January was a BUSY month for all things neurotech, kicking off a blistering start to the year. Here are some curated headlines and articles that caught my eye - please share and forward to your network as you see fit.
Funding
Motif Neurotech closes $18.75 million Series A (PR Newswire)
“The round of financing was led by Arboretum Ventures, with participation from new investors KdT Ventures, Satori Neuro, Dolby Family Ventures, re.Mind Capital and existing investors Divergent Capital, TMC Innovation, PsyMed Ventures, Empath Ventures and Capital Factory.
Proceeds from the Series A financing will be used to advance the development of Motif's lead product, the DOT microstimulator, a miniature brain pacemaker that is designed to precisely stimulate the brain to restore healthy circuit activity to treat mental health disorders. The initial indication Motif is pursuing for the device is treatment-resistant depression (TRD), a form of major depressive disorder (MDD).”
Cognito Therapeutics enrolls first patient in pivotal trial (PR Newswire), raises $35m Series B extension (FirstWord HealthTech)
“The fresh capital brings the digital health firm's Series B round to $108 million, after it pocketed $73 million last March. Cognito has secured a total of $128 million to date.
The extension round was backed by existing investors FoundersX and
Morningside Ventures. Vaughan said the company plans to use the proceeds to support its Phase III HOPE study and prepare for commercialisation of its stimulation therapy. The pivotal study, which launched in late 2022, is testing the company's wearable GammaSense neuromodulation device to treat cognitive and functional symptoms in patients with mild-to-moderate Alzheimer's disease.”
Rune Labs raises $12m Series A led by Nexus Neurotech (PR Newswire)
“Rune Labs, a precision neurology software and data company, today announced a strategic round of $12 million, increasing the total amount raised by the company to over $42 million. The round was led by new brain disorder fund, Nexus NeuroTech Ventures, with participation from existing investors, including Eclipse, DigiTx Partners, Moment Ventures and TruVenturo GmbH. Jordi Parramon, PhD, CEO, General Partner and Co-Founder of Nexus NeuroTech Ventures and former President of Medical Devices at Verily, will join Rune Labs’ board of directors.”
In 2022, Rune Labs’ StrivePD software ecosystem for Parkinson's disease was granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) to collect patient symptom data, including tremors and dyskinesia, through measurements made by Apple Watch.”
Newronika secures SECURES INITIAL €2 million from EIC Accelerator for Parkinson’s Disease Research (LinkedIn)
Newronika S.P.A – a pioneering Milan-based leader in adaptive deep brain stimulation and brain device interface technology – has achieved a major milestone in its mission to enhance the lives of Parkinson's disease patients. Following the signing in March 2023 of a €2.5 million grant agreement with the European Innovation Council (EIC) Accelerator's "Grant first" program, Newronika has successfully attracted an additional €2.0 million in equity financing from EIC Accelerator’s equity program.
Newronika is a spin-off company backed by prominent venture capital funds with extensive experience in the healthcare sector, including Innogest SGR, Indaco Venture Partners, Omnes Capital, F3F, Wille Finance, and TNBT Capital.
Nalu Medical, Inc. Announces $65 Million Equity Financing to Advance Treatment for Chronic Neuropathic Pain (BusinessWire)
“Nalu Medical Inc. (Nalu), a private company focused on innovative, minimally invasive, and non-opioid solutions for chronic neuropathic pain, announced today the closing of a $65 million equity financing. The round was led by a new investor, Novo Holdings (Novo). Also participating in the round were all of the Nalu existing significant investors: Gilde Healthcare, MVM Partners, Endeavor Vision, Decheng Capital, Longitude Capital, Advent Life Sciences, Pura Vida, and Aperture Venture Partners. The proceeds from this financing will be used to accelerate commercial growth, expand clinical and health-economic evidence, continue product development, and scale operations.”
