Latest news with #HistoSonics
Yahoo
29-05-2025
- Business
- Yahoo
HistoSonics' histotripsy system receives early market access authorisation in UK
Amid reports of an acquisition by one of the leading players in the medical device space, HistoSonics' Edison histotripsy system has been granted controlled early limited market access in the UK under an Unmet Clinical Need Authorisation (UCNA). The US company received the 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. Designed for the non-invasive destruction of liver tumours, the Edison system delivers focused ultrasound to target and eliminate cancerous liver tissue. The device received de novo clearance from the US Food and Drug Administration (FDA) in 2023. HistoSonics' president and CEO Mike Blue said the company was 'honoured' to work alongside the National Health Service (NHS) to bring histotripsy to UK patients, many of whom have 'limited options'. He states: 'Securing controlled access through the IDAP pilot programme is a tremendous milestone for HistoSonics and signals clear recognition of our technology's potential to transform healthcare.' HistoSonics' authorisation comes as reports emerge that potential buyers are considering acquiring the company. According to a 1 May report by the Financial Times, HistoSonics is seeking a valuation of more than $2.5bn, 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 the company's $102m Series D funding round. HistoSonics was selected for a UCNA under the IDAP programme after the UK Medicines and Healthcare products Regulatory Agency (MHRA) determined that histotripsy devices may provide "public health value" for patients with primary or metastatic liver tumours. Other companies awarded part of a £10m funding package from the MHRA last year to expedite their medical devices' entry onto the UK market included Upfront Diagnostics for a portable blood test, and Lenus Health for an AI-based tool to predict patients' risk of hospitalisation for chronic obstructive pulmonary disease (COPD). Earlier this month, healthcare payor Blue Cross Blue Shield of Michigan (BCBSM) and health plan option Blue Care Network became the first US medical insurer to cover non-thermal histotripsy using HistoSonics' Edison system. "HistoSonics' histotripsy system receives early market access authorisation in UK" 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. Sign in to access your portfolio
Yahoo
27-05-2025
- Business
- Yahoo
‘Tumor Destroyer' shows promising results at Corewell Health
GRAND RAPIDS, Mich. (WOOD) — Corewell Health has recently acquired a new tool to help treat patients with certain liver cancers, and the first treatments appear to be a success. The tool was developed by , a company that spawned out of the done at the University of Michigan. It has been billed as a but Corewell Health radiologist James Morrison says the key to the tool is its precision. '(It's) completely non-invasive, and unlike other non-invasive technologies, it doesn't damage any of the surrounding tissue. So, we can be very focused on the cancer itself and preserve as much of the normal tissue as much as possible,' Morrison told News 8. The tool uses focused ultrasound pulses to destroy its target. The ultrasound causes bubbles to grow in the tiny gas pockets within the target tissue, causing it to expand and eventually collapse under stress, destroying the cells. Tumor Destroyer? FDA approves tool that uses ultrasound to fight cancer 'But you could stick your hand through the beam and, as long as you're not at that one point in space, it's not going to damage any of the normal tissue,' he explained. The by the U.S. Food and Drug Administration in 2023 and, for now, can only be used to treat cancers in the liver, but experts are confident the tool will work in other parts of the body and that approval will expand. 'Next will be the kidney and then beyond that, things like pancreatic cancer and other places in the body,' Morrison said. Corewell Health doctors have already treated multiple patients with the HistoSonics tool and, so far, the treatments appear to be a success. Latest trial of University of Michigan's 'tumor destroyer' exceeds goals 'Our first few patients, we (wanted to be) extra precautious and keep them in for observation. But in the future, they will go home the same day. It's well tolerated,' he said. 'Everything went smoothly. Even more smoothly than expected. … The tumor was completely ablated.' Corewell Health is one of roughly 30 hospitals in the country to offer the new treatment. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
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:
Yahoo
12-05-2025
- Business
- Yahoo
HistoSonics secures first insurance coverage for histotripsy system
