Latest news with #EdisonSystem
Yahoo
2 days ago
- Business
- Yahoo
HistoSonics Completes Enrollment in #HOPE4KIDNEY Trial Evaluating Non-Invasive Histotripsy to Treat Kidney Tumors
Pivotal Study Advances to Establish Histotripsy as a Non-Thermal, Surgery-Free Alternative to Destroy and Liquefy Kidney Tumors MINNEAPOLIS, June 06, 2025--(BUSINESS WIRE)--HistoSonics, Inc., the manufacturer of the Edison® Histotripsy System and novel histotripsy therapy platforms, today announced the completion of patient enrollment in its pivotal #HOPE4KIDNEY trial. This prospective, multi-center, single-arm trial is designed to evaluate the safety and effectiveness of the Edison System in destroying kidney tissue by treating primary solid kidney tumors. The trial enrolled patients with a single, non-metastatic solid kidney mass ≤3 cm, confirmed by imaging and biopsy. Subjects will be followed for five years post-procedure, with evaluations at multiple time points, including 14-day, 30-day, 90-day, 180-day, and annual assessments. The Edison System remains in investigational use for kidney applications and is not yet FDA-approved for this indication. Data from the #HOPE4KIDNEY trial is expected to support a future submission for regulatory clearance to expand the use of histotripsy to treat kidney tissue/tumors. The Edison System is the first and only platform to use histotripsy, a non-thermal, non-invasive focused ultrasound technology, to mechanically liquefy tumors without surgery, radiation, or systemic therapies. Unlike invasive surgical approaches, histotripsy does not require incisions and enables real-time imaging and treatment monitoring, allowing physicians to target and control tissue destruction while sparing surrounding structures. "Our vision is for the Edison System to become a foundational, non-invasive solution across a wide range of clinical applications," said Mike Blue, President and CEO, HistoSonics. "Completing enrollment in our pivotal kidney tumor trial represents a significant milestone toward that goal and reinforces our confidence in expanding histotripsy into additional tumor types and indications. This achievement reflects the dedication of our team and clinical partners and brings us closer to transforming the treatment of solid tumors without the need for surgery." Dr. William C. Huang, MD FACS, Professor and Vice Chair of Urology at the NYU Grossman School of Medicine serves as a principal investigator at the NYU Langone Medical Center, the top enrolling site in the trial. Dr. Huang commented, "Histotripsy offers a novel, completely non-invasive treatment paradigm for kidney tumors that precisely images and treats tumors while preserving surrounding critical structures thereby minimizing the morbidity associated with traditional surgical and thermal ablative techniques." Dr. Michael McDonald, Assistant Professor of Urology at the University of Central Florida College of Medicine and Urologic Surgeon at AdventHealth at Celebration Florida, serves as a principal investigator for one of the participating sites in the trial. Dr. McDonald commented, "HistoSonics represents a paradigm shift proving that the most profound treatments for both benign and malignant diseases need not be the most invasive. The ability to precisely target and destroy tumors without scalpel or scar is the next step in the evolution of non-surgical intervention." The Edison System has not been evaluated for the treatment of any specific disease, including, but not limited to, cancer or evaluated any specific cancer outcomes (such as local tumour progression, 5-year survival or overall survival). United States Intended Use Statement: The Edison System is intended for the non-invasive mechanical destruction of liver tumors, including the partial or complete destruction of unresectable liver tumors via histotripsy. The FDA has not evaluated the Edison System for the treatment of any disease including, but not limited to, cancer or evaluated any specific cancer outcomes (such as local tumor progression, 5-year survival or overall survival). The System should only be used by physicians who have completed training performed by HistoSonics, and its use guided by the clinical judgment of an appropriately trained physician. Refer to the device Instructions for Use for a complete list of warnings, precautions, and a summary of clinical trial results, including reported adverse events. About HistoSonics HistoSonics is a privately held medical device company developing a non-invasive platform and proprietary sonic beam therapy utilizing the science of histotripsy, a novel mechanism of action that uses focused ultrasound to mechanically destroy and liquify unwanted tissue and tumors. The company is currently focused on commercializing their Edison System in the US and select global markets for liver treatment while expanding histotripsy applications into other organs like kidney, pancreas, prostate, and others. HistoSonics has offices in Ann Arbor, Michigan and Minneapolis, MN. For more information on the Edison Histotripsy System please visit: For patient-related information please visit: View source version on Contacts Media contacts:Josh KingVice President of 608.332.8124 Kimberly HaKKH Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
