☀️ Greetings, Neurotech Friends 🍂
Crunchy leaves and cozy sweaters are here as the heat finally gives way to autumn. With hurricanes abating and political storms abiding, it’s the perfect season to curl up with a good book neurotech paper and your favorite pen.
But if you’re all about that click-and-scroll life, you’ve come to the right place.
Commercial highlights from the last fortnight: A new funding model in the UK, Morgan Stanley’s BCI report, FDA’s deepening industry engagement, IDEs for iota and SetPoint, new neurotech for sale at Science and other companies, a boatload of fresh publications to fill your gourd, a HIFU health system spinout, and more.
Beyond business: a stunning fruit fly connectome, bioelectronic sutures, pain biomarkers and DBS vs. HIFU are some notable research that’s just hit the web. In the real world - sort of - a cascade of neuroethics commentary is worth a scan, at state, national, and global levels. And for a field dedicated to helping those who’ve been historically underserved by medical innovations, I’m excited to curate new resources focused on expanding neurotech to broader, more diverse audiences. Including one pigeon.
Before you dive in, please take a moment to check out our latest articles below, too. These include a double click into the Finance Bros’ math on BCI markets, a thoughtful essay from my friend Dr. Brock Pluimer on what we owe patients, and a supremely nerdy neuroimaging strategy summary based on Alto’s pioneering work in precision psychiatry and drug development.
I’ll see some of you on the East Coast in a couple of weeks for Biofutures and Mt. Sinai’s BCI Summit. And yes, I’m working on my neurotech Halloween costume.
As always, please reach out with questions, ideas for collaboration, or anything at all.
🎃Recent Analysis
ICYMI: Here are three new articles we’ve published over the last two weeks.
Please help me surf the algorithms by clicking the heart button and sharing with your network! I don’t write for clicks, but every click does make a difference... 🖰🧀
Funding
ShiraTronics Raises $66 Million in Oversubscribed Series B Financing to Advance Pioneering Treatment for Chronic Migraine (PR Newswire)
Holobiome, a Microbiome Platform Startup Targeting the Gut-Brain-Axis, Closes Oversubscribed Seed Round (PR Newswire)
From Sept: BrainsWay raises $20m in Purchase Agreement from Valor Equity (Seeking Alpha)
Nyxoah Raises $27 Million through its At-the-Market Offering (Nyxoah)
CeriBell, Inc. Prices $180m Initial Public Offering (Ceribell | Massdevice)
Neurosom, Inc. files form C for “Electric Sleep Therapy” (SEC)
From Sept: Route 92 Medical raises a new $50 million extension from Novo Holdings to previously announced oversubscribed Series F (Route92)
Carnegie Mellon Lands ARPA-H Award for Implantable Bioelectric Medicine Project (CMU)
BRAIN Initiative RFA's Reissued: New Technologies and Novel Approaches for Recording and Modulation in the Nervous System (R01), and Optimization of Instrumentation and Device Technologies for Recording and Modulation in the Nervous System (U01)
Convergent Research Announces Collaboration with UK’s ARIA, Call for Proposals in Spring 2025 (Convergent)
Eight Scientists, a Billion Dollars, and the Moonshot Agency Trying to Make Britain Great Again (Wired)
Commercial
Brainsway Announces 15 DeepTMS systems sold in Taiwan and South Korea (Yahoo)
Noctrix Health Announces Favorable Inclusion of Nidra Tonic Motor Activation (TOMAC) Therapy in New American Academy of Sleep Medicine (AASM) Clinical Practice Guidelines for Restless Legs Syndrome (RLS) (AccessWire)
Route 92 Medical files patent infringement lawsuit against Q’Apel over catheter tech (Mass Device)
Gary Kurdziel Joins Sense Neuro Diagnostics as Executive Vice President, Chief Commercial Officer (Sense)
PathMaker Neurosystems Appoints Industry Veteran John Fletcher as Chairman of Company’s Board of Directors (Pathmaker)
Resilience Lab Expands Care Delivery for Treatment-Resistant Depression and Other Moderate and Severe Mental Illnesses with the Acquisition of Options MD (PR Newswire)
IDUN Announces Launch of IDUN Guardian (LinkedIn)
ONWARD® Medical Signs Agreement with CEA for Exclusive Rights to Clinatec’s WIMAGINE® BCI (ONWARD)
New Scale Technologies Announces Delivery of Modular Insertion Systems to Allen Institute—Next Generation Silicon Probe Insertion System is Now Available (New Scale)
Science Announces New Tools & Other Updates (Max Hodak)
“Modern Tech Stack for Neural Engineering”: Axon probes, the SciFi headstage, the Synapse Protocol, and Science Nexus.
