NeuroTech Newsletter #3
April 17, 2025
Executive Summary
Welcome to the 3rd Installment of the Neurotech Newsletter. The last two weeks have been quite the ride with so much economic uncertainty due to the tariff changes. With a number of Neurotech companies manufacturing in China, there is a lot of concern to iron out in the coming months.
That being said there has been an abundance of positive fundraising, regulatory, clinical and hiring news Take a look below at the latest developments in Neurotech
Funding News
Phantom Neuro Secures $19M Series A Funding
PR Newswire2025-04-15
Austin‑based Phantom Neuro closed an oversubscribed $19 million Series A led by Ottobock to advance its Phantom X neural control platform for prosthetics and robotics. The round, which brings total funding to $28 million, will support preclinical studies, first‑in‑human trials, regulatory submissions and expanded R&D. Backed by a suite of existing and new investors, the company’s device has earned FDA Breakthrough Device and TAP designations and shown 94 percent accuracy decoding 11 hand and wrist gestures, underscoring its potential to deliver lifelike control of assistive devices.
Science Corp Raises $110M in Funding
Business Journals2025-04-14
Alameda‑based startup Science Corp. secured $110 million in convertible debt led by Khosla Ventures, nearly doubling its capital after an earlier $150 million equity raise. Founded by ex‑Neuralink executive Max Hodak, the company is developing a BCI system with its Axon probe, SciFi signal processor and a Prima retinal prosthesis. Rather than rushing to market, Science Corp. is prioritizing robust development for neurological disorders such as paralysis and vision loss, positioning itself for sustained clinical progress.
Kandu Announces $30M Financing for Stroke Recovery
Business Wire2025-04-08
In the wake of its merger with Neurolutions, Kandu closed a $30 million financing co‑led by new and existing investors to scale an integrated noninvasive BCI and telehealth platform for home‑based stroke recovery. The end‑to‑end solution spans immediate post‑acute care through chronic rehabilitation, with clinical evidence showing lower readmissions and improved functional outcomes, aiming to reshape standards of care for stroke survivors and caregivers.
SecondWave Systems Secures $7M Series A
PRNewswire2025-04-08
Clinical‑stage medtech company SecondWave Systems raised $7 million in a Series A round led by Treo Ventures to fuel its next clinical trial of the SecondWave MINI, a wearable ultrasound therapy shown to reduce rheumatoid arthritis activity. Building on DARPA and ARPA‑H support and positive first‑in‑human data, the startup is advancing noninvasive bioelectronic treatments for autoimmune and inflammatory disorders.
Summary
These funding rounds across neural prosthetics, brain‑computer interfaces, stroke rehabilitation and bioelectronic therapies reflect a surge of strategic and venture capital into neurotechnology and adjacent healthcare sectors. The influx of resources and partnerships with established MedTech players like Ottobock will accelerate clinical validation, streamline regulatory pathways and intensify competition as companies transition from early research to scalable product offerings.
Investors are gravitating toward integrated, noninvasive interfaces and holistic treatment platforms that blend hardware, software and telehealth, supported by strong clinical evidence and regulatory designations. From assistive prosthetics to chronic disease management, funding is shifting from exploratory R&D to late‑stage trials and commercialization, ushering in an era of convergent innovation and broader clinical adoption in the neurotechnology landscape.
FDA News
FDA Clears High-Res Cortical Array
GlobeNewswire2025-04-17
The FDA has granted 510(k) clearance to Precision Neuroscience’s Layer 7 Cortical Interface, a high‑resolution electrode array for recording, monitoring, and stimulating cortical activity. Authorized for up to 30‑day implantation, this wireless, fully implantable array is poised to transform intraoperative brain mapping and advanced BCI research by enabling extended neural data collection at unprecedented fidelity.
BEL Announces 510(k) Clearance for NEAT Software
Brain Electrophysiology Laboratory2025-04-15
The FDA’s 510(k) clearance of NEAT, Brain Electrophysiology Laboratory’s AI‑driven EEG Assessment Technology, validates its use in classifying sleep stages in near‑real time or offline. As the core algorithm powering Neurosom’s Sleep WISP system for personalized closed‑loop neuromodulation, NEAT’s clearance bolsters confidence in AI‑led neurotech for research and clinical trial applications.
FDA Clears AI Surgical Guidance Platform
PR Newswire2025-04-08
Proprio has secured a second 510(k) clearance for Paradigm, its AI‑powered surgical guidance platform enabling real‑time, radiation‑free 3D and segmental anatomical measurements during procedures. Adopted by institutions like Duke Health and UW Medicine, Paradigm delivers intraoperative insight into alignment and implant placement, promising reduced revision rates and enhanced surgical training.
Summary
These FDA clearances underscore growing regulatory support for advanced neurotechnology, from implantable BCIs to AI‑driven software and surgical platforms. By validating extended‑duration neural interfaces, AI classifiers, and real‑time guidance systems, the FDA is lowering barriers to clinical adoption, accelerating data‑rich therapies, and fostering industry investment in next‑generation devices.
