REDWOOD CITY, Calif., May 28, 2024 /PRNewswire/ -- Galvanize today announced that it received U.S. Food and Drug Administration 510(k) regulatory clearance for the INUMI Flex endoscopic needle for use with the Aliya® PEF System for soft tissue ablation. The INUMI Flex needle expands the Aliya Pulsed Electric Field ablation portfolio, enabling minimally invasive endoscopic delivery to complement the previously cleared percutaneous Needle.

加利福尼亚州红木市，2024年5月28日/PRNewswire/--镀锌今天宣布，它获得了美国食品和药物管理局510（k）监管许可，用于与Aliya®PEF系统一起用于软组织消融的INUMI Flex内窥镜针。INUMI Flex针头扩展了Aliya脉冲电场消融组合，使微创内窥镜输送能够补充先前清除的经皮穿刺针。

Galvanize will soon initiate commercial release in the United States..

镀锌将很快在美国开始商业发行。。

Aliya, with the INUMI Flex needle, is the first commercially available system to deliver PEF energy through an endoscope, enabling physicians to reach and non-thermally ablate soft tissue lesions. In the ongoing Galvanize AFFINITY clinical trial, clinicians deliver energy immediately after an initial biopsy. .

使用INUMI Flex针头的Aliya是第一个通过内窥镜传递PEF能量的商用系统，使医生能够接触并非热消融软组织病变。在正在进行的Genize AFFINITY临床试验中，临床医生在初次活检后立即提供能量。。

Aliya delivers high voltage, short duration electrical energy locally to alter the transmembrane potential of cells, which results in loss of homeostasis, inducing non-thermal programmed cell death without denaturing cellular proteins and the extracellular matrix. In addition to focal ablation, preclinical and prior clinical feasibility studies suggest this process may release antigens from the dying tumor cells that may stimulate an immune response for a potential systemic effect beyond focal ablation.

Aliya在局部提供高压，短时间的电能，以改变细胞的跨膜电位，从而导致体内平衡的丧失，诱导非热程序性细胞死亡，而不会使细胞蛋白和细胞外基质变性。除了局灶性消融外，临床前和先前的临床可行性研究表明，这一过程可能会从垂死的肿瘤细胞中释放抗原，从而刺激免疫反应，从而产生局灶性消融以外的潜在全身效应。

Aliya can now be delivered using either an endoscopic or percutaneous approach. .

Aliya现在可以使用内窥镜或经皮方法递送。。

'As physicians increasingly shift from percutaneous to endoscopic access of target lesions, our team developed INUMI Flex to meet their needs,' commented Jonathan Waldstreicher, MD, CEO of Galvanize. 'Having demonstrated the effects of Aliya beyond focal ablation in early studies, we continue to invest in understanding the full potential of biologic activation and its unique immune response in clinical trials.'.

“随着医生越来越多地从经皮进入内窥镜进入靶病变，我们的团队开发了INUMI Flex来满足他们的需求，”Genize首席执行官乔纳森·沃尔德斯特雷彻（JonathanWaldstreicher）医学博士评论道在早期研究中已经证明了Aliya在局灶性消融之外的作用，我们继续投资于了解生物激活的全部潜力及其在临床试验中独特的免疫反应。”。

Endoscopic delivery of Aliya has been evaluated in two clinical feasibility studies in patients with Non-Small Cell Lung Cancer (NSCLC), one with robotic-assisted bronchoscopy and the other with navigation bronchoscopy. INCITE-ES was a treat-and-resect study conducted outside of the U.S. and was designed to assess safety and feasibility of Aliya while examining immune activation in patients with early stage IA2‐IB NSCLC (NCT04732520).

在两项非小细胞肺癌（NSCLC）患者的临床可行性研究中评估了Aliya的内镜输送，一项采用机器人辅助支气管镜检查，另一项采用导航支气管镜检查。INCITE-ES是一项在美国境外进行的治疗和切除研究，旨在评估Aliya的安全性和可行性，同时检查早期IA2-IB NSCLC患者的免疫激活（NCT04732520）。

Outcomes demonstrated no device-related adverse events, a significant reduction in malignant tissue in the treated region, and an increase in formation of tertiary lymphoid structures (TLS) in treated patients. This early data suggests Aliya may stimulate a systemic immune effect beyond focal ablation.

结果显示，没有与设备相关的不良事件，治疗区域的恶性组织显着减少，治疗患者的三级淋巴结构（TLS）形成增加。这一早期数据表明，Aliya可能会刺激局灶性消融以外的全身免疫效应。

The AFFINITY study (NCT05890872) which is currently enrolling, is a prospective, single-arm, non-randomized, multi-center, feasibility study in patients with stage IV NSCLC or lung metastases who are indicated for first line standard of care therapy. This study is examining the safety of adding Aliya to the care pathway for these advanced disease patients and further assesses the potential immune modulation and treatment effect..

目前正在招募的亲和力研究（NCT05890872）是一项针对IV期NSCLC或肺转移患者的前瞻性单臂非随机多中心可行性研究，适用于一线标准治疗。这项研究正在研究将Aliya添加到这些晚期疾病患者的护理途径中的安全性，并进一步评估潜在的免疫调节和治疗效果。。

'The ability to diagnose and treat in a single non-invasive endoscopic procedure represents a major advancement', said Michael Pritchett, DO, MPH, Pulmonary Specialist and Director of the Chest Center of the Carolinas at FirstHealth in Pinehurst, North Carolina, and investigator in the AFFINITY trial.

“在一次非侵入性内窥镜手术中诊断和治疗的能力代表了一项重大进步”，迈克尔·普里切特（Michael Pritchett，DO，MPH）说，他是北卡罗莱纳州Pinehurst FirstHealth的肺部专家和卡罗莱纳州胸部中心主任，也是AFFINCY试验的研究者。

'I'm encouraged by early results we are seeing in patients enrolled in the study. The potential to stimulate the patient's immune system to create a systemic response beyond the focal ablation could be a game changer and may provide new hope for patients with metastatic disease. I'm excited to now have this option available to offer patients outside of a clinical trial.'.

“我对我们在参与研究的患者中看到的早期结果感到鼓舞。刺激患者免疫系统产生局灶性消融以外的全身反应的潜力可能会改变游戏规则，并可能为转移性疾病患者提供新的希望。我很高兴现在有这个选项可以为临床试验之外的患者提供。”。

The Aliya PEF System and the INUMI Flex needle are 510(k) cleared in the United States for the surgical ablation of soft tissue. They are not currently commercially available in any other geography.

Aliya PEF系统和INUMI Flex针头在美国被510（k）清除，用于软组织的手术消融。目前，它们在任何其他地区都无法在市场上买到。

About Galvanize™

关于镀锌™

Galvanize aims to become the global leader in delivering medical technology innovations that drive biologic processes to treat a range of diseases, including solid tumors, and chronic bronchitis symptoms. Formed by ATP (Apple Tree Partners), Galvanize is based in Redwood City, Calif., and is developing and commercializing its revolutionary Aliya® PEF energy platform in the United States.

Genize旨在成为全球领先的医疗技术创新提供商，推动生物过程治疗一系列疾病，包括实体瘤和慢性支气管炎症状。Genize由ATP（Apple Tree Partners）成立，总部位于加利福尼亚州红木市，正在美国开发和商业化其革命性的Aliya®PEF能源平台。