Neurotech Notables #20: Nov 2024
Make Neurotech Great Again
Most important thing first: Happy Frickin’ Friday.
What a week, month, year it’s been. Let’s start with the Elephant in the room.
🏄♀️ With the election finally behind us, a new era of “government efficiency” awaits. My top advice for entrepreneurs and change-agents is carpe diem: Seize opportunities for bold action. Don’t wait and fret. Seismic waves don’t happen too often. Surf’s up.
Here’s my three-part activist-analyst punditry before we move on:
A Trump Administration will not be great for society’s most socioeconomically vulnerable people. Policy over politics, I’m interested in protecting Medicaid and Medicare coverage, which will make commercialization more successful, not to mention save lives, improve outcomes, prevent bankruptcy, and relieve suffering.
The next four years will be a tremendous period of corporate confidence and economic growth in certain markets. More capital is coming to life sciences, biotech, CNS. Time for bigger bets and larger rounds in neurotech…. but let’s all keep patients, families, caregivers at the center of what we’re building, mkay?
Our industry was already set to thrive in the coming years, but Elon’s ongoing oligarchical machinations will pour gas on the neurotech fire. FDA, CMS, HHS, NIH, and other agencies are unlikely to come out unscathed from doge-ball and RFK. But will dereg actually help or hinder? I’m curious, nervous, and skeptically optimistic, if that’s a thing. In any case, we’ll follow the fallout closely.
💉Another bloody aftermath: In an update to my saga, I held my dad’s hand during his second bone marrow biopsy yesterday. With the needle behind us, we’re on pins awaiting results and next steps. Pardon my slow replies and rescheduling requests.
🥳In happier news: I’m coming up on ONE YEAR of publishing Neurotech Futures! Nearly 1400 readers in 55 countries from 6 continents, 75+ colleges, 1000+ private firms, and hundreds of students, researchers, and patients. I like the 50+% open rate, but love the 2/3 “re-open” rate, and all the shares, paid upgrades, feedback, questions.
It’s a dream come true to build and share this with you. We’re celebrating with a Brand Refresh as part of doubling down on much more neurotech analysis next year. Stay tuned! Spread the word! Buy me 50 coffees! Marketing leaders take note: our 2025 Sponsorship Program is here. Hit reply for benefits, eligibility and limited pricing.
And now, your Notables:
$100m+ in fresh funding news both small and large, new NIH grants, a spate of new regulatory and reimbursement decisions, Q3 statements trickling in, new commercial deals, hires, launches, and one notable shutdown.
A kerfuffle around pharma-sponsored Alzheimer’s diagnostic recommendations highlights the ongoing opportunity for a comprehensive strategy involving more neurotech integrated into the clinical enterprise. Some great reports about integrating tech & tools into clinical research, patient engagement, integrated care models.
There’s also a trove of recent reporting worth reading in the Industry and Society sections, from BCI trends to “Fickel” billionaire neurotech funders to stories on unmet needs across consumer, medical, military markets. Check out new data, devices, and discussion in Neurotech TV and Research.
Lastly, send me 2025 events! I’ve fallen behind and I want to get out there a bit more next year. My trip to NY reminded me about the power of connection. As we approach Thanksgiving, here’s to embodying the spirit of coming together. Rest and respect!
But first: Have yourself a wonderful weekend. I’m always here if you want to say hi.
Funding
Precision Neuroscience Raises $93M ( Bloomberg, MassDevice)
Restorative Neurotechnologies (RNT) closes € 3M Series A Funding Round to Accelerate the Commercialization of Its Healthcare Certified Digital Therapy Mindlenses Professional In Europe (LinkedIn)
MintNeuro Secures £1M Investment to Advance Transformative Semiconductor Technology for Neural Implants (PR Newswire)
Nexstem raises $3.5m for noninvasive BCI (CXO Today)
Reneural Secures £475K Funding to Advance Disruptive NeuroRehabilitation Platform (ReNeural)
Ottobock becomes Onward Medical’s largest shareholder (MassDevice)
Possibility Neurotechnology one of 6 startups to receive $100k non-dilutive grant from Ontario Brain Institute's NERVE program (LinkedIn)
Feinstein Institutes awarded Lupus Research Alliance funding of $450k for vagus nerve stimulation clinical trial (BioSpace)
Sense Neuro Diagnostics Awarded $2 Million Contract to Advance Brain Hemorrhage Detection Technology for Traumatic Brain Injury (TBI) (PR Newswire)
NIH’s UG3/UH3 and straight to UH3 BRAIN-Initiative funding opportunities now live (NIH BRAIN)
“The goal is to encourage milestone-driven translational and clinical projects for recording and/or stimulating devices to treat CNS disorders and better understand the human brain. These significant risk projects will require an IDE from the FDA, such as chronic implants.”
