Latest news with #HOPE4KIDNEY
Yahoo
2 days ago
- Business
- Yahoo
HistoSonics completes pivotal histotripsy system trial enrolment
As reports of an acquisition by one of the leading players in the medical device space percolate, HistoSonics has completed enrolment in a pivotal trial to evaluate its histotripsy platform in treating kidney tumours. The US company's prospective, multi-centre, single-arm pivotal #HOPE4KIDNEY (NCT05820087) trial is designed to evaluate the effectiveness and safety of the Edison system for the destruction of kidney tissue by treating primary solid renal tumours. A total of 67 patients have been enrolled with a single, non-metastatic solid kidney mass ≤3cm. Patients will be treated with the Edison system and followed for five years post-procedure, with data at the 90-day evaluation point to be submitted in support of regulatory approval with the US Food and Drug Administration (FDA). The Edison system uses a technology called histotripsy, involving the delivery of non-thermal, non-invasive focused ultrasound waves to target and eliminate cancerous liver tissue. The system received de novo clearance from the US Food and Drug Administration (FDA) in 2023 and last month secured its first major insurance coverage from a new healthcare policy from Healthcare payor Blue Cross Blue Shield of Michigan (BCBSM) and health plan option Blue Care Network. HistoSonics' vision is for its Edison system to become a 'foundational, non-invasive' solution across a range of clinical applications, the company's CEO, Mike Blue stated. 'Completing enrolment in our pivotal kidney tumour trial represents a significant milestone toward that goal and reinforces our confidence in expanding histotripsy into additional tumour types and indications,' said Blue. In May, Edison histotripsy system has been granted controlled early limited market access in the UK under an Unmet Clinical Need Authorisation (UCNA) under the UK's Innovative Devices Access Pathway (IDAP), launched by the UK Government in 2023 to help fast-track 'transformative medical technologies' into the healthcare system. As first reported by the Financial Times last month, HistoSonics is seeking a valuation of more than $2.5bn for a takeover of the company, with Medtronic, GE HealthCare and Johnson & Johnson (J&J), a longtime backer of HistoSonics, among the interested parties evaluating the business. J&J most recently participated in HistoSonics' $102m Series D funding round. "HistoSonics completes pivotal histotripsy system trial enrolment" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. 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
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:
