Neurotech Notables #23: Jan 2025
Hello, 2025. BCIs on Butterflies 🦋
Happy New Year!
After two weeks in a holiday cocoon, we’re back with your biweekly roundup.
And so: This edition is LOADED with a month’s worth of notables, from mid-Dec to mid Jan. Updates from CES and JP Morgan are still trickling in, so please share your news directly to make sure I don’t miss it for next time.
Today you’ll find: $200m+ in startup and grant funding. Nearly a billion in new venture funds. New regulatory decisions and brain health bills, multiple federal calls for public input, and new care guidelines. A great new BCI paper and report. Fresh market research on neuromod sales. Original commentary.
Fresh economic and clinical evidence in neuromod. Clinical trial kickoffs. Multiple first sales. New products. Employer channel deals. Industry news and views across segments, including activity from Samsung, Meta, and NVIDIA. Research on digital sensors to digital sensations.
And plenty more….
Before we dive in, two exciting updates at Neurotech Futures to kick off 2025:
Howdy, Partners! I’m delighted to welcome NANS and TTP as new partners to this newsletter. These stellar organizations are supporting our work via curated updates and co-created articles. Read more about how they’re advancing the industry’s progress on our Ecosystem page.
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NANS
TTP
Case Study: Accelerating the design of next-generation neuromodulation systems under tight deadlines
Funding
Zeto, Inc., Secures $31 Million In Series B Funding To Redefine The Future Of EEG Brain Monitoring (PR Newswire)
Saluda Medical Announces Closing of $100 Million Financing (PR Newswire)
Samsung invests in neural sensor startup Pison (ee NewsEurope)
BrainSightAI Bags $5m Led By IAN Alpha Fund (Inc42)
“Size of a grain of rice”: Robeauté raises €27.2 million to transform neurosurgery with microrobots (EU Startups)
A potential competitor to Khosla-funded Bionaut labs? Oh la la.
Phosphenix wins €2.5-million EIC Transition grant neural prosthesis project, SIGHTED, to develop and commercialize BCI for vision restoration (LinkedIn)
Vensana Capital Closes $425 Million Fund III to Back Breakthrough Medical Technology Companies (BusinessWire)
Andreessen Horowitz Partners with Lilly to Launch First-of-Its-Kind $500m Biotech Ecosystem Venture Fund (Business Wire)
Team Led by Columbia Engineering and Columbia University Irving Medical Center Wins ARPA-H Award for Up to $41M (Columbia)
Feinstein Institutes awarded Lupus Research Alliance funding for vagus nerve stimulation clinical trial (Feinstein)
Dr. Kip Ludwig has received a five-year grant from the NIH to improve treatment and quality of life for people suffering from Overactive Bladder (OAB) (UW Neurosurgery)
ReShape Lifesciences Receives NIH Supplementary Grant with USC’s CARSS for Next-Generation Electrodes for ReShape’s Proprietary Diabetes Bloc-Stim Neuromodulation Technology (Reshape Lifescience)
New Priority Areas and Opportunities for Funding in 2025 (Dana Foundation)
Commercial
Axoft to Begin Brain Implant Clinical Study, Marking the First Time Bio-Inspired Material is Authorized for Use in Humans (Business Wire)
Naxon Labs joins ZirconTech: a strategic leap in neurotechnology and AI (OpenPR)
Nexstim Plc and Sinaptica Therapeutics, Inc. Announce Initiation of Co-Development of the SinaptiStim® Precision Neuromodulation System to treat Alzheimer’s Disease (Nexstim)
Helius Announces First Portable Neuromodulation Stimulator (PoNS®) System Sale to the Veterans Affairs (VA) Healthcare System (Helius)
