NaviFUS

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.

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

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

• Focused ultrasound systems
• Blood-brain barrier opening
• CNS drug delivery
• Neuromodulation therapy
• Surgical needle tracking

Headquarters

HQ city

Taipei

HQ country

Taiwan

HQ region

Asia

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Supply Chain

Revenue model

1. 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.
2. 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.
3. 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

Core 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

Named customers8 records

Segments4 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Six partnerships are on record, tiered core, regional and major.

• BraccocoreStrategic or Co-development Partner · 1 April 2024Cooperation 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 or Co-development Partner · 1 October 2022Strategic 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.
• UniPharmaregionalChannel Partner/ Reseller/ Distributor · 1 October 2020Sales distributor contract signed October 31, 2020 for NAVIRFA Scope distribution in Taiwan market following regulatory approval from Taiwan FDA.
• Genovate Biotechnology Co., Ltd.coreStrategic or Co-development Partner · 1 January 2018Parent 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 or Co-development PartnerStrategic 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.majorTechnology or IntegrationCollaboration 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

Emerging 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

• YouTubereurl.cc/vvxz4L

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Subsidiaries3 records

Funding overview

Funding rounds1 record

Investors1 record

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about NaviFUS