NeuroTech Newsletter #1
Published on March 25, 2025
Intro
Welcome to the first Carter Sciences Newsletter, summarizing Funding, FDA, Clinical and Hiring updates across the Neurotech world. These will be bi-weekly and subscription based (free though!) so sign up for the latest Neurotech news summarized and sent to your inbox.
In this edition we look at companies like MicroTransponder, Neuromod, Nervonik, and Subsense who all raised money in the last few weeks, as well as exciting Clinical news in the BCI world, ups and downs in the regulatory space and a few exciting major hiring updates.
Funding News
MicroTransponder Secures $65M to Enhance Vivistim Adoption
PRNewswire2025-03-12
MicroTransponder announced a $65M Series F financing round to boost its FDA-approved Vivistim Paired VNS System. Led by US Venture Partners, this funding supports the company's efforts to establish paired VNS therapy as the standard of care for chronic ischemic stroke survivors by demonstrating clinical improvements in upper extremity function and leveraging robust real-world data.
Neuromod Secures €10 Million Financing for Lenire Expansion
PRNewswire2025-03-11
Neuromod Devices Ltd. closed a €10M equity financing round to drive the commercial expansion of its tinnitus treatment device, Lenire. The oversubscribed funding, led by existing investors Fountain Healthcare Partners and Panakès Partners, will support broader availability in the USA and Europe and enhance partnerships with entities like the US Department of Veteran Affairs.
Nervonik Raises $13 Million Series A to Advance PNS for Chronic Pain
PR Newswire2025-03-04
Nervonik secured $13M in a Series A funding round, led by U.S. Venture Partners, to further develop its opioid-free peripheral nerve stimulation technology. The financing will support clinical studies, regulatory clearance, and commercialization efforts aimed at transforming chronic pain management for millions of patients.
Valencia Technologies Announces $35M Investment and New CEO
PRNewswire2025-02-20
Valencia Technologies secured up to $35M in strategic investment from Brooks Advisory Group and welcomed industry veteran James D. Surek as its new CEO. The capital and leadership change are set to accelerate the commercialization of the company's eCoin system, a minimally invasive neurostimulator designed to treat urinary incontinence.
Subsense Emerges from Stealth with $17M in Seed Funding for a Non-Surgical Brain-Computer Interface
Business Wire2025-02-18
Subsense, a neurotechnology startup focused on non-surgical brain-computer interfacing using nanoparticle-based technology, raised $17M in seed funding led by Golden Falcon Capital. The funding will accelerate development of its bidirectional BCI, which aims to offer innovative therapeutic options for neurological conditions such as Parkinson's, Alzheimer's, and chronic pain.
Summary
These funding announcements demonstrate robust investor confidence in neurotechnology and neuromodulation sectors. With substantial capital infusions supporting innovative stroke, tinnitus, chronic pain, and brain-computer interface technologies, the market is poised for transformative clinical applications. Notable details include strong endorsements from leading venture partners and the utilization of real-world evidence to validate therapeutic efficacy, underscoring a clear shift toward evidence-based and minimally invasive solutions.
The current funding landscape indicates a trend toward next-generation, non-invasive neurotechnologies that promise to redefine standard care. These developments highlight an industry-wide move to integrate advanced clinical data, strategic partnerships, and seasoned leadership to address significant unmet needs in neurological and chronic pain treatments, paving the way for broader market adoption and improved patient outcomes.
FDA News
Sooma wins FDA IDE for neuromod depression tech
MassDevice2025-03-11
Sooma Medical, based in Helsinki, Finland, has received an FDA Investigational Device Exemption (IDE) for its transcranial direct current stimulation (tDCS) device, the Sooma 2GEN. Designed as a wearable cap that delivers mild electrical stimulation to treat major depressive disorder, this device offers a portable, at-home treatment alternative for patients with treatment-resistant depression. The IDE enables the initiation of a pivotal study, in collaboration with Lindus Health, planning to enroll around 200 participants across the U.S., as the company pursues full FDA approval following its earlier breakthrough designation.
Medtronic Recalls Embolization Device After Deaths
MassDevice2025-03-18
The FDA has prompted a serious recall of certain Medtronic Pipeline Vantage embolization devices used to treat brain aneurysms. The recall specifically targets the Pipeline Vantage 027 models, following reports of the device's braided tube failing to attach properly, leading to incomplete wall apposition and deformation. This malfunction has resulted in severe adverse outcomes including thrombosis, stroke, and death, with 13 injuries and 4 deaths reported. Medtronic has updated the usage instructions for the Pipeline Vantage 021 models and advised that affected 027 devices should no longer be used. Physicians are advised to closely monitor patients who have already received the device.
