NaviFUS
NaviFUS Corp. is a Taipei-based, TPEx-listed clinical-stage medical device company that develops neuronavigation-guided transcranial focused ultrasound systems to non-invasively open the blood-brain barrier for CNS drug delivery and perform neuromodulation, serving academic medical centers and pharmaceutical partners with its NaviFUS and NAVIRFA platforms.
- Company typePublic
- Founded2015
- HeadquartersTaipei, Taiwan
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
What NaviFUS does
NaviFUS Corp. is a Taipei-based (founded 2015) clinical-stage medical device company that develops neuronavigation-guided transcranial focused ultrasound (FUS) systems for non-invasive treatment of central nervous system (CNS) diseases. Its core platform, the NaviFUS System (Model 101), uses a multi-channel hemispherical phased-array ultrasound transducer combined with optical-neuronavigation targeting and real-time passive cavitation detection (PCD) to temporarily and reversibly open the blood-brain barrier (BBB), enabling 2–60x improvement in therapeutic-agent delivery to brain tumor tissue, and to perform non-invasive neuromodulation for drug-resistant epilepsy and stroke rehabilitation. The company's secondary product, NAVIRFA, is an optical 3D needle-tracking system that visualizes surgical needle position during RFA/MWA procedures, with reported 60% improvement in surgical hit rate and sub-3.0 mm accuracy.
NaviFUS serves hospital systems and academic medical centers rather than directly treating patients; revenue mechanics depend on a mix of investigational clinical-trial activity, eventual commercial device sales, and—following the April 2024 Bracco partnership—bundled microbubble consumables. Distribution is anchored by direct sales to leading centers (Stanford, Brigham and Women's, UVA, Linkou Chang Gung, NTUH, Taipei Veterans General, Alfred Hospital, Children's National) plus the Brainlab strategic cooperation (October 2022, 6,300 hospital partnerships across 120 countries) for international reach and UniPharma for Taiwan distribution of NAVIRFA Scope. Pricing is not publicly disclosed.
The company is led by founder and Chief Technical Consultant Dr. Hao-Li Liu (NTU Distinguished Professor, post-doctoral training at Harvard, 130+ SCI publications, 30+ patents) and CEO Dr. Arthur Lung (25+ years medical-device experience, 24 product launches at Medtronic and United Orthopedic). It is closely affiliated with Genovate Biotechnology (TPEx: 4130, ~13.55% shareholder) and is publicly listed on the Taipei Exchange under stock code 6872 since March 7, 2025. Regulatory milestones include TFDA and U.S. FDA IDE approvals across multiple indications and 510(k) clearance for NAVIRFA Scope. Cumulative disclosed Series A equity funding totals approximately USD 28.3M (A1–A4), with A5 raised in 2022–2023.
NaviFUS firmographics
Firmographics- Name
- NaviFUS
- Legal name
- NaviFUS Corp.
- Website
- https://navifus.com
- Company type
- Public
- Founded year
- 2015
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- NaviFUS Corp. is a Taipei-based, TPEx-listed clinical-stage medical device company that develops neuronavigation-guided transcranial focused ultrasound systems to non-invasively open the blood-brain barrier for CNS drug delivery and perform neuromodulation, serving academic medical centers and pharmaceutical partners with its NaviFUS and NAVIRFA platforms.