BRAIN issues Brain Behavior Quantification and Synchronization (BBQS) suite of programs to support the development of next generation sensor technologies. (LinkedIn, RFA)
“This program aims to develop novel sensor technologies and/or bioelectronic device streams to improve our understanding of human and organismal behavior. Applicants should propose technologies or devices with superior performance and reliability to achieve real-time acquisition of multiple data streams including, but not limited to: physiologic, physical, chemical, or electrical data. Sensor(s) need to be combined with brain recordings.”
Commercial
Forward Shuts Down (Forward | The Information)
LVIS Corp launches NeuroMatch EEG diagnostics platform in US (Medical Device Network)
Synaps Dx Launches Digital Cognitive Screening and Alzheimer’s Testing with BrainCheck and Clarity Health Clinics (BrainCheck)
Sanofi, Formation and OpenAI design AI tool to slash clinical trial timelines (Fierce)
NeuroOne® Announces Expansion of Existing Distribution Agreement with Zimmer Biomet for Commercialization of OneRF™ Ablation System (NeuroOne)
NeuroPace Announces Submission of Three-Year Data from Post-Approval Study of the RNS System in Focal Epilepsy (Morning Star)
Charco hires Iain Strickland PhD as Chief Commercial Officer (LinkedIn)
Koneksa Appoints Eric Luthi as Chief Business Officer (AI Techpark)
XRHealth builds out 'extended reality' therapeutics portfolio with NeuroReality buy (FirstWord HealthTech)
Neurophet Appoints CTO Donghyeon Kim as Co-CEO, Joining Jake Junkil Been in Dual Leadership to Drive Global Growth (PR Newswire)
LivaNova nerve stim for sleep apnea meets primary study endpoints (MassDevice)
Inspire Medical enters into $75M share repurchase program (MassDevice)
While posting 30% sales growth on track to a $200m year in revenue
Vitazi.ai hits Commercial Milestones in Disease Detection with Point-of-Care Health Screenings via Oculomics (PR Newswire)
Nevro Reports Third-Quarter 2024 Financial Results, new CE Mark, New Employee Options
What does it mean for a $100m/quarter company to struggle with sliding revenues and cost cutting? Anyone know anything about the Mayo Clinic lawsuit? There are many who expect consolidation in the SCS space next year.
SOBRsafe Releases Real-Time Alcohol Detection Wristband with Premium Updates (PR Newswire)
Is this Neurotech? You tell me.
Artinis has acquired TMSI (Artinis)
Avation Medical Announces Jason Whiting as Chief Executive Officer (PR Web)
Norton Neuroscience Institute to acquire INSIGHTEC focused ultrasound technology (Norton)
Norton is a rarity: a midsized, 2500 bed, 9 hospital chain posting a profit. Strategy might have something to do with it? Their Foundation arm posted the $2.8m grant to fund this deal, which is one small part of a broader billion spent on community benefits. Leaders, take note: maybe reimbursement doesn’t have to be so hard?
Regulatory & Reimbursement
Trump to select Robert F. Kennedy Jr. to lead HHS (Politico)
From AI to Musk's brain chips, the FDA's device unit faces rapid change (Economic Times)
Michelle Tarver faces challenges as new CDRH leader. But patient groups, industry are optimistic (MedTech Dive)
FDA updates Breakthrough Device designations database (FDA). Through September 30, 2024, the FDA has:
granted 1,041 devices Breakthrough Device designation.