Perfuze Receives FDA Clearance for Zipline Catheters
NeuroNews International2025-03-13
Perfuze has secured FDA 510(k) clearance for its innovative Zipline access catheters, marking a significant milestone in advancing neurovascular treatments for acute ischaemic stroke. The Zipline catheters are engineered to improve trackability and delivery efficiency of larger aspiration catheters, facilitating faster and more effective clot removal. Alongside this regulatory clearance, the company announced a €22 million funding round, led by prominent investors, which will support the limited U.S. market release of the device and further clinical and research initiatives aimed at enhancing stroke treatment outcomes.
Summary
These developments highlight a dynamic regulatory landscape in neurotechnology, with the FDA actively balancing innovation with patient safety. The recall of Medtronic's embolization device underscores the agency's vigilance in monitoring device reliability, ensuring that identified safety risks are swiftly managed to protect patients. Conversely, the clearance for Perfuze's Zipline catheters and the funding boost received signal a strong push toward advancing interventional technologies that promise enhanced procedural success and improved patient outcomes in acute stroke care. Additionally, the FDA's authorization of an IDE for Sooma's neuromodulation device opens new avenues for non-pharmaceutical treatments in mental health, potentially expanding accessible therapy options for depression.
Overall, the regulatory actions indicate a clear trend toward fostering innovation while upholding rigorous safety standards. The FDA is enabling faster pathways for breakthrough technologies in neurotechnology, as evidenced by IDE and clearance processes, even as it enforces decisive measures like recalls to mitigate risk. This dual approach is likely to encourage further investment and development in neurotechnologies that not only promise clinical advancement but also ensure patient safety and compliance with evolving regulatory expectations.
Clinical News
Helius Establishes Subsidiary for AI-Powered BCI
Morningstar2025-03-13
Helius Medical Technologies announced the creation of Revelation Neuro, its wholly owned subsidiary focused on non-invasive, AI-powered BCI technology. The new unit will leverage Helius' extensive clinical dataset of movement dysfunction evidence to develop algorithms that optimize translingual stimulation for personalized neurorehabilitation. The technology aims to offer a less invasive therapeutic option for improving motor function and may eventually extend to addressing cognitive and mood disorders.
This Startup Lets Paralyzed People Use Computers–Without A Chip In Their Head
Forbes2025-03-12
Cognixion has launched its first clinical trial of Axon‑R, a non-invasive brain‑computer interface helmet that combines EEG and eye tracking to facilitate communication for patients with ALS. The device enables users to interact with augmented reality displays and type via a customized generative AI model trained on their own speech patterns. Early feedback from caregivers hints at promising results and potential for broader application beyond ALS.
Paradromics to Launch BCI Study in 2025
MassDevice2025-03-11
Paradromics announced plans for a clinical trial later this year evaluating its fully implantable Connexus BCI system. The study targets individuals with speech impairments due to paralysis from spinal cord injuries, stroke, or ALS. Under the guidance of leading clinical investigators from UC Davis and Massachusetts General Hospital, the trial will assess both the safety of the device and its potential to restore independent communication by translating neural signals into actionable data.
Synchron Unveils Cognitive AI Model for BCI with Nvidia
MassDevice2025-03-19
Synchron presented its roadmap to "Chiral," a foundation brain model built for its stent‑based BCI platform, during Nvidia's GTC 2025. By shifting from supervised to self‑supervised learning through advanced AI techniques, in collaboration with Nvidia's Holoscan platform and demonstrated via integration with Apple Vision Pro, Synchron's approach aims to empower severely paralyzed patients to control digital and physical environments with thought alone.
Machine Learning Predicts Spinal Cord Stimulation Outcomes
evrimagaci.org2025-03-19
In a study involving 20 chronic pain patients undergoing spinal cord stimulation (SCS) surgery, researchers applied decision tree-based machine learning to predict treatment outcomes. By analyzing intraoperative EEG signals and identifying distinct differences in the alpha-theta peak power ratio between responders and nonresponders, the model achieved an accuracy of 88.2%. These findings suggest that integrating real-time neural data with advanced algorithms could refine patient selection and optimize SCS therapy.
New Tech Offers Hope for Spinal Cord Injury Recovery
Open Access Government2025-03-18
Researchers at NeuroRestore have developed a novel rehabilitative system that combines rehabilitation robotics with an implanted spinal cord neuroprosthesis. By delivering precisely timed electrical pulses in synchrony with robotic-assisted movements, the system produced immediate mobility improvements in a small proof-of-concept study with five spinal cord injury patients. Early results indicate that this integrated approach may foster both immediate functional gains and potential long-term recovery improvements.
Summary
The innovations detailed in these studies and announcements represent a significant leap forward for the neurotechnology industry. Non-invasive and implantable BCIs are opening new pathways for patient communication and motor restoration, minimizing the risks associated with traditional invasive procedures. Integrating AI and machine learning into both BCI and spinal cord stimulation protocols is enhancing prediction accuracy and enabling more personalized treatments. Additionally, the successful pairing of robotics with neuroprosthetic stimulation paves the way for more effective rehabilitative therapies that directly translate to improved quality of life and independence for patients with paralysis, chronic pain, and spinal cord injuries.
