NeuroTech Newsletter #5
Executive Summary
Welcome to the 5th edition of the Carter Sciences Neurotech Newsletter!
Even though a slower couple of weeks on the regulatory side, there has been a ton of exciting Clinical developments, impressive funding headlines and some great hires/promotions
A wave of multi-tranche financings and grant awards—from ClearPoint Neuro’s $105 M note facility and MindSpire’s £850 K pre-seed to INBRAIN Neuroelectronics’ €4 M PERTE Chip grant, Tivic Health’s $8.4 M securities deal, and Firefly’s strategic acquisition—underscores robust investor confidence in AI-enabled neuromodulation, graphene-based BCIs, and data-centric platforms. Complementing these diversified capital inflows, the FDA’s Breakthrough Device designation for Neuralink’s Telepathy BCI signals a regulatory shift toward de-risking advanced implantable systems for communication and motor function, catalyzing faster trial recruitment and heightened market interest. Clinically, first-in-human trials—from Axoft’s ultrasoft high-density neural probes and Syntropic’s rapid depression intervention to NightWatch+ wearable seizure monitors—demonstrate the promise of minimally invasive, closed-loop therapies. Durable results in hypoglossal nerve stimulation for sleep apnea and vagus nerve–augmented remission of PTSD further validate targeted neuroplasticity as a transformative paradigm in bioelectronic medicine, setting the stage for broader device-based care solutions. Strategic leadership hires—including Sam Zibman’s R&D helm at BrainValue Neurotech for emotional BCIs, Dr. Parag Patil’s advisory role at NeuroOne, John Collier’s sales leadership at BIOTRONIK Neuro, and Anoop Antony’s clinical stewardship at NeuroX360—reflect the sector’s maturation toward integrated translational pathways. Moving forward, companies should engage early with regulators, structure hybrid equity-debt-grant financing, and pursue alliances or selective M&A to consolidate IP and clinical data. By aligning capital strategy, regulatory foresight, clinical validation, and multidisciplinary leadership, neurotech firms can unlock the next wave of closed-loop, patient-centric neurotherapeutics.
Check out the highlights below and as always send through any recommendations or feedback to
chay@cartersciences.com
Funding News
ClearPoint Neuro Investment Announcement
ACCESS Newswire2025-05-12
ClearPoint Neuro secured a note financing arrangement with Oberland Capital for up to $105 million, including an initial $30 million funded at closing and options for additional draws through 2026, alongside a $3.5 million equity purchase. The flexible structure is intended to underwrite general corporate needs as the company accelerates its neurosurgical navigation platforms and readies for increasing demand from emerging cell and gene therapy applications.
MYndspan is raising £250,000 investment on Crowdcube
MYndspan2025-05-09
MYndspan launched a £250,000 Crowdcube campaign inviting early users and public backers to fund its brain‐insight scanning platform. By turning clients into investors, the startup aims to forge a community‐driven growth model that scales its neuroimaging service and broadens access to personalized brain health data.
MindSpire announces £850,000 in pre-seed funding to launch SONA
MindSpire2025-05-08
MindSpire closed an £850,000 pre-seed round led by SFC Capital, with backing from SyndicateRoom, angels and Innovate UK non-dilutive funds, to finalize development of SONA™, a medical-grade wearable for personalized vagus nerve stimulation. Leveraging real-time HRV sensing and adaptive AI algorithms, the device is slated for launch later this year to address stress, focus and neurorehabilitation needs.
Tivic Health Systems Enters Securities Purchase Agreement for Up to $8.4M in Funding
Tivic Health Systems2025-05-08
Tivic Health Systems formalized a securities purchase agreement enabling up to $8.4 million in Series B non-voting convertible preferred stock and warrants issuance. Structured in multiple tranches, the financing is designed to underwrite the company’s longer-term objectives in developing its bioelectronic medicine portfolio.
€4M Grant Boosts Graphene BCI Development
BusinessWire2025-05-05
INBRAIN Neuroelectronics was awarded a €4 million grant under Spain’s PERTE Chip initiative to accelerate its graphene-based brain-computer interface technology. The funding will bolster the clinical-stage company’s precision neural interfaces aimed at therapeutic neuromodulation in conditions such as Parkinson’s, stroke and epilepsy, while aligning with national semiconductor autonomy goals.