2 days ago
- Business
- Business Wire
HistoSonics Completes Enrollment in #HOPE4KIDNEY Trial Evaluating Non-Invasive Histotripsy to Treat Kidney Tumors
MINNEAPOLIS--(BUSINESS WIRE)-- HistoSonics, Inc., the manufacturer of the Edison® Histotripsy System and novel histotripsy therapy platforms, today announced the completion of patient enrollment in its pivotal #HOPE4KIDNEY trial. This prospective, multi-center, single-arm trial is designed to evaluate the safety and effectiveness of the Edison System in destroying kidney tissue by treating primary solid kidney tumors. 'Our vision is for the Edison System to become a foundational, non-invasive solution across a wide range of clinical applications,' said Mike Blue, President and CEO, HistoSonics. The trial enrolled patients with a single, non-metastatic solid kidney mass ≤3 cm, confirmed by imaging and biopsy. Subjects will be followed for five years post-procedure, with evaluations at multiple time points, including 14-day, 30-day, 90-day, 180-day, and annual assessments. The Edison System remains in investigational use for kidney applications and is not yet FDA-approved for this indication. Data from the #HOPE4KIDNEY trial is expected to support a future submission for regulatory clearance to expand the use of histotripsy to treat kidney tissue/tumors. The Edison System is the first and only platform to use histotripsy, a non-thermal, non-invasive focused ultrasound technology, to mechanically liquefy tumors without surgery, radiation, or systemic therapies. Unlike invasive surgical approaches, histotripsy does not require incisions and enables real-time imaging and treatment monitoring, allowing physicians to target and control tissue destruction while sparing surrounding structures. 'Our vision is for the Edison System to become a foundational, non-invasive solution across a wide range of clinical applications,' said Mike Blue, President and CEO, HistoSonics. 'Completing enrollment in our pivotal kidney tumor trial represents a significant milestone toward that goal and reinforces our confidence in expanding histotripsy into additional tumor types and indications. This achievement reflects the dedication of our team and clinical partners and brings us closer to transforming the treatment of solid tumors without the need for surgery.' Dr. William C. Huang, MD FACS, Professor and Vice Chair of Urology at the NYU Grossman School of Medicine serves as a principal investigator at the NYU Langone Medical Center, the top enrolling site in the trial. Dr. Huang commented, 'Histotripsy offers a novel, completely non-invasive treatment paradigm for kidney tumors that precisely images and treats tumors while preserving surrounding critical structures thereby minimizing the morbidity associated with traditional surgical and thermal ablative techniques.' Dr. Michael McDonald, Assistant Professor of Urology at the University of Central Florida College of Medicine and Urologic Surgeon at AdventHealth at Celebration Florida, serves as a principal investigator for one of the participating sites in the trial. Dr. McDonald commented, 'HistoSonics represents a paradigm shift proving that the most profound treatments for both benign and malignant diseases need not be the most invasive. The ability to precisely target and destroy tumors without scalpel or scar is the next step in the evolution of non-surgical intervention.' The Edison System has not been evaluated for the treatment of any specific disease, including, but not limited to, cancer or evaluated any specific cancer outcomes (such as local tumour progression, 5-year survival or overall survival). United States Intended Use Statement: The Edison System is intended for the non-invasive mechanical destruction of liver tumors, including the partial or complete destruction of unresectable liver tumors via histotripsy. The FDA has not evaluated the Edison System for the treatment of any disease including, but not limited to, cancer or evaluated any specific cancer outcomes (such as local