US Medical Innovations (USMI) has received the US Food and Drug Administration (FDA) 510k approval for its Canady Helios Cold Plasma (CHCP) ablation system.
The CHCP system is intended for the ablation of soft tissue during surgery.
It comprises the Canady Helios Cold Plasma XL-1000 CP Smart Electrosurgical Generator, Canady Helios Cold Plasma Ablators, Foot Pedal and Trolley Cart.
CHCP system works with a novel approach to soft tissue ablation using plasma, the fourth state of matter formed by ionising neutral gases, combined with electromagnetic fields.
The system creates a plasma jet comprising a pre-programmed, pulsed, non-contact, non-thermal, three-dimensional, plasma-treated electromagnetic field (PTEF).
The plasma jet is applied for five to seven minutes intra-operatively to the microscopic soft tissue surgical margin, after the surgical removal of a solid tumour.
PTEF comprises electronically charged particles, made of reactive oxygen species (ROS) and reactive nitrogen species (RNS).
The ROS and RNS permeate the cellular membrane through an irreversible electroporation process that results in apoptosis, without affecting surrounding healthy tissue.
US Medical Innovations chief technology officer Taisen Zhuang said: “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.
“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.”
The research team at Jerome Canady Research Institute for Advanced Biological and Technological Sciences (JCRI-ABTS) reported the Phase 1 study of the technology.
In the study, the technology has shown superior safety and efficacy profiles with a non-local recurrence rate of up to 80% and an overall survival rate of up to 86%.
JCRI research vice president Saravana Murthy said: “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.”
Surgical Oncologist CEO and co-founder Jerome Canady said: “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.”
