NeuroTech Newsletter #2
April 04, 2025
Executive Summary
The Neurotechnology landscape is witnessing a powerful convergence of robust funding and strategic acquisitions, transformative clinical trials, and agile regulatory approvals. High-profile deals, such as Boston Scientific’s acquisition of SoniVie and Globus Medical’s integration of Nevro, coupled with significant funding rounds like Brainomix’s Series C, underscore an investment climate geared towards expanding capabilities in spinal cord stimulation, neuromodulation, and AI-enhanced diagnostic platforms. Concurrently, regulatory milestones have boosted advancements across pediatric monitoring, non-invasive brain stimulation, and adaptive neuromodulation therapies, setting a new benchmark for patient safety and treatment efficacy.
Strategic leadership appointments further cement this industry's forward momentum, with seasoned executives at Neuspera Medical, SetPoint Medical, and Sense Diagnostics driving the push for market expansion and clinical innovation. These integrated developments signal not only a transformative shift in clinical practices—from Alzheimer’s treatments and Parkinson’s therapies to enhanced pain management—but also a call for cross-disciplinary collaboration. Industry professionals are encouraged to harness these trends, leveraging adaptive technologies and strategic leadership to navigate the evolving competitive landscape and deliver tangible improvements in patient outcomes.
Funding News
Boston Scientific Acquires SoniVie Ltd.
JD Supra2025-03-26
Boston Scientific has entered into a definitive agreement to acquire SoniVie Ltd., a private medical device company that developed the TIVUS intravascular ultrasound system. The technology is designed for renal denervation to help reduce high blood pressure by disrupting excessive sympathetic nerve activity. Valued at approximately $540 million with an initial majority equity payment and potential milestone payments, the transaction is expected to close in the first half of 2025, complementing Boston Scientific’s extensive interventional portfolio.
Brainomix completes £14m Series C round
Health Tech World2025-03-20
AI-powered imaging company Brainomix closed a £14m Series C round co-led by healthtech investors such as Parkwalk Advisors and the Boehringer Ingelheim Venture Fund, alongside new investor Hostplus. This funding will accelerate its commercial expansion into the United States, where it recently secured FDA clearances, while also supporting advancements for its AI-powered diagnostic platforms for stroke and lung fibrosis. The investment also underpins plans to expand operations in Oxford and enhance its global commercial team.
Globus Medical Finalizes Acquisition of Nevro
MassDevice2025-04-03
Globus Medical has completed its acquisition of Nevro in an all-cash transaction valued at approximately $250 million, at $5.85 per share. Nevro is known for its high-frequency spinal cord stimulation (SCS) and sacroiliac joint fusion solutions, which integrate AI and cloud insights for personalized pain relief. The deal expands Globus Medical’s product portfolio and market presence in the musculoskeletal field, tapping into a $2.5 billion opportunity, with further details to be discussed during the upcoming first-quarter earnings call.
Pain Neuromodulation Market to Reach $6.5 Billion by 2030
stardem.com2025-03-31
A new market research report from Neurotech Reports projects that the global market for implanted pain neuromodulation systems will grow from $3.37 billion in 2025 to nearly $6.5 billion by 2030, representing a 12% compound annual growth rate. The report highlights significant growth potential for both spinal cord and peripheral nerve stimulation systems, with the latter expected to grow at a 29% CAGR. The analysis outlines competitive dynamics featuring established players alongside emerging firms and discusses the impact of recent industry transactions on market competition.
Summary
These funding and acquisition developments signal robust consolidation and expansion within the neurotechnology space. The acquisition of Nevro by Globus Medical reinforces strategic moves to broaden treatment offerings in chronic pain management, while Boston Scientific’s strategic purchase of SoniVie Ltd. indicates a diversified interest in technologies that complement interventional portfolios such as renal denervation. Meanwhile, Brainomix’s successful Series C round underscores the growing role of AI in enhancing diagnostics and treatment decisions, particularly in addressing critical conditions like stroke and lung fibrosis. Additionally, the optimistic market forecast for implanted pain neuromodulation systems further reinforces strong investor confidence in the long-term growth and innovation potential of the industry.
The current trends point to an industry marked by strategic consolidation, technology-driven innovation, and significant market growth. Investors and companies are increasingly leveraging acquisitions and targeted funding to strengthen clinical capabilities and expand market reach, setting the stage for enhanced patient care and a more competitive neuromodulation landscape in the coming years.
