Blog

NaviFUS Provides Research Update on Glioblastoma and Epilepsy

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Key Points The Foundation recently hosted a live virtual event featuring Taiwan-based NaviFUS Corporation. NaviFUS’ innovative devices are in clinical trials to address glioblastoma and epilepsy. The company’s CEO Arthur Lung, PhD, and two physicians leading the clinical trials presented during the event. Taiwan-based NaviFUS Corporation recently provided a live virtual update for philanthropists, investors, and the focused ultrasound community. NaviFUS is dedicated to helping patients with neurological diseases such as glioblastoma (GBM) and epilepsy by providing novel focused ultrasound platform solutions to open the blood-brain barrier and enhance drug delivery and neuromodulation. Last year, the company won an Edison Award in the Science & Medical Outpatient Treatment category for their “NaviFUS Focused Ultrasound System.” This win marked an important step for the company toward gaining global recognition and validated the technology’s potential to transform the care of many brain disorders. During the virtual event, the company’s CEO, Arthur Lung, PhD, presented many of the unmet clinical needs that NaviFUS aims to address and explained how the company’s devices can be used in an outpatient setting. Two leading clinicians, Dr. Kuo-Chen Wei and Dr. Hsiang-Yu Yu, also discussed their groundbreaking clinical projects using NaviFUS devices. Dr. Wei, from Chang Gung Memorial Hospital Linkou Medical Center Department of Neurosurgery, is exploring the use of focused ultrasound for GBM. His work shows promise in using NaviFUS devices to noninvasively deliver drugs directly to the tumor site, potentially improving treatment outcomes for patients. Dr. Yu, from the Division of Epilepsy at Taipei Veterans General Hospital, is investigating the use of focused ultrasound for epilepsy. By targeting specific areas of the brain, Dr. Yu’s work with NaviFUS devices could provide a noninvasive alternative to traditional surgery for some patients with epilepsy, reducing the risk of complications and improving quality of life. “We want to thank NaviFUS for sharing how their technology could offer hope for GBM and epilepsy patients,” said Foundation Chairman Neal F. Kassell, MD. “We look forward to spotlighting more device manufacturers and sharing the innovative technologies that are impacting patients around the world.”  
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Debunked: Economic Argument against MR-Guided Focused Ultrasound

Written by Mark Carol, MD
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In this blog post, Mark Carol, MD, a senior consultant at the Foundation, addresses a common misconception about the facility costs of focused ultrasound treatments. Learn why most focused ultrasound procedures are a more profitable use of MRI machines for hospitals than diagnostic studies.
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Mark Carol, MD

J.P. Morgan Healthcare Conference Highlights Wary Investment Community

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Key Points In January, the J.P. Morgan Healthcare Conference was held in-person for the first time since 2020. Senior Advisor Patrick Edelmann shares his takeaways from the meeting, including a general sense of caution spurred by global uncertainty. The 41st Annual J.P. Morgan Healthcare Conference was held January 9–12, 2023, in San Francisco, CA. The conference is a prominent healthcare investment meeting that connects global industry leaders, emerging fast-growth companies, innovative technology creators, and members of the investment community. It was held in-person for the first time since 2020. Patrick Edelmann, a senior advisor for the Foundation, attended the meeting and shared the following key takeaways: Attendance was underwhelming. In general, there was a sense that post-pandemic, companies and participants are content to tune in virtually and forego travel. The in-person attendance and networking opportunities were lower as a result. The investment environment is muted coming out of 2022. In 2021, there were record numbers of initial public offerings and mergers and acquisition (M&A) activity. However, in 2022, M&A and capital activity were notably more conservative. Historically, many companies use the J.P. Morgan conference as a stage for big announcements, and there was a slower pace of news at this meeting.  Breakthrough drugs made headlines. The big players in the pharmaceutical industry are advancing drugs that could slow cognitive decline in Alzheimer’s disease and tackle diabetes. Medical device companies share overall economic concerns. In 2022, the medical devices sector was the only one to nearly match the record investment of the previous year, dropping less than 10% overall. This was despite a sharp decline in the late 2022. Medical equipment companies appear to be cautious going into 2023 in both their spend and investment opportunities amid recession fears, China’s pandemic recovery, and global uncertainty. “Anticipation for the 2023 meeting was high, but there was a general undercurrent of angst related to economic uncertainty about what the coming years will hold,” said Edelmann. “There is some indication that early-stage strategic support for medical device startups may pick up in 2023. It was also good to see focused ultrasound companies – notably Insightec and some of the other startups – participating in this year’s meeting.” The next J.P. Morgan Healthcare Week will take place January 8–11, 2024, in San Francisco.
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HistoSonics to Begin Clinical Trial for Kidney Tumors

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Key Points HistoSonics has received FDA approval to begin a #HOPE4KIDNEY clinical trial in the US to treat primary renal tumors. The company’s Edison platform uses histotripsy to noninvasively and mechanically destroy tissue. This new trial comes on the heels of the #HOPE4LIVER studies, which have completed enrollment. The US Food and Drug Administration (FDA) has approved HistoSonics to begin a kidney tumor clinical trial in the US. The study will be called #HOPE4KIDNEY. The clinical trial will evaluate the safety and efficacy of HistoSonics’ Edison platform – a sonic beam therapy platform using histotripsy – to target and destroy primary renal tumors. Participant enrollment for the clinical trial is expected to begin in the second half of 2023 at up to 15 sites in the US. This trial comes after the company submitted results of their #HOPE4LIVER trials, which were conducted in the US and Europe. The initial analyses indicate the studies met both primary endpoints of safety and efficacy in destroying targeted liver tumors using histotripsy. “We are excited to expand on our experiences in successfully targeting and treating in the liver using our enhanced Edison platform that combines advanced imaging and targeting capabilities with real-time treatment monitoring,” said Mike Blue, president and CEO of HistoSonics, in a press release. “The kidney is a logical next application, as treating in the kidney has very similar procedural and anatomical considerations as the liver, and Edison was specifically designed to treat anywhere in the abdomen, as a starting point.” The Edison platform was granted Breakthrough Device Designation by the FDA in October 2021. The Breakthrough Devices Program was established to allow fast-tracking of novel devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Read HistoSonics’ Press Release >
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