NeurAxis Inc. Announces Strong Preliminary Unaudited Fourth Quarter 2024 Results; Revenues Increased 50% Year-Over-Year (SEC)
Onward Medical announces first commercial sales of system to restore hand strength in chronic spinal cord injury (ONWARD)
Electrocore to acquire NeuroMetrix and its Quell neuromod tech (MassDevice)
ActiGraph Accelerates Clinical Trial Modernization with Transformational Acquisition of Biofourmis Life Science Business (Actigraph)
E8, Inc. Announces Collaborative Partnership with Jacobs Institute to Make Minimally Invasive Solutions the Gold Standard in Neurosurgery (Globe Newswire)
Neuroharmonics launches to bring Focused Ultrasound to brain modulation (LinkedIn)
Brightmind launches pivotal clinical study with MedUni Vienna (LinkedIn)
Clinical Trial of NeuroSigma’s Monarch eTNS System for ADHD at King’s College London Completes Enrollment (GlobeNewsWire)
Bioness Medical (owned by Bioventus) announces rebrand focused on wearable neurostimulation rehabilitation (Bioness)
CLR Neurosthenics® launches neurophysiological assessment platform to help prevent sports injuries, optimize performance and improve rehabilitation (PR Newswire)
Darmiyan Enters Medicare GUIDE Through Partnership with Five Star Home Health Care, CareBrains, and Brain Watch Coalition (PR Newswire)
Roga partners with BeniPlus Inc. on employee access (LinkedIn)
NeuroAge Test Launches Consumer Test (LinkedIn)
CEO Letter to Shareholders Issued by Tivic Health (PR Newswire)
CEO Geoff Martha tells JPM crowd Medtronic is ‘stacking growth drivers’ (MedTechDive)
Stryker strikes $4.9B deal to buy Inari Medical (MassDevice)
NOCIRA® Grows Patent Portfolio for Personalized, Adaptive Migraine Treatments (PR Newswire)
Canary Speech and Prism Care Announce Partnership to Enhance Extended Care Through Vocal Biomarker Technology (Canary)
Davos Alzheimer's Collaborative launches innovative brain health navigator program for intuitive coordination between patients and providers (EurekaAlert)
Dent partners with icoMetrics on AI-driven MRI for ARIA detection in Alzheimer’s (LinkedIn)
BMS pays Leqembi originator $100M for next-gen preclinical Alzheimer's prospects (Fierce)
NeuroStim TMS Reaches Milestone of 200,000 TMS Therapy Treatments; Announces Expansion into Arizona (PR Underground)
Neuvotion Expands Partnership with Intelligent Product Solutions and Commercializes NeuStim™ Technology for Stroke and Spinal Cord Injury (PR Newswire)
MyndSpan and BIOS Health announce stealth collaboration (LinkedIn)
NightWare Launches Campaign to Treat PTSD Nightmares with FDA-Cleared Digital Therapeutic (BusinessWire)
Nyxoah launches Genio neuromodulation system in England (Medical Device Developments)
Zest partners with Flow Neuroscience to revolutionise workplace mental wellbeing (LinkedIn)
Nexstim Plc: Henri Hannula appointed as CCO (Nexstim)
When Focused Ultrasound Becomes Durable Medical Equipment: How Will Payment Work? (FUS Foundation)
Markets to Watch in 2025: Neuromodulation (LSI)
Excellent work from the LSI team, as usual! Some tidbits:
In 2024, LSI's Market Intelligence team estimated the neuromodulation market reached $5.995B in total product sales.
96% of this market is attributable to implantable devices, with 4% of sales attributable to rTMS
SCS is still the largest segment of this market, with an estimated $2.5B in product sales last year.
DBS, was surpassed in 2021 by the Sacral Neurostimulation market, while still reaching an estimated $1.7B in product sales in 2024.
