USMI and JCRI-ABTS Receive FDA Approval to Conduct the First U.S. Clinical Trial Using Cold Atmospheric Plasma for the Treatment of Cancer

On July 31, 2019 US Medical Innovations, LLC (USMI), a Biomedical and Life Science subsidiary of US Patent Innovations, LLC and the Jerome Canady Research Institute for Advanced Biological and Technological Sciences (JCRI-ABTS), LLC reported that the U.S. Food and Drug Administration (FDA) has approved the first clinical trial in the U.S. to evaluate Cold Atmospheric Plasma (CAP) Technology for the treatment of cancer (Press release, US Medical Innovations, JUL 31, 2019, View Source [SID1234537963]).

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USMI is the first company in the world to integrate a high frequency electrosurgical generator and plasma gas to deliver a Cold Atmospheric Plasma (Plasma Helium Beam) for the selective treatment of cancer US Patent #9,999,462 June 19, 2019 (Integrated Cold Plasma and High Frequency Plasma Electrosurgical System and Method). This novel non-thermal process has been developed for treating solid cancerous tumors. JCRI-ABTS and several plasma laboratories around the world have reported that CAP can trigger chemical and molecular changes in the cancerous cells that cause significant stress and drastically decrease the cancer cell’s viability and death. Canady Helios Cold Plasma System (CHCPS) has a selective action only on tumor cells and not healthy normal cells. CHCPS technology demonstrates a temperature equal or less than 30°C (85°F) and cause no thermal injury to normal tissue.

The Canady Helios Cold Plasma System and Canady Plasma Cold Plasma Ablator were developed by Jerome Canady, M.D. CEO, Chief Science Officer and the scientists at the Jerome Canady Research Institute for Advanced Biological and Technological Sciences (JCRI/ABTS), USMI’s engineering team led by Taisen Zhuang, PhD VP Research & Development; Michael Keidar PhD, Professor School of Engineering and Applied Sciences, Director of Micropropulsion and Nanotechnology lab at The George Washington University (GWU); and Alex Shashurin, PhD, Assistant Professor School of Aeronautics and Astronautics at Purdue University.

Dr. Canady explained, "After the surgeon removes the cancerous tumor during surgery, CAP is subsequently sprayed at the surgical margins to target any remaining cancerous tissue or cells for 2 to 7 minutes, thus reducing the chances of cancer recurrence. We see our CAP treatment as an important adjunct to the current treatment protocols for solid cancerous tumors. The FDA has given approval for 20 patients and we plan to start the program in August 2019."

The JCRI-ABTS Translational Molecular Center has developed a robust research program targeting Breast, Ovarian, Lung, Renal Cell, Sarcoma, Prostrate, Melanoma and Gastrointestinal solid tumors.