Neurotech Notables #11: June 2024
Carousel Summer. FRO, yo. iBCI-CC.
Greetings Readers ☀️
As BCI startups go round the media carousel, TMS enters a new phase with Magnus Medical's new CPT codes kicking in July 1, while Alzheimer’s emerges as the next brain stimulation target. A decade on, bioelectronics’ post-drug future is still in R&D.
My network is buzzing about Focused Research Organization (FRO) as a new funding model. How do FRO compare to ARPA funds and Philanthropy VC for neurotech? They’re science, tech, and disease focused, respectively; Strategy is emerging.
As the funding ecosystem for pre-commercial neurotech develops, more groundwork is needed to ensure we’re not going in circles. One month ago, Gerwin Schalk et al argued, “To be widely adopted, any [neurotech] solution needs to be supported by an ecosystem that assists, manages and rewards the interactions with all the involved parties.” The FDA’s TAP program, which Paradromics just joined, is one key example.
Speaking of FDA: I’m excited to share that I’ve joined the agency’s implanted brain-computer interface collaborative community (iBCI-CC) to support “Public messaging, BCI education, and Regulatory science education that could support policy.” After 16 years working at the nexus of government, markets, and advocacy, I believe that “pre-competitive” collaborations hold promise. Stay tuned for more in the coming months.
In the meantime: Read on for some fresh funding, new hires, exciting studies, regulatory decisions, strategic partnerships, and more. Like what? Glad you asked:
Neurotech TV. Hot Brains. Coffee as neuromodulation. Market maps. Innovation Communities. DOJ crackdowns. Wearables. Event recaps. And new events.
It’s busy times in Neurotech, so don’t forget to make time to hug someone and find small ways to enjoy yourself this summer. Hit reply and say hi! See you in two weeks.
Funding
Nexalin Technology Announces Pricing of $5.2 Million Public Offering (Biospace | SEC )
Insightec raises $150M to expand the therapeutic power of focused ultrasound, co-led by Fidelity, Nexus Neurotech Ventures, and Ally Bridge Group (PR Newswire)
CABHI announces $9.5 million investment in 30 companies including C.Light, Cognixion, Roga, and others (CABHI)
Brain Canada Launches $26 Million Platform Support Grants (PSG) Program to Accelerate Neuroscience and Mental Health Research (Brain Canada Foundation)
Opto awarded a £500k Innovate UK Smart grant for minimally invasive neural interface to improve treatment for patients with glioma (LinkedIn)
Mint Neurotechnologies, Amber Therapeutics, and Imperial College London announce 800k strategic partnership to develop advanced chip technology for neural implants (MintNeuro)
New models of life science innovation are emerging: What can we learn and how can we help them grow? (Whitespace)
Want to learn more about FRO, ARPA, R&D funding programs for brain health?[Your Input Needed!] Introducing Brainstem Workshops (SpecTech)
Commercial
Firefly Neuroscience Appoints Samer Kaba, MD as Chief Medical Officer in advance of merger with WaveDancer (AiTechPark)
GT Medical Technologies appoints new chief commercial, financial officers (MassDevice)
NeuroOne® Announces First in Human Ablations Completed with OneRF™ Ablation System (Globe Newswire)
Epitel Announces Appointment of Wearables Industry Leader Ken Nelson to Board of Directors (PR Newswire)
Neurolief Announces Breakthrough Results from Pivotal Clinical Trial of Brain Neuromodulation System for Treating Major Depressive Disorder (PR Newswire)
BrainsWay Launches Prospective, Randomized, Controlled, Multicenter Trial Evaluating Accelerated Deep TMS™ for Depression (Brainsway)
Note: Key signal? Despite the IP moat around the SAINT protocol for TMS, offering accelerated (“aTMS”) may become an adapt-or-die strategy.
IDUN launches Guardian in-ear EEG earbuds (LinkedIn)
Advocate Health Care, Aurora Health Care extends project to increase memory care resources, cognitive screenings with Davos Alz Collaborative grant (Advocate Health)
Theranica’s remote electrical neuromodulation device improves outcomes in migraine (Healio)
electroCore Announces the Commercial Launch of TAC-STIM non-invasive vagus nerve stimulator for military use (Biospace)
BIOS: Using neural biomarkers to personalize dosing of vagus nerve stimulation (Bioelectronic Medicine)
The Neurostimulation Appropriateness Consensus Committee (NACC)®: Recommendations for Spinal Cord Stimulation Long-term Outcome Optimization and Salvage Therapy (Neuromodulation)
Nexalin secures US patent for Alzheimer’s deep-brain stimulation device (Medical Device Network)
Zeto Announces Winners of Clinical Trial Sponsorship Program (PR Newswire)
Regulatory & Reimbursement
Paradromics accepted into FDA TAP program, launches patient registry (Paradromics)
Stimwave CEO Sentenced To Six Years In Prison For Creating And Selling A Fake Component That Was Implanted Into Patients (DOJ)
NeuroOne® Granted Approval of ICD-10 Procedure Code for sEEG RF Ablation (NeuroOne)
MCRA Supports 3D Systems with 510(k) FDA Clearance for VSP PEEK Cranial Implant Device (MCRA)
Boston Scientific secures CE mark for Deep Brain Stimulation software (Medical Device Network)
Advocacy Update: Seniors' Act and BRAIN Initiative Funding Goes to the Hill (NANS)
NANS Leads Response Objecting to Cigna’s Depiction of PNS (NANS)
Akili Announces FDA Authorization of EndeavorOTC, the First FDA Clearance of a Digital Treatment for Adults with ADHD Through a Video Game (PR Newswire | Paper)
Note: Yes, this is the same Akili that just de-SPAC’d and then got acquired for parts. No, the disconnect between innovation, regulation, and reimbursement doesn’t make sense to me either.
