Neurotech was on fire this quarter. A conservative tally of Q1 2024:
$400m raised in private capital. Over 20 FDA decisions. 2 public offerings. A handful of new coverage decisions, along with dozens of partnerships, commercial hires, new federal initiatives, and mainstream media spotlights.
As for the last two weeks: More BCI news. Interesting deals across segments. Encouraging partnerships from non-profits. Lots of FDA activity, internal and external. And some Neuroethics ripples worth examining.
A special thank you to the diverse group of folks who have shared their insights, advice, encouragement, and enthusiasm as this project has gotten off the ground. What began as a nerdy passion project has already started becoming a community.
And we’re just getting started.
Some exciting updates are coming your way next month! You can always reply with an introduction about your work and interests, and ideas for this Substack (and beyond…)
Funding
Flosonics Medical Secures $20 Million USD in Series C Funding Led by New Leaf Venture Partners to Accelerate Growth (Flosonics)
ONWARD Medical Raises €20 Million in a Capital Increase towards Public Offering in France (Globe Newswire)
Epilepsy Foundation Partners with Iaso Ventures to Launch the NeuroImpact Fund (PR Newswire)
Cumulus Neuroscience Receives Innovate UK Small Business Research Initiative (SBRI) Grant Focused on Clinical Biomarker Tools and Technologies for Dementia (Cumulus)
$2M Encova grant aids focused ultrasound research at WVU Rockefeller Neuroscience Institute (WVU Medicine)
SecondWave Systems Announces $3m from ARPA-H and DARPA to Accelerate Development of Wearable Ultrasound System, Appoints New Advisory Board Members (Business Wire)
NIH Common Fund announces ROA for Oculomics Venture Initiative (NIH)
Manifest Technologies Emerges From Stealth With Strategic Investors for AI-Powered Precision Neuroscience Platform (BusinessWire)
Neurobionics raises funding for precision bioelectronic medicine (Empath Ventures)
Industry & Market News
Neurotech makes Fast Company’s Most Innovative Companies 2024 List: Cumulus Neuroscience, Graymatters Health, Viz.AI, with a nod to Apple’s ALS app
BIOS named finalist in 2024 Cambridge Independent Science and Technology Awards (Cambridge Independent)
Neuralink livestreams first patient playing chess with BCI (Neuralink X)
See Nolan Arbaugh’s full remarks at a Neuralink company meeting
Meet Austin, a research study participant involved in the Reconnecting the Hand and Arm to the Brain (ReHAB) study (Cleveland FES)
Precision Neuroscience Expands BCI research with new studies at Mount Sinai Health System and Penn Medicine (Globe NewsWire)
Motif Neurotech’s brain implant is made to treat mental health problems (Wired)
Inside the Operating Room: Doctors Test a Revolutionary Brain-Computer Implant (WSJ)
Brain-computer interface technology rapidly evolves in China, expected to form a new quality productive force (Global Times)
The brain-computer interface race is on, with AI speeding up developments (Semafor)
Introducing a Wearable BCI Platform with AR & AI (Cognixion)
Deep Brain Recordings to Study Human Cognition | Ignacio Saez (OneMind)
Meet the Designer Behind Neuralink’s Surgical Robot (Wired)
Viz.ai and Medtronic Collaborate to Improve Post-Acute Stroke Patient Care in the United States (Viz AI)
Koneksa’s Usability Testing Case Study: Alignment with DiMe’s V3+ Framework (Koneska)
Koneksa Announces Merck Joins Data Syndication Partnership Program Around Parkinson’s Digital Biomarkers Observational Study (Koneska)
Chris Benko, CEO Koneksa: “We are establishing Data Syndication partnerships as a new form of pre-competitive collaboration that brings together a community around real-time data sharing and analysis throughout our studies to accelerate the validation and adoption of better digital measures.”
