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AngioDynamics和伦敦大学学院医院启动国际多中心研究,评估NanoKnife®系统治疗的长期效果

AngioDynamics and University College London Hospital Launch International Multi-Center Study to Assess Long Term Effects of Treatment with The NanoKnife ® System

businesswire 等信源发布 2024-10-23 17:58

可切换为仅中文


LATHAM, N.Y.--(BUSINESS WIRE)--AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving patient quality of life, today announced the launch of an international multi-center prospective registry study to assess the long term effects of treating men with unifocal intermediate-risk prostate cancer with the NanoKnife® System in partnership with the University College London Hospital (UCLH)..

纽约州莱瑟姆(商业新闻短讯)--AngioDynamics,Inc.(纳斯达克:ANGO)是一家领先的变革性医疗技术公司,专注于恢复人体血管系统的健康血流,扩大癌症治疗选择并改善患者生活质量,今天宣布启动一项国际多中心前瞻性登记研究,以评估与伦敦大学学院医院(UCLH)合作使用NanoKnife®系统治疗单灶性中危前列腺癌男性的长期效果。。

Approximately 40% of all diagnosed prostate cancer cases are classified as intermediate risk.1 In the first year after surgery, 36% of men report urinary leakage, and 95% are affected by erectile dysfunction (70% described as moderate/severe).2

在所有确诊的前列腺癌病例中,约有40%被归类为中等风险。1在手术后的第一年,36%的男性报告尿漏,95%的男性受勃起功能障碍的影响(70%被描述为中度/重度)

The NanoKnife® System delivers an innovative alternative to conventional radical surgery or radiotherapy, each of which often results in significant dysfunction in urinary continence and erectile potency. With its non-thermal approach, the NanoKnife system is engineered to preserve vital structures inside and outside the prostate, offering patients effective treatment of tumors, low complication rates, and minimal impact on quality of life.3.

NanoKnife®系统为传统的根治性手术或放疗提供了一种创新的替代方案,每种手术或放疗通常会导致尿失禁和勃起能力的严重功能障碍。通过其非热方法,纳米刀系统被设计用于保存前列腺内外的重要结构,为患者提供有效的肿瘤治疗,并发症发生率低,对生活质量的影响最小。

In 2023, the National Institute for Health and Care Excellence (NICE) in the U.K. upgraded the use of the NanoKnife® System from “Research Only” to “Special Arrangements” allowing hospitals to start new services while collecting more data4 and signaling its growing acceptance in national urology guidelines..

2023年,英国国家健康与护理卓越研究所(NICE)将NanoKnife®系统的使用从“仅研究”升级为“特殊安排”,允许医院启动新服务,同时收集更多数据4,并表明其在国家泌尿外科指南中的接受度越来越高。。

AngioDynamics is conducting the international multi-center prospective registry study in partnership with UCLH. UCLH is the largest center for robotic prostate surgery in the U.K. and a leading provider of focal therapy, radiotherapy, robotic surgery, and active surveillance treatment options for men with prostate cancer.

AngioDynamics正在与UCLH合作进行国际多中心前瞻性登记研究。UCLH是英国最大的机器人前列腺手术中心,也是前列腺癌男性焦点治疗、放射治疗、机器人手术和主动监测治疗选择的领先供应商。

Additionally, UCLH was the first facility in the National Health Service to use the NanoKnife® System to treat prostate cancer,5 and provide standardized patient selection, treatment, and long-term follow-up..

此外,UCLH是国家卫生服务局第一家使用NanoKnife®系统治疗前列腺癌的设施,5并提供标准化的患者选择,治疗和长期随访。。

“Focal therapy has developed over the past ten years to identify patients with the most to gain from treatment effectively. We can now test a large cohort of patients to show benefit without adding long-term risk,” said Laura Piccinini, AngioDynamics Senior Vice President and General Manager of Endovascular Therapies and International.

血管动力学高级副总裁兼血管内治疗和国际总经理劳拉·皮奇尼尼(LauraPiccinini)说:“过去十年来,焦点治疗已经发展起来,可以有效地识别从治疗中获益最多的患者。我们现在可以测试一大批患者,以显示其益处,而不会增加长期风险。”。

“We are proud of the partnership with UCLH in conducting this important study. This extensive prospective study will help support broader adoption, expanded treatment pathways, and increased patient access to improved treatment modalities for men in the U.K. with prostate cancer and help establish treatment with this technology as a standard of care.

