A new force has emerged in the innovative medical devices sector! NaviFUS Corporation is expected to go public in early March. Chairman Cheng Yu Long stated on the 5th that the company’s “NaviFUS Ultrasound Navigation System” for treating recurrent glioblastoma multiforme (rGBM) has begun Phase III clinical trials. As this technology is a world-first and has been designated as a key project by Taiwan's TFDA for open-label trials, there is hope for clinical validation of its effectiveness and potential certification by 2026 or 2027.
Additionally, NaviFUS plans to accelerate its cash flow and profit generation through international collaborations, selling and leasing NaviFUS system research machines, and expanding its non-invasive treatment applications, including brain metastasis (from lung and breast cancer), Alzheimer’s disease, 5-ALA sonodynamic therapy, and drug addiction.
Glioblastoma (GBM) is one of the most difficult brain cancers to treat worldwide. In the U.S., around 10,000 people die from it each year, with a five-year survival rate of only 6.9%. The average survival time for patients is estimated at just eight months, and the survival and mortality statistics have shown little progress for decades. Over the past 100 years, there has been limited advancement in GBM treatment, with only five treatments for GBM approved by the U.S. FDA, according to the American Brain Tumor Association.
General Manager Cheng Yu Long stated that NaviFUS’s “NaviFUS Ultrasound Navigation System” is an innovative solution that uses non-invasive technology to safely open the blood-brain barrier and allow drugs to precisely reach brain lesions. The entire treatment process requires no anesthesia, is completely non-invasive (no surgery, no blood, no wounds), and can be completed in about 0.5 to 1 hour, allowing for outpatient treatment and fundamentally changing traditional therapy. Currently, the system is undergoing pivotal trials in Taiwan for combination therapy with Bevacizumab for rGBM and has started pilot trials in the U.S.
Since the NaviFUS system can precisely deliver ultrasound energy to deep areas of the brain, enabling local regulation of nerve signal transmission to achieve therapeutic effects, it provides a new treatment option for epilepsy. Taiwan has already started a Phase II clinical efficacy trial for drug-resistant epilepsy (DRE) in Q3 2024. The innovative technology from NaviFUS and the pressing demand for new treatments have attracted key opinion leaders (KOLs) from renowned medical centers globally. DRE pilot clinical trials are also underway in Melbourne, Australia, and at prestigious U.S. institutions (Stanford, Harvard, and the University of Virginia).
Traditional MRI-guided technology, due to its high cost and operational complexity, limits the widespread adoption of outpatient treatments. NaviFUS's optical navigation technology has broken through the spatial limitations of surgical treatment, enabling flexible and portable focused ultrasound applications. According to a 2021 report by Nature Reviews Neurology, NaviFUS is recognized as one of the top three global leaders in focused ultrasound for brain diseases, alongside Israel's Insightec and France's Carthera. Based on the two core technologies of "cranial-focused ultrasound" and "treatment-guided tracking," NaviFUS offers greater non-invasiveness, real-time guidance, and flexible application advantages compared to other technologies that require semi-invasive or implanted devices.
NaviFUS has also partnered with the world’s largest "neuro-navigation system" provider, Brainlab, and the world's largest "microbubble contrast agent" manufacturer, Bracco, to enhance its international visibility. Through these global networks, the company aims to accelerate connections with international end customers.
Resource: 浩宇3月初上櫃 首創超音波導航治腦癌 拚2026年取證