- Ownership category
- akta.pro rank
NaviFUS industry classification
Industry- Product category
- Therapeutic Ultrasound Medical Devices
- NAICS
- Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Navigational, Measuring, Electromedical, and Control Instruments Manufacturing (3345), Medical Equipment and Supplies Manufacturing (3391)
- SIC
- Electromedical & Electrotherapeutic Apparatus (3845), Surgical & Medical Instruments & Apparatus (3841)
- akta.pro primary industry
- Intraoperative Imaging & Guidance (C-arms, O-arm, IOUS, fluorescence) (HLAHADAH)
- akta.pro secondary industries
- Implantable Neuromodulation & Neurostimulation (SCS/DBS/VNS/PNS) (HLAHAEAK), Connected Therapeutics & Smart Drug Delivery Monitoring (HLACAFAL), Neuro-oncology (HLAKAIAL)
Keywords
Where NaviFUS is headquartered
LocationHeadquarters
- HQ city
- Taipei
- HQ country
- Taiwan
- HQ region
- Asia
Offices3 records
Markets served
NaviFUS business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Operations, Marketing or Sales, Supply Chain
Revenue model
- Medical Device Sales: Sale of NaviFUS System (Model 101) focused ultrasound devices to hospitals and clinical centers. NAVIRFA Scope received regulatory approvals from Taiwan FDA (TFDA) and US FDA 510(k) in 2022, enabling commercial sales.
- Medical Device Consumables (Microbubbles): Bundled microbubble OEM product supply arrangement with Bracco for use with NaviFUS System treatments. Consumables model provides recurring revenue alongside device sales.
- Clinical Trial Services: Investigational device exemption (IDE) clinical trials conducted in partnership with hospitals and pharmaceutical companies. Company is pre-commercial with primary focus on regulatory approval and clinical validation.
Go-to-market motion2 records
Distribution channels3 records
Marketing channels5 records
NaviFUS product offering
Product offeringCore offering
NaviFUS develops and sells the NaviFUS® neuronavigation-guided transcranial focused ultrasound system, which uses multi-channel phased-array ultrasound combined with microbubble-enhanced low-intensity focused ultrasound (LIFU) to temporarily and reversibly open the blood-brain barrier (BBB), enabling 2-60 fold improvement in CNS drug delivery and non-invasive neuromodulation for glioblastoma, drug-resistant epilepsy, stroke rehabilitation, and Alzheimer's disease. The company also offers the NAVIRFA® optical 3D needle tracking surgical guidance system for radiofrequency ablation (RFA) and microwave ablation (MWA) procedures, providing real-time needle tip position tracking with sub-3.0mm accuracy. Products are sold with regulatory clearances from Taiwan FDA and US FDA 510(k).
Product overview
NaviFUS Corp. offers two core medical device products: the NaviFUS® Neuronavigation-guided transcranial focused ultrasound system and the NAVIRFA® Needle Tracking System. The NaviFUS system is a non-invasive focused ultrasound platform designed for CNS diseases, using ultrasound energy to temporarily open the blood-brain barrier (BBB) for enhanced drug delivery and for neuromodulation of brain tissue. The NAVIRFA system is an optical 3D surgical navigation technology for needle-based interventions such as radiofrequency ablation (RFA) and microwave ablation (MWA).
Differentiator
Problem solved
Functional benefit
Brands
- NaviFUS®: Neuronavigator-guided transcranial focused ultrasound system for non-invasive FUS treatment of CNS-related diseases including glioblastoma and epilepsy
- NAVIRFA®
- NaviFUS System Model 101
- NAVIRFA Scope
Products and services
- NaviFUS® Neuronavigation-guided transcranial focused ultrasound system A non-invasive focused ultrasound device that uses neuronavigation guidance with optical tracking and pre-treatment CT/MRI imaging to deliver ultrasound energy through the skull for transient and reversible blood-brain barrier opening and neuromodulation. Enables 2-60 fold improvement in CNS drug delivery to glioblastoma and other CNS tumors, and seizure suppression in drug-resistant epilepsy, with focal point steering from 3mm to 20mm and sub-30-minute outpatient sessions. Targeted at hospitals, academic medical centers, and pharmaceutical companies conducting CNS clinical trials or commercial treatment.
- NAVIRFA® Needle Tracking System An optical 3D surgical guidance kit and software that accurately visualizes the spatial position of surgical needles in vivo through proprietary imaging algorithms, functioning as a GPS for needle placement during RFA and microwave ablation procedures. Provides real-time needle tip position tracking with accuracy error less than 3.0mm and a 60% increase in surgical hit rate. Sold to hospitals and interventional radiology/surgical centers in Taiwan and via UniPharma distribution.