A clear trend emerges toward 510(k) approvals of AI‑enabled neurodevices and expanded use‑period clearances for implantables. The FDA’s readiness to accommodate innovative algorithms and longer‑term implants signals a maturing regulatory framework that balances patient safety with rapid clinical translation of complex neurotechnologies.
Clinical News
gammaCore nVNS Effective for Concussive Symptoms
GlobeNewswire2025-04-17
In a clinical study presented at the 2025 International Brain Injury Association World Congress, Dr. Michael Ament of Cherry Creek Neurology reported that adjunctive gammaCore non‑invasive vagus nerve stimulation (nVNS) delivered to 102 mild TBI patients produced significant relief across 22 of 27 concussive symptoms. Notably, post‑traumatic headache, nausea, dizziness and depression scores improved regardless of whether injuries occurred within three months or over three years prior. The findings underscore gammaCore’s potential as a nonpharmaceutical neuromodulation option for both acute and persistent mTBI symptoms.
SpineX SCONE Improves Bladder Function
Business Wire2025-04-15
SpineX Inc.’s global, multisite pivotal CONTINENCE trial demonstrated that SCONE non‑invasive spinal cord neuromodulation yielded a statistically significant reduction in neurogenic bladder symptoms versus sham. More than half of the paralysis patients—post–spinal cord injury, stroke or MS—achieved a ≥10‑point improvement on the Neurogenic Bladder Symptom Score. Participants experienced fewer incontinence episodes, enhanced urgency control, reduced nocturnal awakenings and decreased daytime catheter use, supporting SCONE’s Breakthrough Device Designation pathway toward regulatory approval.
Sinaptica’s rTMS Device Meets Primary Endpoint in Phase 2 Alzheimer Trial
Neurology Live2025-04-11
In one of the lengthiest rTMS studies for Alzheimer’s, Sinaptica’s 52‑week Phase 2 trial enrolled 48 mild‑to‑moderate AD patients for an intensive 2‑week daily precuneus stimulation followed by weekly maintenance sessions. Active treatment slowed cognitive decline by 44% compared to sham, stabilized MMSE scores, and improved daily living activities. EEG analyses revealed consistent TMS‑evoked potentials correlating with clinical gains, validating personalized neuromodulation of the precuneus as a promising precision therapy.
ANEUVO’s ExaStim® Earns CE Mark Certification
GlobeNewswire2025-04-09
ANEUVO announced that its ExaStim non‑invasive spinal cord stimulation system has secured CE Mark certification and ISO 13485 compliance under the EU Medical Devices Regulation. ExaStim delivers targeted motor‑function enhancement via a programmable multi‑electrode pad controlled by a mobile interface. CE approval enables European commercialization, marking a key regulatory milestone in bringing this investigational therapy to chronic spinal cord injury patients.
Dynamic Pulse SCS Extends Analgesia in Rats
Frontiers in Pain Research2025-04-09
In a randomized, blinded preclinical study of 23 rats with chronic constriction injury, time‑dynamic spinal cord stimulation (TDP SCS) was compared to conventional tonic SCS over 90 minutes. Both paradigms reversed allodynia within 30 minutes, but TDP SCS showed a slower onset and significantly prolonged analgesic wash‑out phase, resisting the efficacy decline seen with tonic SCS. Modeling of paw withdrawal thresholds suggests dynamic modulation may mitigate neural adaptation and extend pain relief.
Cala TAPS Therapy Clinical Study Results
PRNewswire2025-04-07
At AAN 2025, Cala presented evidence from a 263‑patient multicenter study showing that home use of its FDA‑cleared transcutaneous afferent patterned stimulation (TAPS) system improved essential tremor severity across eight daily activities in over 80% of users at one and three months. A 12‑month real‑world analysis of 153 TAPS users versus matched controls revealed reduced ET‑related healthcare costs. Mechanistic recordings in eight patients confirmed modulation of the ventral intermediate nucleus, paralleling deep brain stimulation effects.
Summary
These studies highlight the rapid evolution of non‑pharmaceutical neuromodulation across neurological indications. From gammaCore’s mTBI symptom relief and SCONE’s bladder control restoration to precision rTMS in Alzheimer’s and wearable TAPS for tremor, clinicians now have a growing arsenal of device‑based therapies that deliver targeted, durable benefits while reducing reliance on drugs. Regulatory advances such as CE Mark approval for ExaStim and Breakthrough Device Designation for SCONE accelerate patient access. Meanwhile, preclinical insights into dynamic pulse SCS chart a path toward longer‑lasting analgesic protocols, underscoring the translational synergy between bench and bedside.