“我们为与UCLH合作进行这项重要研究而感到自豪。这项广泛的前瞻性研究将有助于支持英国前列腺癌男性更广泛的采用,扩大治疗途径,增加患者获得改进治疗方式的机会,并帮助将这项技术作为护理标准建立治疗。

This collaboration demonstrates our steadfast commitment to supporting the physician community and their patients with innovative and effective products.”.

这一合作表明我们坚定地致力于用创新和有效的产品支持医生社区及其患者。”。

“The international registry will allow us to track patients’ outcomes over time and allow us to quality control the dissemination of this novel technology across the world,” said Professor Mark Emberton, Interventional Oncology, Division of Surgery and Interventional Science at the University College Hospital London.

伦敦大学学院医院外科和介入科学部介入肿瘤学教授马克·恩伯顿(Mark Emberton)表示:“国际注册中心将使我们能够跟踪患者的预后,并使我们能够在全世界范围内对这项新技术的传播进行质量控制。”。

“This will enable us to learn from every patient treated and, as a result, continue to refine this treatment that allows men to have their prostate cancer treated and maintain their quality of life.”.

“这将使我们能够向每位接受治疗的患者学习,并因此继续改进这种治疗方法,使男性能够接受前列腺癌治疗并维持其生活质量。”。

The study will enroll a minimum of 500 patients worldwide to confirm the multiple single-center published papers indicating that the NanoKnife® System is safe and effective in the treatment of targeted tumors,3 and the prevention or delayed need for radical intervention in the preservation of patient quality of life..

该研究将在全球范围内招募至少500名患者,以确认多篇单中心发表的论文,这些论文表明NanoKnife®系统在靶向肿瘤的治疗中是安全有效的,3以及预防或延迟需要根治性干预以保持患者的生活质量。。

Complementing the ongoing Randomized Controlled Trial studies evaluating NanoKnife versus radical treatment,6,7 this investigator-initiated trial will closely monitor patients post-treatment, measuring critical quality of life metrics and tracking any necessary follow-up interventions. In addition to quality of life, the study will assess overall and prostate-specific mortality rates..

作为正在进行的评估纳米刀与根治性治疗的随机对照试验研究的补充,6,7这项由研究者发起的试验将密切监测患者治疗后的情况,测量关键的生活质量指标并跟踪任何必要的随访干预措施。除了生活质量外,该研究还将评估总体死亡率和前列腺特异性死亡率。。

For important risk information, visit https://www.angiodynamics.com/about-us/risk-information/#inano

有关重要风险信息,请访问https://www.angiodynamics.com/about-us/risk-information/#inano

About the NanoKnife System

关于纳米刀系统

The NanoKnife System utilizes Irreversible Electroporation (IRE) technology to effectively destroy targeted cells without the use of thermal energy by delivering high-voltage pulses, creating permanent nanopores within the cell membrane. This stimulus induces an apoptotic-like cellular death in the targeted tissue, resulting in a complete ablation of the targeted tissue.

纳米刀系统利用不可逆电穿孔(IRE)技术,通过传递高压脉冲,在细胞膜内产生永久性纳米孔,在不使用热能的情况下有效破坏靶细胞。这种刺激在靶组织中诱导凋亡样细胞死亡,导致靶组织的完全消融。

Visit nanoknife.com for full product information..

。。

The NanoKnife System when used for the treatment of prostate cancer is an investigational device in the United States. The NanoKnife System has not received FDA clearance for the therapy or treatment of any specific disease or condition. In the European Union, the NanoKnife System is indicated for the ablation of prostate tissue in patients with intermediate risk prostate cancer.

用于治疗前列腺癌的纳米刀系统是美国的一种研究设备。纳米刀系统尚未获得FDA批准用于治疗或治疗任何特定疾病或病症。在欧盟,纳米刀系统适用于中等风险前列腺癌患者的前列腺组织消融。

The use of this device in other organs for other disease states has not been fully evaluated..

尚未充分评估该设备在其他器官中用于其他疾病状态的情况。。

About AngioDynamics, Inc.

