Somnics Receives GMP Certification from Korean MFDS

Somnics, Inc. announced that the company has passed the GMP approval of the Korean Ministry of Food and Drug Safety (MFDS, formerly known as the Korea Food & Drug Administration or KFDA) overseas inspection in May 2021 and is expected to obtain the product certification of the iNAP® Sleep Therapy System in the third quarter of this year. The company is joining forces with LMT Korea Co. Ltd. to enter the Korean market to benefit Obstructive Sleep Apnea patients in Korea.


According to Somnics, in 2020, the company signed a contract with LMT Korea Co., Ltd, based in Gyeonggi-do to promote the iNAP® Sleep Therapy System and services in Korea after obtaining certification. LMT Korea is one of the leading sleep respiratory diagnostic and treatment equipment providers in South Korea and the exclusive Korea distributor of Lowenstein respirators from Germany. With its comprehensive service coverage and close collaboration with more than 200 medical institutions, LMT holds the largest market share of CPAP devices in Korea. LMT Korea also operates LÖWENSTEIN Academy, the only sleep professional training center in South Korea. Based on similar company missions, that "patients deserve a better OSA treatment experience", LMT Korea and Somnics have joined together in a strategic partnership.


The iNAP® Sleep Therapy System developed by Somnics, Inc. has been marketed and promoted in many countries, including Taiwan, the United States, Germany, Hong Kong, Singapore, Thailand, etc. Korea is also one of the main target markets in Asia. According to the research report of Ansan Hospital of Korea University and Korea Center for Disease Control and Prevention, one out of every five Koreans may suffer from sleep apnea. There isstrong growth potential in sleep apnea treatment services for OSA patients in Korea, and the innovative, safe and effective iNAP® sleep therapy treatment solution offers a promising market potential in Korea.

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