tumor progression, 5-year survival or overall survival). The System should only be used by physicians who have completed training performed by HistoSonics, and its use guided by the clinical judgment of an appropriately trained physician. Refer to the device Instructions for Use for a complete list of warnings, precautions, and a summary of clinical trial results, including reported adverse events. About HistoSonics HistoSonics is a privately held medical device company developing a non-invasive platform and proprietary sonic beam therapy utilizing the science of histotripsy, a novel mechanism of action that uses focused ultrasound to mechanically destroy and liquify unwanted tissue and tumors. The company is currently focused on commercializing their Edison System in the US and select global markets for liver treatment while expanding histotripsy applications into other organs like kidney, pancreas, prostate, and others. HistoSonics has offices in Ann Arbor, Michigan and Minneapolis, MN. For more information on the Edison Histotripsy System please visit: For patient-related information please visit:
Business Wire
12-05-2025
- Business
- Business Wire
HistoSonics Secures First Major Insurance Coverage for Non-Invasive Histotripsy Treatment for Liver Tumors With Blue Cross Blue Shield of Michigan
MINNEAPOLIS--(BUSINESS WIRE)-- HistoSonics, the developer of the Edison Histotripsy System, today announced that Blue Cross Blue Shield of Michigan (BCBSM) and Blue Care Network have created a new medical policy for histotripsy of the liver. The policy covers non-thermal histotripsy using the Edison® Histotripsy System for the treatment of primary and metastatic liver tumors. 'We applaud BCBSM for being the first to recognize the clinical value of histotripsy and for leading the way in ensuring their members have insurance coverage for this novel therapy," said Mike Blue, President and Chief Executive Officer, HistoSonics. Share As of February 1, 2025, histotripsy is a reimbursable procedure for the non-invasive mechanical destruction of liver tumors under CPT code 0686T, giving eligible patients in Michigan early access to this groundbreaking, non-invasive, incisionless treatment ahead of the broader policy effective date of July 1, 2025. 'Liver tumors are often a leading cause of death for patients with serious cancers, and it's critical that they have access to safe, effective and non-invasive treatment options,' said Mike Blue, President and Chief Executive Officer, HistoSonics. 'We applaud BCBSM for being the first to recognize the clinical value of histotripsy and for leading the way in ensuring their members have insurance coverage for this novel therapy. This milestone marks an important precedent, and we expect additional states and payers to follow in expanding access to histotripsy for patients with liver tumors across the U.S.' The Edison System received De Novo authorization by the U.S. Food and Drug Administration (FDA) in 2023 and subsequently received two 510(k) clearances in 2024. The system uniquely employs high amplitude focused ultrasound to mechanically destroy targeted tumor tissue through acoustic cavitation, eliminating the need for heat, radiation, or incisions. The platform enables real-time image guidance, allowing the treating physician to continuously monitor treatment progress. To date, the Edison Histotripsy System has been adopted at over 50 leading medical centers across the United States and has been used by surgeons, radiologists, and oncologists to treat more than 1,500 patients. BCBSM's coverage decision was based on compelling clinical evidence demonstrating that histotripsy is a safe, effective, and non-invasive treatment option for patients with primary or metastatic liver tumors who have not responded to, or are intolerant of, standard-of-care therapies. Histotripsy has shown to precisely target and destroy tumors while tending to spare critical structures such as blood vessels and bile ducts within and adjacent to the treated area. A key finding from the recently released 12-month #HOPE4LIVER trials follow-up analysis is a 90% local tumor control rate observed across all treated tumors regardless of tumor type or origin, which compares favorably to current standard of care local regional therapies at one year. The performance of these outcomes provides sufficient evidence to determine the technology's impact on health outcomes. In addition to commercial insurance recognition, the United Network for Organ Sharing (UNOS) recognizes histotripsy as an accepted loco-regional treatment option for patients needing bridging therapy for liver transplant. The addition