Neurotech Notables #14: August 2024

Refine, Add Value, Get Reimbursed

Wake me, I must be dreaming because my boat commute is unbelievable.

Greetings, and Happy Friday.

As a teenaged edition, Neurotech Futures is undergoing some changes.

Based in part on your feedback, here’s your streamlined, more discerning roundup. Less stuff, less fluff. Events are now pinned. And more updates soon.

Meanwhile, neurotech = exciting times as per usual. Here’s what you need to know.

• Clinical vs Social Value in BCI
  A pair of NYTimes highlight the “magic” of BCI and neurotech in understanding and exploring our humanity. A father with ALS speaks to his daughter again. Evidence emerges that the unconscious might still be conscious.
  But what will it take to turn these clinical breakthroughs into accessible treatments? Commercial leaders and advocates are focused on time to access, device cost, and ongoing amount of clinical care, research visits, and more.

• Faster Money
  CMS released their long-awaited Transitional Coverage program, TCET. “Coverage with Evidence Development” offers a 6 month reimbursement status following clearance of FDA-designated Breakthrough Devices. Starting this October, CMS will accept 5 companies a year into this program. What are your questions about this program?

• Neuromod Market Movement

  Nevro’s news suggests M&A ahead in Spinal Cord Stimulation. TMS sands are shifting with Neuronetics acquisition of Greenbrook and Magnus readying. And focused ultrasound is poised to gain momentum in treating cancer, addiction, tremors, and more.

• I’ll Have The Usual
  Great, here you go: Some modest funding news along with several executive appointments, strategic partnerships, along with new companies, new products, new clearances, new codes, new research, and more.

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🤝🏽 Please continue to send questions, share feedback, and introduce yourself.

🫶🏽Most importantly: Have a great weekend. You deserve it! Now, let’s dive in.

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Funding

• Firefly completes merger, raises $3.5m, starts public trading (Globe Newswire).

• NeuroOne® Announces $2.65 Million Equity Financing And $3.0 Million Credit Facility (StockTitan)

• REMspace: Neurotech Company Raises $1 Million In Seed Funding (Pulse 2.0)

• NeuroBionics awarded NSF Phase I SBIR grant to support development of neural probe connectors (LinkedIn)

• NIH reissues HEAL Initiative funding for pain and OUD related diagnostic and therapeutic devices (NOSI } Blueprint Neurotech )

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• Second brain implant by Elon Musk’s Neuralink: Will it fare better than the first? (Nature)

Commercial

• Neuronetics to acquire GreenbrookTMS (Medtech Dive)

  • Big Deal. Quick thoughts. I half-predicted this in last month’s TMS Teardown: “Neuronetics…is likely too entrenched in their existing operation - not to mention cash-strapped - to explore such forward-looking revenue diversification. (Unless of course, someone decides to buy these legacy brands outright and change things up in this space. As of today, Greenbrook’s market cap is $3.3m. Neuronetics’ is $54m. That’s chump change to some. )”

• Onward Shares Strategic Priorities and Company Highlights (ONWARD | LinkedIn)

  • Note: What do you think about ONWARD’s unveiled $40k pricepoint for ARC-EX? A few BCI companies have stated $100k as an anticipated pricepoint. How will CMS consider and compare “value” for digital control, communication, and motor neuroprosthetics?

• Longeviti Neuro Achieves Patent Approval and New ICD-10 code (MorningStar)

  • “The ICD-10-PCS code XNR80D9, which stands for "Replacement of Skull with Ultrasound Penetrable Synthetic Substitute, Open Approach, New Technology Group 9," is exclusively named and is only associated with the Longeviti ClearFit® device.”

• Science Corporation Welcomes Tricia Gugler as Chief Financial Officer, Alex Feerst as Chief Legal Officer, and Joe Mornin as General Counsel (Science)

• EMOTIV appoints Jukka Wallasvaara as Director of Ecosystem Partnerships. (LinkedIn)

• Motif hires Jon Nelson as Director of Lived Experience (LinkedIn)

• Cionic hires Senior Manager of Reimbursement Colleen O’Connell (LinkedIn)

• Bottneuro launches Priority Access Program after successful study using MRI & PET scanning for precise transcranial alternative current stimulation (tACS) (Startup Ticker)

• InBrain’s brain implant made from graphene is set to begin UK clinical trial (Financial Times)

• Creation of the World's First "Neuromap" by Utah-based Recursion Pharmaceuticals Triggers a $30 Million Payment from Roche and Genentech (Utah Moneywatch | Recursion CCO Najat Khan Phd)

• Sonde Health launches voice-based cognitive fitness tracker (Pharma Phorum)

• EMVision unveils (proof-of-concept) backpack-sized brain scanner (EMVision)

Note this is a proof-of-concept stage idea.