Quantifiable outcome
- 66.7% 6-month progression-free survival (PFS-6) vs 42.6% historical for bevacizumab alone in recurrent GBM
- +5 more outcomes
Companies that use NaviFUS
Customer profileNamed customers8 records
Segments4 records
Ideal customer profiles2 records
NaviFUS technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature6 records
NaviFUS partnerships and signals
Strategic signalPartnerships
Six partnerships are on record, tiered core, regional and major.
- BraccocoreCooperation agreement with global leader in ultrasound imaging agents signed April 2024. Bracco provides microbubble imaging agents as part of NaviFUS System treatment to open BBB. Bracco to supply microbubble OEM product and authorize NaviFUS to bundle as medical device consumable for acoustic therapy sales. Collaboration includes joint product development and supply arrangements.
- BrainlabcoreStrategic cooperation agreement signed October 2022 to combine focused ultrasound and surgical guidance technologies. Brainlab is a global leader in surgical imaging and navigation with 6,300 hospital partnerships in 120 countries. Enables clinical integration of NaviFUS FUS technology with Brainlab's surgical navigation systems.
- UniPharmaregionalSales distributor contract signed October 31, 2020 for NAVIRFA Scope distribution in Taiwan market following regulatory approval from Taiwan FDA.
- Genovate Biotechnology Co., Ltd.coreParent company relationship. Genovate Biotech (TPEX: 4130) co-invested with NaviFUS to establish subsidiary Genovate NaviFUS (Australia) Pty.Ltd. in 2018 for clinical trial operations. Genovate provides clinical operations support, regulatory expertise, and R&D collaboration. Joint execution of Australian epilepsy trial from protocol design through regulatory submissions.
- Focused Ultrasound Foundation (FUSF)coreStrategic partnership and collaboration with the Focused Ultrasound Foundation led by Chairman Dr. Neal Kassell. Foundation provides funding support for clinical trials, facilitates collaboration with global clinical experts, and supports technology development and clinical adoption.
- YoungTek Electronics Corp.majorCollaboration with Chairman Bily Wang contributed to development of clinical trial device Model 101. YoungTek provides specialized semiconductor components and microprocessors for ultrasound generation and reception in NaviFUS devices.
Scale indicators10 records
Recent moves9 records
Expansion highlights6 records
NaviFUS competitors and assessment
Company assessmentEmerging players
- Theraclion: Theraclion commercializes echotherapy systems (SONOVEIN, Echopulse) using high-intensity focused ultrasound for varicose veins and thyroid nodules. It is a smaller European peer with similar capital equipment + per-treatment consumable economics in the FUS space.
- HistoSonics: HistoSonics is developing Edison, a non-invasive histotripsy platform for destroying tissue with focused ultrasound. While primarily focused on liver and other solid tumors today, its platform represents an adjacent non-invasive FUS approach that could extend into CNS over time.
Direct peers
- Insightec: Insightec is the global leader in MR-guided focused ultrasound (ExAblate) for essential tremor, Parkinson's and other CNS indications. It is the most direct competitor to NaviFUS's neuronavigation-guided transcranial FUS platform, targeting overlapping neurosurgery and neuromodulation use cases.
- Profound Medical: Profound Medical commercializes TULSA-PRO and Sonalleve MR-guided focused ultrasound systems for prostate and uterine conditions. It is a focused-ultrasound device peer with overlapping R&D, regulatory and hospital-channel economics.
- Carthera: Carthera is developing the SonoCloud implantable and transcranial ultrasound devices for blood-brain barrier opening in glioblastoma and other brain tumors. It pursues the same core mechanism of ultrasound-mediated BBB opening for enhanced drug delivery that NaviFUS is commercializing.