FDA News
REMI EEG System FDA Clearance
Business Wire2025-03-31
Epitel’s REMI Wireless EEG System has received another FDA 510(k) clearance, now indicated for infants and children aged one year and older. The innovative wireless system uses disposable, wearable sensors to capture brain electrical activity for up to 30 days and is managed via a mobile app, providing a comfortable and reliable alternative to traditional wired EEG monitoring for vulnerable patients.
FDA Issues Nyxoah an Approvable Letter for its Genio® System
BioSpace2025-03-26
The FDA has issued an Approvable Letter for Nyxoah SA’s Genio® system, a leadless, battery-free hypoglossal neurostimulation therapy for treating obstructive sleep apnea (OSA). This decision, contingent on successful manufacturing facilities and methods review, confirms that the application substantially meets regulatory requirements, bolstering Nyxoah’s trajectory to make the device available in the U.S. market.
brAIn SPS Transforms Shoulder Surgery Planning
PRNewswire2025-03-24
The collaborative brAIn™ SPS system, developed by Avatar Medical and FX Shoulder Solutions, has received FDA 510(k) clearance. Designed to revolutionize preoperative planning in shoulder arthroplasty, this AI-powered, cloud-based solution offers automatic segmentation and precise 3D imaging to enhance implant positioning and surgical outcomes.
FDA Clearance for Adolescent TMS
Magstim2025-03-19
Magstim’s Horizon Inspire and 3.0 Transcranial Magnetic Stimulation systems have been cleared by the FDA for treating Major Depressive Disorder in adolescents aged 15-21. This non-invasive treatment expands therapeutic options for young patients, offering a promising alternative to more traditional depression therapies with enhanced safety and efficacy.
Route 92 Receives Australian TGA Approval
NeuroNews International2025-04-02
Route 92 Medical has secured approval from the Australian Therapeutic Goods Administration (TGA) for its neurovascular interventional portfolio, which includes pioneering 0.088-inch super bore reperfusion systems such as the FreeClimb and HiPoint catheters. This regulatory milestone supports the company’s strategy to extend its global footprint and innovate in neurovascular intervention.
Summary
These regulatory developments underscore a robust momentum in neurotechnology innovation. With expanded FDA clearances for systems addressing neurological monitoring in pediatric populations and advanced non-invasive treatments for mental health, industry stakeholders can anticipate enhanced patient care and broader market access. The issuance of an Approvable Letter for neuromodulation therapy and clearance for AI-driven surgical planning tools further illustrates the evolving landscape of regulatory review—balancing rigorous safety assessments with rapid innovation. Collectively, these actions are poised to stimulate research investments and elevate standards of care across the neurotechnology ecosystem.
The trend reflects an increasingly adaptive regulatory framework that is embracing advanced neurotechnologies and addressing previously underserved patient segments. Regulators are not only expediting approvals for breakthrough technologies but also emphasizing integrated solutions that combine real-time data analytics with precise therapeutic interventions. This convergence of innovation and regulatory agility signals a promising future for the neurotechnology industry, with enhanced opportunities for companies, improved patient outcomes, and evolving clinical practices.
Clinical News
Cognito Therapeutics Announces Spectris Data
Business Wire2025-04-02
Cognito Therapeutics presented new data from its OVERTURE feasibility trial at the AD/PD International Conference, demonstrating that its non‐invasive Spectris device maintains the structural integrity of the corpus callosum and evokes statistically significant gamma oscillation responses. In a comparative MRI analysis, patients treated daily for six months showed preservation or slight increase in brain volume, as opposed to controls with a decline. These findings, which also correlated EEG gamma power with brain structure, support Spectris’ potential for biomarker‐guided treatment in mild-to-moderate Alzheimer’s disease and set the stage for the subsequent pivotal HOPE trial involving 670 patients.
Pain Neuromodulation Market to Reach $6.5 Billion
Neurotech Reports2025-03-31
A new market research report forecasts significant growth in the worldwide pain neuromodulation market, with projections rising from approximately $3.37 billion in 2025 to $6.49 billion by 2030—reflecting a 12% CAGR. The report examines both spinal cord stimulation (SCS) and peripheral nerve stimulation (PNS) systems, highlighting the rapid expansion within the PNS segment (anticipated at 29% CAGR). The analysis also profiles key industry players and discusses strategic partnerships, mergers, and innovations reshaping clinical approaches to pain management.
