Neurotech Notables #17: Sept 2024
BCI Blitz, Consumer Markets, Neuroethics News
Greetings, Neurotech Movers & Shakers! And welcome, New Readers 👋🏽
We’ve got a LOADED edition for you today, so buckle up. The last two weeks was light on fundraising news, but heavy on everything else.
Let’s start with Brain-Computer Interfaces. Fresh off the iBCI-CC’s inaugural meeting, Synchron just published results from their COMMAND trial today at the Congress of Neurological Surgeons meeting, where BCI takes center stage with Elon Musk talking about Neuralink’s second product, Blindsight, which just gained FDA Breakthrough designation.
Meanwhile, INBRAIN just implanted the first graphene-based BCI in a human patient, while ONWARD completed their third BCI implant on the back of publishing H1 2024 updates. BCI Pioneer Jen French won a well-deserved award for her critical work leading this field into the future. If you want to learn more about the history and state of clinical trials in BCI, a fantastic new paper just dropped that you should read (or, at least skim and peruse the pretty pictures.)At the other end of the spectrum in consumer neurotech, Meta announced a new EMG “neural interface” as part of their metaverse push, while Neurable and Wispr announced product launches that have been years in the making.
Summer’s over, but Neuroethics is heating up: California just approved a neurorights bill, following a similar bill in Colorado. As the tech capital of the world and a policy frontier, California’s actions are sure to broaden important discussions and debates worldwide. Meanwhile new articles about “device abandonment,” conflict of interests, and industry guidance continue emerging.
Brain health stories related to Professional Football, Pregnancy, Epilepsy, Dementia, and other areas are steadily pushing Neurotech into the mainstream. From the UN’s annual General Assembly to televised stories reaching living rooms worldwide, audiences are tuning in to the latest developments from diagnosis to treatment, data to devices, and patients to policies.
And as usual, scroll down for a rich roundup from the last two weeks of new executive hires, promotions, and appointments, commercial partnerships, research studies, and plenty of exciting industry updates spanning fresh clinical data, ecosystem fortification, leadership interviews to watch, and original thought leadership.
You’ll also see a pair of article collaborations below (with more to come!) and updates about the Bioelectronics panel I’m leading in New York City at the end of October.
Lastly, a personal update after the last edition: We got my dad into a clinical trial and treatment is underway! Thanks for all of your kind messages of support.💓
Regrettably, I won’t be in attendance at SfN next week, but if you are going, feel free to send me your notes and impressions from Chicago! Now, let’s dive in.
Fundraising
Fisher Wallace Labs files offering memorandum (Exhibit A to Form C) (SEC)
ARCH Venture Partners raises $3 billion for a new biotech fund (STAT)
Cordance Medical Receives NIH/NCI SBIR Phase I Grant to Advance Non-Invasive Focused Ultrasound for Brain Tumor Liquid Biopsy in Glioma Models (Cordance) - See Cordance’s new partnership below, too.
Regulatory
Neuralink Gains FDA Breakthrough Designation for Blindsight, BCI-based vision prosthesis (X)
Here’s a good analysis from IEEE, and a bad analysis from a talking head.
See also: A chat with Neuralink’s Science Officer in NeurotechTV, below.
FDA Grants Aesculap Breakthrough Device Designation for the M.scio® Non-Invasive Telemetric Pressure Measurement System (Aesculap)
FDA OKs Forest Devices' SignalNED EEG for Brain Analysis (MPO)
Mindstate Design Labs receives both FDA & EMA approval to begin human trials for neurotech platform for designing altered states (LinkedIn)
FDA approves schizophrenia drug that could alter how disorder is treated (STAT)
Adhesive cortical device enables artifact-free neuromodulation for closed-loop epilepsy treatment (Science Daily)
Blueprint MedTech continues to fuel the innovation of devices to treat and diagnose conditions affecting the nervous system (NIH)
FDA releases guidance on Decentralized Trials (FDA)
From Dr. Neha Bhutani: “The guidance outlines key recommendations for DCT design, including oversight, remote visits, data acquisition, informed consent, investigational product handling, participant safety, and software use. It also clarifies the roles of sponsors and investigators. The guidance emphasizes that FDA's regulatory standards for DCTs are the same as for traditional trials.”