• Nevro considers sale as competition for pain market ramps up (MedTechDive)

  • Note: Interesting times in the Spinal Cord Stimulation market. If you have insights to share about commercial headwinds here, let’s chat.

• Cumulus Neuroscience Presents Data on “user friendliness” and suitability for at-home trial participation at AAIC 2024 (Cumulus)

  • Related: This feature on Cumulus: Reshaping Clinical Trials (Hira-Ni)

• Magnus Medical Highlights New Clinical Data on Groundbreaking SAINT Therapy at 2024 NYC Neuromodulation Conference (MorningStar)

• Sense Neuro Diagnostics joins Innovators’ Network at American Heart Association Center for Health Technology & Innovation (Sense)

• Fred Ehrsam and Quintin Frerichs launch Nudge, an ultrasound based consumer headset (X)

• Stanford spinout Enigma Project launches “to build foundation models of the brain at single-neuron resolution.” (Enigma Project)

Regulatory

• FDA updates list of 950 AI/ML-enabled medical devices (FDA)

• Medtronic receives landmark FDA approval for Asleep Deep Brain Stimulation surgery (Medtronic)

• CVRx getsMedicare reassignment for Barostim procedure (MassDevice)

  • This reassignment for FY 2025 moves Barostim to MS-DRG 276, with a national average payment of around $43,000 and takes effect on Oct. 1, 2024

• CMS launches Transitional Coverage for Emerging Technologies (TCET) Pathway (CMS | Federal Register)

  

  “The new TCET pathway for certain FDA-designated Breakthrough Devices increases the number of NCDs that CMS will conduct per year and supports both improved patient care and innovation by providing a clear, transparent, and consistent coverage process while maintaining robust safeguards for the Medicare population. CMS anticipates accepting up to five TCET candidates per year and, for technologies accepted into and continuing in the TCET pathway, CMS’ goal is to finalize a national coverage determination (NCD) within six months after FDA market authorization.” (CMS.gov)

Research

• Unresponsive Brain-Damaged Patients May Have Some Awareness (NYTimes)

• A.L.S. Stole His Voice. A.I. Retrieved It. (NYTimes)

• Transcranial Temporal Interference Stimulation of the Right Globus Pallidus in Parkinson's Disease (Movement Disorders)

• Long-term cognitive and psychiatric effects of COVID-19 revealed in new study ( Story |  Paper)

• An automatic measure for speech intelligibility in dysarthrias—validation across multiple languages and neurological disorders (Frontiers in Digital Health)

• Caltech Team Develops First Noninvasive Method to Continually Measure True Blood Pressure (CalTech)

• Brain electrical stimulation suppresses appetite. A new frontier in obesity treatment? (Eureka Alert)

Events

Where’d the events go?

Industry Buzz

• TELL Is Building the Leading Voice Biomarkers for Latin America (Startup Health)

• MindMaze, ‘A Ratio Of Luke Skywalker And R2-D2’, Navigates The DTx Galaxy (Medtech Insight)

• Amber Therapeutics just finished a $100M Series A. Learn more: NEA, MedTech Strategist, Lifeblood

• What’s Your Brain Age? EEG Algorithm Scans for Problem Gaps (Emotiv)

• Podcast: Natus CEO Chris Landon (DeviceTalks)

Neurotech TV

• BCI Thursday: Next Gen: Industry Academia Talk 7 with Dr. Ben Rapoport of Precision and Dr. Sergey Stavisky of UCDavis (Youtube)

• Neurosurgeon Dr. Ali Rezai works to slow Alzheimer's progression, treat addiction with cutting-edge technology (CBS News)

• Toronto-based RetiSpec uses AI to detect Alzheimer’s through eye exams (BNN Bloomberg)

• A Conversation on Language AI (Google Research)

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It’s been a busy stretch. What did I miss? Please send so I can include next time.

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