Emerging trends in neurotechnology emphasize the convergence of artificial intelligence, non-invasive interfaces, and robotics to create adaptable, patient-centered therapeutic solutions. There is a clear shift toward utilizing large-scale neural data to build foundation models that can generalize across patient populations, refined by machine learning to optimize clinical outcomes. This multidisciplinary approach is reshaping clinical practices in neurorehabilitation and pain management, pointing to a future where personalized, less invasive, and more effective neurotechnological interventions become the standard of care.
Leadership Appointments
Cognito Therapeutics Strengthens Executive Team
Medical Product Outsourcing2025-03-10
Cognito Therapeutics has reinforced its leadership team with four key appointments aimed at accelerating growth, advancing clinical programs, and driving commercialization of its neurotechnology-driven therapies. Steve Worthy has been named Chief Business and Financial Officer, bringing extensive experience in healthcare finance and capital markets from previous roles at Aetion and J.P. Morgan. Dr. Robbert Zusterzeel steps in as Chief Clinical and Regulatory Officer, leveraging his background with the FDA, IQVIA, and Woebot Health to guide regulatory strategy. Deanna Angello is appointed as Chief Commercial Officer, noted for her transformative leadership across major pharmaceutical companies and expertise in launching breakthrough therapies. Dr. Pritesh Shah joins as Chief Strategy Officer, with significant experience from his leadership roles at Novocure and other key industry players. Together, these appointments are designed to position Cognito at the forefront of advancing its lead product, Spectris, aimed at addressing neurodegenerative diseases.
Openwater Appoints Aaron Timm as New CEO
BUSINESS WIRE2025-03-06
Openwater has named Aaron Timm as its new Chief Executive Officer. Timm brings over two decades of clinical leadership experience, having previously held executive roles at Vivalink and led strategy and regulatory initiatives at Synarc. His appointment is set to guide Openwater as it scales its portfolio of portable diagnostic and therapeutic devices, which combine open-source principles with advanced, non-invasive technology. The company's strategy involves transitioning from research partnerships to broader commercialization while keeping healthcare affordable and accessible. Company founder Mary Lou Jepsen will continue to serve as Chairperson, maintaining focus on product vision and strategic partnerships.
Summary
These leadership changes underscore a strategic industry shift where neurotechnology firms are prioritizing executive teams with a blend of financial acumen, regulatory expertise, and commercial experience. Such appointments are poised to accelerate product commercialization, strengthen regulatory positioning, and boost global market reach. With leaders experienced in high-stakes growth and innovation, companies are better equipped to navigate competitive markets and rapidly evolving technological landscapes, thereby enhancing overall patient care and advancing neurotech market dynamics.
Current trends reveal a clear emphasis on recruiting executives with cross-industry and multifaceted healthcare backgrounds. This convergence of talent from clinical, regulatory, financial, and commercial domains signals that neurotechnology firms are strategically aligning leadership with long-term growth and innovation goals, ultimately setting the stage for transformative advancements in the field.
Closing Thoughts
Across every facet of this edition—from robust funding rounds and landmark regulatory milestones to pioneering clinical trials and strategic leadership appointments—clear transformative forces are reshaping the neurotechnology landscape. Companies are attracting significant capital to fuel the next generation of non-invasive neuromodulation and brain-computer interface technologies, while regulatory bodies are balancing innovation with patient safety through expedited clearances and vigilant recalls. Clinical advancements underscore a pivotal convergence of AI, machine learning, and robotics, promising more personalized and effective treatments for previously intractable neurological conditions. Meanwhile, strategic leadership appointments are anchoring these initiatives, equipping firms with the financial, regulatory, and commercial expertise necessary to navigate an increasingly competitive market.
The interconnections between funding, regulatory actions, clinical studies, and executive moves signal a broader industry shift: holistic progress is driving accelerated commercialization of technologies that combine rigorous data validation with patient-centric innovation. Professionals in the sector are advised to closely monitor these synergistic developments—identify emerging partnerships, prioritize investments in minimally invasive platforms, and leverage dynamic leadership to guide strategy in this rapidly evolving ecosystem. Looking ahead, the neurotechnology market is poised for further breakthroughs as integrated approaches unlock new therapeutic avenues and redefine standards of care. Strategic planning informed by these trends—whether through agile clinical trial designs, targeted regulatory planning, or cross-disciplinary executive recruitment—will be crucial for seizing upcoming market opportunities. With robust momentum and a clear path forward, the future of neurotechnology is both promising and ripe with transformative potential.