SciFi: Ruggedized, WiFi-Enabled Synapse-Compatible Headstage
Synapse: Flexible, Powerful Standard API for Neural Interface Devices
PRIMA: Prioritizing the Science Eye and PRIMA
Regulatory
FDA Grants iota Biosciences IDE Approval for First-In-Human Early Feasibility Study with Implantable Bladder Device (PR Newswire)
SetPoint Medical Receives FDA’s IDE Approval for U.S. Pilot Study of Neuroimmune Modulation Platform in Adults with Relapsing-Remitting Multiple Sclerosis (SetPoint)
Next Important Milestone Reached for First-in-Human Implantation of the CorTec Brain Interchange System as a Therapeutic Brain-Computer Interface (CorTec)
Arrayus Announces Health Canada Approval of its Focused Ultrasound Therapy System (PR Newswire)
Fibroids was one of INSIGHTEC’s first applications, too…see this pair of articles for more details:
SRI spin-off company, Arrayus, announces Health Canada approval of its focused ultrasound therapy system (Sunnybrook)
Behind the Research: How a next-generation helmet could revolutionize focused ultrasound (Sunnybrook)
FDA’s Center for Devices and Radiological Health (CDRH) Expands Total Product Life Cycle Advisory Program Pilot (FDA), publishes Engagement Tips
DATAcc by DiMe Awarded FDA Grant to Boost Use of Sensor-Based Digital Health Technologies in Clinical Trials (PR Newswire)
A Recap of the FDA’s Final Guidance for Decentralized Clinical Trials (DCTs) (Lindus Health)
PhotoPharmics Announces First Subject Completes FDA Pivotal Clinical Trial for the Celeste Device in Parkinson’s (PhotoPharmics)
Biden Signs 2 New Laws to Protect and Expand ‘National Alzheimer’s Project’ (Being Patient)
The number of AI medical devices has spiked in the past decade (Medtech Dive)
In the last 12 months, the companies who received authorization under “Neurology” include: Brainlab, ClearPoint Neuro, Epitel, Holberg EEG, Empatica, Beacon Biosignals, Oxehealth, Enovis
📺Neurotech TV
Total Product Lifecycle Advisory Program (TAP) Engagement with Device Developers (FDA)
I Missed SfN 2024 but my goal is to be this unflappable next year.🪽
J&J MedTech’s John Murray and Dr. Berenstein on the early evolution of neurovascular treatments (DeviceTalks)
Making Deep Brain Stimulation Minimally Invasive with MJ Antonini and Nicki Driscoll of NeuroBionics (FocalPoint Partners)
Adaptive DBS, Symptom Tracking, and Exercise — Living with Parkinson’s Meetup: September 2024 (Davis Phinney Foundation for Parkinson's)
Creating more independence for those living with ALS (Video)
Giving the Voice Back: Speech Neuroprosthesis Meets Avatar (Neurocareers)
Industry
Calyx and Invicro rebrand as Perceptiv (PR Newswire)
Rune Labs’ StrivePD Nearly Halves ER Visits for Parkinson’s Patients in Program with Kaiser Permanente (PR Newswire)
To paraphrase our outgoing President: This is a BFD. Value-based care built on neurotech & digital health could save real money. Speaking of Medicare…
Annual Wellness Visits and Early Dementia Diagnosis Among Medicare Beneficiaries (Jama | Editorial)
Penn Medicine, Rockefeller Neuroscience Institute and Precision Neuroscience Unveil Breakthrough Neural Implant Data at the 2024 Congress of Neurological Surgeons Annual Meeting (Biospace)
