NeuroTech Newsletter #7
Executive Summary
Welcome to the 7th edition of the Carter Sciences Neurotech Newsletter!
From DoD-backed reinvestments in brain-computer interface ventures and oversubscribed women's health seed rounds to FDA IDE clearance for ultra-low-frequency neuromodulation and veteran-care procurement of photo-biomodulation devices, this issue underscores a surge of capital and regulatory momentum driving breakthroughs in accelerated Deep TMS, gamma-frequency Alzheimer's therapy and ICU diaphragm neurostimulation.
Strategic leadership hires, AI-powered trial optimizations and cross-industry collaborations—from quantum-enabled mind-controlled computing to HSA/FSA-eligible wearables—are coalescing an interoperable neurotech ecosystem. Explore how this integrated wave of funding, approvals, clinical validation and commercial alliances is shaping the next era of personalized brain-health solutions.
Funding News
Capital Factory is doubling down on Neurable
Neurable | 2025-06-10
Capital Factory has reinvested in Neurable, bolstering its brain-computer interface development after helping the startup secure over $5 million in Department of Defense contracts and forge strategic partnerships in health and wellness, underscoring strong investor confidence in Neurable's push to make brain input universal.
Samphire Neuroscience announces close of over-subscribed $5m seed round
Samphire Neuroscience | 2025-06-05
Samphire Neuroscience closed an oversubscribed $5 million seed round led by Inventure, Fortify Ventures and APEX, alongside existing backers, to scale its at-home PMS treatment Nettle™ and the Samphire brain-based menstrual tracking app across the EU and UK, marking a milestone for consumer neurotech in women's health.
XEIA Venture Partners closes new fund
TIL (The Investment Lawyers) | 2025-06-05
XEIA Venture Partners completed its initial closing on a closed-end venture capital fund targeting early-stage startups that develop products and services to improve human health, wellbeing and performance, signaling continued investor appetite for specialized healthtech ventures.
BrainsWay | 2025-06-04
BrainsWay invested $5 million for a minority equity stake in Stella MSO, a management services organization operating over two dozen mental health clinics, to accelerate patient access to Deep TMS Therapy and support the provider's expansion, reflecting strategic vertical investment in care delivery.
Industry Analysis
These funding moves illustrate a deepening commitment to neurotechnology across defense, women's health, mental health and investment infrastructure, with capital flowing into both specialized startups and service platforms. By reinforcing BCI development, consumer neurotech adoption and clinical service networks, investors are enabling a more integrated ecosystem poised to drive product validation, regulatory progress and broader market penetration in the coming years.
Trend Conclusion
The diverse nature of these financings points to a maturing neurotech industry where funding is extending beyond core hardware and software R&D into application-specific therapies, consumer health experiences and delivery channels, backed by dedicated funds and strategic corporate partnerships that together signal robust growth and consolidation of the sector.
FDA News
IDE Approval and CFO Appointment
Business Wire | 2025-06-12
Presidio Medical, Inc. received FDA Investigational Device Exemption approval for its Ultra Low Frequency neuromodulation platform targeting chronic nociceptive low back pain, enabling a pivotal randomized controlled trial in the United States and Australia using epidurally implanted leads. This milestone follows promising initial data from early Australian studies and positions the company to explore novel neuromodulation paradigms. Concurrently, Presidio appointed industry veteran Dimas Jiménez as Chief Financial Officer to strengthen the financial infrastructure and support forthcoming commercialization efforts for the ULF system.
Vielight-Lovell Veteran Care Partnership
EIN Presswire | 2025-05-20
Vielight and Lovell Government Services have formed a partnership to expand access to Vielight's wearable photo biomodulation (PBM) devices across federal healthcare systems including the Veterans Health Administration, Military Health System, and Indian Health Service. As a Service-Disabled Veteran-Owned Small Business vendor, Lovell will facilitate procurement of devices that have undergone safety testing for traumatic brain injury, PTSD, and chronic traumatic encephalopathy. The initiative leverages federal supply schedules to streamline acquisition, enabling veterans to self-administer PBM therapy at home and reduce clinic visits.
