US Medical Innovations Submits IPO Prospectus for FDA-Approved Canady Helios Cold Plasma Scalpel in Oncology

On August 20, 2019, VCBeat (WeChat ID: vcbeat) learned from foreign media reports that Alexey Shashurin, an engineer at the School of Aeronautics and Astronautics of Purdue University in the United States, assisted in the development of the Canady Helios Cold Plasma Scalpel System, which has been approved by the U.S. Food and Drug Administration (FDA) for clinical trials. Currently, this system is the only method available for eliminating microscopic residual cancer tumors during surgery.

For solid tumor cancers (such as breast cancer and lung cancer), standard treatments include chemotherapy, radiation therapy, surgery, or other methods. When these tumors are not completely resected, they may lead to cancer recurrence. For example, approximately 20%–40% of women undergoing mastectomy in the United States each year require reoperation due to incomplete tumor removal by the surgeon.

A multi-institutional team, including Alexey Shashurin, an engineer at Purdue University’s School of Aeronautics and Astronautics in the United States, has developed a pen-like electrosurgical scalpel. This device, known as the Canady Helios Cold Plasma Scalpel, consists of a cold plasma generator connected to a pen-shaped electrosurgical instrument that emits blue cold plasma from its tip. The entire ablation process lasts 2–7 minutes. The device targets tumors exclusively, without damaging healthy cells.

US Medical Innovations, LLC (USMI) and the Jerome Canady Research Institute for Advanced Biological and Technological Sciences (JCRI/ABTS) are leading the team and sponsoring this clinical trial, with patient enrollment scheduled to begin this September. In 2014, USMI developed and filed a patent application for the first high-frequency electrosurgical generator incorporating cold plasma technology for cancer treatment.

The FDA has now approved the device for a Phase I clinical trial involving 20 patients. Cold atmospheric plasma may not necessarily replace existing cancer treatments, but it can join the arsenal to eliminate residual cells that other technologies might miss. If these cancer cells are overlooked, they often return with a vengeance.

In addition to developing cold plasma solutions for cancer treatment technologies, Shashurin’s laboratory also conducts research on various topics in experimental plasma science. These include the generation and diagnostics of micro-scale cold atmospheric pressure plasmas, sterilization using cold plasma, laser-induced plasma for combustion applications, propulsion systems for spacecraft, and control of plasma discharges.

“Plasma is highly reactive and can induce a variety of responses in the cells of biological tissues. However, because plasmas are typically very hot gases, efforts over the past two decades have focused on generating and testing cold plasma for biomedical applications,” said Alexey Shashurin, an engineer in the School of Aeronautics and Astronautics at Purdue University.

(Compiled by Cheng Tao)