of histotripsy to UNOS guidelines was made active in July 2024. The Edison® System is intended for the non-invasive mechanical destruction of liver tumors, including the partial or complete ablation of unresectable liver tumors using histotripsy. The FDA has not evaluated the Edison System for the treatment of any specific disease, including cancer, nor has it assessed outcomes such as local tumor control, five-year survival, or overall survival. The device should only be used by physicians who have completed HistoSonics-provided training, and its use should be guided by the clinical judgment of a qualified and appropriately trained physician. For a complete list of warnings, precautions, and a summary of clinical trial results, including reported adverse events, please refer to the device's Instructions for Use. About HistoSonics HistoSonics is a privately held medical device company developing a non-invasive platform and proprietary sonic beam therapy utilizing the science of histotripsy, a novel mechanism of action that uses focused ultrasound to mechanically destroy and liquify unwanted tissue and tumors. The company is currently focused on commercializing their Edison System in the US and select global markets for liver treatment while expanding histotripsy applications into other organs like kidney, pancreas, prostate, and others. HistoSonics has offices in Ann Arbor, Michigan and Minneapolis, MN. For more information on the Edison Histotripsy System please visit: For patient-related information please visit:
Business Wire
28-04-2025
- Health
- Business Wire
HistoSonics' Histotripsy System Demonstrates 90% Local Tumor Control at 12 Months in #HOPE4LIVER Trials
MINNEAPOLIS--(BUSINESS WIRE)-- HistoSonics, the developer of the Edison Histotripsy System, announced today 12-month follow-up clinical data from its prospective #HOPE4LIVER trials, designed to evaluate the safety and efficacy of histotripsy for the non-invasive destruction of primary (hepatocellular cancer-HCC) and metastatic liver tumors. 'The one-year outcome data for the HOPE4LIVER trial are truly remarkable as the safety profile was maintained throughout the first year of follow-up ... and it became clear that the treatment effect was durable," Tim Ziemlewicz MD. The Edison System, which received U.S. Food and Drug Administration (FDA) De Novo clearance in October 2023, uses focused ultrasound energy to mechanically destroy and liquefy targeted tissue and tumors without the invasiveness or toxicity of traditional procedures. These latest data reinforce histotripsy's potential to emerge as a new category of non-invasive therapy for patients suffering from liver tumors. The #HOPE4LIVER trials enrolled 47 patients across 14 centers in the United States, United Kingdom and Europe, with tumors either originating in the liver or metastasizing to the liver, primarily from colorectal origins. The initial trial results published in 2024 were utilized by the FDA to support the De Novo marketing authorization in the US. In the trials, all patients treated with histotripsy had previously failed, were deemed ineligible for or were intolerant of standard therapies such as surgery, radiation, and ablation. As previously reported, the primary efficacy endpoint was successfully achieved in 95.5% of tumors treated as measured by the number of tumors where complete tumor coverage was achieved (42/44). Additionally, the co-primary safety endpoint of the trial was also achieved with only 3/44 (6.8%) of patients reporting a major complication. Adding to the strong safety profile, there was only a single Adverse Device Effect (ADE) reported beyond 30-days, and it was classified as non-serious, resolving on its own. Nineteen patients had tumors originating from the liver (HCC) and 28 had metastatic tumors of the liver, with the most frequent originating from the colon or rectum (39.3%). A key finding in the 12-month follow-up analysis is a 90% local tumor control rate observed across all treated tumors regardless of tumor type or origin which compares favorably to current standard of care local regional therapies at one year. The 12-month evaluation highlighted histotripsy's unique tendency to preserve critical collagen-rich structures, such as blood vessels and bile ducts, within the treated area due to its non-thermal, mechanical mechanism of action. An independent imaging core laboratory conducted post hoc radiographic assessments of all follow-up imaging to account for preserved vascular structures and ensured precise interpretation of treatment outcomes. Overall survival was analyzed using the Kaplan-Meier method, showing survival rates comparable to current systemic or combination therapies. Full interim 12-month results are published in the May 2025 issue of Annals of Surgery. 