MINNEAPOLIS--(BUSINESS WIRE)--HistoSonics, (www.histosonics.com), the developer and manufacturer of the Edison® Histotripsy System, announced today the publication of the company’s pivotal clinical trials data in Radiology. The prospective, international, multi-center, single arm #HOPE4LIVER Trials were designed to evaluate the safety and efficacy of histotripsy for the non-invasive destruction of primary (hepatocellular carcinoma) and metastatic liver tumors.

明尼阿波利斯-（商业新闻）-HistoSonics（www.HistoSonics.com），Edison®Histotripsy系统的开发和制造商，今天宣布发布该公司在放射学方面的关键临床试验数据。前瞻性，国际性，多中心，单臂#HOPE4LIVER试验旨在评估组织碎石术对原发性（肝细胞癌）和转移性肝肿瘤的非侵入性破坏的安全性和有效性。

Safety and efficacy were measured against performance goals established using extensive real-world evidence from ablative therapies. The analysis included 49 targeted tumors in 44 patients: 18 with primary liver tumors and 26 with metastatic tumors from the colon, rectum, breast, pancreas, and other primary origins..

安全性和有效性是根据使用烧蚀疗法的广泛现实证据建立的性能目标来衡量的。该分析包括44例患者中的49例靶向肿瘤：18例原发性肝肿瘤，26例来自结肠，直肠，乳腺，胰腺和其他原发灶的转移性肿瘤。。

The trials met the co-primary endpoints for technical success and safety. In the evaluable analysis at ≤ 36 hours post procedure, the histotripsy treatment completely covered the tumor in 42/44 tumors (95.5%), as evaluated by the independent core laboratory indicating that histotripsy destroys liver tumors sufficient to cover a physician’s planned treatment volume.

这些试验符合技术成功和安全性的共同主要终点。在术后≤36小时的可评估分析中，组织分解术治疗完全覆盖了42/44个肿瘤中的肿瘤（95.5%），这是由独立核心实验室评估的，表明组织分解术破坏的肝脏肿瘤足以覆盖医生计划的治疗量。

This outcome is key as the investigators treated both primary and metastatic disease and represented a diverse group of liver experts with no prior experience performing histotripsy, signaling a quick learning curve. The safety endpoint was achieved with only 3/44 (6.8%) of patients reporting a procedure-related major complication within the first 30-days post histotripsy procedure.

这一结果至关重要，因为研究人员治疗了原发性和转移性疾病，并代表了一组不同的肝脏专家，他们之前没有进行组织学检查的经验，这表明学习曲线很快。在组织切片术后的前30天内，只有3/44（6.8%）的患者报告了与手术相关的主要并发症，达到了安全终点。

All participants were required to have either not responded to, relapsed from, and/or been intolerant of other local-regional therapies, thus the patient population was not typical of those who undergo ablative therapies. Successfully achieving these co-primary endpoints in patients with more advanced disease further highlights the safety profile and technical success of histotripsy.

所有参与者都被要求对其他局部区域治疗没有反应，复发和/或不耐受，因此患者人群并不是接受消融治疗的典型人群。在患有更晚期疾病的患者中成功实现这些共同主要终点进一步突出了组织分解术的安全性和技术成功。

Data from #HOPE4LIVER were submitted to the US FDA as part of the HistoSonics market access submission resulting in an October 2023 FDA De Novo grant for the non-invasive destruction of liver tumors using histotripsy..

来自#HOPE4LIVER的数据作为HistoSonics市场准入提交的一部分提交给美国FDA，导致2023年10月FDA重新批准使用histotripsy非侵入性破坏肝肿瘤。。

Clifford Cho MD, #HOPE4LIVER Co-National Principal Investigator, Professor of Surgery and Chief Medical Officer at the University of Michigan Health-West Medical Center added, “As a liver surgeon with the insights learned in our laboratory about the enormous and varied potential benefits of histotripsy, it was professionally rewarding to see histotripsy utilized to benefit such a diverse patient population in the #HOPE4LIVER Trials.”.

Clifford Cho医学博士，#HOPE4LIVER联合国家首席研究员，密歇根大学健康西部医学中心外科教授兼首席医学官补充说，“作为一名肝脏外科医生，在我们的实验室中了解到了组织分解术的巨大而多样的潜在益处，在#HOPE4LIVER试验中看到组织分解术被用于使如此多样化的患者群体受益，这在专业上是有益的。”。

Tim Ziemlewicz MD, Assistant Professor of Radiology at the University of Wisconsin and Co-National Principal Investigator added, “The fact that this trial supported the first FDA authorization for the treatment of liver tumors using this unique new histotripsy platform is incredibly gratifying.”

威斯康星大学放射学助理教授兼联合国家首席研究员Tim Ziemlewicz医学博士补充说：“这项试验支持FDA首次授权使用这种独特的新组织学平台治疗肝肿瘤，这一事实令人难以置信地满意。”

As a result of these early data, HistoSonics initiated planned commercialization of the Edison System in the first half of 2024, rapidly establishing histotripsy programs in leading academic and private institutions across the US and globally. To date, the accelerated clinical adoption of histotripsy has led to hundreds of histotripsy procedures completed by liver surgeons, interventional radiologists, and radiation oncologists with a high rate of success.