Onward Announces First Human Use of ARC-IM Lumbar Lead
MassDevice2025-03-26
Onward Medical reported the first human implantation of its investigational ARC-IM lumbar lead, performed by Dr. Jocelyne Bloch at Lausanne University Hospital. Designed to be positioned in the lumbar region, this lead targets therapies for restoring lower limb mobility and treating blood pressure instability post–spinal cord injury—with potential applicability in Parkinson’s disease as well. The device facilitates precise placement and, when used in ongoing feasibility studies (with and without an implanted brain-computer interface), may enhance outcomes in neurorehabilitation.
AlphaDBS CE Mark Approval
PR Newswire2025-03-31
Newronika, a leader in neuromodulation technology, secured CE Mark approval for its AlphaDBS device—a next-generation, closed-loop deep brain stimulation system for Parkinson’s disease and similar neurological disorders. AlphaDBS dynamically adjusts stimulation based on continuous real-time brain signal monitoring, offering enhanced symptom control and minimized side effects compared to conventional, fixed-setting DBS. Supported by robust clinical data, this regulatory milestone paves the way for wider adoption in the European market and further pivotal trials in the U.S.
Decreasing the Invasiveness of Deep Brain Stimulation
nibib.nih.gov2025-03-20
A collaborative research team from Rice University and The University of Texas introduced a novel, minimally invasive method to deliver deep brain stimulation without requiring a craniotomy. By implanting a tiny, battery-free pulse generator via a lumbar puncture and using a stimulating catheter guided through cerebrospinal fluid, the team achieved targeted stimulation of deep brain regions in sheep. This breakthrough technique, which utilizes wireless activation via magnetoelectric films, has the potential to transform DBS protocols—reducing surgical risk and recovery time, and potentially making these therapies as routine as cardiac pacemaker implantations.
Spark Biomedical Completes Enrollment for Pivotal Trial in Neonatal Opioid Withdrawal Treatment
Spark Biomedical2025-03-21
Spark Biomedical has finalized enrollment for its pivotal Phase II clinical trial aimed at neonates suffering from Neonatal Opioid Withdrawal Syndrome (NOWS). The trial evaluates the efficacy of non-invasive transcutaneous auricular neurostimulation (tAN®) therapy—combined with standard opioid treatments—to reduce the duration and intensity of withdrawal symptoms. Funded by the National Institute on Drug Abuse under the HEAL Initiative and conducted across multiple centers, the study will also track long-term neurodevelopmental outcomes, potentially offering a novel therapeutic option for improving recovery in the most vulnerable patients.
Summary
These selected developments illustrate a dynamic evolution in neurotechnology and neuromodulation therapies—with clinical trials and regulatory breakthroughs paving the way for transformative patient care. Innovations such as Cognito Therapeutics’ Spectris device and AlphaDBS’ adaptive stimulation techniques enable more personalized and effective management of conditions like Alzheimer’s and Parkinson’s disease. Meanwhile, the pioneering minimally invasive approach for deep brain stimulation and targeted neuromodulation in neonates signal a shift toward safer, less disruptive interventions that can reduce surgical risks and improve long-term outcomes. Furthermore, the robust market forecasts underscore rising investments and demand, which is expected to drive further innovation and accessibility in pain management and neurorehabilitation.
A clear trend in the neurotechnology space is the integration of real-time, adaptive, and less invasive approaches in neuromodulation therapies. Advances in imaging, AI-driven signal processing, and streamlined device design are converging to enhance clinical precision and patient safety. The progressive move from high-risk surgical interventions toward methods that use non-invasive or minimally invasive techniques is reshaping treatment paradigms, while market growth analysis reflects robust industry confidence in these evolving therapeutic strategies. These trends suggest an imminent expansion of personalized treatments and an overall shift toward higher efficiency and broader accessibility in managing neurological conditions.