'It's very exciting to see these interim 12-month data,' said Clifford Cho, M.D., Chief Medical Officer at the University of Michigan Health-West and Co-Principal Investigator of the #HOPE4LIVER trials. 'As important as the initial report of #HOPE4LIVER was to the world of liver-directed therapy, it was absolutely necessary to follow those very early observations with longer-term data. We are not yet at a point where we can fully characterize the longitudinal effects of this brand-new technology, but these data confirm that the excellent local control and safety profile hinted at in our first #HOPE4LIVER paper are still there one year later. We will continue to do our due diligence with longer-term follow up, but I think these findings strongly support the rapid clinical adoption that we have seen for histotripsy.' 'The one-year outcome data for the #HOPE4LIVER trials are truly remarkable as the safety profile was maintained throughout the first year of follow-up and, as we gained understanding of the imaging findings post-histotripsy, it became clear that the treatment effect was durable,' said Tim Ziemlewicz, M.D., Professor of Radiology at the University of Wisconsin and Co-Principal Investigator of the #HOPE4LIVER trials. 'Local therapies have a long history of a steep learning curve before optimal outcomes can be achieved, while outcomes more equivalent to experienced users were achieved in this trial despite only a single investigator having prior experience treating patients with histotripsy. This speaks to the broad applicability of histotripsy and ensures that patients will have access to expert-level treatment from the earliest clinical adoption. This expands the number of patients we can successfully treat with local therapies, particularly for patients with tumors in critical locations, such as along central bile ducts, where histotripsy is rapidly becoming a leading treatment option.' Histotripsy harnesses focused sound energy to create controlled acoustic cavitation, mechanically destroying and liquefying targeted liver tumors at the sub-cellular level. The HistoSonics platform uniquely enables physicians to plan, target, treat, and monitor tumor destruction with continuous real-time visualization and control—capabilities unmatched by any existing modality. Following FDA De Novo clearance in October 2023, the Edison Histotripsy System has been successfully adopted across leading U.S. academic centers, integrated health systems, and community hospitals eager to offer this breakthrough, non-invasive treatment to patients. Additional clinical trials are ongoing to evaluate the safety and efficacy of histotripsy in the non-invasive treatment of kidney tumors (#HOPE4KIDNEY Trial NCT05820087) and pancreatic tumors (GANNON Trial NCT06282809) in advance of planned regulatory submissions in both organs. The Edison System is intended for the non-invasive mechanical destruction of liver tumors, including the partial or complete destruction of unresectable liver tumors via histotripsy. The FDA has not evaluated the Edison System for the treatment of any disease including, but not limited to, cancer or evaluated any specific cancer outcomes (such as local tumor progression, 5-year survival or overall survival). The System should only be used by physicians who have completed training performed by HistoSonics, and its use guided by the clinical judgment of an appropriately trained physician. Refer to the device Instructions for Use for a complete list of warnings, precautions, and a summary of clinical trial results, including reported adverse events. About HistoSonics HistoSonics is a privately held medical device company developing a non-invasive platform and proprietary sonic beam therapy utilizing the science of histotripsy, a novel mechanism of action that uses focused ultrasound to mechanically destroy and liquify unwanted tissue and tumors. The company is currently focused on commercializing their Edison System in the US and select global markets for liver treatment while expanding histotripsy applications into other organs like kidney, pancreas, and others. HistoSonics has offices in Ann Arbor, Michigan and Minneapolis, MN. For more information on the Edison Histotripsy System please visit: For patient-related information please visit: 'The #HOPE4LIVER single-arm pivotal trial for histotripsy of primary and metastatic liver tumors: 1-year update of clinical outcomes' published in Annals of Surgery by Ziemlewicz, is licensed under CC BY-NC-ND.
