JSR Medical Co., Ltd. (CEO, Dr. Kim Jaehwang), a company specializing in the development of next-generation medical devices, announced Central IRB approval for their U.S. multicenter pivotal clinical trial on August 21.
The IRB-approved product is a stool management device which can replace the need for conventional stoma. The U.S. FDA has approved its IDE in January 2023 and JSR has been preparing for its clinical trial. According to the JSR official, the device not only minimizes postoperative complications and recovery period for colorectal cancer surgery but also eliminates the need for ileostomy bag and secondary stoma reversal surgery which will dramatically improve the patient’s quality of life.
Multiracial patients of ages between 19-80 who need colorectal cancer surgery will participate in the trial with 180 days of monitoring period after operation.
An official from JSR Medical said, “Through this IRB approval, we will accelerate the multicenter pivotal clinical trial with total of 256 patients at 7 hospitals across the United States, starting with the State University of New York at Buffalo Hospital.”
He added, “We are confident that this device will give new hope to the U.S. medical community and patients in the rising colon cancer, IBE and diverticulitis markets in particular, due to the severe obesity rates in the United States.”
JSR Medical also revealed that they are in the process of license-out negotiations with a number of global-level medical device companies at the time of US FDA registration upon completion of this clinical trial.