Onera raises over €30M in Series C funding (company website)
“Onera Health, pioneer and leader in remote sleep diagnostic and monitoring solutions enabling clinicians to conduct sleep studies anytime, anywhere, announced the completion of its Series C financing round, bringing total investment to date to more than €55 million.
The round was led by new investor EQT Life Sciences, investing from its EQT Health Economics 3 fund, co-led by new investor Gimv, and joined by existing investors, including Innovation Industries, Invest-NL, imec.xpand, BOM, and 15th Rock.”
Neurosity raises $345k via crowdsourcing platform (WeFunder)
JOGO Health raises $5m from Mayo and others (WeFunder)
Commercial Headlines
Synchron buys equity stake in manufacturer, announces patient registry (MSNBC)
“Synchron announced Thursday that it has acquired a minority equity stake in the German manufacturer Acquandas, which has the unique ability to layer the metals that make up one component of the company’s implant. As part of the deal, Synchron will get exclusive access to Acquandas’ layering technology for medical devices, and Synchron’s CEO Tom Oxley and CTO Riki Banerjee will join the manufacturer’s board.
As the company is working to ramp up its manufacturing, it is also hoping to gauge interest from more prospective patients. Synchron is planning to launch an official patient registry in mid-February that will allow patients with limb or motor impairment to stay updated about trials and share details about their needs. “We wanted to create a mechanism where people could express interest, and it’s going to help us shape the consideration for which clinical sites across the US we focus in first,” Oxley said.
Neuralink completes first human implant, names product “Telepathy” (Guardian)
Elon Musk, the billionaire founder of the neurotechnology company Neuralink, has said the first human received an implant from the brain-chip startup and is recovering well.
In follow-up tweets sent in between arguing about video games and bantering with far-right influencers, the businessman said the first Neuralink product was called Telepathy. ”It enables control of your phone or computer, and through them almost any device, just by thinking,” he wrote. “Initial users will be those who have lost the use of their limbs. Imagine if Stephen Hawking could communicate faster than a speed typist or auctioneer. That is the goal.”
Gate teams up with Beacon to use EEG biomarkers in Phase II MDD trial (Clinical Trials Arena)
“US-based Gate Neurosciences has partnered with Beacon Biosignals to use electroencephalogram (EEG) biomarkers in developing its neuropsychiatry and cognition clinical pipeline.
As part of the collaboration, the Phase II trial investigating Gate’s zelquistinel will use Beacon’s Dreem 3S headband device and neuro biomarker platform to conduct exploratory EEG and sleep analyses in patients with major depressive disorder (MDD). The trial is expected to start in mid-2024.
Beacon’s Dreem 3S is a wearable headband that uses integrated machine-learning algorithms to help acquire EEG data from the brain for monitoring sleep architecture and assisting in disturbed sleep diagnosis. The device can be used to record EEG data at home for up to 24 hours. It received 510(k) clearance from the US Food and Drug Administration (FDA) in September 2023.
GrayMatters Health Launches New FDA-Cleared Self-Neuromodulation PTSD Therapy in the United States (PR Newswire)
“GrayMatters Health (GMH), developer of digital self-neuromodulation therapies for mental health care, announces the official launch of Prism for PTSD in the United States. Prism for PTSD is currently being used to treat patients at two centers. Prism for PTSD is the first self-neuromodulation device to receive FDA clearance as a prescribed adjunct to standard-of-care (SOC) for PTSD.
During Prism therapy, a computer simulation and EEG headset create an immersive environment for training individuals to gain control over amygdala-based biomarker activity associated with PTSD. For clinics, Prism for PTSD is covered by existing business models, thereby providing clinics with opportunities to add revenue-generating services while augmenting existing treatment outcomes.
