Neurotech Notables #13: July 2024

Dog Days. Market Movement. Sponsored Content.

Glacier National Park in Montana (picture taken by my brother)

🫡Welcome to August, Neurotech Aficionados!

The back half of July was another stimulating fortnight for all things neuro.

• BCI’s news blitz was led by Synchron, who announced integrations with OpenAI’s ChatGPT 4o and Apple’s VisionPro. What does this mean for the field? In a single word: “Platform.” Below you’ll find my chat with Dr. Oxley, good articles about Paradromics and InBrain, as well as my interview with Dr. Rapaport at Precision about building BCI for the real world.

• Numerous digital dementia screening tools are entering clinical practice at blue chip health systems, three months after I wrote about this market’s shifting sands. This comes on the heels of CMS announcing nearly 400 providers participating in the GUIDE model. Next up: neurotech diagnostics? Yes please.

• While Pharma’s uptake of neurotech for drug discovery is a step behind, I think the emergence of blood testing for Alzheimer’s Disease could slow down adoption in that segment. Hopefully I’m wrong. Parkinson’s, M.S., ADHD, and other CNS areas are seeing more promising evidence every week, and a fantastic new paper from DiME and Tufts Center for the Study of Drug Development suggest strong ROIs could hasten adoption of digital endpoints in clinical trials.

• Conference season doesn’t care about your summer plans, with AAIC, Neuromodec, and Neuraseed’s BCI Expo this week. Check out (and let me know about) other upcoming events, live and virtual.

And stop me if you’re heard this before, but we’ve got: Fresh Funding. Clearances. New Products. Commercial Hires. Acquisitions. Partnerships. Market Uptake.

Not to mention: Origami ECoG! Eyelid Neurotech! Podcasts, Videos, and even a Book Club. Semantic Debates. Neuroethics Discussions. And refreshingly, several company blog posts, articles, and other written resources that are original and informative.

Finally, I’m excited to share our very first Sponsored Article below.

I’ve put a lot of thought and energy into this publication; While I am continually seeking ways and means ($) to keep it going, it’s of paramount importance to me that A) any sponsored pieces are clearly marked as such, and B) they don’t detract from your reading experience, i.e. they are relevant to your interests in this space.

So, as always, feedback is appreciated, along with your ideas for collaboration.

All good? Good. Now, let’s dive in.

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Sponsored Article

I recently collaborated with the a2 Collective, who you can learn more about here. a2 operates as an NIH/NIA funded accelerator for innovations in AI x Aging.

This piece was actually my second collaboration with a2, following a recap of their spring Symposium. They paid me to write those, but not to say this: Check them out! Their work is excellent, patient-centered, and forward thinking, through and through.

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Funding

• RetiSpec Closes $10M to Advance Commercialization of its AI-Driven Eye Test for Detection of Alzheimer's Disease (PR Newswire)

• Alto Neuroscience Receives $11.7m Funding Award from Wellcome Trust to Accelerate Development of ALTO-100 in Bipolar Depression (Alto)

• Imperative Care completes $150M Series E, Shacey Petrovic becomes vice chair of board (MassDevice)

• Syntropic raises €1.1 million from The Austrian Research Promotion Agency (Tech EU) ​​

• WISE Completes  €25 million Financing Round to Accelerate Development of Heron Lead for Spinal Cord Stimulation (EIN Presswire)

• Indian Startup Neuphony Closes “multi-million dollar seed round” to launch Wearable Neurotech Device (EIN Presswire)

• Seven Neurotech Startups receive funding as part of UK Biomedical Catalyst Accelerator (Innovate UK)

  • Congrats to Samphire, ESP Diagnostics, Mind Health AI, Mindspire, Mint, NEUROBITE, and NeuroVirt !

• Rice neuroscientists to build state-of-the-art neural recording system with $2.9m NIH grant (Rice)

• CraniUS Gains $1 Million in Maryland State Grant to Advance its Neurotechnology Platform (Medical Product Outsourcing)

• Battelle wins five-year, $22 million contract through DARPA’s Cornerstone program, for “Stopping Brain Injury Before It Starts” (Battelle)

• Balancing Act: How Do Investors Weigh Founders Versus Markets in Medtech and Healthtech Venture? (LSI)

  • Note: Do you have opinions and perspectives on “Medtech” vs “Neurotech?” I want to hear from you!

