On January 26, 2023, US FDA approved JSR Medical Co., Ltd. for its multicenter pivotal clinical trial in the U.S.
The FDA announced that JSR Medical’s clinical trial protocol and safety and efficacy data were appropriate, and that it is sufficient to start multicenter pivotal clinical trial in the U.S.
Jaehwang Kim, CEO of JSR Medical, said “This IDE approval was the FDA’s recognition of the safety and effectiveness of our product which is the result of the numerous research and surgical analysis in the past 40 years of colorectal practice.” He also mentioned he would prove the safety and effectiveness of the product through a successful clinical trial, and accelerate the US market entry.
The IDE-approved product is a colorectal cancer surgery device developed by JSR Medical which is considered to be the next-generation medical technology that overcomes the limits of conventional stoma surgery. In accordance with the FDA IDE approval letter, JSR medical will start its multicenter pivotal clinical trial with 256 patients at 5 clinical centers including State University of New York and its affiliated hospitals.