Precision Neuroscience: Breakthrough in Brain–Computer Interface Technology: A New Era of Neural Decoding at the Society for Neuroscience Annual Meeting, Neuroscience 2024 (Globe Newswire)
Sonera: Magnetic Sensing for Human-Computer Interaction (Blog | Preprint)
FUSMobile’s NeurolyserXR: Focused Ultrasound for Sacroiliac Joint Pain Clinical Trial (FUS Foundation)
Enhancing ALS Research with the DuoMAG MP Dual TMS System (BrainBox)
What does it take to add new digital biomarkers to health wearables? (DHI)
Synaptrix wins first place award at NYU Entrepreneurs Festival (LinkedIn)
Tivic Health's Non-Invasive Cervical Vagus Nerve Stimulation Approach Wins Study Approval from Feinstein Institutes’ IRB (MPO Mag)
Cogniscreen launches, announces acceptance into Startup Health Alzheimer’s Moonshot (LinkedIn)
A scoping review of remote and unsupervised digital cognitive assessments in preclinical Alzheimer’s disease (medRxiv)
Helius Medical Technologies, Inc. Announces Positive Preliminary Results of the PoNSTEP Study (Biospace)
Development and Evaluation of a Real-Time Phase-Triggered Stimulation Algorithm for the CorTec Brain Interchange (IEEE Xplore)
Neurolief Presents Study Results of Proliv™Rx Brain Neuromodulation Therapy for Treating Major Depression (PR Newswire)
Lisnom Health “exits stealth” and launches spinal cord transplant therapy (Longevity.Tech | Study)
Can flashing lights stall Alzheimer’s? What the science shows (Nature)
Spotlight On Neuronic: An Interview with Co-Founder Liam Pingree (Invenia Group)
Controlling computers just by thinking (Lenovo & OpenBCI)
Spark Biomedical: No bandage needed: electrical impulses to major nerve help stop bleeding (Nature)
Still can’t stop the bleeding? See bioelectronic sutures in “Research,” below.
Neurobionics: Multifunctional Implant Performs Variety of Functions (Neurotech Reports)
See Focalpoint Partners chat with Neurobionics in “Neurotech TV,” above.
UCLA claims new patent on “wirelessly-powered battery-free neural sensing, enabling closed-loop neuromodulation with implantable devices” (LinkedIn)
This Earbud Could Rival Neuralink. Its Inventor Just Needs to Build a Business First (Inc)
A good article about the challenging path to scale DTC neurotech.
What is wearable neurotech and why might we need it? (TechCrunch)
Could new implants treat depression, dementia and chronic pain? (BBC)
The full list is now anchored. New webinars and events added regularly (though, I’ve fallen behind… please share your upcoming events going into 2025!)
🗽Hello, New York! 🎃
I’ll be moderating a panel of brilliant speakers following Dr. Kevin Tracey’s morning remarks at the Biofuture Conference Oct 28-30 in NYC. Register now with code 2024BFINVITE to save $95. That’s a lot of Halloween candy, folks.
Do you even BCI? I’ll be Mount Sinai’s Symposium 11/1-2. Let’s find time to interface.
Ethics & Society
Beyond neural data: Cognitive biometrics and mental privacy (Neuron)
Impact, opportunities and challenges of Neurotechnology with regard to the promotion and protection of al human rights (UN Human Rights Council)
From our friend Dr. Rommelfanger at IONX - “You can also want the comments from member countries (starting at 1.21) from the UN HRC 57th session here.”
Neurotech is Changing the Way We Treat Disease and Understand the Brain (Dana Foundation)
A new frontier of data privacy in the US - your brain (Thomson Reuters Foundation)
The regulation of neurotechnology: the neurorights bill in Mexico (Lancet Psychiatry)
The Future of Schizophrenia Care: A Lived Experience–Based Call for Innovation (Biological Psychiatry)
Neuroscience: Deciphering the brain's mysteries (JHU)
Exploring the Bidirectional Relationship Between Artificial Intelligence and Neuroscience: Proceedings of a Workshop (NASEM)
Human Flourishing in the Age of Computational Neuroscience (Trip Report)
Electroconvulsive Therapy Is Not What You Think It Is (UW Medicine)
Why can’t more organizations publish stuff like this?
A new law in California protects consumers’ brain data. Some think it doesn’t go far enough (MIT Technology Review)
Patient files suit against whole-body MRI provider Prenuvo claiming radiologist overlooked signs of stroke (Radiology Business)
fNIRS Brain imaging at the fair with Ka Ip (The Transmitter)
Diversity, Equity & Inclusion in Neurotech
Go Vote. But DEI isn’t politics. Neurotech Futures is a Big Tent. All are welcome!
UC Berkeley’s Neurotech Collider Lab launches ENSURE Program to Address Healthcare Equity with Support from Dana Foundation (Berkeley)
Accounting for Diversity, Inclusion, and Accessibility in Early-Stage Neurotechnology Research (Gen Biotechnology)
Inclusive rehabilitation and assistive technologies development: An exploration of considerations, principles, and stakeholder engagement (Journal of Rehabilitative and Assistive Technologies Engineering)
Diversity in Neurotech: October 17 - (NeuroTechX LDN and Samphire Neuroscience)
Research
After a Decade, Scientists Unveil Fly Brain in Stunning Detail (NYTimes)
🎸LinkedIn says this Brain is Pretty Fly (for DrosophilAI). See also this table that Google published that puts the fly connectome into context:
(Im)poster syndrome: preparing for Neuroscience 2024 (Peter Zhegin)
A comprehensive review of advanced focused ultrasound (FUS) microbubbles-mediated treatment of Alzheimer's disease (Heliyon)
Potentiation of cortico-spinal output via targeted electrical stimulation of the motor thalamus (Nature)
Brain’s waste-clearance pathways revealed for the first time (OHSU)
Adding Vagus Nerve Stimulation to Training Sessions May Boost How Well Sounds Are Perceived (NYU Langone)
Global effort to map the human brain releases first data in BICAN Rapid Release Inventory (Allen Institute)
Investigating the interaction between EEG and fNIRS: A multimodal network analysis of brain connectivity (Journal of Computational Science)
Clinic-Based Assessment and Treatment Strategies for Functional Neurologic Disorders (Practical Neurology)
Neurosurgical Focus Publishes Special Issue on Focused Ultrasound (FUS Foundation)
Advances in Neuromodulation for Essential Tremor (Practical Neurology)
Representation of Verbal Thought in Motor Cortex and Implications for Speech Neuroprostheses (BioRxiv)
Evoked response signatures explain deep brain stimulation outcomes (medRxiv)
Johns Hopkins Department of Neurology is recruiting participants for a clinical trial investigating Blackrock’s Neuroport implantable brain-computer interface (iBCI), to help improve communication for patients with ALS, brainstem stroke and other causes. (JHU)
A bioabsorbable mechanoelectric fiber as electrical stimulation suture (Nature Communications)
Deep Brain Stimulation of Symptom-Specific Networks in Parkinson Disease (Neurology Journal)
Can Neuromodulation Improve Sleep and Psychiatric Symptoms? (Current Psychiatric Reports)
Beyond pain privacy and pain meters: a new vision for pain biomarkers (Frontiers in Pain Research)
Tetra codes: A precise, concise notation system for scalp-based neuronavigation (Brain Stimulation)
Making progress with peripheral nerve interfaces (UNSW)
👋🏽 Sponsors: 2025 budgeting season is here. Help me help you! Let’s talk.
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