Neurotech Notables #30: April 16-30
Squishy Funding. Can of Worms.
Greetings Readers!
April began with a funding downpour in neurotech, and while the back half of the month was less eventful, a familiar, Musky stormcloud has re-emerged, suggesting a record year could be in wait.
Here’s what’s new in commercial neurotech over the last two weeks.
Squishy Funding : a $500m+ pre-raise bugle from Neuralink is still news, especially in parallel with their third BCI user’s emergence on social media. New strategic commercial capital from non-profits around the world offers a positive signal. A raft of ‘announced, but undisclosed’ raises makes me wonder about culture, optics, brand of sharing funding information openly, versus not. Curious for your thoughts here.
Commercial Bonanza: A bit of everything: New M&A, Contracts, Products, Patents, Coverage, Appointments, Filings, Submissions.
On the Reg: Breakthroughs, clearances & approvals - it’s nice when the FDA says yes isn’t it? Across BCI, EEG, AI/SAMD, plus positive milestones for regulated clinical studies, a longevity science caucus, and fresh scrutiny of neural data in Congress.
Black Mirror to White House: Social commentary on neurotech is evolving, isn’t it? The society section contains a microcosm of the different but overlapping interests spanning ethics, regulation, research, treatment, business, culture, and beyond.
Research Advances: Behavioral biomarkers. Optimizing optogenetics. Clinical neurotech for pain, PD, personality disorder, and more. Research advances spanning corporate clinical studies of tDCS, VNS, PNS, and FUS, all the way down to a global worm study that, while lowly, is not without its own elegans (20,000 of ‘em)🪱
Updates from Me
🙏🏽 I’m doing my best to juggle work with an ongoing family health situation, thanks for your patience with slow replies or follow-ups over the coming weeks.
May 6th - I’ll be at SynBioBeta 2025 covering a panel of top-tier founding leaders from E11 Bio, ARPA-H, Aspen Neuroscience, Science Corporation, Forest Neurotech, and MIT. If you’re there on Tues, let’s sync up.
May 16 - I’ll be at PsyMed Venture’s Frontier Neuro Unconference, for an exciting gathering covering BCI, neuroinflammation, psychedelics, and much more. Let me know if you’re attending. The event is at capacity but see yesterday’s call for volunteers.
Drinks on Me! This June in Virginia. See the NANS event below to sign up.
Founder & Investor Poll: Our survey to gauge impact of US federal changes on neurotech startups’ EU strategy is still live. Please weigh in if you are a global startup or investor, and share with your network.
💼 Register Interest: Neurotech Job Board! Startups and investors who plan to hire neurotech roles this year: Share interest and input to support the creation of a Job Board. Let’s build the future together.
👋🏽 Hi, I’m Naveen. I believe brain health is human health. You are one of the 2,356 readers of my biweekly reports on emerging neurotech markets.
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NANS
Register today for Neural Interfaces 2025. Let’s share thinks & drinks🍸
TTP
Signal-to-noise issues: how to close the loop for the next generation of neuromodulation therapy solutions - Read more
Funding
Neuralink reportedly expects to raise $500M at $8.5B valuation (MassDevice | Bloomberg)
“Elon Musk’s Neuralink is planning to raise about $500 million at a pre-money valuation of $8.5 billion, according to people with knowledge of the matter. The brain-implant company has begun preliminary discussions with potential investors about the funding round...Terms aren’t finalized and could still change, one of the people cautioned.”
Weigh in: Is this net positive or negative for the neurotech field?
Brain Health Startup Ivory Raises $1M (Economic Times Tech)
Leo Lion invests in Neurable (LinkedIn)
Click Therapeutics announces Series C led by Dassault Systèmes and Medidata Solutions (Click)
Cadwell Makes a Strategic Investment in Seer Medical (Cadwell)
Onward takes steps to improve U.S. investor access (Mass Device)
ONWARD Medical Announces Release of 2024 Annual Report
Enabling Stroke Victims to Speak: $19M Toward Brain Implants to Be Built at U-M (University of Michigan News)
Impact Ventures by J&J Foundation invests in Mobio Interactive’s selfie for stress-assessment, unlocking "precision psychiatry at scale" for patients and healthcare workers around the world (Impact Ventures by J&& Foundation)
This includes a grant to study Community Health Worker training.