1,029 from the Center for Devices and Radiological Health (CDRH)
12 from the Center and for Biologics Evaluation and (CBER)
authorized 128 Breakthrough Devices for marketing
GE Healthcare’s head-only MRI scanner cleared by the FDA (Medtech Dive)
This, from GE, seems like a big deal. Penny for your thoughts? FDA Expands the Age Indication for Nerivio® as the First-and-Only REN Wearable for Migraine Treatment for Children Aged Eight and Above (PR Newswire)
QuantalX Secures FDA Clearance for its breakthrough Delphi stimulator, advancing direct brain health diagnosis at the point of care (PR Newswire)
“Delphi-MD was granted FDA Breakthrough Designation Device status twice, the first for the detection of patients at risk for stroke and dementia and the second for detection of NPH and prediction of treatment response to ventriculoperitoneal shunt (VPS) surgery. Delphi-MD was also selected for the prestigious FDA Total Product Life Cycle Advisory program (TAP), supporting the company's efforts to advance the successful adoption of the technology in the US healthcare market. Delphi-MD brain health evaluation test has already obtained a dedicated CPT reimbursement code (0858T).”
FDA authorizes Icometrix’s AI-driven MRI solution for safer Alzheimer's treatment (PR Newswire)
Zeta Surgical wins FDA nod for AI-powered surgical nav tech (MassDevice)
Magstim earns FDA clearance for transcranial magnetic stimulation that treats depression, OCD (MassDevice)
Apple’s device's new Digital Prism Correction Feature (DPCF) received an FDA 510(k) to digitally adjust images for users with certain vision disorders that require prism correction. (FDA)
Salute to Brian Dolan at Exits and Outcomes for covering this in Issue 237. He added, “Apple continues to rack up FDA market authorizations: Late last month it secured its first 510(k) for its Vision Pro augmented reality device….The FDA took 98 days to OK the feature.” That’s OHT1, not OHT5.
NeurAxis wins expanded FDA clearance for non-implanted neurostim for pain relief (MassDevice)
“President and CEO Brian Carrico said the company also received an expansion of payer coverage and a new reimbursement code. The American Medical Association assigned IB-Stim to CPT Category I, effective in January 2026.”
Humana Imposes Further Restrictions on Medicare Coverage for Neuromodulation Therapies (NANS)
Magnus Medical Announces CMS Approval of New Payment Rate for SAINT Treatment in 2025 Hospital Outpatient Rule (Magnus)
BlueWind Medical picks up favorable reimbursement decision for tibial neuromod (MassDevice)
CVRx earns Medicare win for Barostim procedure (MassDevice)
For those keeping track: This is on top of last month’s coding news.
Industry
Precision Neuroscience - AI Summit Recap: Dollars and Cents in AI and Health Tech (The Information)
Neurobionics: Multifunctional Neural Probes Enable Bidirectional Electrical, Optical, and Chemical Recording and Stimulation In Vivo (Advanced Materials)
See comments from CTO/Co-founder Nicolette Driscoll on LinkedIn
Startups Like Science and Musk's Neuralink Aim to Help Blind People See (Bloomberg)
Motif - Rewiring psychiatry: how a miniature wireless brain implant is advancing neurostimulation (Medical Devices Zone)
Buoyed by clinical success, Onward Medical charts future of neurostimulation (Stat)
A Better Brain Chip than Elon Musk’s? (The Information)
Is Stentrode 2.0 in the works? As per Akash Pasricha: “Oxley and I met in Synchron's industrial Brooklyn Navy Yard office. There he showed me the newest iteration of the company's device, the Stentrode, gingerly withdrawing the tiny gizmo - slightly longer than the spring of a ballpoint pen - from a hefty aluminum briefcase."