Commercial

• Precision Neuroscience hires Jayme Strauss as Chief Clinical and Commercial Officer, and Mike Kaswan as Chief Financial Officer (Globe Newswire)

• Jogo links up with Mayo Clinic to develop AI-powered DTx for tremors (MorningStar  |  First Word Health Tech)

• Beacon Biosignals Announces Strategic Collaboration with Skye Bioscience to Integrate Sleep Quality and Sleep Apnea Endpoints in CBEYOND™ Phase 2 Trial of Nimacimab for Obesity (Beacon)

• Inspire Medical COO steps down to take on CEO role at another medtech company (MassDevice)

  • Note: Interesting times at Inspire, who faced a device recall earlier this month before posting nearly $200m in sales for the most recent quarter for their sleep apnea device

• Neuralink's value jump leaves some Musk employees itching to cash out (Reuters)

• Startup aims to tackle ‘undruggable’ neuro targets with tech from Kevan Shokat's UCSF lab (Endpoints News)

• SPR: 30,000 Patients Treated with SPRINT PNS (SPR)

  • SPR also published new data at ASPN

• Cleveland Clinic Broadly Deploys Cognitive Screening Tool from spinout, Qr8 Health, as a Standard of Care for Medicare Patients (Cleveland Clinic)

• LANGaware awarded Patient Engagement Solutions agreement with Premier, Inc. for Early Detection of Cognitive and Behavioral Health Diseases (LANGaware)

• Linus Health Acquires Together Senior Health to Expand its Platform to Better Serve Patients and Providers with End-to-end Workflow Capabilities (Linus Health)

• VUMC set to debut focused ultrasound treatment for tremors, Parkinson’s disease (VUMC)

• MintNeuro launches EXPLORE to extend advanced neural implant applications with Innovate UK Biomedical Catalyst funding (Mint Neuro)

• Tivic Health Expands Intellectual Property Portfolio (MorningStar)

• NeuroCatch and Crankworx Join Forces to Prioritize Brain Health in Mountain Biking Competitions (Neurocatch)

• BrainLit and NESTRE Forge Partnership to Optimize Human Health and Performance Environments (BrainLit)

• Cognito Therapeutics Announce OVERTURE I Study Demonstrated Significant Time Savings Using Composite Measures of Function and Cognition (Business Wire)

• New Product Applications: C. Light Launches First-of-Its-Kind Retitrack (Retinal Physician)

• Boston Scientific warns some Wavewriter Alpha SCS systems may stop and reset while charging (MassDevice)

• Corticare acquires Arium EEG to expand EEG tech personnel (LinkedIn)

• Galvani Bioelectronics announces clinical progression of its therapy platform and addition of new Chief Medical Officer (Galvani)

• Upscript Health partners with Spark Biomedical on telehealth support for Sparrow Opioid Treatment (LinkedIn)

• Neuromodulation Vendors Target Diabetes Pain (Neurotech Reports)

Regulatory & Reimbursement

• Jeff Shuren, medical devices head at FDA, to leave the agency (STAT)

• California Medicaid Adds TMS Access for 14.8 Million Adolescents and Adults (Neuronetics)

• UK’s NICE backs Qbtech to diagnose ADHD in children (First Word Health Tech)

  • Qbtech to Provide $4M of Free FDA-Cleared ADHD Testing for Former Done Patients Seeking Re-evaluation (Business Wire)

• Nervonik receives regulatory approval to start First-in-Human study with Novel Peripheral Nerve Stimulation Technology for Chronic Pain (PR Newswire)

• Subtle Medical Receives FDA-Clearance for Industry First AI-powered Synthetic Imaging Software  (SubtleMedical)

• Stryker wins FDA nod for spine guidance software (MassDevice)

  • Also: As per their latest 10-Q, Stryker pulled in $327m in Neurovascular and $416m in Neurocranial sales in Q2 2024. And, they’re betting big on M&A…

• NeuroLF receives FDA clearance in the US (Positrigo) 

• Is FDA Breakthrough Device Designation Worth It? You might be surprised by the answer - featuring Caroline Aguilar of InBrain (LSI)

• 2025 Medicare Physician Fee Schedule Proposed Rule: Updates to Physician Payment System (NANS) 

• First-in-the-World Neural Data Protections Law Goes Into Effect (Colorado House Dems)