Firefly Neuroscience Acquires Evoke Neuroscience
GlobeNewswire2025-05-05
Firefly Neuroscience acquired Evoke Neuroscience for $6 million (half cash, half stock) plus a potential earn-out, gaining access to over 180,000 EEG/ERP records, 27 patents and 60 commercial users. This strategic purchase expands Firefly’s data assets and IP portfolio to accelerate development of its EEG-based brain network analytics foundation model with NVIDIA’s support.
Summary
Industry Impact Analysis The spectrum of financings—from venture debt and convertible equity to grants, crowdfunding and strategic acquisitions—reflects growing investor confidence in neurotechnology’s potential to deliver novel diagnostics, therapeutics and analytical platforms. By securing diverse capital sources, companies are equipped to advance product pipelines, scale clinical deployment and integrate AI and advanced materials into their offerings, which in turn intensifies competition and accelerates innovation across neurosurgical navigation, wearable neuromodulation and brain-computer interface domains.
Trend Conclusion These developments underscore an emerging trend toward hybrid funding models and community engagement in the neurotech sector, with incumbents leveraging structured financial instruments and public grants while startups tap retail investors to de-risk innovation. Simultaneously, there is a clear pivot to personalized, AI-driven neurotherapies and precision interfaces, signaling a maturing ecosystem prepared for rapid commercialization and cross-disciplinary collaboration.
FDA News
NeuroOne FDA Submission for Trigeminal Ablation
Globe Newswire2025-05-05
NeuroOne Medical Technologies has filed its 510(k) submission for the OneRF® Trigeminal Nerve Ablation System targeting trigeminal neuralgia, a condition affecting roughly 100,000 U.S. patients. The proprietary multi-contact probe maps, stimulates and ablates pain foci via a single electrode, offering temperature-controlled radiofrequency ablation. Early clinical data show high initial relief, durable efficacy with repeat treatments and a low complication rate. Pending clearance, commercialization is expected later in 2025, extending NeuroOne’s RF ablation platform from epilepsy and other brain procedures into facial pain management.
Neuralink wins FDA breakthrough nod for treating speech impairment
MassDevice2025-05-02
Neuralink has received FDA Breakthrough Device designation for its fully implantable Telepathy BCI to restore communication in patients with severe speech impairment due to ALS, stroke, spinal cord injury, cerebral palsy and multiple sclerosis. The cosmetically invisible system uses electrode-laced threads to capture neural signals and has already demonstrated computer cursor control and online chess play in early human implants. An R1 surgical robot enables precise implant placement while avoiding vasculature, and the company secured approval to begin a study of its N1 actuator implant for robotic arm control.
Summary
Regulatory Impact Analysis These developments illustrate the FDA’s increasing recognition of advanced neurotechnologies, from minimally invasive ablation tools to implantable brain-computer interfaces. NeuroOne’s accelerated 510(k) filing underscores confidence in repurposing existing RF platforms for novel indications, while Neuralink’s breakthrough designation signals regulatory openness to pioneering BCI therapies. Together they may propel investment, spur competitive innovation across surgical and neural interface domains, and shorten paths to market for high-need neurological treatments.
Regulatory Trend Conclusion A clear trend emerges toward expedited pathways for technologies addressing unmet neurotherapeutic needs, with an emphasis on less invasive procedures and seamless device-brain integration. The FDA’s use of 510(k) and Breakthrough Device frameworks in these cases suggests continued momentum for regulatory support of multifunctional neurotech platforms.
Clinical News
Cognixion and Blackrock Neurotech Expand Access to Non-Invasive, Multi-Modal BCI Research with Axon-R
Cognixion2025-05-14
Cognixion has partnered with Blackrock Neurotech to distribute its Axon-R wearable neural interface platform to research institutions, enabling synchronized collection of high-quality surface and implantable BCI data. The non-exclusive agreement is designed to broaden access to advanced non-invasive research tools that combine AI-driven augmented reality with precise neurofeedback, accelerating investigations in neuroscience, neurorehabilitation and education.
Axoft’s Ultrasoft BCI Study Results
Medical Product Outsourcing2025-05-13
In its FINESSE first-in-human trial, Axoft demonstrated that its Fleuron-based ultrasoft iBCI can be safely implanted and explanted during brain tumor resections, immediately capturing stable, high-density single-neuron recordings and field potentials across cortical depths. The 10,000-times-softer material reduced tissue disruption, maintained signal stability for 20-minute recording sessions, and detected consciousness biomarkers under stimulation, laying groundwork for scalable 1,024-sensor interfaces.