关于AngioDynamics,Inc。

AngioDynamics is a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving patient quality of life.

AngioDynamics是一家领先且具有变革性的医疗技术公司,专注于恢复人体血管系统的健康血流,扩大癌症治疗选择并改善患者的生活质量。

The Company’s innovative technologies and devices are chosen by talented physicians in fast-growing healthcare markets to treat unmet patient needs. For more information, visit www.angiodynamics.com.

该公司的创新技术和设备是由快速增长的医疗保健市场中的天才医生选择的,用于治疗未满足的患者需求。有关更多信息,请访问www.angiodynamics.com。

Safe Harbor

安全港

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements regarding AngioDynamics’ expected future financial position, results of operations, cash flows, business strategy, budgets, projected costs, capital expenditures, products, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as statements that include the words such as “expects,” “reaffirms,” “intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” “projects,” “optimistic,” or variations of such words and similar expressions, are forward-looking statements.

本新闻稿包含1995年《私人证券诉讼改革法案》所指的前瞻性声明。所有关于AngioDynamics预期未来财务状况、经营成果、现金流、业务战略、预算、预计成本、资本支出、产品、竞争地位、增长机会、未来经营管理计划和目标的报表,以及包含“预期”、“重申”、“打算”、“预期”、“计划”、“相信”、“寻求”、“估计”、“项目”、“乐观”等词语或类似词语的变体的报表,均为前瞻性报表。

These forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties. Investors are cautioned that actual events or results may differ materially from AngioDynamics’ expectations, expressed or implied. Factors that may affect the actual results achieved by AngioDynamics include, without limitation, the scale and scope of the COVID-19 global pandemic, the ability of AngioDynamics to develop its existing and new products, technological advances and patents attained by competitors, infringement of AngioDynamics’ technology or assertions that AngioDynamics’ technology infringes the technology of third parties, the ability of AngioDynamics to effectively compete against competitors that have substantially greater resources, future actions by the FDA or other regulatory agencies, domestic and foreign healthcare reforms and government regulations, results of pending or future clinical trials, overall economic conditions (including inflation, labor shortages and supply chain challenges including the cost and availability of raw materials), the results of on-going litigat.

这些前瞻性陈述并不能保证未来的表现,并且会受到风险和不确定性的影响。投资者应注意,实际事件或结果可能与血管动力学的预期(明示或暗示)存在实质性差异。可能影响AngioDynamics取得实际成果的因素包括但不限于新型冠状病毒全球大流行的规模和范围、AngioDynamics开发现有和新产品的能力、竞争对手取得的技术进步和专利、侵犯AngioDynamics技术或声称AngioDynamics技术侵犯第三方技术、AngioDynamics有效竞争拥有更大资源的竞争对手的能力、FDA或其他监管机构的未来行动、国内外医疗改革和政府法规、未决或未来临床试验的结果、整体经济状况(包括通货膨胀、劳动力短缺和供应链挑战,包括原材料的成本和可用性)、正在进行的诉讼的结果。

NanoKnife and the NanoKnife logo are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or subsidiary.

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1 https://www.npca.org.uk/wp-content/uploads/2021/01/NPCA-Annual-Report-2020_Final_140121.pdf (p.25)

1 https://www.npca.org.uk/wp-content/uploads/2021/01/NPCA-Annual-Report-2020_Final_140121.pdf (p.25)

2 https://bjui-journals.onlinelibrary.wiley.com/doi/10.1111/bju.15739

2.https://bjui-journals.onlinelibrary.wiley.com/doi/10.1111/bju.15739

3 https://doi.org/10.1016/j.urology.2023.01.024

3.https://doi.org/10.1016/j.urology.2023.01.024

4 https://www.nice.org.uk/guidance/ipg768

4 https://www.nice.org.uk/guidance/ipg768

5 https://www.uclh.nhs.uk/news/uclh-first-nhs-use-nanoknife-prostate-cancer

5 https://www.uclh.nhs.uk/news/uclh-first-nhs-use-nanoknife-prostate-cancer

6 https://fundingawards.nihr.ac.uk/award/17/150/01

6 https://fundingawards.nihr.ac.uk/award/17/150/01

7 https://clinicaltrials.gov/study/NCT05513443

7https://clinicaltrials.gov/study/NCT05513443