BIOS Health announces US “commercial beachead” in Bakersfield CA (The Bakersfield Californian)
“BIOS, founded in 2015, says it has pioneered technology to read and interpret neural signals with the benefit of AI. Last year the company announced its receipt of capital investment from several sources. Earlier, in November 2022, the company said its data platform will serve the largest-ever study of the human vagus nerve, in collaboration with the NIH and other major institutions. The expansion into Bakersfield, CEO Hewage said, marks the company's launch of its primary commercialization stage. He said locating in Bakersfield will give it relatively close access to the biotech and medical device companies from San Diego to San Francisco that tend to drive spending on clinical trials.”
Insightec announces launch of Exablate Prime, The Next Generation of MR-guided focused ultrasound (Company Blog)
Insightec, a global healthcare company dedicated to using acoustic energy to transform patient care, today announced its launch of Exablate Prime, a significant enhancement to the Exablate Neuro platform. Like its predecessor, Exablate Prime enables incisionless neurosurgery as an outpatient procedure to provide relief to people living with movement disorders, such as essential tremor.
Insightec also announced new approval from Defense Health Agency: “9.5 million US military members and their covered dependents, covered by Tricare are now eligible for coverage reimbursement.”
Magstim wins FDA nod for latest transcranial magnetic stim tech (MassDevice)
Magstim announced today that it received FDA clearance for its Horizon 3.0 transcranial magnetic stimulation (TMS) system with StimGuide Pro.
The latest platform builds on the previous H 3.0 system for treating patients with depressive or obsessive-compulsive conditions.
Neuralace announces US FDA clearance for Axon therapy for Pain Management (NeuroNews)
“Neuralace Medical has announced the US Food and Drug Administration (FDA) clearance of its “groundbreaking” Axon therapy for the treatment of chronic painful diabetic neuropathy (PDN). This “landmark approval” marks the first ever FDA clearance of a non-invasive, magnetic peripheral nerve stimulation (mPNS) treatment for PDN
Neuralace further claims that Axon therapy utilises the “pioneering approach” of mPNS to deliver a quick, painless, non-pharmacological and non-invasive treatment. Each session with the technology lasts just 13.5 minutes, and harnesses the power of magnetic pulses to provide relief—representing, in the company’s view, a “significant advancement” in pain management.”
Boston Scientific acquires Axonics for $3.4 B (PR Newswire)
Boston Scientific Corporation (NYSE: BSX) today announced it has entered into a definitive agreement to acquire Axonics, Inc. (Nasdaq: AXNX), a publicly traded medical technology company primarily focused on the development and commercialization of differentiated devices to treat urinary and bowel dysfunction. The purchase price is $71 in cash per share, reflecting an equity value of approximately $3.7 billion and an enterprise value of approximately $3.4 billion.
The Axonics product portfolio includes the Axonics R20TM and the Axonics F15TM Systems used to deliver sacral neuromodulation (SNM) therapy. SNM therapy is a minimally invasive procedure used in the treatment of OAB and fecal incontinence. It works by delivering mild electrical pulses to the sacral nerve to restore communication between the brain and the bladder.
Abbott launches Liberta RC deep brain stimulation system with remote programming capabilities (NeuroNews)
Abbott recently announced that it has received approval from the US Food and Drug Administration (FDA) to launch the Liberta RC deep brain stimulation (DBS) system to treat people living with movement disorders.
The Liberta RC DBS system is the only rechargeable DBS device compatible with Abbott’s proprietary NeuroSphere virtual clinic, which the company describes as a first-of-its-kind connected care technology in the USA that allows people to communicate with their doctors, ensure proper settings and functionality, and receive new treatment settings remotely as needed without going to a doctor’s office. Abbott says it developed its NeuroSphere virtual clinic after research showed that the average Abbott DBS user in the USA has to travel more than 150 miles to access a movement disorder specialist.
US FDA approves Medtronic’s Percept RC neurostimulator (Medical Device Network)
The US Food and Drug Administration (FDA) has approved Medtronic‘s Percept RC deep brain stimulation (DBS) system to help improve treatment for movement disorders. This rechargeable neurostimulator joins the Medtronic Percept family, said to be the first and only DBS system with sensing capabilities, directionality and advanced programming options.