US-based HistoSonics has secured the first major insurance coverage for its histotripsy system, amid media speculation of a $2.5bn sale. Healthcare payor Blue Cross Blue Shield of Michigan (BCBSM) and health plan option Blue Care Network have created a new medical policy that covers non-thermal histotripsy using the HistoSonics' Edison system for the treatment of primary and metastatic liver tumours. The policy coverage took effect on 1 February 2025, giving 4.5 million residents in Michigan early access to the treatment if eligible. A broader policy will go into effect on 1 July 2025. The coverage is a win for the treatment modality as HistoSonics looks to grapple for market share amongst more established surgical techniques. Founded in 2009 with technology developed by the University of Michigan, HistoSonics received US Food and Drug Administration (FDA) approval in October 2023 for its Edison system, which uses short pulses of focused ultrasound energy to mechanically destroy and liquefy affected tumours. The therapy, which is delivered via a robotic arm, does not carry the same invasiveness or toxicity as traditional approaches. Edison is the only FDA-approved histotripsy system currently on the market. A 12-month follow-up analysis from the HOPE4LIVER study demonstrated a 90% local tumour control rate observed across all treated tumours, regardless of type or origin. This, HistoSonics says, compares favourably to the current standard of care of local regional therapies at the one year follow-up mark. Current surgical approaches used to kill liver tumours include radiofrequency ablation, microwave ablation, and cryoablation. The company is conducting further clinical trials to expand the system's use into kidney and pancreatic cancer treatment. The Edison system has been adopted at over 50 medical centres in the US to treat over 1,500 patients. 'Liver tumours 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 HistoSonics' CEO Mike Blue. 'This milestone marks an important precedent, and we expect additional states and payers to follow in expanding access to histotripsy for patients with liver tumours across the US.' The coverage is set against a backdrop of acquisition talk, with the Financial Times reporting that major medtech companies are eyeing the histotripsy specialist. Medtronic, GE HealthCare, and Johnson & Johnson (J&J) are all reported to be evaluating the business. Through its investment arm, J&J has been a long-time backer of HistoSonics, the latest cash injection occurring via the participation in a $102m Series D round in August 2024. "HistoSonics secures first insurance coverage for histotripsy system" 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
12-05-2025
- Business
- Yahoo
HistoSonics secures first insurance coverage for histotripsy system
US-based HistoSonics has secured the first major insurance coverage for its histotripsy system, amid media speculation of a $2.5bn sale. Healthcare payor Blue Cross Blue Shield of Michigan (BCBSM) and health plan option Blue Care Network have created a new medical policy that covers non-thermal histotripsy using the HistoSonics' Edison system for the treatment of primary and metastatic liver tumours. The policy coverage took effect on 1 February 2025, giving 4.5 million residents in Michigan early access to the treatment if eligible. A broader policy will go into effect on 1 July 2025. The coverage is a win for the treatment modality as HistoSonics looks to grapple for market share amongst more established surgical techniques. Founded in 2009 with technology developed by the University of Michigan, HistoSonics received US Food and Drug Administration (FDA) approval in October 2023 for its Edison system, which uses short pulses of focused ultrasound energy to mechanically destroy and liquefy affected tumours. The therapy, which is delivered via a robotic arm, does not carry the same invasiveness or toxicity as traditional approaches. Edison is the only FDA-approved histotripsy system currently on the market. A 12-month follow-up analysis from the HOPE4LIVER study demonstrated a 90% local tumour control rate observed across all treated tumours, regardless of type or origin. This, HistoSonics says, compares favourably to the current standard of care of local regional therapies at the one year follow-up mark. Current surgical approaches used to kill liver tumours include radiofrequency ablation, microwave ablation, and cryoablation. The company is conducting further clinical trials to expand the system's use into kidney and pancreatic cancer treatment. The Edison system has been adopted at over 50 medical centres in the US to treat over 1,500 patients. 'Liver tumours 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 HistoSonics' CEO Mike Blue. 'This milestone marks an important precedent, and we expect additional states and payers to follow in expanding access to histotripsy for patients with liver tumours across the US.' The coverage is set against a backdrop of acquisition talk, with the Financial Times reporting that major medtech companies are eyeing the histotripsy specialist. Medtronic, GE HealthCare, and Johnson & Johnson (J&J) are all reported to be evaluating the business. Through its investment arm, J&J has been a long-time backer of HistoSonics, the latest cash injection occurring via the participation in a $102m Series D round in August 2024. "HistoSonics secures first insurance coverage for histotripsy system" 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. Sign in to access your portfolio