Commercial
INBRAIN Neuroelectronics Announces World’s First Human Graphene-Based Brain Computer Interface Procedure (BusinessWire)
Cumulus Neuroscience promotes Tina Sampath to Interim CEO (LinkedIn)
Prophetic hires Christopher Bawiec, formerly of Openwater, as Head of Ultrasound (LinkedIn)
Darmiyan, Inc. Announces Launch of Groundbreaking BrainSee Platform for Alzheimer's Testing (PR Newswire)
Predictom Launches Data Catalogue to Enhance Research Collaboration (Predictom)
This collaborative research platform for Alzheimer’s Research involves numerous vendor partners.
Bayer launches new healthy-ageing ecosystem for consumers (EPM)
Neurable Inc. Launches First Smart Brain-Computer Interface Enabled Headphones for Consumer Market (PR Newswire) (CNN)
Consider me skeptical. $700 is way more than I can afford! Can Neurable actually deliver on their promise? Despite global defense contracts and breathless hype for years, their Kickstarter reveals delay after delay after delay on actual shipping. Even after issuing the press release above, the product website is still in “pre-order” with a promise to ship Oct 31. Treat, or trick?
Meta developed a ‘neural interface’ for its next-gen Orion AR glasses (TechCrunch | (NYTimes)
Note: It’s interesting that most mainstream coverage has overlooked the EMG neural interface component of this announcement.
Professor William Bosl of the University of San Francisco Partners with EMOTIV, Quantum Computing Inc. & Purple Point Neurodiagnostics to Advance Brain Health Monitoring (PR Newswire)
NaviFUS and Bracco Join Forces to Revolutionize Brain Disease Treatment (NaviFUS)
ONWARD publishes Half Year 2024 Financial Results and Business Update (LinkedIn)
ONWARD also completed their third BCI implant (Mass Device)
BrainsWay Announces Significant Expansion on U.S. East Coast with 14 Deep TMS devices ordered (SEC)
Axonics Prevails in Patent Infringement Lawsuit with Medtronic (Morningstar)
Dr. Scott Parazynski Joins Advisory Board of NeuroLight, Inc.(EIN Presswire)
Asian Institute of Nephrology and Urology (AINU) selects JOGO's digital therapeutics for non-drug and non-surgical treatments for urinary incontinence and erectile dysfunction (LinkedIn)
Nevro Announces the Launch of HFX AdaptivAI™, the Only AI-Driven Technology in Spinal Cord Stimulation (Nevro)
Tengable Partners with Cortec to restore sensation via miniature implants (LinkedIn)
Flow partners with Boots to make tDCS available to consumers via Online Doctor Service Referrals (LinkedIn)
Business Collaborative for Brain Health Partners with HERO to Launch the Brain Health Best Practice Score for Employers (Morning Star)
Stryker adds devices to remove brain tumors, clots with Nico buy (MedTech Dive)
Axonics Prevails in Patent Infringement Lawsuit with Medtronic (Morningstar)
Microvascular Therapeutics and Cordance Medical Announce Strategic Partnership (Cordance)
Nevro announces launch of “only AI-driven technology in spinal cord stimulation” (NeuroNews)
Wispr launches Flow, a voice AI (Wispr | ProductHunt)
Industry
The state of clinical trials of implantable brain–computer interfaces (Nature Reviews Bioengineering)
Building consensus on clinical outcome assessments for BCI devices. A summary of the 10th BCI society meeting 2023 workshop (Journal of Neural Engineering)
Jennifer French Named Craig H. Neilsen Visionary Prize Awardee (Craig H. Nielsen Foundation)
Synchron Announces Positive Results from U.S. COMMAND Study of Endovascular Brain-Computer Interface (PR Newswire)
Beacon Biosignals announces launch of HEADFIRST basket study (“Home EEG Application and Dreem Feasibility In Research Study”) (Beacon)
SunnyBrook: Exploiting the mechanical effects of ultrasound for noninvasive therapy (Science)
Neuros: Twelve-Month Results from Landmark QUEST Study Published in Neuromodulation (LinkedIn)
Spark Biomedical Launches New Academic Research Fellowship Program Focused on Medical Device Entrepreneurship (Spark Biomedical)
Motif Minds: Unpacking Suicide Prevention Month with Jon Nelson (LinkedIn)