Regulatory Impact Analysis
The FDA's IDE approval of Presidio's ULF neuromodulation system highlights growing regulatory support for innovative spinal cord stimulation approaches and signals readiness to evaluate non-traditional frequency modalities in robust clinical trials. Simultaneously, the Vielight-Lovell partnership underscores the importance of federal procurement pathways in accelerating the deployment of non-invasive neurotechnologies. Together, these developments illustrate how both regulatory clearances and strategic distribution agreements are critical levers for advancing neurotherapeutic adoption across clinical and veteran care settings.
Regulatory Trend Conclusion
Recent news points to a dual trend of FDA facilitation for cutting-edge neuromodulation trials alongside an increased focus on partnerships that enhance access to non-invasive neurotechnologies within government healthcare systems. This convergence suggests a maturing regulatory environment where innovative device approvals and strategic procurement collaborations jointly drive expansion of neurotech solutions.
Clinical News
GlobeNewswire | 2025-06-11
In a multicenter randomized non-inferiority trial across eight sites, accelerated Deep Transcranial Magnetic Stimulation using intermittent theta burst stimulation demonstrated comparable reductions in HDRS-21 depression scores and high response and remission rates (87.8% and 78.0%, respectively) to standard Deep TMS, while condensing treatment into five daily sessions over six days. Time to remission was shortened by one week, and the protocol was well tolerated with no serious adverse events reported, suggesting that an accelerated regimen may offer equivalent efficacy with improved convenience for patients with major depressive disorder.
Cognito Therapeutics Delays Alzheimer's Progression
Business Wire | 2025-06-11
A post hoc analysis of the OVERTURE feasibility trial showed that daily one-hour Spectris AD™ therapy preserved cognitive and functional performance and slowed whole-brain atrophy in patients with mild-to-moderate Alzheimer's disease over an 18-month study period. Treated participants demonstrated meaningful delays in decline across cognitive scores, activities of daily living, and brain structure compared with a sham group, underscoring the promise of non-invasive gamma-frequency neuromodulation to extend critical functional thresholds in Alzheimer's patients.
Lungpacer Medical | 2025-06-11
The RESCUE3 randomized controlled trial involving 223 ICU patients across 48 centers demonstrated that AeroPace diaphragm neurostimulation significantly increased ventilator weaning success (posterior probability of superiority 97.9%), reduced ventilator days by three on average, halved reintubation and tracheostomy rates, and boosted respiratory muscle strength by 50%. The therapy was well tolerated with minimal discomfort, marking a substantial advance in mechanical ventilation management.
Doctors Could Hack the Nervous System With Ultrasound
IEEE Spectrum | 2025-06-09
Researchers at the Institute of Bioelectronic Medicine have shown that non-invasive low-intensity focused ultrasound stimulation of the spleen suppresses inflammatory cytokines in animal models and a first-in-human trial without adverse hemodynamic effects. Additional preclinical studies targeting liver-associated glucose-sensing neurons normalized blood sugar in diabetic rodents, and spleen stimulation improved cardiopulmonary outcomes in pulmonary hypertension models, revealing focused ultrasound as a versatile bioelectronic modality for inflammation and metabolic disorders.
Brainify.AI Unveils Breakthrough publication in Predicting Placebo Response with AI
Brainify.AI | 2025-06-06
A peer-reviewed Neuroinformatics publication by Brainify.AI demonstrates that deep convolutional neural networks applied to baseline EEG recordings can accurately identify placebo responders in CNS trials. This AI-driven approach promises to optimize trial design by stratifying participants beforehand, reducing sample sizes, and accelerating precision medicine development in neuroscience.
Business Wire | 2025-06-03
Muse's launch of the S Athena wearable integrates clinical-grade EEG, fNIRS, and SpO₂ sensors with a transformer-based Foundational Brain Model trained on over one billion minutes of data. The platform delivers lab-validated sleep staging and real-time neural state insights in home settings, supporting at-scale diagnostics, decentralized trials, and personalized brain health monitoring.