Neuromod's FDA-Approved Lenire Device Now a Treatment Option for 2.9 Million US Veterans with Tinnitus (PR Newswire)
May 2024 NIH BRAIN Initiative Multi-Council Working Group Meeting (NIH)
UC San Diego Brain Recording Device Receives FDA Approval for a Clinical Trial (Newswise/UCSD)
Articles, Analysis, Resources
Three Years post Deep Brain Stimulation Surgery by Ben Stecher (Tomorrow Edition)
Picostim neurostimulator by Amber therapeutics fitted in UK boy's skull to treat epilepsy (BBC)
Sinaptica’s Novel Approach to Alzheimer’s Leverages Electrical Brain Stimulation (Startup Health)
Blue Arbor goes beneath the surface for better control of limb prosthetics (MDO)
Bia Neuroscience CEO/Founder Michael Byrne - Podcast (Dynamic Neurotech)
Seizure Assessment and Forecasting With Efficient Rapid-EEG, using Ceribell’s EEG technology (Neurology)
Digital Medicine Society partners with pharma giants for new digital endpoints project (Fierce)
Neuro20 Sparks Hope for Long COVID Recovery (Newswire | White Paper)
Prediction of Alzheimer's disease progression within 6 years using speech: A novel approach leveraging language models (Alz Association)
The Gerontechnologist releases the Agetech Market Map, 7th edition (Gerontechnologist)
In conversation with inContAlert (Praxis Institute)
Filling in the Care Management Gaps for Parkinson disease With Software Technologies (Neurology Live)
Stanford’s Wu Tsai Neurosciences Institute announces 10 EEG and TMS Pilot Grant Awardees (Stanford)
NeuroDots: From Single-Target to Brain-Network Modulation: Why and What Is
Needed? (Neuromodulation)
Writing Proposals as a Trust Mechanism (Matt Gaidica)
Human neuroscience is entering a new era — it mustn’t forget its human dimension (Nature)
The implications of NeuroAI: What we lose when we ignore culture by Karen Rommelfanger (LinkedIn)
If language is not essential for thought, then what is language for? (NY Times | Nature)
Companies Are Racing To Put A Chip In Your Brain (Morning Brew)
UChicago scientists invent “living bioelectronics” that can sense and heal skin (UChicago)Neuroethics & Society
Synaptic modulation by coffee compounds: Insights into neural plasticity (Progress in Brain Research)
How Heat Affects the Brain (NY Times)
How a Baltimore neuroscience study is rewriting Black America’s relationship with medical research (STAT)
Ecosystem Map Reveals Collaborations, Care Pathways, and Technologies for Dementia (PR Newswire)
Circling back from Schalk’s paper at the top: Neurotech’s “Ideal Care” Ecosystem Map doesn’t exist yet. But let’s start thinking around the corner. An Interpretative Phenomenological Study of the Experiences and Value of Flow Transcranial Direct Current Stimulation (tDCS) and Behaviour Therapy Training Software Used at Home for Specialist Perinatal Mental Health Service and Maternal Loss Psychology Service Patients with Depression (paper)
Note: Neurotech’s communication problem on full display here. Is this study about neurotech’s ability to help those who have lost a pregnancy? Or not? SMH at scientists undermining the relevance of their own work.
Cybiosis: From Pacemakers to Wearables: Exploring Cybiosis in Technology (Neurotech Nerds’ Nexus)
Novel neurotech form factors - Robert Murcko (Neurotech X)
Holographic acoustic device with genetic engineering allows researchers to precisely, flexibly modulate brain (Washington University)
Investor notes from the fields of LabWeek at Edge Esmeralda 2024: neurotech frontier (Peter Zhegin)
Building an Innovation Community: Why Kristina Malzbender of Gates Ventures Joined StartUp Health’s Alzheimer’s Moonshot Impact Board (Startup Health)
Wearable Scanner Maps Children’s Brain Activity (Neuroscience News | Paper)
See how your body works in real time — wearable ultrasound is on its way (Nature)
📺NEUROTECH TV
Highlights from OneMind’s 2023 Accelerator, featuring Ceretype, Motif, and nine other startups (OneMind)
Revolutionizing accessibility: Next-gen brain-machine interfaces unveiled (AI for Good)
Spark Biomedical | Wearable Neuromodulation (TechBlick)
Neurotechnology: Past, Present, and Future by Sumner Norman (Protocol Labs)
Joe Rogan Interviews Noland Arbaugh (Joe Rogan Experience)
Paradromics gears up to test its brain implant in humans (CNBC)
📅Events
July 18: BCI: State of the Art, Art of the Future. Orlando (EMBC)
August 2: Neuraseed BCI Expo - Virtual (Neuraseed BCI)
August 6: 2024 Neurotech Commercialization Workshop - Zoom (Neurotech Reports)
August 10-11: BMI Summit - Morgantown, WV (BMI Summit)
Sept 1: The International BCI Award by g.Tec - (LinkedIn)
Sept 18: iBCI-CC Inaugural Meeting - Silver Spring, MD (Jennifer French)
Sept 19-20: FDA+NIH BCI Clinical Outcomes Assessment Workshop - Silver Spring, MD (Devjani Saha)
Sept 19: Brainbox Initiative Conference 2024 for Non-Invasive Brain Stimulation - London (BrainBox)
October 28-30: Biofuture - NYC (Biofuture)
Nov 6-7: Neurotech Leaders Forum - SF (Neurotech Reports)
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