Leadership Appointments
Steve Paul joins Neuspera Medical as CCO
Steve Paul2025-04-03
Steve Paul has joined Neuspera Medical Inc. as Chief Commercial Officer. Neuspera Medical is pioneering wireless, directionally adaptive energy systems that enable innovative, battery-free medical implants. Steve, who previously contributed to Vertos Medical, is set to build the commercial team to launch a breakthrough percutaneous sacral neuromodulation device aimed at transforming treatments in a $1B market.
Erik Styacich joins SetPoint Medical as VP of Sales
Erik Styacich2025-03-28
Erik Styacich has been appointed Vice President of Sales at SetPoint Medical. In his new role, Erik is poised to drive the company’s mission to revolutionize chronic disease treatment through neuroimmune modulation. His appointment underscores SetPoint’s commitment to leveraging innovative strategies that enhance patient outcomes in the neurotechnology arena.
Sense Neuro Diagnostics Appoints New CEO
MarketWatch2025-03-21
Gary Kurdziel has been named the new Chief Executive Officer of Sense Diagnostics, Inc., effective April 1, 2025. With over three decades in global leadership and extensive experience from prior roles including Executive Vice President and Chief Commercial Officer, as well as significant tenures at Medtronic, Gary succeeds retiring CEO Geoff Klass. His leadership is expected to propel strategic initiatives focused on real-time brain injury detection and monitoring, transforming care for stroke and traumatic brain injury patients.
Neurolief has announced the appointment of a new CMO
Neurolief2025-03-21
Neurolief has appointed Dr. Owen Scott Muir as its fractional Chief Medical Officer. Recognized for his dual board certification in child and general psychiatry and his leadership in integrating innovative neuromodulation techniques, Dr. Muir brings extensive expertise to enhance Neurolief’s brain stimulation therapies. His appointment is set to advance the company’s mission in treating major depressive disorder and other neurological conditions by combining clinical excellence with strategic innovation.
Summary
The recent leadership appointments indicate significant momentum in the neurotechnology industry, with companies prioritizing executives who can drive commercialization and innovation. The appointment of Steve Paul and Erik Styacich reinforces a trend toward bolstering sales and commercial strategies to support breakthrough medical devices. Similarly, the leadership transition at Sense Diagnostics with Gary Kurdziel and the strategic addition of Dr. Owen Scott Muir at Neurolief highlight the sector’s focus on leveraging deep clinical expertise and robust business acumen to scale advanced neurotechnologies.
Recent appointments reveal a clear trend of recruiting seasoned leaders with diverse backgrounds in medtech and clinical innovation. Executives with proven track records in large-scale commercialization, advanced device development, and academic-clinical integration are being positioned to steer companies toward achieving both market expansion and technological breakthroughs. This trend signals a consolidation of expertise in the neurotechnology field and sets the stage for transformative growth driven by strategic leadership.
Closing Thoughts
The neurotechnology landscape is undergoing a transformative shift, characterized by strategic consolidation, breakthrough clinical innovations, agile regulatory adaptations, and visionary leadership appointments. Together, these developments underscore an industry dynamically aligning funding, regulatory, and clinical strategies with the evolving needs of patient care.
Recent funding activities—from high-profile acquisitions like Boston Scientific’s purchase of SoniVie and Globus Medical’s integration of Nevro to Brainomix’s Series C round—highlight a robust investment climate. This momentum is mirrored by regulatory milestones, such as FDA clearances reinforcing safety and efficacy for pediatric monitoring, adaptive neuromodulation, and innovative non-invasive treatment methods. Clinically, groundbreaking trials and novel device applications are redefining therapeutic approaches across disorders from Alzheimer’s to chronic pain, while leadership investments emphasize the importance of seasoned commercial strategy and deep clinical expertise. For industry professionals, it is an optimal moment to integrate strategic planning with these market-moving trends. We recommend prioritizing collaboration across sectors—leveraging AI and adaptive technologies to inform product development, fostering partnerships that marry clinical insights with regulatory compliance, and making strategic leadership hires to accelerate market adoption. Emphasis on cross-disciplinary innovation will be critical for navigating the competitive landscape, optimizing patient outcomes, and driving long-term growth. As we look ahead, the convergence of funding strength, regulatory agility, clinical precision, and strategic leadership is charting a path toward a more efficient, patient-centric neurotechnology ecosystem. The industry is poised for breakthrough advancements, promising a future where transformative neurotherapies become the standard of care and strategic foresight translates into tangible patient benefits.