Paradromics First Human Brain Implant
CNBC | 2025-06-02
For the first time, Paradromics successfully implanted and removed its Connexus Brain-Computer Interface in a human subject during epilepsy surgery, confirming device safety and neural recording capability in about 20 minutes. This milestone transitions Paradromics into clinical-stage development ahead of a full safety and application trial, advancing BCI feasibility for communication in motor-impaired patients.
Video Webinar: A New Era in Menstrual Care: The Revolutionary Science of Wearable Neurostimulation
National Bleeding Disorders Foundation | 2025-05-30
National Bleeding Disorders Foundation and Spark Biomedical will host a webinar detailing clinical trial evidence for OhmBody's wearable neurostimulation device, which has shown promise in reducing heavy menstrual bleeding and alleviating period pain. The session will review study design, outcomes, and potential applications in women's wellness.
Wearable Device Tracks Brain Waste System
Neuroscience News | 2025-05-29
In a study published in Nature Biomedical Engineering, researchers used a wearable electrode-embedded cap to monitor glymphatic fluid dynamics, neural activity, and blood flow through multiple sleep stages and wake transitions in participants aged 56–66. Findings revealed that the brain's waste-removal system operates progressively during deep, REM, and wake-transition phases, challenging the on-off model and highlighting sleep quality's impact on neurodegenerative disease risk.
Rune Labs and Parkinson's Foundation Clinical Program Launch
Business Wire | 2025-05-29
Rune Labs and the Parkinson's Foundation have launched a clinical program integrating StrivePD AI-driven analytics of passive Apple Watch and iPhone data with PD GENEration genetic testing to map digital biomarkers to genetic variants in Parkinson's patients. The initiative aims to refine patient stratification, enable earlier diagnosis, and contribute anonymized data to a global repository, with initial findings expected in 2026.
Breakthrough in Seizure Prediction: Wearable Devices Offer Hope for Long-Term Epilepsy Management
Epilepsia | 2025-05-24
This Epilepsia study demonstrates that combining machine learning algorithms with cycle-based analysis applied to ultra-long-term wearable EEG and physiological data can predict epileptic seizures both in the immediate minutes and up to weeks in advance, significantly reducing high-risk periods. The hybrid system outperformed conventional models, marking a leap toward practical seizure forecasting for epilepsy management.
ONWARD Medical Advances BCI Implants
GlobeNewswire | 2025-05-21
ONWARD Medical reported two additional successful implants of its investigational ARC-BCI therapy in individuals with spinal cord injury, bringing the total to five procedures. The combined brain-computer interface and spinal stimulation system decoded intention into movement, further validating feasibility and safety and advancing thought-driven mobility restoration toward regulatory progress.
Clinical Impact Analysis
Collectively, these reports illustrate a rapid convergence of non-invasive neuromodulation, wearable monitoring, and advanced AI analytics reshaping patient care and clinical workflows. Demonstrations of accelerated Deep TMS and gamma-frequency light-sound stimulation underscore the scalability of tailored brain therapies with improved efficacy and convenience, while diaphragm neurostimulation extends neuromodulation into critical care. Wearable platforms for glymphatic monitoring and seizure forecasting exemplify the potential for real-time, at-home diagnostics. First-in-human BCI case studies and spinal stimulation feasibility trials signal the maturation of implantable neurotechnologies for motor restoration. Together, these innovations promise more precise, personalized interventions, streamlined clinical trials, and broader access to neurotherapeutics.
Research Trend Conclusion
A clear trend emerges toward integrating AI-driven analytics with both non-invasive and implantable neurotechnologies to enable personalized interventions and remote monitoring. The proliferation of wearable devices and foundational brain models is democratizing continuous neural data collection, while adaptive neuromodulation protocols and BCI systems are transitioning from proof-of-concept to clinical feasibility. This convergence of bioelectronic medicine, deep learning, and decentralized trial designs points to a future where precision neuromodulation and real-time brain-health feedback become standard in both research and patient care.
