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.
NaviFUS® was approved for an upcoming trial investigating the synergy of focused ultrasound treatment with radiotherapy in patients with end-stage primary brain tumors.
Low radiotherapy doses may yield high-dose therapeutic effects and significantly reduce serious side effects attributed to high-dose radiotherapy.
NaviFUS believes this treatment can also be extended to metastatic brain tumors from lung cancer, breast cancer, etc. The market potential for this treatment is expected to be more than $2 billion US dollars.
NaviFUS announced that it recently made its first overseas sale with its FUS System for Pre-Clinical Research. While the NaviFUS System is currently still in the process of acquiring pre-market approval, a modified version strictly for research purposes can be sold to academic and medical institutions, providing an alternative source of income to NaviFUS.
The clinical results from Taiwan-based NaviFUS’ first phase I clinical trial to open the blood-brain barrier (BBB) in patients with glioblastoma has been published in the journal Science Advances. In “Neuronavigation-Guided Focused Ultrasound for Transcranial Blood-Brain Barrier Opening and Immunostimulation in Brain Tumors,” researchers enrolled six patients with recurrent glioblastoma who were scheduled to undergo surgical resection.
“This is an important study to show the breadth and depth of worldwide research that is currently underway using focused ultrasound to treat these deadly brain tumors,” said Foundation Chairman Neal F. Kassell, MD. “We congratulate the authors and NaviFUS for developing this novel, safe, and innovative way to use the technology.”…
NaviFUS, a subsidiary of Genovate Biotech (4130), is developing a Radiofrequency Ablation (RFA) product called the NAVIRFA Scope. Simultaneous applications for regulatory approval are underway in both the United States and Taiwan.
NaviFUS has already submitted a pre-market notification 510(k) application to the U.S. FDA on December 4, 2020, and it expects to receive approval as early as mid-2021; at the same time, NaviFUS will also seek regulatory approval in Taiwan for the NAVIRFA Scope, and it has previously signed a sales distributor contract with UniPharma on October 31, 2020. NaviFUS believes that regulatory approval can also be acquired in 2021 and thus begin commercial sales in Taiwan…