Neumora’s antidepressant stumbles in first Phase 3 trial readout (STAT)
Recent advances in facilitating the translation of bioelectronic medicine therapies (Current Opinion in Biomedical Engineering)
Tone by NextSense Debuts First-of-its-Kind Biosensing Smart Earbud at CES 2025 (BusinessWire)
Emotiv launches MW20, new model of EEG earphones (Emotiv)
Meta discontinues its $1,500 Meta Quest Pro headset (FastCompany)
Nalu: Nalu PNS System Significantly Reduces Healthcare-Related Costs in Chronic Pain Patients (BusinessWire | Pain Management)
Cognito Theraeutics Releases Cost-Effectiveness Analysis of Spectris Therapy (MPO-Mag)
Cost-Effectiveness of rTMS as a Next Step in Antidepressant Non-Responders: A Randomized Comparison With Current Antidepressant Treatment Approaches (Acta Psychiatria Scandanavia)
Relative effectiveness of antidepressant treatments in treatment-resistant depression: a systematic review and network meta-analysis of randomized controlled trials (Neuropsychopharmacology | LinkedIn comments)
Clerkenwell Health extends deadline to Jan 31 for Clinical Development Accelerator, built for Mental Health and CNS innovators seeking CRO services (Clerkenwell)
Regulatory & Agency
Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations. (FDA)
“This draft puts together what we have learned from over 1000 AI-enabled device authorizations. The webinar is on February 18, and comments are due by April 7.”
Network Survey for Accelerating Medical Device and Diagnostic Reimbursement: due by Friday, February 21, 2025 (ARPA-H)
FDA Grants Breakthrough Device Designation for Closed-Loop Transcranial Alternating Current Stimulation to Treat Major Depressive Disorder (Healthcare Dive)
Comphya Receives FDA IDE Approval to Initiate U.S. Clinical Trial for CaverSTIM, first implantable neuromodulator designed to treat erectile dysfunction (LinkedIn)
ONWARD Medical Receives FDA De Novo Classification and US Market Authorization for World’s First Non-Invasive Spinal Cord Stimulation System for People with Chronic Spinal Cord Injury (Globe Newswire)
Medtronic wins CE mark for adaptive deep brain stim tech for Parkinson’s (MassDevice)
Abbott announces Liberta RC™ DBS System is now CE approved (LinkedIn)
ARPA-H launches its PROSPR program, to build on NIA’s foundational work and will work with industry and regulators to accelerate the testing and availability of new therapeutics targeted at healthspan (ARPA-H)
New TBI Care Guidelines Released by ACS (Practical Neurology)
Defense Bill Orders Military to Take New Action on Brain Injury (NYTimes)
U.S. Senate Passes Act Tripling Funding to State and Local Dementia Programs (Being Patient)
Vision check with FDA CDRH Director Dr. Michelle Tarver (MDO)
FDA “Home as a Health Care Hub” Idea Lab (HKS)
BCI: Applications, Challenges, and Policy Options (GAO)
Industry
An application-based taxonomy for brain–computer interfaces (Nature)
This paper, and the ensuing discussion it has created, is a signal that BCI discourse is maturing to substantive debates on product/market fit. Despite puffy valuations, it’s not all hype. Kudos to Jacob Robinson and all co-authors on publishing meaningful thought leadership.
Synchron to Advance Implantable Brain-Computer Interface Technology with NVIDIA Holoscan (Business Wire)
Team Gleason and Synchron Expand Collaboration to Drive Awareness of The Synchron BCI Community to Advance Brain Computer Interface Technology (BusinessWire)
Sinaptica: Alzheimer's researchers say brain stimulation device may slow symptoms (NBC | Fortune)
Elon Musk’s Neuralink Announces 3rd implanted user, aims to for 10 Times More Brain Chips in 2025 (Observer)
Human-Computer Input via a Wrist-Based sEMG Wearable (Meta Blog | More from Meta)
Ampa: Real-world effectiveness of a single-day regimen for transcranial magnetic stimulation using Optimized, Neuroplastogen-Enhanced techniques in Depression (ONE-D) (Research Square | LinkedIn)
See Dr. Muir’s commentary at Frontier Psychiatrists.