Commercial Collaborations and Launches
Reprogramming Cancer: How Coherence Neuro Is Pioneering Therapeutic Neurotechnology
Coherence Neuro | 2025-06-11
Coherence Neuro, formerly opto.bio, has unveiled its MRI-transparent SOMA-1 therapeutic brain-computer interface and identified a novel electrical biomarker for cancer detection and staging. Advancing SOMA-1 toward an October glioma first-in-human trial and pursuing a pancreatic cancer indication, Coherence Neuro seeks to reshape oncology through implantable neurotechnology that intercepts cancer's neural signals.
Emotiv MW20 is available for pre-order
EMOTIV | 2025-06-06
Emotiv has opened pre-orders for the MW20, the first true wireless neuro earphones with high-fidelity audio, co-engineered with Master & Dynamic. Aimed at boosting mental well-being, focus and cognitive performance, the MW20 combines advanced EEG sensing with premium audio hardware and is available at an introductory price via the company website.
New Partnership Announcement - Pupil Labs x Cognixion
Pupil Labs | 2025-06-05
Pupil Labs and Cognixion are integrating NeonNet eye-tracking with the Axon-R SDK to deliver a unified research platform for simultaneous EEG and eye movement data. The collaboration will simplify multimodal study development with a single interface and cross-platform analytics, with initial tools due in six months for clinical researchers and HCI professionals.
Neuronic is now HSA/FSA Eligible
Neuronic | 2025-06-04
Neuronic has partnered with TrueMed to make its LIGHT photobiomodulation device eligible for HSA and FSA purchases, enabling up to 30 percent tax-free savings on brain health therapies. TrueMed manages eligibility verification and paperwork, widening access to cognitive optimization and recovery treatments for wellness-focused consumers.
IBM and Inclusive Brains Team Up
The National | 2025-06-02
IBM and Inclusive Brains have launched a joint study to develop mind-controlled computing by combining AI, quantum computing and non-invasive multimodal interfaces. Using IBM's Granite models and quantum machine learning, the study aims to optimize algorithms for interpreting brain activity and physiological signals to enable mental commands, with findings released as open science.
Cortechs.ai Partners with ALZ-NET
Medical Device Network | 2025-05-20
Cortechs.ai has allied with the Alzheimer's Network for Treatment and Diagnostics to integrate its NeuroQuant for ARIA imaging platform into ALZ-NET's data network at discounted rates. The AI-driven solution quantifies and tracks amyloid-related imaging abnormalities on FLAIR and susceptibility-weighted scans, enhancing clinician decision-making for patients on anti-amyloid therapy.
electroCore Expands Sparrow Ascent Distribution
GlobeNewswire | 2025-02-27
electroCore has partnered with Spark Biomedical to distribute Sparrow Ascent, an FDA-cleared non-invasive auricular neuromodulation device for opioid withdrawal, across VA facilities. This distribution expands veteran access to a validated, drug-free therapy that complements electroCore's neuromodulation portfolio and supports recovery from withdrawal symptoms.
Market Impact Analysis
These collaborations and launches illustrate a maturing neurotechnology ecosystem that emphasizes interoperability across modalities, leverages strategic alliances to accelerate R&D and regulatory pathways, and broadens commercial access through novel payment models and established distribution networks. The convergence of consumer-grade devices, clinical platforms and benefit-account financing is intensifying competition while lowering adoption barriers, enabling companies to scale across research, clinical and consumer markets more rapidly.
Commercial Trend Conclusion
Strategic partnerships are solidifying as the primary route for integrating complementary expertise in hardware, software and distribution. Simultaneously, product launches are increasingly characterized by hybrid offerings that merge neuroscience capabilities with user-centric design and flexible financing. The sector's shift toward collaborative ecosystems and hybrid solutions points to a new phase of commercial strategy focused on interoperability, accessibility and scalable deployment.