The Percept family includes the Percept PC neurostimulator, BrainSense technology and SenSight directional leads.
It allows physicians to provide personalised treatment for patients with movement disorders such as essential tremor, Parkinson’s disease, dystonia as well as epilepsy.”
Alto Neuroscience Announces Pricing of Upsized Initial Public Offering (Business Wire)
Alto Neuroscience, Inc. (“Alto”) (NYSE: ANRO) today announced the pricing of its upsized initial public offering of 8,040,000 shares of common stock at a public offering price of $16.00 per share. The aggregate gross proceeds to Alto from the offering are expected to be approximately $128.6 million before deducting underwriting discounts and commissions and other offering expenses payable by Alto.
Notable: See biotech analyst Eliot Hershberg’s take (LinkedIn)
Neurotech highlights from CES (CES)
See pertinent neurotech buzz from dozens of companies, including Afferenz, ClinaTec BCI, Frenz, Neurable, OpenBCI,Sens.AI WImagine, many others; I suggest selecting “digital health” and “accessibility and aging tech”
Nice recap here: AgeTech Innovations at CES (A2 Collective)
Neuroethics & Society
International Neuroethics Society opens registration for 2024 annual conference in Baltimore, MD (April 17-19). The theme is “Neuroethics Engages the Arts” (INS)
Dana Foundation announces new $150k pilot grants focused on Neuroscience & Society - Due Feb 16 (Dana Foundation)
What is Neuroethics? (Joseph Devlin)
Advances in Mind-Decoding Technologies Raise Hopes (and Worries) (UnDark)
“In the last 10 years, the field of neurotechnology has proliferated at an astonishing pace. According to a report by NeuroTech Analytics, an industry research firm, annual investment in the sector increased more than 20-fold between 2010 and 2020, rising to more than $7 billion per year. Over 1,200 companies have crowded into the space, while large-scale government efforts, such as former president Barack Obama’s BRAIN Initiative, have unlocked billions in public funding.
But in opening the door to the brain, scientists have also unleashed a torrent of novel ethical concerns, raising fundamental questions about humanity and, crucially, where it may be heading. How society chooses to address the ethical implications of neurotechnology today, scientists like Yuste argue, will have profound impacts on the world of tomorrow. “There’s a new technology that’s emerging that could be transformational,” he said. “In fact, it could lead to the change of the human species.”
BIOADAPTED from Transforma Theater uses open-source BCI from OpenBCI in a stage production incorporating EEG, GPT, haptic clothes, LEDs, and audience participation. (Transforma)
Brain Talks: Exploring Sexuality, Mental Health & Neurofeedback with Dr. Ruth Cohn (Neuronoodle)
Other News & Analysis
ICYMI: I’ve reposted my JPM writeup for those who can’t access Forbes
The Race to put Brain Implants in People is Heating Up (Wired)
Neuralink implantation marks milestone for startups in $8B neurotechnology vertical (Pitchbook)
Precision Neuroscience publishes preprint detailing their Layer7 Cortical Interface (BioRxIV)
BCI listed as one of “Seven Technologies to Watch in 2024” (Nature)
Tips to Overcome 4 Challenges in the Neurotech Startup World (Med Device Online)
Startup Health, Alzheimer’s Drug Discovery Foundation’s Diagnostics Accelerator, and Gates Ventures team up for new Moonshot program (Startup Health)
Neurotechnologies for Brain Health and Wellness in the Digital Age (Lee Sidebottom)
January NeuroModulation News curated by Lindsay Hartland (LinkedIn)
CalTech research explores functional ultrasound for BCI (SciTechDaily)
This neural haptic glove lets you feel things that aren’t there (Interesting Engineering)
Biogen to halt sales and development of controversial Alzheimer's drug Aduhelm (Endpoints News)
What did I miss? Comment below, or hit me up on email, LinkedIn, Twitter (sigh I mean X)