• BRAIN issues funding opportunity for exploratory intracranial human neuroscience research (NIH BRAIN)

• BRAIN at 10: A View from the National Institute on Aging (NIH BRAIN)

• US Medicare “continues to undervalue” stroke thrombectomy, new research shows (NeuroNewsInternational)

Industry News

• Synchron Announces First Use of Apple Vision Pro with a Brain Computer Interface (PR NewsWire)

• InBrain: Next-Gen Brain Implant Uses a Graphene Chip A brain-computer interface from the startup Inbrain could help Parkinson’s patients (IEEE)

• Paradromics expects to test its brain chip on humans next year (QZ)

• Why some BCI should still be called BMI (Nature)

  • Note: I agree with the sentiment of the above perspective (“words matter”) but not the conclusion. “BMI” is already taken (body-mass index) and mainstream media has embraced BCI. So let’s just go with BCI, no? On the flipside, calling just any neurotech “BCI” is not helpful either. An example?

• Brain-Computer Interfaces: The Latest Breakthroughs and Developments (NewFund)

I disagree that these are all “BCI.” Newfund’s full presentation is here.

• First Reported Series of Cerebral Angiography Performed at an Outpatient Center: Safety and Satisfaction Results (Neurosurgery)  

• Barrow Neurological Institute's CEO and President, Dr. Michael Lawton Shares His Insights and Vision (MDM2)

• Center for Brain Health & Aging Innovation releases Impact Report (CABHI)

• State of the Field Report (FUS Foundation)

  • Note: This report is da bomb. Do people still say that? See pp 26-35 for Neurology’s Indication pipeline by stage. Across all indications (including non-neuro), 2023 funding was down compared to 2022 by nearly a quarter billion dollars, while federal funding hit an all time high ($801m) led by NCI. But FUS Foundation concludes “The ecosystem is growing. There are more companies to invest in, and we will start to see the investment rounds becoming larger as the companies in the field mature.” (p 380)

    

    Investment landscape for Focused Ultrasound (See section starting p 373)

• Assessing the Risks and Safety of Neuromodulatory Transcranial Focused Ultrasound (tFUS) (by Luke Lamontagne at Prophetic)

• Sinaptica On Precision Neuromodulation To Combat Alzheimer’s: ‘No Drug Dares Go After Moderate Patients’ (Citeline)

• Saluda announces presentation of two chronic pain biomarker-based analyses at ASPN 2024 (NeuroNews)

• Kernel: Reliability of brain metrics derived from a Time-Domain Functional Near-Infrared Spectroscopy System (Nature)

• Mapping the Brain: Google Research (Google)

• “Flow” Transcranial Direct Current Stimulation (tDCS) for Depression Treatment in a Primary Healthcare General Practice—An Open-Label Cohort Study Measuring Montgomery-Åsberg Depression Rating Scale (MADRS-S) Outcomes (Open Journal of Psychiatry)

• New Study Evaluates Use of the Nerivio® REN Wearable for Treatment of Migraine in Children Under the Age of 12 (MorningStar)

• Robotics in Neurovascular Care: perspectives & roundup (Tom Salemi on LinkedIn)

• Medicare has a new pilot program to help people with dementia. Here’s how it works (Fortune)

• Two new dementia risks identified by major report (BBC)

• Modality.AI Celebrates Milestone with 100th Peer-Reviewed Publication: Cognitive Symptoms in Cross-Sectional Parkinson Disease Cohort Evaluated by Human-in-the-Loop Machine Learning and Natural Language Processing (Neurology Clinical Practice)

• RetiSpec’s AI-Driven Eye Test Detects Alzheimer’s Early (Startup Health)

• Groundbreaking U of Utah TBI Study with Vielight Neuro | The Effect of Intranasal Plus Transcranial Photobiomodulation on TBI (VieLight)

• Parkinson’s Disease Drug Therapies in the Clinical Trial Pipeline: 2024 Update (IOS Press)

• Assessing the net financial benefits of employing digital endpoints in clinical trials (Clinical & Translational Science)

  • “In phase III base case analyses, the increase in eNPV ranged from $27 million to $40 million, with returns that were four to six times the investment. Digital endpoints do not simply promise to address some of the greatest challenges facing today's clinical trials enterprise but are actively capturing this value today.”