Leadership Appointments
Craig Cook Appointed at ABILITY Neurotech
Business Wire | 2025-06-12
Craig Cook, formerly Head of Business Development & Licensing at the Wyss Center for Bio and Neuroengineering, has been named Chief Business Officer and Co-founder of ABILITY Neurotech SA. Cook's leadership in spinning out six neurotech startups and securing early-stage investments positions him to drive ABILITY's fundraising and operational growth. His appointment is expected to accelerate the translation of the company's end-to-end brain-computer interface solutions into clinical impact.
Precision Neurosciences announces two significant additions to leadership team
Precision Neuroscience | 2025-06-11
Vanessa Tolosa, PhD, a Neuralink co-founder and microfabricated neural implant expert, has joined as Senior Vice President of Research and Development, while Vivek Pinto, PhD, MBA, former Division Director at the FDA's CDRH, will serve as Director of Medical Affairs. Their combined scientific and regulatory expertise is set to strengthen Precision Neurosciences' clinical pipeline and pave the way for accelerated human trials of its neural interface technologies.
NXTSTIM Welcomes Richard Roberts as Global VP of Sales
NXTSTIM | 2025-06-10
Richard Roberts joins NXTSTIM as Global VP of Sales, bringing decades of commercial strategy, physician engagement, and market-expansion leadership. His appointment comes on the heels of 180% growth for EcoAI's chronic pain solutions and is aimed at scaling the company's sales operations and accelerating adoption among healthcare providers.
Axoft announces Oliver Armitage as new VP of Neural Data and Clinical Strategy
Axoft | 2025-06-10
Oliver Armitage, former Founder and Chief Scientific Officer of BIOS Health and Forbes 30 Under 30 honoree, has been appointed VP of Neural Data and Clinical Strategy at Axoft. He will lead the development of AI-driven neural decoding models and guide their integration into clinical protocols, reinforcing Axoft's leadership in data-driven neurostimulation therapies.
Jake Wiederin joins Motif Neurotech as Head of Medical Device Manufacturing
Motif Neurotech | 2025-06-09
Jake Wiederin, with over 15 years in Class III implantable device development at Boston Scientific and Saluda Medical, has been named Head of Medical Device Manufacturing at Motif Neurotech. His expertise in neuromodulation operations and scaling manufacturing will support Motif's efforts to meet growing demand for its spinal cord stimulation technologies.
Andrew Gaess joins brain4care as VP of Growth
Brain4Care | 2025-06-06
Andrew Gaess has been appointed VP of Growth at brain4care, where he will spearhead market expansion for the company's non-invasive intracranial monitoring solutions. Gaess's background in ICU neuromonitoring at Moberg and his industry network are expected to drive strategic partnerships and accelerate adoption in critical-care settings.
Dr Antonella Santuccione Chadha joins the BoD at Bottneuro AG
Bottneuro AG | 2025-06-04
Dr. Antonella Santuccione Chadha, co-founder of the Women's Brain Foundation and former CMO and interim CEO at Altoida, has joined Bottneuro AG's Board of Directors. Her clinical, regulatory, and entrepreneurial experience will inform the company's precision neuromodulation strategy targeting Alzheimer's disease and related disorders.
Tyler Binney Joins SetPoint Board
SetPoint Medical | 2025-06-04
Tyler Binney, a MedTech commercial leader with roles at Teleflex, NeoTract, and as President and CEO of an acquired medical systems company, has been appointed to SetPoint Medical's Board of Directors. He will leverage his expertise in scaling disruptive platforms to support the commercialization of SetPoint's neuroimmune modulation therapies for autoimmune diseases.
Subsense welcomes Anthony Di Pasqua as Nanoscience Lead
Subsense Inc. | 2025-06-03
Anthony Di Pasqua, PhD, a chemist and pharmaceutical scientist with 41 publications and three patents in nanomaterials and drug delivery, has joined Subsense as Nanoscience Lead. He will advance the non-surgical, nanoparticle-based brain-computer interface platform through preclinical development and materials innovation.