Transcranial Focused Ultrasound (tFUS) is Coming to Brain Health (Owen Muir)
Psyrin and the Future of Vocal Biomarkers in Psychiatry (Owen Muir)
From Blood Tests to Brain Scans: How AI is Revolutionizing Alzheimer’s Research (USC)
Averaging is a convenient fiction of neuroscience (The Transmitter)
Kooth: A public mental health business with software margins? (Hemingway Report)
UChicago Medicine implants first Revi neuromodulation device to improve bladder control (News Medical)
New roadmap to advance UK’s bioelectronics for healthcare through materials innovation (Head Topics)
Spine surgeons weigh Medicare exit amid pay cuts (Becker’s)
Accelerating the design of next-generation neuromodulation systems under tight deadlines (TTP)
French Startup Sensars Is Transforming Diabetic Neuropathy Care to Relieve Pain, Restore Mobility, and Prevent Amputation (Grit Daily)
The new regulation of non-medical neurotechnologies in the European Union: overview and reflection (Journal of the Law & Biosciences)
Lehigh Valley Neuroscience Institute announces availability of INSIGHTEC treatments for Essential Tremor & Parkinson’s Disease (LinkedIn)
Punto Health Offers Personalized Care Plans and Remote Monitoring for People with Dementia (Startup Health)
Neuropathic Pain and Focused Ultrasound (FUS Foundation)
Mark Edwards of ViewMind Inc. Wins Business Worldwide Magazine 2024 CEO Award (PR Newswire)
Altoida’s Vision For Alzheimer’s Care Combines Digital Screening, Blood-Based Tests, New Drugs (Citeline - Registration Required - Part 1 | Part 2)
Strolll’s AR Glasses Rehabilitate Neurological Conditions (Healthcare Digital)
Photobiomodulation: A Promising Light in Stroke Recovery (Neuronic)
MedTech Innovator Announces 2024 Grand Prize and Execution Award Finalists, including Brainspace, Juniper, Neurobionics, and Vonova (Medtech Innovator)
Mind the Sound: Apple’s New Hearing Aids and Other Breakthroughs in Neurotechnology - Issue #11 (Nexstem)
Events
The full list is now anchored. New webinars and events added regularly (please forward me details on any events you’d like to share!)
🗽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.
Bioelectronics: Delivering on the Promise
In the decade since the field of bioelectronic medicine emerged as a potential alternative to pharmaceuticals, over $1.5 billion dollars in private capital has been invested in neuromodulation startups. Panelists will share signals of progress at their companies and discuss challenges, trends, and commercial momentum in the field.
Manfred Franke, CEO & Co-founder, Neuronoff
Yaakov Levine, Head of Research, Setpoint Medical
Shriram Raghunathan, CEO & Co-Founder, Noctrix
Ana Maiques, CEO & Founder, Neuroelectrics
We’ll have the whole body covered: Head, Neck, Torso, & Feet - spanning implanted to minimally invasive and wearable neurotech. It’s going to be awesome. Be there!
I’ll also be at Mount Sinai’s New York BCI Symposium. Reach out to meet up :)
📺Neurotech.TV
For Founders/Operators: Funding a Focused Ultrasound Product (FUS Foundation)
“More than $30 million in capital and at least 5 to 10 years are required to develop a focused ultrasound product.”
iBCI-CC Annual Meeting | 2024 (iBCI-CC)
Helen Mayberg - What is Well? (BrainMind)
My Journey with Dr. Daniel Adams, Chief Scientist for Neuralink (Sikh Foundation)
Podcast: Guy Wagner from Mudra Band meets Cody Rall MD (Youtube)
Research to Reality: Mindr’s Innovative Approach to Cognitive Health - Beta App & Big Vision Updates (Startup Health)
Neuronic: A Breakthrough in Addiction Treatment: Unilateral Light Therapy with Dr. Fredric Schiffer (Youtube)
J&J: Understanding Biomarkers in Alzheimer’s Disease (Youtube)
Ceribell: New tech helps with early seizure detection - New Day NW (King5)
Restoring Movement and Sensation: The Double Neural Bypass | Chad Bouton | Neurocareers 92 Video ( Youtube)
New wearable technology takes us into the minds of babies (PBS Newshour)
Calling all sleuths: What is the product/company featured in this video?