Commercial
Beacon Biosignals Acquires CleveMed (Sleep Review Mag)
Cumulus Neuroscience announces research collaboration with Boehringer Ingelheim and University of Oxford on a first of its kind study in Borderline Personality Disorder (LinkedIn)
BCI company Paradromics names new chief medical officer (MassDevice)
Nia Therapeutics welcomes former Chairman and CEO of Neuspera as new Independent Director (LinkedIn)
Iota announces two new GMs for urological and neurological therapies (LinkedIn)
Inspire adds senior medical directors (MassDevice)
Mainstay Medical Announces Exclusive Coverage of ReActiv8® by Anthem Blue Cross/Blue Shield (BusinessWire)
Axoft Completes First Four Cases of First-in-Human Clinical Study of its Ultrasoft High-Density BCI (Business Wire)
Lifeforce Launches Brain Protection Program to Optimize Cognitive Health and Reduce Dementia Risk (CBS4 Indy)
Sonomotion completes enrollment in pivotal clinical trial for kidney stone treatments with focused ultrasound, secures $2.2m NIH grant (PR Newswire)
ReShape Lifesciences® Receives Notice of Allowance for Additional U.S. Patent Related to Its Proprietary Diabetes Neuromodulation Technology (Globe Newswire)
ReShape Lifesciences® Partners with Motion Informatics to Bring AI-Driven Neurorehabilitation Technology to the U.S. Market (Globe Newswire)
Under the terms of Reshape’s ongoing merger with Vyome, contract manufacturer Bioradmedisys will purchase this IP.
Nexalin Technology Secures USPTO Patent for Deep Intracranial Frequency Stimulation (DIFS™) Technology in Treating Substance Use Disorders (Globe Newswire)
NeuroOne completes FDA submission for nerve ablation tech to treat facial pain (MassDevice)
Theranica Announces Coverage Policy from the Second Largest U.S. Health Insurer for Its Nerivio® REN Wearable Migraine Treatment, Reaching Access for 80 Million Americans
Firefly 10-k (SEC): Just $108k in revenue last year for Firefly’s pre-commercial EEG-AI platform. “As of December 31, 2024, we had an accumulated deficit of $87,084,000 and negative cash flow from operating activities for the year ended of $6,155,000.”
EndoStream Announces Completion of Patient Enrollment in Pivotal TORNADO-US Clinical Study, a Key Milestone Toward Nautilus FDA clearance (LinkedIn)
ClearPoint Neuro launches new navigation software (Mass Device)
Nexalin Technology Receives IRB Approval in Brazil and Begins Clinical Trial for Anxiety and Insomnia (Globe Newswire)
Wearable Devices Unveils Gesture Mapper for Mudra Link, Ushering in a New Era of Personalized Neural Control (Globe Newswire)
Regulatory
Precision Neuroscience Receives FDA Clearance (Bloomberg)
FDA Clears Ceribell’s Clarity™ Algorithm for Pediatric Patients (Ceribell)
BEL/Neurosom’s NEAT Sleep Staging Software Receives FDA 510(k) Clearance (BEL)
CereVasc wins FDA breakthrough designation for eShunt in pediatric patients (MassDevice)
Epiminder Receives FDA Authorization for Seizure Detection Device (Epiminder)
Proprio Receives FDA Clearance For the World's First AI Surgical Guidance Platform (Proprio)
Click Therapeutics announces FDA Clearance for CT-132 for the preventive treatment of episodic migraine (Click)
EnsoData’s Celeste+ App Adds 3 Channels to Home Sleep Testing Solution (Sleep Review)
FDA cuts outlined in draft HHS budget (Medtech Dive)
Bilirakis, Tonko, Crenshaw, Khanna, Peters, and Liccardo Celebrate Re-Launch of Longevity Science Caucus (Bilirakis House)
MedCon: FDA officials review common medical device compliance pitfalls (RAPS)
Neurotech companies are selling your brain data, senators warn (The Verge)
“In a letter to the FTA, Sens. Chuck Schumer (D-NY), Maria Cantwell (D-IN), and Ed Markey (D-MA) called for an investigation into neurotechnology companies’ handling of user data, and for tighter regulations on their data-sharing policies, citing a 2024 report by the Neurorights Foundation.”
💼 Job Board!🆕
It’s not here yet. But I am working on it with help from a few volunteers. Please register your interest and help me spread the word!
