NaviFUS®
Pioneer in the non-invasive FUS treatment of Central Nervous System (CNS)-related diseases
NaviFUS®
Neuronavigation-guided focused ultrasound system
About NaviFUS®
As a pioneer in FUS technology, NaviFUS is committed to creating quality solutions and user-friendly products that provide an optimal experience for both patients and therapists. NaviFUS cares about the needs and wants of its end users and CNS patients, so NaviFUS is just as passionate about creating patient-centred therapies as it is in innovating new technologies.
NaviFUS® is a device designed to transcranially deliver focal energy into deep tissues in the brain. Before the focused ultrasound (FUS) treatment, a personalized treatment plan is created based on cranial bone information derived from the patient’s CT images. With our innovative and patented technology, FUS focal points can be visualized and guided during the entire intervention. Also, NaviFUS® uses real-time PCD (passive cavitation detection) to help monitor the patient during the intervention and provide a personalized FUS treatment.
How does it work?
Exploere NaviFUS®
Patient-Friendly Platform
NaviFUS® using neuronavigator to guide the FUS. The patient only needs to sit on the chair to receive FUS treatment with less than 0.5hour, no holes on the skull.
Features & Benefits
NaviFUS® uses a neuronavigator to guide the FUS energy. The patient only needs to sit in a chair for less than a half-hour to receive the FUS treatment. The FUS sonication is entirely non-invasive, which means no holes need to be drilled into the patient’s skull, and no implants or fixtures are required to be attached onto the patient’s skull.
Patient-Friendly Treatment Experience
•Personalize Treatment Planning
•Outpatient clinic room
•FUS Treatment time < 30 minutes
Precise Focal Point Guidance
•Neuronavigation-guided ultrasound
•Focal point steering from 3mm~20mm
Safe and Non-invasive FUS Sonication
•Realtime energy management
•Intraoperatively MRI-free
•No anesthesia need
The mechanism of
NaviFUS®
NaviIFUS® incorporates a custom-designed multi-channel hemispherical phased-array ultrasound to generate focused treatment units capable of covering a large tumor volume. The location of the treatment units is determined using pre-treatment planning software that analyzes the patient’s CT/MRI images. Guidance of FUS energy to the desired treatment area is done using a neuronavigation tracking system, allowing for more precise treatment.
FUS Treatment Process
Step 1.
Personalize Treatment Planning
•Based on patient’s MR and CT scans
•Physicians determine ROIs and transducer positionings
•Transcranial penetration calculation
Step 2.
FUS Focal Point Guidance
•Integrate with Neuronavigation System
Step 3.
FUS Sonication Treatment
•Focused Ultrasound Spatial control
Focal point steering (diameter of 3mm~20mm)
•Realtime Energy Management
Passive Cavitation Detection (PCD) feedback control
Treatment Technologies
Blood-Brain-Barrier (BBB) Opening
- To enhance drug delivery to the brain
- Potential Indications：rGBM, Alzheimer’s Disease
The Blood-brain-barrier (BBB) is a physiologic barrier that protects the brain from potential toxic substances in the bloodstream. It is created by tight junctions between endothelial cells that line the capillaries in the brain. While the BBB acts to protect brain tissue to ensure normal brain function, it also inevitably prevents passage of therapeutic drugs with molecular weights greater than 180 Daltons, which account for over 95% of current drugs.
The BBB is considered responsible for the poor efficacy of chemotherapy for malignant primary or metastatic brain tumors. NaviFUS Corp. has developed a novel technology using microbubble-enhanced transcranial low-intensity focused ultrasound to locally and temporarily enhance the delivery of CNS drugs across the BBB for better treatment outcomes. The mode of action is physical effect and non-invasive. Our technology has obtained several IP protections worldwide from fundamental technologies to clinical applications.
Preclinical studies have shown safety and efficacy of BBB permeability enhancement using the NaviFUS System in small and large animal models. The enhanced permeability of BBB is reversible within 24 hours and can lead to 2-60 fold improvement of therapeutic agent delivery to targeted brain tumor tissues in published preclinical studies.
Neuromodulation for Epilepsy Therapy
- To relieve the brain abnormal electrical activity
- Potential Indications：Epilepsy
More than 65 million people worldwide suffer with epilepsy and 20-40% of all epilepsy patients are ineffective with anti-seizure drugs. Surgery or deep brain stimulation techniques may cause invasively serious adverse events or somewhat difficult to focus. Thus, transcranial focused ultrasound (FUS) is considered as a novel technology that can non-invasively modulate neuronal activity in deep brain tissue.
As Nobel Prize’s research discovered a new channel protein that was directly activated by applying ultrasound pressure to the cell membrane, FUS has been widely applied to modulate ion channels, synaptic transmission in recent years. Now FUS has been confirmed to consequently affect activity in the brain network, and even has potential to retard the onset of epileptic signals. Moreover, another temperature-sensitivity receptor was identified on nerve endings that respond to heat, which may also have the potential to respond to ultrasound effects. While using the energy that ultrasound provides, specific tissues can be heated and might also help interfere with epileptiform activity and seizure onset.
As Nobel Prize’s research discovered a new channel protein that was directly According to our previous FUS-epilepsy preclinical research and clinical trial, FUS has the potential to not only modulate the epilepsy onset loop but might also induce neuroprotective effects for long-term epilepsy suppression. In the future, FUS neuromodulation might provide sufficiently long-lasting benefits to be useful in the treatment of clinical epilepsy and improve quality of life for refractory epilepsy patients.
Confidence Outcomes
Ref: http://blog.medillsb.com/audra-geras-the-blood-brain-barrier/
Clinical Research/Evidence
NaviIFUS® can bring benefits to CNS disease patients suffering from GBM, Epilepsy, and Alzheimer’s Disease, all of which can be treated non-invasively through methods such as opening the Blood-brain-barrier (BBB) or neuromodulation.
● Completed the safety and efficacy clinical trial for its FUS device, and results showed that the system can precisely open the blood-brain barrier (BBB) with safe recovery afterwards.
● NaviFUS® provides a non-invasive and user-friendly focused ultrasound system that can provide a variety of clinical applications, such as drug delivery, neuromodulation, immuno-stimulation, and more.
● With non-invasive FUS exposure, NaviIFUS® provided safe neuromodulation and relieved epileptic seizure in epilepsy patients in our previous clinical trial.
Related Research
● Blood-Brain-Barrier (BBB) Opening
● Neuromodulation
Clinical Pipeline
Know more about NaviFUS® system?
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