由于这些早期数据，HistoSonics于2024年上半年启动了爱迪生系统的计划商业化，在美国和全球领先的学术和私人机构中迅速建立了组织学计划。迄今为止，组织学检查的加速临床应用已经导致肝外科医生，介入放射科医生和放射肿瘤学家完成了数百种组织学检查程序，取得了很高的成功率。

These data are being prepared for publication later this year. Furthermore, longer-term 12-month efficacy data from #HOPE4LIVER is in analysis and in preparation for publication..

这些数据正在准备今年晚些时候公布。此外，#HOPE4LIVER的长期12个月疗效数据正在分析中，并准备发表。。

Centers adopting the Edison Histotripsy System in their routine clinical practice have recognized the unique benefits to both patients and their institution. 'Edison clearly represents the future of liver-directed therapies realized; non-invasive, precise, effective and with an excellent initial safety profile, histotripsy potentially has all of the benefits of traditional tumor treatments, but without all of the disadvantages,' said Evan S.K.

在常规临床实践中采用爱迪生组织检查系统的中心已经认识到对患者及其机构的独特益处。”爱迪生清楚地代表了肝脏导向疗法的未来；Evan S.K.说，组织碎石术是一种非侵入性、精确、有效且具有良好初始安全性的方法，它可能具有传统肿瘤治疗的所有优点，但没有所有缺点。

Ong, M.D., MS, FACS, surgical oncologist and hepatic-biliary specialist with Providence Swedish in Seattle..

Ong，医学博士，MS，FACS，外科肿瘤学家和肝胆专家，位于西雅图的瑞典普罗维登斯。。

Brian Fuller, Senior Director, Clinical Operations at Providence Mission Hospital in Mission Viejo, California said, “ Histotripsy has been a true game changer for Mission Hospital and the patients we service. The clinical impact we have seen at Providence Mission is well publicized and is truly amazing.

加利福尼亚州Mission Viejo的Providence Mission Hospital临床运营高级总监Brian Fuller说：“Histotripsy对Mission Hospital和我们服务的患者来说是一个真正的游戏规则改变者。我们在Providence Mission看到的临床影响是广为宣传的，确实令人惊讶。

Also impressive has been the impact on screening awareness and overall elevation of our oncology programs. Additionally, HistoSonics has given us a big boost in physician and caregiver engagement.”.

同样令人印象深刻的是对筛查意识的影响和我们肿瘤学项目的整体提升。此外，组织超声学给我们带来了医生和护理人员参与度的大幅提升。”。

HistoSonics recently announced its plans to enroll patients in a novel Master Study design by the end of the year. The study and post market clinical program, called BOOMBOX, aims to collect data across all clinical use cases, and liver tumor pathologies, observing the use of histotripsy across all stages of liver disease.

HistoSonics最近宣布，计划在年底前将患者纳入一项新颖的硕士研究设计。该研究和上市后临床计划称为BOOMBOX，旨在收集所有临床使用病例和肝肿瘤病理学的数据，观察肝病各个阶段使用组织病理学的情况。

This comprehensive study is in addition to the company’s active Investigator Sponsored Research (ISR) program and other company directed studies in new indications..

这项综合研究是对该公司积极研究者赞助研究（ISR）计划和其他公司指导的新适应症研究的补充。。

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).

爱迪生系统用于肝肿瘤的非侵入性机械破坏，包括通过组织切片术部分或完全破坏不可切除的肝肿瘤。FDA没有评估爱迪生系统治疗任何疾病，包括但不限于癌症，也没有评估任何特定的癌症结果（如局部肿瘤进展，5年生存率或总生存率）。

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..

该系统只能由完成组织超声学培训的医生使用，其使用由经过适当培训的医生的临床判断指导。有关警告、注意事项和临床试验结果摘要（包括报告的不良事件）的完整列表，请参阅设备使用说明。。

About HistoSonics

关于组织超声学

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是一家私营医疗器械公司，开发了一种非侵入性平台和专有声束疗法，利用组织分解科学，这是一种使用聚焦超声波机械破坏和液化不需要的组织和肿瘤的新型作用机制。该公司目前专注于在美国将爱迪生系统商业化，并选择全球肝脏治疗市场，同时将组织分解术的应用扩展到肾脏、胰腺等其他器官。

HistoSonics has offices in Ann Arbor, Michigan and Minneapolis, MN..

HistoSonics在密歇根州安娜堡和明尼苏达州明尼阿波利斯设有办事处。。

For more information on the Edison Histotripsy System please visit: www.histosonics.com/. For patient related information please visit: www.myhistotripsy.com/.

有关Edison Histotripsy系统的更多信息，请访问：www.histosonics.com/。有关患者相关信息，请访问：www.myhistotripsy.com/。

“The #HOPE4LIVER Single-Arm Pivotal Trial for Histotripsy of Primary and Metastatic Liver Tumors” published in Radiology by Mishal Mendiratta-Lala, et.al. is licensed under CC BY 4.0.

Mishal Mendiratta Lala等人在《放射学》上发表的“HOPE4LIVER单臂关键性试验，用于原发性和转移性肝肿瘤的组织学检查”，已获得CC 4.0的许可。