JCRI-ABTS Seeks FDA Emergency Use Authorization for the Canady Helios Cold Plasma HERO System for the Treatment of COVID-19

TAKOMA PARK, Md.--()--US Medical Innovations, LLC (USMI), a Biomedical and Life Science subsidiary of US Patent Innovations, LLC (USPI) announced today that the Jerome Canady Research Institute for Advanced Biological & Technological Sciences (JCRI-ABTS), a research partner for USPI/USMI, is seeking approval from the Food and Drug Administration (FDA) under its Emergency Use Authorization (EUA) for using the Canady HeliosTM Cold Plasma HEROTM (Humidified Electrical Reactive Oxygen) System for the treatment of patients infected with COVID-19 virus.

The Canady Helios™ Cold Plasma HERO™ system is designed to inactivate the COVID-19 virus within 5 to 7 minutes after breathing in a mixture of ionized Helium (He), Oxygen (O2) and Air via a hospital airway delivery system. The Cold Plasma HERO system can be used in conjunction with a standard ventilator, CPAP (Continuous Positive Airway Pressure), BIPAP (Bilevel Positive Airway Pressure) or O2 face mask.

Jerome Canady, M.D., CEO, explained, “Plasma is an ionized gas often referred to as the '4th State of Matter.'" Plasma medicine has been qualified as a new scientific field after intense research efforts in low temperature or cold atmospheric plasmas (CAPs) applications. CAPs are defined as specific forms of ionized gas composed of ions, photons, free electron and complex chemical compositions. CAPs produce various reactive and nitrogen species (ROS, RNS) i.e. (H2O2, O2_, ∙NO, ∙OH, O3, ∙NO2, O2) which have important biological and biomedical activities. CAPs have already been proven to be effective in wound healing, skin diseases, antifungal treatments, and dental care.”

JCRI-ABT’s laboratory has demonstrated and reported in the literature that the Canady HeliosTM Cold Plasma System (CHCPS) for Solid Tumors is effective in killing numerous solid tumor cell lines without damage to normal tissue. JCRI-ABTS and USMI are currently conducting an FDA-approved Phase I clinical trial in the U.S. and Israel for stage IV solid tumors under an investigational device exemption program (#G190165).

CAPs have been reported to induce inactivation of viruses by several researchers around the world. (i.e., inactivation of airborne aerosols, Newcastle virus, adenovirus, feline calicivirus, HIV-1 virus, avian influenza virus, without destruction of the antigenic determinants for vaccine preparation, and antiviral therapy effect on human herpes simplex virus type 1).

What is the possible mechanism?

The Cold Plasma HERO™ system is a modified version of the FDA-approved Canady Plasma® Smart Electrosurgical Generator XL-1000 (#K192124) and FDA-approved IDE (#G190165) Canady Helios™ Cold Plasma System for Solid Tumors CP-1000, specifically designed and patent pending for respiratory failure secondary to viruses, pneumonia and lung cancer.

The Canady HeliosTM Cold Plasma HEROTM System generates an ionized cold plasma which is blended with the Air/O2 from a ventilator or other oxygen source. The cold plasma gas mixture is distributed in the patient’s respiratory system via an endotracheal tube, face mask, CPAP or BIPAP. One of the proposed mechanisms of the Cold Plasma HERO™ system is that ROS and RNS inactivate the virus present in the patient’s bronchial cells by inducing structural disruption to the receptor-binding domain in the spike glycoprotein that forms homotrimers protruding from the viral surface of the COVID-19 virus and by disrupting the COVID-19 transmembrane lipid layer by peroxidation and cross-linking of the fatty acid chain.

Dr. Canady continued, “We see the Canady Helios™ Cold Plasma HERO™ System as a possible solution to the recovery of the COVID-19 infected virus patients. Preliminary data in our laboratory demonstrated that the Cold Plasma HERO system was able to kill Lung cancer cells via a ventilator simulated setting. Our team have demonstrated that our Canady Helios Cold Plasma for Solid tumors can eradicate tumors in human cancer cells while preserving healthy biological tissue.”

About JCRI-ABTS

JCRI-ABTS is a Biosafety Level 2 translational molecular research laboratory. The Canady HeliosTM Cold Plasma HEROTM System was recently developed by Jerome Canady, M.D. CEO, Chief Science Officer and his team, Taisen Zhuang, PhD. Vice President of Research and Development, Xiaoqian Cheng, PhD, Director of Plasma Research, Saravana Murthy, PhD Director of Plasma Immunotherapy and consultant anesthesiologist Jerome McQueen, M.D.

About US Medical Innovations

US Medical Innovations, LLC (USMI) is a private U.S. biomedical device company and wholly-owned subsidiary of US Patent Innovations, LLC. USMI’s focus is developing advanced innovative affordable plasma and robotic electrosurgical devices and striving to develop innovative devices in the field of plasma technology for the eradication of cancer.

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

Contacts

US Medical Innovations, LLC
Kenniah Chestnut, Esq. VP Corporate Affairs
301-270-0147
KChestnut@usmedinnov.com
www.usmedinnovations.com

Contacts

US Medical Innovations, LLC
Kenniah Chestnut, Esq. VP Corporate Affairs
301-270-0147
KChestnut@usmedinnov.com
www.usmedinnovations.com