Assessing the net financial benefits of employing digital endpoints in clinical trials (graphics from paper’s appendix)

• ShiraTronics’ neuromodulation device reduces migraine frequency (Clinical Trials Arena)

  • “ShiraTronics raised $5m in an August 2023 funding round. Spun off from the accelerator NuXcel, the Brooklyn Park-based company raised $33m in Series A financing in 2019.”

• Utility of Helius’ Neuromodulation System to Treat Gait in Multiple Sclerosis (Neurology Live) 

• CIONIC Receives Multiple Recognitions in Fast Company’s 2024 Innovation by Design Awards for its Digital Therapeutic Benefiting Patients with Disabilities (Business Wire)

• Wispr: Creating the future of human-technology interfaces (LinkedIn)

• 7 Neurotech Companies to Know (Mass Device)

• Podcast: Seamless Neural Interfaces with Nicky Driscoll of NeuroBionics (MedTech Impact)

• How do Neural Interfaces Work? by Asvin Soundarajan (Wisear)

• The tongue controlled touchpad helping those with physical impairments access the online world (BBC)

• Why Five Spinal Cord Injury Organizations Teamed Up to Launch a New Venture Philanthropy Fund (Inside Philanthropy)

• Blink Energy’s eyelid wearable can predict and alert to epileptic seizure (Israel 21C)

Blink’s 0.4 grams (0.014 ounces) device is “less than half the weight of a paperclip." After 4 years of R&D, “Blink Energy has yet to test its device on epileptic patients.”

Events & Community

• Podcast: Where there’s Blood, there’s Signal featuring ‍Sumner Norman of Forest Neurotech, Ryan Field of Kernel‍, Mary Lou Jepsen of Openwater (Paradromics)

  • I rarely listen to podcasts but caught this one during a long drive. It’s awesome! Four rockstar founders discuss science, engineering, business, leadership, strategy, regulatory, and more. Tune in to find out who was daydrinking. To join along, take a sip every time you hear “laser.”

• Neurotech News #3: Macro-Neuro-Tech (Dynamic Neurotech)

• August Book Club: Battle for Your Brain by Nita Farahany (Chanel Matney)

• Kaleida Capital’s Q2 Update (Kaleida Capital)

• Building Cybiosis Intuition: Essential Elements (Neurotech Nerds Nexus)

  • “Cybiosis measures how well a technology integrates with humans, considering physical, economic, social, and emotional factors. 

• Earning Trust in Neurotech (MedCityNews)

• Recap: Future of bioelectronics takes center stage at Rice Global Paris event (Rice)

  UPCOMING EVENTS & WEBINARS

• Aug 2: Neuraseed BCI Expo - Virtual (Neuraseed BCI)

• Aug 6: 2024 Neurotech Commercialization Workshop - Zoom (Neurotech Reports)

• Aug 5-7: Montana State University to host annual workshop on BRAIN-funded multiphoton characterization resource - Bozeman, MT (NIH BRAIN) 

• Aug 10-11: BMI Summit - Morgantown, WV (BMI Summit)

• Aug 28: Harnessing AI in Neuromodulation - Webinar (NANS)

• Sept 1: The International BCI Award by g.Tec - (LinkedIn)

• Sept 10 - New Diagnostic Tools to Predict Symptom Improvements in Personality Disorders -Webinar (BBR Foundation)

• Sept 12: Financing Your Neuromodulation Practice Date - Webinar (NANS)

• Sept 12, 18, 27 - Brainstem Workshop Applications Open. 12th is Virtual, 18th is in Boston, 27th is in SF (SpecTech)

• Sept 18: iBCI-CC Inaugural Meeting - Silver Spring, MD (Jennifer French)

• Sept 19-20: FDA+NIH BCI Clinical Outcomes Assessment Workshop - Silver Spring, MD (FDA)

• Sept 19: Brainbox Initiative Conference 2024 for Non-Invasive Brain Stimulation - London (BrainBox)

• Sept 23 - 27, 2024,  INCF ASSEMBLY 2024 Austin,TX (INCF Neuroinformatics Assembly)

• Oct 3-4: Neurotechnologies for Targeted Plasticity: A Practical Introduction to H-Reflex Conditioning and Paired Associative Stimulation” and the related Symposium “Targeted Neuroplasticity to Enhance Rehabilitation.” Chicago, IL (Shirley Ryan AbilityLab)