Neuroethics & Society
California Passes Law Protecting Consumer Brain Data (NYTimes)
This article offers a nuanced discussion of these new bills’ limits. Here is the press release from the Neurorights Foundation, who helped architect the bill.
Brain Privacy Rights Are Not Enough—Neurotech Calls for Strengthening Freedom of Thought (Tech Policy Press)
An out-of-warranty battery almost left this paralyzed man’s exoskeleton useless (The Verge)
Beyond neural data: Cognitive biometrics and mental privacy (Neuron)
Q&A: Ethical decision-making around neurotechnology treatments (PSU)
Ethical challenges in translating brain–computer interfaces (Nature Human Behavior)
Picture imperfect: Scores of papers by Eliezer Masliah, prominent neuroscientist and top NIH official, fall under suspicion (Science)
Accounting for Diversity, Inclusion, and Accessibility in Early-Stage Neurotechnology Research (GEN Biotech)
Hooray for DEI Research in Neurotech. Boo for making this subject matter inaccessible behind a paywall.
Memory Loss Isn’t the Only Sign of Dementia: 5 Common Red Flags (NYTimes)
Retired NFL Hall of Fame quarterback Brett Favre reveals he has Parkinson's disease (NPR)
Former Vikings All-Pro QB Tommy Kramer goes public with dementia diagnosis (NYTimes)
Perceived Chronic Traumatic Encephalopathy and Suicidality in Former Professional Football Players (Jama Neurology)
How Does Pregnancy Change the Brain? Clues Are Emerging. (NYTimes)
“The study participant, Elizabeth Chrastil, is a neuroscientist at the University of California, Irvine…She had 26 brain M.R.I.s — four pre-pregnancy scans, which started three weeks before; 15 during pregnancy; and seven in the two years after her son’s birth in 2020.”
A grey matter? Nature, nurture and the study of forming political leanings (Guardian)
New Collaborations
I’m excited to share a new pair of collaborated articles. Let me know if you want to author, co-author, sponsor, or otherwise collaborate on original analyses or coverage.
Dr. Sharena Rice, Dr. Victor Pikov, and Steven Veld authored an excellent roundup of the various neuromodulation techniques that are hitting the market. It’s a thorough primer with company examples and more.
Earlier this year, I had the opportunity to attend the Foresight Institute’s workshop on neurotechnology’s potential role in contributing to AI Safety and Alignment. See my quick summary below, and click through for the full report, as well as more information on Foresight’s work. Full disclosure: I was paid to produce this report.
Research
Advancing science and learning from people with lived experience of pain to improve pain research (NIH)
New Research Will Elucidate the Effects of Space Travel on the Human Brain (Practical Neurology)
Detecting Dementia: Emerging Innovations and Their Implications for American Adults and Their Health Care (NEHI | Report - see Appendix B)
In Young People With Conduct Disorder, Study Finds Widespread Brain Structure Alterations (BBRF | Lancet)
Neuroanatomical changes observed over the course of a human pregnancy (Nature Neuroscience | Summary)
Multiple Sclerosis Brain Health: Time Matters (Report | Infographic)
Post-hospitalisation COVID-19 cognitive deficits at one year are global and associated with elevated brain injury markers and grey matter volume reduction (Nature Medicine | Summary)
Effects of repetitive transcranial magnetic stimulation at different targets on brain function in stroke patients: a randomized controlled trial (Frontiers in Neurology)
A potential target for noninvasive neuromodulation of PTSD symptoms derived from focal brain lesions in veterans (Nature Neuroscience)
Digital health technology (DHT) derived features as sensitive measures of disease progression in early Parkinson’s disease under stable dopaminergic treatment (Movement Disorder Society)
👋🏽 Collaborators and Sponsors: I am starting 2025 planning. Let’s brainstorm!
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