TAKOMA PARK, Md.--(BUSINESS WIRE)--US Medical Innovations, LLC (USMI) announced today it has received FDA 510k Clearance (K240297) for the Canady Helios Cold Plasma™ (CHCP) Ablation System for the ablation of 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..

美国医学创新有限责任公司（USMI）今天宣布，它已获得FDA 510k批准（K240297），用于Canady Helios Cold Plasma™（CHCP）消融系统，用于手术期间消融软组织。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。。

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 C to 30 C), 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 Cold Plasma™系统引入了一种使用等离子体进行软组织消融的新方法。该系统产生一个等离子体射流，该射流由预编程、脉冲、非接触、非热（24 C至30 C）、三维等离子体处理电磁场™（PTEF）组成。

This plasma jet is applied for 5 to 7 minutes intra-operatively to the microscopic soft tissue surgical margin following the surgical removal of a solid tumor. The PTEF consists of electronically charge particles comprised of reactive oxygen species (ROS) and reactive nitrogen species (RNS) that permeate the cellular membrane via 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，它们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 (IDE #G190165) for Cold Atmospheric Clinical Trial for the Treatment of Advancement of Solid Tumors1. The technology has demonstrated exceptional safety and efficacy profiles with a non-local recurrence rate of up to 80% and an overall survival rate of up to 86%..

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大气临床试验的第一阶段I期临床试验（IDE#G190165）。该技术已证明具有特殊的安全性和有效性，非局部复发率高达80%，总生存率高达86%。。

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

首席技术官Taisen Zhuang博士表示：“这一里程碑使我们能够将我们的革命性技术与我们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，这种强大的组合代表了外科肿瘤学领域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 pivotal 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，这将我们带到了这一关键时刻，我们很自豪能够站在医疗保健变革时代的最前沿。”。

Saravana R.K. Murthy, PhD, Vice President of Research at JCRI, highlighted the potential systemic effects of CHCP treatment, stating, “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研究副总裁Saravana R.K.Murthy博士强调了CHCP治疗的潜在全身效应，他说：“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，或者作为与既定护理标准一起的补充方式。”。

Jerome Canady, MD, FACS, CEO and Co-Founder, Surgical Oncologist stated, “This is a very exciting time for our company. We have been working very hard towards this milestone for fourteen years. We are very proud of this remarkable achievement and feel confident that this disruptive technology will help the advancement of medicine and patient care.

外科肿瘤学家兼首席执行官兼联合创始人、FACS医学博士Jerome Canady表示：“这对我们公司来说是一个非常激动人心的时刻。14年来，我们一直在为这一里程碑而努力。我们为这一非凡的成就感到骄傲，并相信这种颠覆性的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, PhD (George Washington University), the late Barry Trink, PhD (Johns Hopkins University), Alexey Shashurin, PhD (Purdue University), Giacomo Basadonna , MD, PhD, FACS (University of Massachusetts, Worcester), Steven Gitelis, MD and Keith Millikan, MD, FACS of Rush University Medical Center (RMC), Aviram Nissan, MD and Mohammed Adileh, MD of Sheba Medical Center (SMC) as well as the surgical teams at RMC in Chicago, IL, USA, and SMC in Tel HaShomer, Israel performing these high risk surgical procedures and our research teams Plasma Medicine Engineers, and the JCRI’s researcher for their years of hard work and dedication.”.

特别感谢富有同情心的使用和第一阶段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·特里克博士（约翰霍普金斯大学）、亚历克斯·沙舒林博士（普渡大学）、贾科莫·巴萨多纳博士（Giacomo Basadonna）、博士（Giacomo Basadonna）、FACS（马萨诸塞大学伍斯特分校）、史蒂文·吉特利斯（Steven Gitelis）和基思·米利根（Keith Millikan），拉什大学医学中心（RMC）FACS、阿维拉姆·尼桑（Aviram Nissan）医学博士和谢巴医学中心（SMC）穆罕默德·阿迪勒（Mohammed Adileh）医学博士以及美国伊利诺伊州芝加哥市RMC的外科团队和以色列Tel HaShomer的SMC执行这些高风险外科手术，我们的研究团队血浆医学工程师以及JCRI的研究人员多年来的辛勤工作和奉献。”。

The Company plans to distribute the Canady Helios™ Cold Plasma System in Hospitals in late 2024.

该公司计划于2024年底在医院分发Canady Helios™冷等离子体系统。

For more information on US Medical Innovation’s products and technology please visit: www.usmedinnovations.com.

有关美国医疗创新产品和技术的更多信息，请访问：www.usmedinnovations.com。

1. The First Cold Atmospheric Plasma Phase I Clinical Trial for the Treatment of Advanced Solid Tumors: A Novel Treatment Arm for Cancer. Cancers 2023,15,3688, 12-17

1、第一个用于治疗晚期实体瘤的冷常压血浆I期临床试验：一种新型的癌症治疗手段。癌症2023,153688,12-17

About US Medical Innovations

关于美国医疗创新

US Medical Innovations, LLC (USMI), based out of Takoma Park, MD, is a privately held FDA registered life science and biomedical device company. USMI is dedicated to expanding the boundaries of plasma medicine by pioneering new technologies for the development of state-of-the-art medical devices that advance patient outcomes and improve human lives..

美国医疗创新有限责任公司（USMI）总部位于马里兰州塔科马公园，是一家在美国食品和药物管理局（FDA）注册的私营生命科学和生物医学设备公司。USMI致力于开拓新技术，开发先进的医疗设备，以提高患者的预后并改善人类生活，从而扩大血浆医学的界限。。