TAKOMA PARK, Md., April 16, 2015 /PRNewswire/ -- A surgical team coordinated by the US Medical Innovations, LLC (USMI) family of companies, completed the world's first clinical procedure using cold plasma for the selective killing of cancerous tissue at Baton Rouge General Medical Center in Baton Rouge, LA This groundbreaking surgery was performed on a patient who had previously been diagnosed with inoperable Stage 4 Colon Cancer, through a one-time pre-market Compassionate Use exemption from the Food and Drug Administration. The new cold plasma device has not yet been cleared by the Food and Drug Administration for general commercial use or marketing. The company plans to submit an application for such authorization during the coming months.
The surgery was the first of its kind in the world, utilizing USMI's Canady Helios™ Cold Plasma Scalpel, a new technology that specifically targets cancer cells while sparing normal cells and tissue. The Canady Helios™ Cold Plasma Scalpel is a cold atmospheric plasma device used to eradicate microscopic remnants of the cancer, which is used in conjunction with the Canady Hybrid Plasma™ Scalpel, a device approved and in use since 2011.
USMI CEO, Chief Science Officer and surgeon, Jerome Canady, M.D., designed the clinical and treatment protocols, and guided the surgical team through the procedure. A multidisciplinary group of healthcare professionals, physicians, engineers and scientists collaborated over a 12-month period leading up to the procedure. Extensive treatment plans were implemented including preoperative chemo and radiation therapies to cytoreduce (shrink) the tumor. CT scans were utilized to develop the 3D computer guided imagery to map out the surgical procedures for the patient, who was initially diagnosed as surgically inoperable.
Stephen V. Gordon, M.D., of Baton Rouge General Medical Center, completed the surgical procedure under the watch of Dr. Canady while using this new potentially life-saving medical technology. The guidance of several top Consulting Scientists to the USMI family of companies was leveraged in this work as well, including input from Dr. Michael Keidar, the co-inventor of the technology, who is also a Professor in the Department of Mechanical and Aerospace Engineering at The George Washington University.
"For years we've worked tirelessly in a global race-against-time to leverage innovative plasma technologies in the pursuit of the cure for cancer. As other research teams based in Germany, Japan, Korea and elsewhere continue to pursue this research in the lab, we are proud to be the first to utilize cold plasma technology in a surgical device within a clinical setting to prolong the life of this remarkable patient," commented Dr. Canady.
The procedure was cleared by the Food and Drug Administration as an emergency measure, after receipt of the application and request from US biomedical device manufacturing company, Canady Biotechnology, LLC (CB), manufacturer of the USMI surgical product line. The devices used in the procedure were designed by CB's sister company Plasma Medicine Life Sciences, LLC, while the translational and molecular protocols were developed by the Jerome Canady Research Institute for Advanced Biological and Technological Sciences, Benefit LLC, a research organization also within the USMI family of companies. As the new device has not yet been cleared by the FDA for commercial use or marketing, the USMI family of companies will coordinate on the submission of an application for such authorization during the coming months.
About US Medical Innovations
US Medical Innovations, LLC (USMI), an innovate leader in the field of plasma technology for the eradication of cancer, is a private FDA registered U.S. biomedical device specification manufacturing company founded by surgeon and inventor, Dr. Jerome Canady. USMI's focus is developing advanced, innovative and affordable plasma electrosurgical devices. The company's products are designed for ambulatory and inpatient endoscopy centers as well as complex surgical procedures.
About the Canady Hybrid Plasma™ Scalpel
The Canady Hybrid Plasma™ Scalpel is the first multifunctional electrosurgical scalpel in the world allowing a surgeon to simultaneously cut and coagulate through biological tissue at a temperature of less than 98 degrees F, significantly reducing intraoperative blood loss and operative time, improving wound healing, minimizing the length of stay for the patient, and reducing the risk of hospital acquired infections.
SOURCE US Medical Innovations, LLC