Inner Cosmos: Brain Tech Is Here and Not as Creepy as You Think (Bloomberg)
Why Medtronic wants every business unit to have a plan for AI (Fortune)
How does this connect to AI in BCI? Here’s a better question: How doesn’t it? I bumped into a big strategic in NY. Interesting conversation…
World’s first ear-worn AI/ML platform for physiological monitoring introduced by Nokia Bell Labs and Cambridge Future Tech (Yahoo)
Two-minute automated speech analysis: comparable performance to Beck Depression Inventory-II in distinguishing depressed and healthy individuals (ki: elements)
REGEnLIFE Is Trying to Prove That Advanced Light Therapy Can Cure Alzheimer’s (Startup Health)
Low-Frequency Focused Ultrasound Donation Allows UNC to Enroll Brain Tumor Patients in a New Clinical Trial (UNC)
Samphire Neuroscience Wins 1st place in the 16th Healthcare Innovation World Cup at MEDICA (LinkedIn)
Zied Tayeb, PhD, Co-Founder & CEO of Myelin-H, wins 2024 MedTech World Rising Star of the Year award (LinkedIn)
Cortechs.ai Highlights Groundbreaking NeuroQuant® ARIA Technology in Anticipation of Growing Market Demand (PR Newswire)
GT Medical Technologies Achieves Two Clinical Milestones with GammaTile® to Help Treat Brain Tumors (PR Newswire)
NaoTrac Robot Pioneers Robotic Neurosurgery in Bolivia with Successful Brain Tumor Biopsies (PR Newswire)
HoneyNaps AI Diagnostic Medical Software as Featured in International Journal "Digital Health" (PR Newswire)
SPIRE/DIADEM: Chronic Pain and Depression: Two Focused Ultrasound Clinical Trials Published (FUS Foundation)
NeuroAI: A field born from the symbiosis between neuroscience, AI (The Transmitter)
Surviving The Valley Of Death: The 7-Step Approach For Neurotech Startups (Med Device Online)
Defining and Demonstrating the Value of Patient Engagement (PE) in Medtech Research and Product Development (Milken Institute)
Great work from Esther Krofah and colleagues. “This report delves into why PE has been slower to evolve in medtech compared to the pharmaceutical sector, the key barriers facing PE in medtech R&D, the benefits and metrics and measures to quantify the value of PE, and the opportunities to enhance PE in medtech. It also offers recommendations for improving patient involvement throughout the medtech product R&D process.”Clinical Biomarkers for Precision Psychiatry will Need the Help of Focused Research Organizations (Neurotech X)
Interdisciplinary and Collaborative Training in Neuroscience: Insights from the Human Brain Project Education Programme (Neuroinformatics)
Market Access: What Medtech Can Learn from Pharma (SmartTrak)
Clinical Trials for Tinnitus Treatments (Lenire)
Kip Ludwig’s comments are always worth considering.
Dr. Lauren Wengerd’s New Lab Space (Neurotech Institute)
Jonathon Parker - Looking for clues to stop seizures (Mayo Clinic)
Alzheimer Disease as a Clinical-Biological Construct—An International Working Group Recommendation (Jama Neurology)
CNSA White Paper Advocates for Earlier Detection of Alzheimer’s Using Biomarkers (Practical Neurology) and Commentary from Simon Spichak
Collaborative effort to conduct a study aimed at improving the diagnosis of Alzheimer’s and related dementias for everyone (Global ALZ Platform )
Neurotech.TV
LSI Europe 2024 - Ana Maiques, Neuroelectrics (Youtube)
Fortune Global Forum 2024: Mind Meld - A Breakthrough in Brain Powered Communication with Tom Oxley, Synchron (Fortune)
Update on Noninvasive Neuromodulation Devices for Headache Treatment (Practical Neurology: Neuroview)
E11 Bio in Biocom California
Therapeutic Advantages of StrivePD for Parkinson Disease Management: Amanda Hare, DNP (Neurology Live)
Cutting-edge technology helping young Valley stroke survivor more easily navigate recovery (ABC 15)
Pairing AI with our brains: Precision Neuroscience's big bet (Yahoo)
Pod: Shan Siddiqi – Bringing Human Brain Connectomics to Clinical Practice in Psychiatry (Stimulating Brains podcast)
Pod: Genetic Medicine for Brain Health with Dana Watt of Breakout Ventures (PsyMed)
Ethics & Society
Report Launched: Brain health - time matters (MS Brain Health | Infographic)
Related? 75+ Key Companies Charting New Frontiers in Multiple Sclerosis Therapeutic Space | DelveInsight (PR Newswire) - Some of those companies might be interested in better tools for neuroimaging and beyond?
