Schüttler. “Oliver is a highly regarded leader in the medical device industry, with a proven track record of building great businesses and creating shareholder value. We’re confident that Oliver’s experience and leadership skills are an excellent complement of our team at the right point in time.”, adds Dr. Jörn Rickert.

The company further strengthens its focus on the development of new therapies together with partners worldwide and adds four new members to the Advisory Board: Helmut Jeggle, who succeeds Prof. Dr. Klaus Mangold as Chairman of the advisory board, Prof. Dr. Tim Denison, Prof. Dr. Pascal Fries and Dr. Christoph Mangold. Helmut Jeggle has successfully built a number of global life-science companies, among them BioNTech, where he also holds the role as Chairman of the Board.

CorTec bids farewell to its long-standing chairman of the company’s Advisory Board, Prof. Dr. Klaus Mangold, as well as Dr. Harald Poth and Dr. Hans Dietl. “CorTec GmbH has supplemented its advisory board with Prof. Dr. Denison and Prof. Dr. Fries. We thank all leaving members, and especially Prof. Dr. Klaus Mangold for his excellent support and commitment in the past years. Of course, Prof. Dr. Klaus Mangold will continue to be a key shareholder of CorTec GmbH.”, explains Chairman of the Advisory Board, Helmut Jeggle. Marco Winzer, HTGF, remains board member and Dr. Harald Poth, LBBW Venture Capital GmbH, and Mrs. Ruth Mörkved, Santo Venture Capital GmbH, complete the advisory board as observers.

Prof. Dr. Tim Denison holds the Royal Academy of Engineering Chair in Emerging Technologies at the University of Oxford, with appointments in both Engineering Science and Clinical Neurosciences. He explores the fundamentals of physiologic closed-loop systems. Before, Tim helped pioneer the development of closed-loop implants with Medtronic and establish research tool partnerships that link academics and industry to accelerate clinical translation.

Prof. Dr. Pascal Fries is one of the world’s most respected neuroscientists working to understand communication between the brain’s highly complex networks. He is a Scientific Member of the Max Planck Society and Director at the Ernst Strüngmann Institute in Frankfurt and holds a professorship at Radboud University in Nijmegen, the Netherlands.
“CorTec’s work in the field of neuroscience is exceptional and I am more than happy to now be a part of the Advisory Board. The Brain Interchange® System has the potential to become the leading tool for researchers and clinicians worldwide to develop new therapies.”, says Prof. Dr. Tim Denison. “CorTec has already proven the ability to turn state-of-the art electrode technology into approved products and new therapy options. The goal is to realize an even larger step with the Brain Interchange® System that will allow new therapies based on closed-loop approaches”, concludes Prof. Dr. Pascal Fries.

“I am looking forward to working with our new board in my new role as Chief Strategic and Scientific Officer, which allows me to fully concentrate on the application of our Brain Interchange® system for therapy development together with our partners from science and industry.”, comments Dr. Jörn Rickert. “With Prof. Dr. Tim Denison and Prof. Dr. Pascal Fries, we gained two experts in our field of highest international repute for our Advisory Board, who will support CorTec’s mission to bring the Brain Interchange® Technology into human application,” adds Dr. Martin Schüttler.

“We have an exceptionally strong team, a fantastic technology, and leading-edge products in the pipeline – CorTec is well positioned and poised to make a difference in the neurotechnology space. Priorities for us are to further grow the business and to have the first Brain Interchange® System implanted in a human.”, adds Dr. Oliver Bärtl.
With the support of the extended expertise in the advisory board as well as the newly shaped executive leadership team, CorTec now aims for further growth and an early first human application of the Brain Interchange® System for closed-loop interaction with the human brain, to enable innovative personalized neurotherapies.

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Der Beitrag CorTec strengthens Executive Leadership Team and Advisory Board erschien zuerst auf CorTec | Thinking ahead – Innovation in Neurotechnology.