- EDAP TMS: EDAP TMS markets Ablatherm and Focal One high-intensity focused ultrasound (HIFU) devices for prostate cancer. As another listed, commercially active FUS device company, it shares NaviFUS's business model of selling capital equipment plus recurring treatment revenue to hospitals.
Broad incumbents
- LivaNova: LivaNova is a large medical device company whose Vagus Nerve Stimulation (VNS) Therapy is a standard-of-care option for drug-resistant epilepsy. It is a broad incumbent competing for the same neurology patient pool that NaviFUS's neuromodulation program is pursuing.
Regional players
- NeuroPace: NeuroPace markets the RNS System, an implantable closed-loop neurostimulator for drug-resistant epilepsy. It addresses the same drug-resistant epilepsy patients NaviFUS targets, but via an invasive, implantable approach — useful for competitive positioning.
Others
- Focused Ultrasound Foundation: The Focused Ultrasound Foundation is a non-profit that funds and coordinates FUS research globally and is a NaviFUS partner. It is included as an ecosystem peer shaping the field, clinical adoption, and reimbursement environment in which NaviFUS competes.
- Brainlab: Brainlab is NaviFUS's strategic distribution partner and the dominant surgical navigation platform used in neurosurgery worldwide (6,300+ hospitals in 120 countries). It is both a channel partner and an adjacent navigation/imaging peer, with which NaviFUS is integrating its FUS technology.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks5 records
Key highlights7 records
Customer concentration
NaviFUS social profiles
Digital presenceNaviFUS compliance and trust
Trust signalCompliance1 record
NaviFUS financial estimates
Financial estimateRevenue estimate
Valuation estimate
NaviFUS leadership team
Management profileNumber of profiles
Profiles5 records
NaviFUS subsidiaries and ownership
Company hierarchySubsidiaries3 records
NaviFUS funding detail
Funding detailFunding overview
Funding rounds1 record
Investors1 record
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
NaviFUS M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about NaviFUS
What does NaviFUS do?
NaviFUS develops and sells the NaviFUS® neuronavigation-guided transcranial focused ultrasound system, which uses multi-channel phased-array ultrasound combined with microbubble-enhanced low-intensity focused ultrasound (LIFU) to temporarily and reversibly open the blood-brain barrier (BBB), enabling 2-60 fold improvement in CNS drug delivery and non-invasive neuromodulation for glioblastoma, drug-resistant epilepsy, stroke rehabilitation, and Alzheimer's disease. The company also offers the NAVIRFA® optical 3D needle tracking surgical guidance system for radiofrequency ablation (RFA) and microwave ablation (MWA) procedures, providing real-time needle tip position tracking with sub-3.0mm accuracy. Products are sold with regulatory clearances from Taiwan FDA and US FDA 510(k).
Is NaviFUS a public or private company?
NaviFUS is a public company. It is classified as public and is currently operating.
When was NaviFUS founded?
NaviFUS was founded in 2015. It employs 11 to 50 people.
Where is NaviFUS based?
NaviFUS is headquartered in Taipei, Taiwan, in the Asia region.
How does NaviFUS make money?
Three revenue lines are on record. Medical Device Sales are the primary driver. The others are medical Device Consumables (Microbubbles) and clinical Trial Services.
Who are NaviFUS's main competitors?
Emerging players on record are Theraclion and HistoSonics. Direct peers are Insightec, Profound Medical, Carthera and EDAP TMS. LivaNova is listed as a broad incumbent. NeuroPace is listed as a regional player. Others are Focused Ultrasound Foundation and Brainlab.
Does NaviFUS have an API?
No public API is recorded for NaviFUS.
What industry is NaviFUS in?
NaviFUS's product category is Therapeutic Ultrasound Medical Devices. Its primary akta.pro industry code is HLAHADAH, Intraoperative Imaging & Guidance (C-arms, O-arm, IOUS, fluorescence), with a secondary code of HLAHAEAK, Implantable Neuromodulation & Neurostimulation (SCS/DBS/VNS/PNS). Its NAICS code is 334510 and its SIC code is 3845.