We are excited to announce that NaviFUS® Model 101 Neuronavigation-guided focused ultrasound system is nominated for the 2022 Edison Awards! Congratulations to our team members for the incredible work they do! The Edison Awards™, named after Thomas Alva Edison, is a leader in globally recognizing, honouring and fostering innovation and innovators to create a positive impact in the world.
Pilot Study of Focused Ultrasound for Drug-Resistant Epilepsy
Researchers in Taiwan recently published the data from a small pilot clinical trial testing the safety and efficacy of using focused ultrasound to provide neuromodulation for patients with drug-resistant epilepsy.
Participants received low-intensity focused ultrasound in the seizure origination zone from the NaviFUS neuronavigation-guided system.
Results from a study published in Epilepsia suggest that focused ultrasound, which can be used to non-invasively target circuits in the brain, may benefit some patients with epilepsy who experience seizures that do not respond to standard anti-seizure medications.
Results from a study published in Epilepsia suggest that focused ultrasound, which can be used to non-invasively target circuits in the brain, may benefit some patients with epilepsy who experience seizures that do not respond to standard anti-seizure medications.
In the study of six patients with drug-resistant seizures, two patients had fewer seizures within three days of receiving focused ultrasound; however, one patient showed signs of more frequent subclinical seizures (which are not felt by the individual).
Imaging tests after the treatment revealed no negative effects on the brain. One patient reported feeling heat on the scalp during the treatment, and one patient experienced temporary memory impairment that resolved within three weeks.
The annual meeting of the CNS was held October 16-20 in Austin, Texas.
Suzanne LeBlang, MD, presented recent advances in focused ultrasound for treating brain tumors. She covered research using focused ultrasound for blood-brain barrier opening and drug delivery, radiation sensitization, and sonodynamic therapy to treat glioblastomas. She also addressed focused ultrasound–enhanced liquid biopsy for the diagnosis and monitoring brain tumors. The presentation also featured data from recent clinical trials using the Insightec, NaviFUS, and CarThera devices, which each use a different method for guidance.
NaviFUS Founder & Chief Technical Consultant Hao-Li Liu, Ph.D. also participated in the virtual workshop this year. He presented the seminar Neuronavigation-Guided Focused Ultrasound: A Platform for Accelerating the Treatment of CNS Disease on October 8th, 2021. He shared the results of innovative research using the NaviFUS® with microbubbles to 1) open the Blood-brain barrier (BBB) and enhance CNS drug delivery and 2) neuromodulation for better treatment outcomes.
NaviFUS Corp. Founder & Chief Technology Consultant Dr. Hao-Li Liu will present on the topic of Neuronavigation Focused Ultrasound Induced CNS Intervention. He will share results of innovative research using the NaviFUS® (Neuronavigator-guided transcranial focused ultrasound system) in enhancing CNS drug delivery, neuromodulation, and opening the Blood-brain barrier (BBB) with FUS energy for better treatment outcomes.
NaviFUS also participated in the virtual exhibition and conference this year. Notable highlights from NaviFUS at the conference include exciting results from its Epilepsy clinical trial, which received much attention and interest at the conference.
NaviFUS’ Epilepsy trial (NCT03860298) conducted at Taipei Veterans General Hospital has successfully completed 6 subjects since October 2020. Dr. Chien-Chen Chou presented the exciting clinical results.
The results show that
1. NaviFUS® neuronavigation-guided focused ultrasound system can deliver low-intensity focused ultrasound (LIFU) safely and feasibly through neuromodulation of the targeted region in drug-resistant epilepsy.
2. Simultaneous SEEG recording showed change of power and node strength after using a NaviFUS® neuronavigation-guided focused ultrasound system.
Ko-Ting Chen, MD presented data from a clinical trial of the NaviFUS system in combination with bevacizumab. Clinical trials have shown that FUS BBBO can enhance drug delivery in rGBM using different ultrasound systems. Data about FUS BBBO in conjunction with bevacizumab in rGBM are lacking. In a mouse model, FUS significantly enhanced penetration of bevacizumab into the CNS compared with the non-exposed brain. FUS significantly increased median survival time by 135%. In a pilot trial, researchers were able to precisely open the BBB in rGBM patients and suggested a potential immunostimulatory effect by FUS alone.
Tim Liu presented the NaviFUS device (also referred to as NAviFUS-001). NaviFUS uses a novel neuronavigation technique to help simulate the optimal opening of the BBB near a tumor. The neuronavigator uses optical tracking to visualize the position of a surgical instrument by recognizing fiducial markers (registration), which are custom NaviFUS markers.
The standard treatment workflow includes pre-treatment MR imaging to confirm the tumor and select target location, CT scan, personalized treatment plan, and skull penetration estimation that is integrated into the neuronavigator. The procedure takes 30 minutes and consists of 4 steps:
1. setting up the neuronavigation guidance,
2. IV microbubble injection,
3. FUS sonication, and
4. post-treatment MR imaging.
Taiwan-based manufacturer NaviFUS has announced it will begin a new clinical trial using its focused ultrasound therapy system to temporarily open the blood-brain barrier (BBB) as a way to increase efficacy of radiotherapy in patients with primary brain tumors.
Radiotherapy is a standard-of-care therapy for these patients, but research suggests that reduced blood flow and oxygen concentration in the tumor area inhibits the efficacy of radiotherapy. NaviFUS has conducted preclinical studies that suggest disrupting the BBB using their focused ultrasound system significantly increases the oxygen content of brain tissue, which – when combined with radiotherapy – can increase the tumor-inhibiting effect of the therapy. Results of these studies were presented at the Foundation’s 7th International Symposium on Focused Ultrasound. The upcoming clinical trial aims to confirm these results in humans.