Magnus/SAINT: Small Preliminary Trial of Psychoactive Drug Ibogaine Yields ‘Initial Evidence’ for Powerful Therapeutic Potential in Traumatic Brain Injury (BBRF)
Cambridge Cognition: Enhancing Patient Outcomes in ADRD (Cambridge Cognition)
Firefly’s groundbreaking BNA technology identifies brain age biomarker, potentially advancing early Alzheimer’s screening (BioTuesdays)
ViewMind Joins Bio-Hermes-002 Landmark Study in Partnership with Global Alzheimer’s Platform Foundation (EIN Presswire)
Linus Health: AI that identifies undiagnosed cognitive impairment could improve VBC (Healthcare IT News)
CES2025: Medical Technologies to Know (Medical Design & Outsourcing)
Datwyler: How Users Rule The Market—And Wearables Are No Exception (Forbes)
Neurovalens Wins National Sleep Foundation's 2024 SleepTech® Award (PR Newswire)
Elemind: I Tested a $349 Headband to Take a Power Nap. It Put Me Right Out (CNET)
Nyoxah: Multicentre study conducted across centres in the USA, Europe and Australia to assess the safety and effectiveness of a bilateral hypoglossal nerve stimulation system for the treatment of obstructive sleep apnoea (BMJ Open)
Ciatrix: Revolutionizing Brain Health Through the Science of Movement (Startup Health)
SpineX: Transcutaneous Spinal Stimulation and Short-burst Interval Treadmill Training in Children with Cerebral Palsy: A Pilot Study (IEEE Xplore)
Driving innovations for early diagnosis of Alzheimer's disease (Predictom)
Unlocking Alzheimer's Progress: Advancing Diagnosis and Treatment Through Interdisciplinary Expertise (Predictom)
1606 Corp. Expresses Strong Support for Adnexus Biotechnologies'
Groundbreaking AI Technology (SEC)
Weird press release, interesting tech.
Cognixion: Tech turning thoughts into speech (BBC)
Q&A with Marcus Capone, CEO of TARA Mind (Satori Neuro)
Osmo: Digital smell has arrived. Are we ready for Stinkygram? (Salon)
Omniscient: Connectome imaging to facilitate preservation of the frontal aslant tract (Clinical Neurology & Neurosurgery | LinkedIn)
Clinical validity of IntelliSpace Cognition digital assessment platform in mild cognitive impairment (Frontiers)
Neuromodulation Wristband ObeEnd Reduces Heart Rate and Perceived Exercise Exertion with “Electroacupuncture.” (Cision)
The Case for Clinical Trial Abundance (IFP) + On how to test more drugs (Ruxandra Teslo)
Intelligent Clinical Trials: Using Generative AI to Fast-Track Therapeutic Innovations (WEF & ZS)
This Medical Device Went to Market…(Frontier Psychiatrists)
The Best Talks From Longevity Summit 2024 (Lifespan.io)
Taking a more patient approach to longevity investment (Longevity News)
2024 Recaps: Spark Biomedical, Beacon Biosignals NeuroOne Shiratronics, Rune Labs, Epitel (These are just ones I caught on LinkedIn - if you want to share yours with me, please go ahead!)
NeurotechTV
Rajesh Rao reflects on predictive brains, neural interfaces and the future of human intelligence (The Transmitter)
Pioneering the Future of Bionic Dexterity and Rehabilitation Technology (AI for Good)
NeurotechTV: The Role of Technology in Mental Health (IEEE)
Personalizing Precision Neural Health (From HLTH2024 (Awesome Future)
Red Light & Ultrasound Revolution in Healthcare: Dr Mary Lou Jepsen Interview (Modern Healthspan)
Soft and flexible electronics for stem cell engineering and brain-machine interfaces @ Stanford (Harvard)
Stealth Neurotech CEO, Dr. Lothar Krinke: Previously w/ Newronika, Welcony, Medtronic, McKinsey (Dynamic Neurotech)
Lothar’s sudden departure from Newronika was a tidbit that came up at JPM this week…do you have any insights to share?
