US Medical Innovations Secures FDA Clearance for Canady Helios Cold Plasma™ Ablation System
07 Mayo 2024 - 11:23AM
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.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20240507587574/en/
Canady Helios Cold Plasma. (Photo:
Business Wire)
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). 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.
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%.
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. 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.”
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.”
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. 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.”
The Company plans to distribute the Canady Helios™ Cold Plasma
System in Hospitals in late 2024.
For more information on US Medical Innovation’s products and
technology please visit: 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
About US Medical Innovations
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240507587574/en/
US Medical Innovations, LLC Kenniah Chestnut, Esq. VP Corporate
Affairs 301-270-0147 KChestnut@usmedinnov.com
www.usmedinnovations.com