Laurie Cigan joins PSR as VP of Customer Engagement
SPR | 2025-06-02
Laurie Cigan, a neuromodulation sales and education veteran with nearly 20 years of industry experience, has been named VP of Customer Engagement at SPR. She will lead initiatives to enhance the customer experience, professional training programs, and partnerships aimed at optimizing patient outcomes for SPR's pain relief devices.
Leadership Impact Analysis
These appointments reflect a strategic push across the neurotechnology sector to bolster expertise in commercialization, regulatory navigation, and clinical translation. Companies are securing leaders with deep domain knowledge—from AI-driven neural decoding to nanoscience and manufacturing—to accelerate product development, strengthen investor confidence, and expand market access. Board additions of seasoned MedTech executives and clinical experts signal a concerted effort to streamline regulatory pathways and foster cross-industry collaborations that will drive the next wave of neurotech innovations into mainstream healthcare.
Executive Trend Conclusion
The convergence of talent from academic spin-offs, regulatory agencies, and established medical device firms highlights a maturing neurotechnology landscape focused on scaling from R&D to commercialization. There is a clear emphasis on non-invasive interface technologies, clinical strategy, and customer-centric growth, indicating that companies are prioritizing market readiness and patient outcomes. This trend suggests the industry is entering a phase where operational execution and strategic leadership will differentiate market leaders in the brain-computer interface and neuromodulation arenas.
Closing Thoughts
Key Strategic Insights
This edition underscores a pivotal transition: neurotechnology is coalescing from disparate R&D pockets into a unified, capital-rich ecosystem where diversified investments—from DoD-backed BCI ventures and women's health seed rounds to dedicated healthtech funds—are simultaneously driving AI-powered diagnostics, non-invasive and implantable neuromodulation, and integrated care delivery.
Breakthroughs in accelerated Deep TMS, gamma-frequency Alzheimer's therapy, ICU diaphragm stimulation, and first-in-human BCI implants demonstrate that personalized, scalable brain-health interventions are moving beyond proof-of-concept. Coupled with FDA IDE approvals and veteran-care procurement pathways, these trends signal an inflection point where interoperable neurotech platforms are poised for mainstream clinical and consumer adoption.
Cross-Functional Analysis
A virtuous cycle is now evident: targeted funding accelerates technology maturation and clinical trials—enabling Presidio's IDE for ultra-low-frequency neuromodulation and Paradromics' BCI feasibility—while strategic leadership hires in regulatory, manufacturing, and data science ensure these innovations clear approval hurdles and scale effectively.
Regulatory successes unlock commercial channels—VA and DoD procurement for PBM devices, HSA/FSA-eligible consumer wearables and hybrid distribution agreements—magnifying return on R&D investment. This orchestration of capital, clinical validation, regulatory navigation, and go-to-market acumen is emerging as the critical framework for turning neurotech breakthroughs into accessible, reimbursable products.
Future Outlook & Recommendations
Looking ahead, the market will consolidate around multi-modal platforms that integrate EEG, AI-driven analytics, photo- and focused-ultrasound stimulation, and BCIs to address both therapeutic and wellness segments. Executives must prioritize assembling cross-disciplinary teams—combining regulatory affairs, reimbursement strategy, and AI expertise—to expedite IDE and 510(k)/de novo filings, while forging early alliances with federal health systems and payers to secure procurement and coverage.
Investments in modular manufacturing, standardized data pipelines, and decentralized trial infrastructure will be essential to meet surging demand, and companies should seek symbiotic partnerships that blend clinical evidence, advanced analytics, and robust distribution networks to outflank competitors.
Final Word
With synchronized momentum across funding, regulatory breakthroughs, clinical validation, leadership, and commercial alliances, neurotechnology is on the threshold of redefining standard care—now is the moment to integrate capabilities and scale brain-centered solutions into the fabric of next-generation healthcare.
© 2025 Carter Sciences. All rights reserved.
This newsletter is compiled for professionals in the Neurotechnology industry.