Pod: Pulverizing the Stigma of Mental Illness with Jon Nelson from OneMind’s Lived Experience Council (brainSTEM)
Pod: What We Saw at CES: Health Innovation at the Consumer Tech Circus (Startup Health)
Pod: Ben Reinhardt: How to Discover New Technology, Playing the Longest Game, and Philanthropy in Technology (SmartFriends)
Pod: Roxanne Lofredi – Striatal recordings and the stopping triangle: How DBS advances knowledge (Stimulating Brains)
Pod: Vagus Nerve Stimulation: Effects Beyond the Nervous System (Practical Neurology)
Society
9 unexpected things we learned about mental health and our brains in 2024 (NPR)
The unbearable slowness of being: Why do we live at 10 bits/s? (Neuron | NYTimes)
Almost all leading AI chatbots show signs of cognitive decline (BMJ Group)
Memory Loss Isn’t the Only Sign of Dementia (NYTimes)
Make America Ageless: Trump’s Health Picks Take Longevity Movement Mainstream (MSN)
Annual ‘winners’ for most egregious US healthcare profiteering announced (Guardian)
#8: Shady billing practices from Zynex Medical, a company specializing in nerve-stimulation devices used for pain management
Don’t forget the upside of neurotechnology (AI & Society)
Inside a Gait Lab: My Final Visit With A Wizard + The Adventures of Tokkiri (Tomorrow Edition)
Related: Troubleshooting Gait in PD (JPD)
Plug (In) and Play: The State of BCI Gaming in 2025: Why This 25-Year-Old Technology Is Finally Getting the Attention it Deserves (IEEE Xplore)
An Innovation Agenda for Addiction (Recursive Adaptation & IFP)
Future watch: What should neuroscience prioritize during the next 10 to 20 years? (The Transmitter)
Neuroethics hackathons bridge theory to practice (Neuron)
BCI patient preferences: a systematic review (Journal of Neural Engineering)
Clinical trials for implantable neural prostheses: understanding the ethical and technical requirements (The Lancet)
Aligning Visual Prosthetic Development With Implantee Needs (Translational Vision Science & Technology)
Is Neurotechnology Developing Faster Than Its Ethical and Legal Guardrails? (Neurology Today)
What It's Like to Have Brain Fog With Migraine (The Mighty)
The Neurosurgeon's Role in Brain Health Diplomacy: The Next Step for Global Neurosurgery (World Neurosurgery)
Navigating the Future of BCI Technology (Dana Foundation)
Research
New Wearable Device Monitors Joint Pain (Georgia Tech)
Advancing digital sensing in mental health research (NPJ Digital Medicine)
Detecting momentary reward and affect with real-time passive digital sensor data (Research Square)
Digital phenotyping from wearables using AI characterizes psychiatric disorders and identifies genetic associations (Cell | Summary)
USC study finds new evidence linking dementia to problems with the brain’s waste clearance system (USC)
Could ultrasound be the key to treating Alzheimer’s disease? (Nature/University of Queensland)
A retrospective, observational study of real-world clinical data from the Cognitive Function Development Therapy program (Frontiers in Human Neuroscience)
Label free, capillary-scale blood flow mapping in vivo reveals that low-intensity focused ultrasound evokes persistent dilation in cortical microvasculature (Communications Biology)
A microendovascular system can record precise neural signals from cortical and deep vessels with minimal invasiveness (bioRxiv | Website)
Integrating bioelectronics with cell-based synthetic biology (Nature)
Moving beyond the motor cortex: a brain-wide evaluation of target locations for intracranial speech neuroprostheses (bioRxiv)
Brain-computer interface makes breakthrough by deciphering Chinese speech in brain (China Daily)
A novel robot-assisted method for implanting intracortical sensorimotor devices for brain-computer interface studies: principles, surgical techniques, and challenges (JNS)
Bionic Hands: Stimulating localizable sensations (Nature)
A Roadmap for Implanting Electrode Arrays to Evoke Tactile Sensations Through Intracortical Stimulation (Human Brain Mapping)
Proportional myoelectric control of a virtual bionic arm in participants with hemiparesis, muscle spasticity, and impaired range of motion (Journal of Neuroengineering & Rehabilitation)
Effect of DLPFC rTMS on anhedonia and alpha asymmetry in depressed patients (Scientific Reports)
UC Irvine, Columbia University researchers invent soft, bioelectronic sensor implant (UCI | Nature)
via UCI. For the record, our bioelectronic butterfly design at the top of this email came first. You can call this (wait for it…) “The Butterfly Effect.” 📲 If you’re feeling Social (Media): LinkedIn | Twitter/X |BlueSky| Email
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