Effective Seizure Detection
NightWatch Epilepsy2025-05-07
NightWatch+ has proven its median sensitivity for major motor seizures at 86% for adults and 100% for children, with tonic-clonic seizure detection exceeding 96% in adults and 100% in children over four. Validated in residential and home settings, the wearable system alerts caregivers to dangerous nocturnal seizures, reducing stress and providing reliable support for unattended patients.
LivaNova Announces 12-month Data from OSPREY Clinical Study for Moderate to Severe Obstructive Sleep Apnea, Demonstrating Strong Response and Durability of Therapy
LivaNova2025-05-07
The OSPREY randomized controlled trial reported a 65% responder rate at 12 months for the aura6000™ proximal hypoglossal nerve stimulator, with median AHI and ODI reductions of 68%. Patients also showed clinically meaningful improvements in sleepiness and functional outcomes, and no serious device-related events. These sustained results support the FDA premarket approval submission and underscore p-HGNS as a durable alternative for CPAP-intolerant OSA patients.
Epineuron Announces Topline Pilot Study Results Published in Bioelectronic Medicine Showing the Potential of the PeriPulse® System in Accelerating Nerve Regeneration
Epineuron2025-05-07
A first-in-human pilot trial of the PeriPulse® wearable stimulator showed 87.5% of acute peripheral nerve injury patients achieved clinically meaningful sensory recovery six months post-surgery. Published in Bioelectronic Medicine, the study confirmed safety, high patient tolerance, and a simple perioperative workflow, paving the way for the multinational REGAIN™ trial across Canada and the US toward FDA approval.
Vagus Nerve Stimulation Erases PTSD
Neuroscience News2025-05-06
In a pioneering study at UT Dallas and Baylor University Medical Center, treatment-resistant PTSD patients underwent prolonged exposure therapy paired with brief implanted VNS bursts, achieving complete symptom remission sustained to six months without serious adverse events. The results suggest VNS-enhanced neuroplasticity can transform exposure therapy, and a double-blind, placebo-controlled Phase 2 pilot is now underway.
Summary
Clinical Impact Analysis The featured studies showcase a transformative shift in neurotechnology toward minimally invasive, high-resolution interfaces and targeted neuromodulation. The expansion of non-invasive tools like Axon-R, along with ultrasoft and multi-sensor iBCIs, promises more precise brain mapping and therapeutic control. Concurrent advances in peripheral nerve stimulation and sleep apnea neuromodulation highlight the industry’s drive to broaden clinical applications beyond motor and sensory domains. Collectively, these innovations are poised to enhance diagnostic accuracy, accelerate recovery pathways, and personalize neuromodulatory treatments across central and peripheral nervous system disorders.
Research Trend Conclusion Current trends emphasize convergence of soft-materials engineering, AI-powered feedback, and hybrid stimulation modalities to unlock new therapeutic avenues. There is a clear movement toward first-in-human validation of pioneering interfaces, integration of neurostimulation with behavioral therapies, and seamless perioperative workflows. The industry is moving rapidly from proof-of-concept toward scalable, durable, and patient-friendly neurotechnologies, signaling a new era of precision neuromedicine.
Leadership Appointments
Sam Zibman joins BrainValue Neurotech as VP of Research and Development
Sam Zibman2025-05-14
Sam Zibman has been named Vice President of Research and Development at BrainValue Neurotech, where he will lead efforts to build the world’s first emotional Brain Computer Interface for neuronal-level targeted neuromodulation aimed at curing PTSD. His appointment underscores BrainValue’s commitment to pioneering advanced neurotechnology through a multidisciplinary team of psychiatrists, neuroscientists and engineers.
NeuroOne Appoints Chief Medical Advisor
Globe Newswire2025-05-12
NeuroOne Medical Technologies has elevated Parag G. Patil, M.D., Ph.D., from its Scientific Advisory Board to Chief Medical Advisor. Dr. Patil brings two decades of neurosurgical and engineering expertise to refine the clinical strategy, product development and physician education for NeuroOne’s thin film electrode platforms, advancing minimally invasive solutions for epilepsy, movement disorders, chronic pain and emerging indications in mood and cardiovascular health.