Current research converges on personalized, adaptive neuromodulation delivered via minimally invasive or wearable platforms. There is a clear shift toward leveraging real‑world data to validate safety, efficacy and cost‑effectiveness, while regulatory frameworks adapt to rapidly maturing device innovations. Preclinical modeling of stimulation parameters informs clinical trial design, and multi‑center pivotal studies are becoming the norm to support global market entry. This trajectory points to a future in which patient‑centric, non‑drug interventions become integral to standard neurological care.
Leadership Appointments
Paradromics Appoints Dr. Ryu as CMO
Paradromics Inc.2025‑04‑17
Paradromics has appointed Dr. Stephen Ryu as Chief Medical Officer. A board‑certified neurosurgeon and adjunct Stanford professor with over two decades at the Stanford Neuroprosthetics Laboratory and more than 80 peer‑reviewed BCI publications, Dr. Ryu will steer clinical strategy, product design and research pathways as Paradromics advances its Connexus high data‑rate brain‑computer interface through FDA approval toward commercial launch.
Nia Therapeutics announces new Senior Director of Quality and Systems Engineering
Nia Therapeutics2025‑04‑16
Nia Therapeutics has named Chuck Vadala Senior Director of Quality and Systems Engineering. Holding a master’s in biomedical engineering, Vadala brings extensive expertise in systems engineering, product safety, risk management and regulatory compliance from roles at ZOLL Medical, Aspect Medical, Heartware and Insulet. He will lead quality operations and systems engineering to support Nia’s pipeline of closed‑loop neurostimulation therapies.
Turing Medical Appoints King as CEO
Business Wire2025‑04‑15
Precision brain‑mapping company Turing Medical has appointed Kevin King as President and CEO. With three decades of leadership at iRhythm Technologies, Affymetrix and Thomson Reuters Healthcare, King will spearhead a clinical trial of PACE Therapy for treatment‑resistant depression, leveraging Turing’s Bullsai targeting platform. His mandate is to accelerate the company’s expansion and bring minimally invasive neuromodulation solutions to market.
Prof. Michael Kahana joins Nia Therapeutics as CEO
Nia Therapeutics2025‑04‑09
Nia Therapeutics has appointed Prof. Michael Kahana as CEO. A University of Pennsylvania memory science pioneer with over 230 publications and author of “Foundations of Human Memory,” Kahana co‑developed closed‑loop neurostimulation techniques under DARPA’s Restoring Active Memory program. He will drive Nia’s mission to deliver transformative BCI therapies for memory loss in TBI and other neurological conditions.
Summary
These appointments reflect a maturing Neurotechnology sector focused on clinical validation, regulatory readiness and scalable commercialization. Paradromics’s addition of Dr. Ryu bolsters its clinical decision‑making as it navigates FDA processes, while Nia Therapeutics’s hires of Chuck Vadala and Michael Kahana align quality systems with cutting‑edge memory restoration science. Turing Medical’s selection of Kevin King brings proven commercial leadership to advance neuromodulation trials. Collectively, these strategic hires will intensify competition, foster deeper collaborations with regulatory and academic institutions, and accelerate the transition from laboratory innovation to patient‑ready neurotherapeutics.
Across the Neurotechnology landscape, companies are recruiting leaders with dual expertise in clinical science and commercial execution, underscoring an industry shift from pure research toward translational impact. The convergence of academic rigor, quality engineering and precision‑medicine leadership signals readiness to deliver next‑generation BCI and neuromodulation therapies to market.
Closing Thoughts
The current quarter has crystallized a shift toward integrated, data‑driven neuromodulation and brain‑computer interface platforms, underpinned by record funding for noninvasive and hybrid solutions and buoyed by clinical studies demonstrating durable, personalized gains across concussion, paralysis, stroke, and Alzheimer’s populations. The convergence of capital and clinical validation is catalyzing the transition from exploratory research to scalable therapeutic offerings.
Venture capital influx and FDA’s broadened 510(k) clearances for implantables and AI‑enabled software are reinforcing one another, creating a feedback loop that de‑risks investments and expedites market entry. Simultaneously, real‑world evidence emerging from pivotal TMS, spinal cord, and vagus nerve stimulation trials is directly informing executive hirings and quality‑systems hires, ensuring development roadmaps align with regulatory and clinical benchmarks. Going forward, organizations should allocate resources toward modular platforms that integrate hardware, AI analytics, and telehealth, forging partnerships with regulatory‑savvy CROs to streamline approval pathways. Budgets must prioritize adaptive trial designs and real‑world data infrastructure to anticipate FDA and CE requirements. Expect strategic M&A around noninvasive BCIs and programmable neuromodulation by late 2025 as companies vie for leadership in convergent care models. With robust capital flows, a maturing regulatory framework, decisive clinical breakthroughs, and multidisciplinary leadership in place, the neurotechnology industry stands poised for rapid commercialization. Stakeholders that synchronize funding strategies, regulatory engagement, clinical development, and executive governance will unlock the next wave of patient‑centric innovations and redefine neurological care at scale.
