US Medical Innovations LLC (USMI) has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Canady Helios Cold Plasma (CHCP) Ablation System for ablating soft tissue during surgery. The CHCP system consists of the Canady Helios Cold Plasma XL-1000 CP Smart Electrosurgical Generator, Canady Helios Cold Plasma Ablators, Foot Pedal, and Trolley Cart..

US Medical Innovations LLC（USMI）已获得美国食品和药物管理局（FDA）510（k）批准，用于在手术期间消融软组织的Canady Helios冷等离子体（CHCP）消融系统。CHCP系统由Canady Helios冷等离子体XL-1000 CP智能电外科发电机、Canady Helios冷等离子体烧蚀器、脚踏板和手推车组成。。

“This milestone allows us to integrate our technology with our vision of creating the world's first AI-driven cold plasma robotic delivery system,' US Medical Innovations Chief Technology Officer Taisen Zhuang, Ph.D., said. 'We believe this combination represents the most promising path forward in surgical oncology, offering unprecedented precision and efficacy.

美国医学创新首席技术官庄泰森博士说：“这一里程碑使我们能够将我们的技术与创建世界上第一个人工智能驱动的冷等离子体机器人输送系统的愿景相结合。我们相信，这种结合代表了外科肿瘤学最有希望的前进道路，提供了前所未有的精确度和功效。

Our commitment to pushing the boundaries of medical science and technology has brought us to this moment, and we are proud to be at the forefront of this transformative era in healthcare.”.

我们致力于推动医学科学和技术的界限，这使我们走到了这一刻，我们很自豪能够站在医疗保健变革时代的最前沿。”。

Plasma is the fourth state of matter formed by ionizing neutral gases (i.e., argon or helium) combined with electromagnetic fields. The Canady Helios Cold Plasma System introduces a novel approach to soft tissue ablation using plasma. The system creates a plasma jet consisting of a pre-programmed, pulsed, non-contact, non-thermal (24 degrees Celsius to 30 degrees Celsius), three-dimensional, Plasma Treated Electromagnetic Field (PTEF).

等离子体是由电离中性气体（即氩或氦）与电磁场结合形成的第四种物质状态。Canady Helios冷等离子体系统介绍了一种使用等离子体进行软组织消融的新方法。该系统产生由预编程、脉冲、非接触、非热（24摄氏度至30摄氏度）、三维等离子体处理电磁场（PTEF）组成的等离子体射流。

This plasma jet is applied for five to seven minutes intra-operatively to the microscopic soft tissue surgical margin after a solid tumor is surgically removed. The PTEF consists of electronically charge particles comprised of reactive oxygen species (ROS) and reactive nitrogen species (RNS) that permeate the cellular membrane through an irreversible electroporation process resulting in apoptosis (cell death) without affecting surrounding healthy tissue..

在手术切除实体瘤后，术中将该等离子体射流应用于显微软组织手术边缘5至7分钟。PTEF由由活性氧（ROS）和活性氮（RNS）组成的带电颗粒组成，这些颗粒通过不可逆的电穿孔过程渗透细胞膜，导致细胞凋亡（细胞死亡），而不会影响周围的健康组织。。

The Jerome Canady Research Institute for Advanced Biological and Technological Sciences (JCRI-ABTS) team previously reported the first Phase I Clinical Trial for Cold Atmospheric Clinical Trial for the Treatment of Advancement of Solid Tumors.1 The technology has demonstrated exceptional safety and efficacy profiles with an 80% non-local recurrence rate and an 86% overall survival rate..

Jerome Canady高级生物与技术科学研究所（JCRI-ABTS）团队先前报道了用于治疗实体瘤进展的冷空气临床试验的第一阶段I期临床试验。该技术已证明具有特殊的安全性和有效性，非局部复发率为80%，总生存率为86%。。

“In addition to the advantages associated with surgical margin ablation, our preclinical investigations—supplemented by a multitude of published studies—indicate that CHCP-treated cancerous cells elicit the release of highly specific and immuno-stable antigens, potentially inducing a systemic response conducive to targeted immunotherapeutic applications or as complementary modalities alongside established standards of care,” JCRI Vice President of Research Saravana R.K.

“除了与手术切缘消融相关的优势外，我们的临床前研究辅以大量已发表的研究表明，CHCP治疗的癌细胞引发高度特异性和免疫稳定抗原的释放，可能诱导有利于靶向免疫治疗应用的全身反应，或与既定护理标准一起作为补充方式，”JCRI Saravana R.K.研究副总裁。

Murthy, Ph.D., said..

墨西博士说。。

US Medical Innovations plans to distribute the Canady Helios Cold Plasma System to hospitals later this year.

美国医疗创新公司计划在今年晚些时候向医院分发Canady Helios冷等离子体系统。

“This is a very exciting time for our company. We have been working very hard towards this milestone for 14 years,' US Medical Innovations Co-Founder/CEO and surgical oncologist Jerome Canady, M.D., commented. 'We are proud of this achievement and feel confident this technology will help the advancement of medicine and patient care.

“这对我们公司来说是一个非常激动人心的时刻。14年来，我们一直在努力实现这一里程碑，”美国医学创新联合创始人/首席执行官兼外科肿瘤学家Jerome Canady医学博士评论道。“我们为这一成就感到骄傲，并相信这项技术将有助于医学和患者护理的进步。

Special thanks to the Compassionate Use and Phase 1 patients participant and their families who led the way and the multi-disciplinary team of physicists, engineers, translational molecular scientists, clinical researchers and Michael Keidar, Ph.D. (George Washington University), the late Barry Trink, Ph.D.

特别感谢富有同情心的使用和1期患者参与者及其家人，以及物理学家，工程师，转化分子科学家，临床研究人员和迈克尔·凯达尔博士（乔治华盛顿大学），已故巴里·特林克博士组成的多学科团队。