Is Being Busy Good for People With A.D.H.D.? (NYTimes)
…and probably related in my case: Why Humans Cry (NYTimes)
How Neuroethicists Are Grappling With Artificial Intelligence (Neurology Today)
Prevalence of Unrecognized Cognitive Impairment in Federally Qualified Health Centers (Jama)
Men And Women Process Pain Differently, New Study Finds (Women’s Health via PNAS Nexus)
New Book Highlights Emerging Therapeutic Uses of Ultrasound Technology in Medical Applications (IABC Nashville)
Chronic Brain Trauma Is Extensive in Navy’s Elite Speedboat Crews (NY Times)
He’s the F.D.A.’s Cancer Chief, Not a Fortune Teller (NYTimes)
Dr. Richard Pazdur for 25 years has overseen innovations in the treatment of deadly diseases at the agency. What will the Brain Health/Neurotech version of this story entail, a few years down the line?
All troops to get baseline cognitive testing in bid to treat traumatic injuries: DOD (ABC)
How a Winning Bet on Crypto Could Transform Brain and Longevity Science (Bloomberg)
“Fickel has funded E11 Bio, an organization developing novel brain mapping techniques, and Forest Neurotech, which makes a brain implant that emits an ultrasound pulse to study the causes of mental health disorders and neurological conditions. One of its most recent investments is a $30 million commitment to a secretive initiative at Stanford called the Enigma Project, which is building an ambitious model of the brain’s structure and detailing how each neuron fires across an entire mind.”
Vaping Linked to Cognitive Impairment in College Students (Being Patient)
Exploring VR for Dementia Caregiver Training (Being Patient)
Raise the ROOF! Support Ethical XR Orgs (Julian Reyes on LinkedIn)
Dana Foundation: Connecting Advances to Communities, Advocacy, and Education (ENMEDIA)
Research
Pic Above: Wearable ultrasound tech for muscle monitoring opens new possibilities in healthcare and human-machine interfaces (Eureka Alerts)
Biomarkers: What Makes One Great? (Brooks Leitner)
Great stuff here. This brought me back to Abby’s article from May
“Wearable” devices for cells (MIT News)
Alzheimer's timeline shows changes start as trickle, become torrent (NPR)
“The study also found evidence that a small subset of neurons known as somatostatin inhibitory neurons begin to die off during the early phase of Alzheimer's, Lein and a team of nearly 100 other scientists report in the journal Nature Neuroscience.”
Near SUDEP in a patient with craniosynostosis syndrome and temporal lobe encephaloceles (Epileptic Disorders)
Advancing embodied AI through progress in touch perception, dexterity, and human-robot interaction (Meta)
The future of transcranial ultrasound as a precision brain interface (PLOS Biology)
Resting-state functional MRI of the nose as a novel investigational window into the nervous system (Scientific Reports)
“Nosy Window” - Beautiful images from fMRI. What are the market implications for clinical and research applications in something like this? The quest to build bionic limbs that feel like the real thing (Nature)
Endocisternal interfaces for minimally invasive neural stimulation and recording of the brain and spinal cord (Nature BME)
Bioelastic state recovery for haptic sensory substitution (Nature)
Aesthetic chills modulate reward learning in anhedonic depression (Journal of Affective Disorders)
This one needs more neurotech. Aesthetic Chills is the name of my next band.
Surgical Management of Epilepsy in Older Adults: Focus on Neurostimulation and Neuromodulation (Practical Neurology)
Source: Kapil Gururangan, MD
👋🏽 Sponsors: 2025 budgeting season is here. Help me help you! Let’s talk.
📲 If you’re feeling Social (Media): LinkedIn | Twitter/X |BlueSky| Email
❤️ Click the heart & share with your network. Brain Health = Human Health.