Octave Bioscience Accelerates Leadership in Precision Care for Neurodegenerative Diseases with New Commercial Hires (Business Wire)
Case Study: Sumitomo & Cumulus: Objective, Longitudinal, Broad-Spectrum Real-World Data for Drug Development (XTalks)
Preprint: Reliability of brain metrics derived from a Time-Domain Functional Near-Infrared Spectroscopy System (Kernel)
Biogen forges Parkinson’s pact with Indivi to develop digital biomarkers (Firstword Healthtech)
Multiple Sclerosis Association of America (MSAA) Selects SEQSTER to Accelerate Patient-Centricity & Innovation (Business Wire) (Fierce)
CIONIC Partners with UCHealth UColorado Hospital, Craig Hospital, and Neuro PT to Expand Clinical Availability of Neural Sleeve (Business Wire)
Neuronetics Announces 5-Year Exclusive Partnership with Transformations Care Network (Neuronetics)
Nyxoah Advances Partners with the American Association of Otolaryngology – Head & Neck Surgery Foundation (Nyxoah)
Neurable Inc. and Healthspan Digital Inc. Announce Partnership to Empower Precision Health and Longevity Clinics in Canada (PR Newswire)
BlueWind Medical Revi Implantable Tibial Neuromodulation Device Now Available to Patients in Texas (PR Newswire)
Two FDA-cleared options for tibial nerve stimulation (Urology Times)
Neuromodulation growth expected in obstructive sleep apnea treatment (GlobalData)
UK’s NHS trial on Flow’s tDCS wearable for treatment resistant depression (BBC)
NeoSensory Is Aiming to Combat Rock & Roll’s Legacy of Hearing Loss (Rolling Stone)
Rethinking Consumer Health and Care: The Role of Digital Health in Neurodegenerative Diseases (7Wire)
“Between 2020 and 2023, total investment exceeded $3B, with 2021 alone seeing a staggering $1.5B in private investment.1 We believe the neurodegenerative care market landscape can be segmented into six different categories: Patient Engagement, Diagnostics & Biomarkers, Virtual PT, Caregiver Support, Clinical Care Management, and Neurostimulation.”
Note: Do you consider virtual PT as “Neurodegenerative Care?”
Regulatory
AI & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together (FDA)
CDER Establishes New Quantitative Medicine Center of Excellence (FDA)
Guidance Document: Early Alzheimer’s Disease: Developing Drugs for Treatment (FDA)
New Partnership between American Brain Coalition and FDA to Include Patients and Families in TAP Regulatory Process (Dana Foundation)
Setpoint Medical Accepted into FDA TAP program for M.S. Neuromodulation Platform (Setpoint)
InBrain Neuroelectrics announces acceptance into FDA TAP program (LinkedIn)
Signed appropriations package includes $100 million funding increase for dementia research (McKnights)
NANS leads response to Humana's new policy that excludes coverage of PNS (NANS)
FDA clears Neuronetics' neurostim for adolescents with depression (MassDevice)
SyntheticMR receives FDA 510(k) clearance for their next Generation Solution SyMRI 3D (SyntheticMR)
Beacon Biosignals Expands Sleep Analysis Capabilities with FDA Clearance of Sleep Stage ML (PR Newswire)
🗓️ Events & Community News
April 2: Happy Hour in San Francisco (Hazy’s, 501 Hayes St, 6pm PT)
April 5: Bioelectronic Medicine Forum (Neurotech Reports)
April 17-19: International Neuroethics Forum (INS)
April 30-May 1: Interface Rice (Rice.edu)
May 2: Neuronal Ensembles 2024 (Neurotechnology Center @ Columbia)
May 21 - 22: Foresight Neurotech, BCI and WBE for Safe AI Workshop - Lighthaven, Berkeley (Foresight Institute)
June 17-18: 10th Annual BRAIN Initiative Conference - in Rockville, MD (NIH)
Neuroethics & Society
Take this short Public Neuroethics Survey! (INS)
UNESCO forms a 24-person Neuroethics Council (UNESCO)
February 2024 NIH BRAIN Initiative Neuroethics and Multi-Council Working Group Meetings (NIH)
See also: BRAIN Initiative’s Toolmakers Newsletter
Neuroscience and Society Series: Aligning Science with the Public’s Values (Hastings Center)
Rep Blumenauer asks FDA about Neuralink’s human trials (PCMag)
What we talk about when we talk about Neuroplasticity by Zach Haigny (Beckley Waves)
Colorado Senate approves new brain privacy laws (X)
Mobile EEG for NeoUrbanism Research: What Could Possibly Go Wrong? A Critical Review With Guidelines by Klauss Gramann (Biorxiv)
Note: A banger. Come for the EEG validity insights, stay for the shots fired at scientific publishers.
“The promise of “neuro” in Neurourbanism is to incorporate neuroscientific measures besides the existing assessment tools to provide more “objective” insights into the subjective responses to specific aspects of the urban environment and how these relate to well-being….with electroencephalography (EEG), functional magnetic resonance imaging (fMRI), and functional near-infrared spectroscopy (fNIRS) as the leading methods in this field.”
tldr: “The results paint a deeply concerning picture of the scientific rigor in the emerging field of Neurourbanism.”
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