John Collier joins BIOTRONIK Neuro as VP of Sales
BIOTRONIK Neuro2025-05-12
BIOTRONIK Neuro has appointed John Collier as Vice President of Sales. With over 20 years in medical devices—including 13 years in neuromodulation—Collier will drive disciplined growth of the sales organization to ensure consistent, high-quality service and expand market reach for BIOTRONIK’s neurostimulation and neuromonitoring portfolios.
Anoop Antony joins NeuroX360 as Director & Head of Clinics
NeuroX3602025-05-02
Anoop Antony has stepped into the role of Director & Head of Clinics at NeuroX360, spearheading the evolution of NeuroX Clinics into a fully integrated ecosystem. He will oversee the fusion of neuroscience, neurotechnology and data-driven therapies to make brain health measurable, optimizable and accessible, reinforcing NeuroX360’s mission to revolutionize mental wellbeing and cognitive performance.
Summary
Leadership Impact Analysis These appointments reflect a strategic push across R&D, clinical translation, commercial expansion and patient-facing services within Neurotechnology. BrainValue’s elevation of a dedicated R&D leader and NeuroOne’s bolstering of clinical expertise signal accelerating innovation in emotional BCIs and high-definition neural interfaces. BIOTRONIK Neuro’s sales leadership hire underscores the imperative of disciplined commercialization in a crowded device market, while NeuroX360’s clinic leadership appointment highlights the growing convergence of clinical care and consumer-grade neurotech. Collectively, these shifts are likely to intensify competition, streamline pathways from lab to market and expand end-user access to advanced brain-health solutions.
Executive Trend Conclusion Across these firms, there is a clear trend toward appointing specialized leaders with interdisciplinary backgrounds to bridge research, clinical strategy and market execution. Neurotech companies are maturing from pure-play R&D organizations into integrated enterprises that demand cohesive leadership in development, clinical validation, sales operations and direct-to-patient services. This signals a phase of industry consolidation where expertise in both technological innovation and commercial scale-up becomes a critical differentiator.
Closing Thoughts
In this month’s briefing, the neurotechnology sector demonstrates a clear shift from standalone innovations toward integrated, platform-driven solutions underpinned by hybrid financing, streamlined FDA pathways, and robust clinical validation. Investors are deploying a mix of debt, equity, grants and community capital to accelerate neurosurgical navigation, wearables and BCIs, while regulatory bodies increasingly favor expedited reviews for high-need indications. Concurrently, first-in-human studies of ultrasoft interfaces, multi-modal BCIs and neuromodulation therapies are yielding durable outcomes, validating a wave of patient-centric precision neuromedicine. Against this backdrop, strategic executive appointments are fortifying cross-disciplinary teams, ensuring that technical breakthroughs translate swiftly into market-ready offerings.
These developments are tightly interwoven: targeted funding rounds and grants are explicitly channeling resources into projects with clear regulatory pathways, while FDA breakthrough and 510(k) designations are catalyzing follow-on capital and M&A activity. Clinical proof points for non-invasive and minimally invasive neurotech not only de-risk product roadmaps but also inform regulatory strategy and attract seasoned leaders in R&D, medical affairs and commercialization. This confluence accelerates the feedback loop between laboratory advances, regulatory submissions and market deployment, creating a virtuous cycle of innovation and scale.
For industry stakeholders, the imperative is to adopt an integrated approach that aligns R&D priorities with available funding instruments and regulatory levers. Companies should diversify capital sources—including venture debt, convertible instruments and grants—while actively pursuing breakthrough designations to truncate approval timelines. Investment in AI-enabled pipelines, soft-material interfaces and modular platforms will yield competitive differentiation, and appointing leaders who bridge scientific, clinical and commercial domains will be critical to execution. We anticipate further consolidation and partnerships in the coming quarters, with success hinging on agility, cross-sector collaboration and a relentless focus on patient outcomes.
Looking ahead, neurotechnology is poised for a new phase of acceleration where ecosystem maturity meets unprecedented market demand. Organizations that can seamlessly integrate financing, regulatory insight, clinical excellence and leadership acumen will capture the expansive opportunities emerging across diagnostics, therapeutics and consumer brain-health services. The path forward is clear: harness the full spectrum of industry dynamics to deliver scalable, life-transforming neurotech solutions and define the next frontier in precision neuromedicine.
© 2025 Carter Sciences. All rights reserved.
This newsletter is compiled for professionals in the Neurotechnology industry.