• Oct 28-30: Biofuture - NYC (Biofuture)

• Nov 1-2: New York BCI Symposium - NYC (Mt. Sinai Biodesign)

• Nov 6-7: Neurotech Leaders Forum - SF (Neurotech Reports)

📺NEUROTECH TV

• Wandercraft exoskeleton used in Olympic torch relay (MassDevice)

• A neurological disease stole Rep. Jennifer Wexton's voice. AI helped her get it back (NPR)

• ONWARD Medical Keynote at HLTH Europe, June 2024 (ONWARD)

• Categorizing Biomarker Criteria for Alzheimer Disease Diagnosis and Staging: Clifford R. Jack Jr., MD (Neurology Live)

• Spark Biomedical: Origin Story & Product Vision

• Idea: Movement Glasses for people with Parkinsons (Ben Stecher | Full Video)

• Building The Matrix: BCI-XR-AI - Sam Hosovsky of uCat lays out why “coupling state-of-the-art BCIs with VR maximizes their value to people with paralysis” (Foresight Institute & Protocol Labs)

Ethics and Society

• Science Corp: Brain-Computer Interfaces and Patients' Rights: Some Key Principles (Science)

  • Note: A+. Every implantable device startup should communicate like this.

• Putting Ethical Guidelines in Place for Portable MRI Research (Dana Foundation)

• Effects of the first successful lawsuit against a consumer neurotechnology company for violating brain data privacy (Nature)

• Mind-reading in AI and neurotechnology: evaluating claims, hype, and ethical implications for neurorights (AI and Ethics)

• The ethical landscape of human brain organoids and a mindful innovation framework (Nature Reviews Bioegineering)

• Bridging the gap between neurotech and law (LSJ)

• Wildfire smoke may increase the risk of dementia, study finds (Guardian)

• Correlations of Socioeconomic and Clinical Determinants with United States County-Level Stroke Prevalence (Annals of Neurology)

• Record numbers of people in England given dementia diagnosis in past year (Guardian)

  • “This is the result of a range of structural barriers, including cultural differences, difficulties in seeing a GP, long waits for memory assessment, lack of post-diagnostic support, insufficient scanners and problems travelling to appointments.”

• Optimist? Pessimist? How a dose of techno-pragmatism can make tech the good guys again (Impact Alpha)

• This Is Literally Your Brain on Drugs (NYTimes)

Research

• UW model shows cortical implants like Elon Musk’s Blindsight unlikely to ‘exceed normal human vision’ (Paper  |  Summary)

• Accelerated transcranial magnetic stimulation: A pilot study of safety and efficacy using a pragmatic protocol (Brain Stimulation)

• Utilization and outcomes of transcranial magnetic stimulation and usual care for MDD in a large group psychiatric practice (BMC Psychiatry)

• Antidepressant class and concurrent rTMS outcomes in major depressive disorder: a systematic review and meta-analysis (eClinicalMedicine)

• Safety and Efficacy of Staged, Bilateral Focused Ultrasound Thalamotomy in Essential Tremor: An Open-Label Clinical Trial (Jama Neurology)

• The road ahead to successful BBB opening and drug-delivery with focused ultrasound (Journal of Controlled Release)

• Towards enhanced functionality of vagus neuroprostheses through in silico optimized stimulation (Nature Communications)

• Voice signals database of ALS patients with different dysarthria severity and healthy controls (Nature Scientific Data)

• UC San Diego researchers use non-invasive technique to record involuntary nervous system (Eureka Alert)

• Potential of Photoelectric Stimulation with Ultrasmall Carbon Electrode on Neural Tissue: New Directions in Neurostimulation Technology Development (Advanced Functional Materials)

• New Program Enables Home-Based Transcranial Stimulation (MirageNews)

• Transcranial photobiomodulation: an emerging therapeutic method to enhance brain bioenergetics (Neuropsychopharmacology)

• Visual Impairment, Eye Conditions, and Diagnoses of Neurodegeneration and Dementia (Jama)

• Non-invasive Transcutaneous Spinal Cord Stimulation Programming Recommendations for the Treatment of Upper Extremity Impairment in Tetraplegia (Neuromodulation)

• Origami-inspired soft fluidic actuation for minimally invasive large-area electrocorticography (Nature)

We’ve come a long way from paper cranes. Source

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