Industry
Third Neuralink Brain Implant Patient Able to Communicate Despite Non-Verbal ALS (Fox Business)
AI for Aging Innovation: Shaping the Future of Diagnostics, Support, and Care (a2 Collective)
Nura Pain Clinics Continues its Expansion Across the Twin Cities with Brand New Woodbury Clinic (PR Newswire)
Corticale touts study results for sensors used in BCI development (Mass Device)
Smart brain implants are helping people with Parkinson’s and other disorders (The Conversation)
Lenire: Retrospective chart review demonstrating effectiveness of bimodal neuromodulation for tinnitus treatment in a clinical setting (Nature | Press Release)
gammaCore Non-Invasive Vagus Nerve Stimulation (nVNS) Shown to be Effective in Treating Concussive Symptoms Associated with Mild Traumatic Brain Injuries (GlobeNewswire)
Four-year Follow-up Data on SPRINT® PNS for Low Back Pain Highlights Sustained Pain Relief Avoiding Costly and Invasive Treatments (Globe Newswire)
Flow: Transcranial Direct Current Stimulation (tDCS) Used at Home for People with a Diagnosis of Depression: Sleep Quality Outcomes (Open Journal of Psychiatry)
Flow: Transcranial Direct Current Stimulation (tDCS) and Online Wellbeing Training Used at Home for Perinatal and Maternal Loss Patients with a Diagnosis of Depression: Depression, Real World-Functioning, and Quality of Life Outcomes (Open Journal of Depression)
Investigating the SAINT iTBS Protocol for Bipolar I Depression (Psychiatric Times)
Insightec: Focused Ultrasound for Opioid Addiction: New Clinical Trial Results Published (FUS Foundation)
Adaptability is a Key Determinant of Healthspan (Where Theory Meets Practice)
Developing digital health technologies for frontotemporal degeneration (Alzheimer’s Association)
High Intensity Focused Ultrasound (HIFU) Industry Report 2025 | Revenues to Reach $1.8 Billion by 2030 (Globe Newswire)
Global Neuroprosthetics Market Expanding Rapidly at a CAGR of ~13% by 2032 Amid Surge in Demand for Advanced Neurological Treatments (Globe Newswire)
Source: Delve Insight
Neurotech.TV
FDA Layoffs and the Impact to Industry - MCRA Webinar (MCRA) and brief summary here
Neuralink’s 3rd trial participant posts to X
Pod: Ep28: Breaking the Cycle: Focused Ultrasound for Addiction with James Mahoney, PhD (Curing with Sound)
Society
Longevity Clinics Selling Unproven Treatments (MIT Technology Review)
Cutting Edge: The Cautious Optimism for Psychiatric Brain Surgery (Undark)
Full Circle: Why Funding Mental Health Research Isn’t Optional-It’s Life‑Saving (One Mind)
Advancing Neurotechnology Responsibly: The Power of Collaboration (Dana Foundation)
The World Needs Standards for Neurotechnology (WPR)
Mind for Sale: When Cognitive Function Becomes a Monthly Fee (BMJ Medical Ethics Blog)
Deep Sleep, REM, and Brain Health (The New York Times)
Neuroscience, Estrogen and Hormones (The New York Times)
Focused Ultrasound for ALS: Neuromodulation Clinical Trial Begins in Spain (Focused Ultrasound Foundation)
“investigators will test whether transcranial pulse stimulation (TPS) can be used to decrease motor cortex hyperexcitability and therefore slow the progression of ALS….using the Storz Medical Neurolith device.”
Feinstein Institutes scientists discover how the nervous system encodes immune signals in the body through the vagus nerve (Business Wire)
Research
25 Year Study Finds DBS for Parkinson’s Disease Has Long-Term Benefits (Neurology Today)
Editorial: Deep brain stimulation think tank: updates in neurotechnology and neuromodulation, volume V (Frontiers)
Basic Pain Research Is Not Working: Q&A With Steven Prescott and Stephane Ratté (The Transmitter)
Neuropixels Opto: ‘Perturb and record’ optogenetics probe aims precision spotlight at brain structures (The Transmitter)
Noninvasive Technologies Can Map and Target Human Brain With Unprecedented Precision (The Transmitter)
Clusters of healthy lifestyle behaviours are associated with symptoms of depression, anxiety, and psychological distress: A systematic review and meta-analysis of observational studies (Clinical Psychology Review)
Inflammation in the Brain: How Immune Activity Can Alter Mood, Fuel Anxiety (Harvard Medical School)
An intuitive, bimanual, high-throughput QWERTY touch typing neuroprosthesis for people with tetraplegia (medRxiv)
Population Attributable Fraction of Incident Dementia Associated With Hearing Loss (JAMA Otolaryngoly Head Neck Surg)
Wirelessly Powered, Battery-less, Miniaturized Microchip for Implantable Biopotential-Monitoring Applications (IEEE Sensors)
The Worm That No Computer Scientist Can Crack (Wired)
“The C. elegans nematode is a tiny worm, barely as long as a hair is wide, with less than a thousand cells in its body. Of those, only 302 are neurons—about as small as a brain can get…. to “reverse engineer” the worm completely (is) an ambitious proposal, one that will require an unprecedented level of collaboration between some 20 different worm labs….pulling it off may take up to 10 years, cost tens of millions of dollars, and require something in the neighborhood of 100,000 to 200,000 real-life worms.”
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