Development of Products Without Ostomy Bags
Collaboration to Obtain FDA Approval
[Asia Economy Yeongnam Reporting Headquarters Reporter Koo Dae-sun] K-Medi Hub (Daegu-Gyeongbuk Advanced Medical Industry Promotion Foundation, Chairman Yang Jin-young) signed a business agreement on the 17th with JSR Medical Co., Ltd., a medical device development company that aims to replace artificial anus after colorectal cancer surgery, for mutual cooperation including information exchange.
JSR Medical Co., Ltd. is currently developing the world's first artificial intestinal stoma management device to replace the artificial anus, which had to be created by protruding outside the abdomen during colorectal cancer surgery.
Both organizations agreed to closely cooperate to obtain approval from the U.S. FDA for the medical device.
The artificial intestinal stoma management device eliminates the need for secondary stoma restoration surgery and wearing a colostomy bag, which are essential for an artificial anus. If successfully developed, it is expected to change the treatment paradigm and dramatically improve patients' quality of life.
Kim Gilsu, Head of the Preclinical Center at K-MediHub (left in the photo), and Kim Jaehwang, CEO of JSR, are signing a business agreement.
A K-Medi Hub official said, "Currently, conditional approval has been obtained to conduct clinical trials with the U.S. FDA. We are proceeding with the procedures to receive formal approval. We understand that the product has already been approved and is on the market domestically. Obtaining U.S. FDA approval is necessary for export and full-scale sales in the domestic market."
JSR Medical Co., Ltd., headquartered in Seongseo Industrial Complex, Daegu, was established in 2016 by Professor Kim Jae-hwang of Yeungnam University, a colorectal surgery specialist. The company holds world-class technology and domestic and international patents related to minimally invasive colorectal surgery.
K-Medi Hub's Preclinical Center is an institution that conducts evaluations of developed products and research for various domestic and international certifications. It possesses diverse non-clinical evaluation infrastructure and supports companies across the medical industry.
Yang Jin-young, Chairman of K-Medi Hub, said, "We will utilize non-clinical research facilities and human resources infrastructure to help companies obtain U.S. FDA approval and alleviate the suffering of patients struggling with colostomy bags." He added, "Especially, the Future Medical Technology Research Building, a mini pig specialized research facility scheduled to begin construction this year, is expected to be of great help for research on medical devices replacing artificial anus."
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