FDA Clears Canady Helios Cold Plasma Ablation System

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.

“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. 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.”
 
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). 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.
 
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.
 
“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. Murthy, Ph.D., said.

US Medical Innovations plans to distribute the Canady Helios Cold Plasma System to hospitals later this year.
 
“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. 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. (Johns Hopkins University), Alexey Shashurin, Ph.D. (Purdue University), Giacomo Basadonna, M.D., Ph.D. (University of Massachusetts, Worcester), Steven Gitelis, M.D., and Keith Millikan, M.D., of Rush University Medical Center (RMC), Aviram Nissan, M.D., and Mohammed Adileh, M.D., of Sheba Medical Center (SMC) as well as the surgical teams at RMC in Chicago, 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.”
  
Takoma Park, Md.-based US Medical Innovations LLC is a privately held U.S. Food and Drug Administration-registered life science and biomedical device company. USMI aims to expand the boundaries of plasma medicine by pioneering new technologies for developing medical devices that advance patient outcomes and improve human lives.

Reference 
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