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iNAP® Granted KFDA, Somnics Makes its debut in South Korea

iNAP® Granted KFDA, Somnics Makes its debut in South Korea

Somnics, Inc. announced that the company has received Korea Medical Device Registration and Approval(KFDA)for iNAP® One Sleep Therapy System, and the company joins forces with LMT Korea Co. Ltd., looking forward to launching the product in the second half of 2022. 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 has a high market share of CPAP devices in Korea.

“Demand for Sleep Tech services has increased at a rapid pace. ” said Eric, the Vice President of Somnics. “According to the research of NHIS Korea, the medical expenditure for sleep disorders grows at a rate of 25.2% from 2016 to 2020. Therefore, there is a considerable potential for the market.”

iNAP® is a new, patient-preferred, non-surgical device for the treatment of Obstructive Sleep Apnea (OSA) in adults of all severities-mild, moderate, and severe. With the mobile App and cloud-based platform, users can record the information of efficacy and get the treatment outcome for analysis and adjustment. Hence, users of iNAP do not have to go to hospital for treatment, because the online communication between patients and health professionals has been established, especially during the Covid-19 pandemic.

iNAP® Sleep Therapy System has scored medical device licenses and entered the market in lots of areas, including Taiwan, USA, EU, UK, Australia, Hong Kong, Singapore, Thailand and Malaysia, etc. Somnics expects to expand its business portfolio in the East-Asia area and provide a more convenient and comprehensive sleep care treatment for OSA patients.

About Somnics

Somnics Inc. is a medical device company that focuses on developing innovative technologies for the treatment of Obstructive Sleep Apnea (OSA).

Unlike existing OSA-treatment machine that uses Continuous Positive Airway Pressure (CPAP), our product, iNAP® comes with revolutionary therapy system of applying Negative Pressure to oral cavity, provides a simple, more comfortable, and discreet way that allows patients to breath naturally during OSA treatment.

For more information about Somnics, please visit www.somnics.com.https://money.udn.com/money/story/11799/6351647

了解更多關於iNAP
iNAP產品取得英國UKRP許可 將在英銷售

萊鎂醫iNAP產品取得英國UKRP許可 將在英銷售

萊鎂醫(6633)旗下iNAP負壓睡眠呼吸治療裝置產品海外布局有斬獲,繼美國業務成功拓展後,在英國布局也更進一步。萊鎂醫表示,於農曆年前順利取得UKRP登記以及相關認證,在獲准對應英國進口法規的認證下,即日起可順利在英國銷售,將有助於今年營收表現。

萊鎂醫表示,在去年底對英國訂單出貨後,該經銷商對於未來的銷量看好。但因英國已經脫離歐盟體制,相關的進口法規也需要重新申請以及註冊。在應對新法規的前提下,英國經銷商敦促萊鎂醫取得UKRP登記以及相關認證,以利出貨。

萊鎂醫受惠於公司業務拓展,包括萊析樂™家用快篩試劑出貨與美國子公司推展線上醫療服務等綜合效益,去年12月營收為2,582.1萬元,連續2個月創同期新高,累計年營收1.46億元,年成長1204.3%。

萊鎂醫表示,近一季以來因新興變種病毒肆虐加上季節性因素,新冠居家快篩試劑持續受到關注,萊析樂™核酸快篩的市場需求可望再度提升,再加上iNAP負壓睡眠呼吸治療裝置在歐美各國等海外市場的正面進展,有助後市營運表現。

iNAP產品取得英國UKRP許可 將在英銷售
萊鎂醫(6633)旗下iNAP負壓睡眠呼吸治療裝置產品海外布局有斬獲,繼美國業務成功拓展後,在英國布局也更進一步。

報導原文網址:萊鎂醫iNAP產品取得英國UKRP許可 將在英銷售

萊鎂醫無畏疫情嚴峻 再添英國經銷

在全球疫情緊張的情勢下,許多公司在開發新市場都面臨巨大的挑戰。萊鎂醫(6633)在逆勢中不斷修正戰略,且於12月24日與寶捷新材料(Boshic Advanced Material. Co.,Ltd.)完成了英國銷售代理的合約簽署。並因應英國需求與12月21日正式提前出貨以滿足預購的訂單。

繼2020年與德國順利合作後,萊鎂醫在歐洲大陸的佈局又再增加一個重大的版圖。在英國患有睡眠呼吸中止症年齡30~69歲的人口約為800萬人,佔了該年齡層人口的25%,市場潛在量能相當驚人。

此次經由寶捷委由英國合作的經銷商TMX Electronics Ltd(TMX)建立了iNAP專屬的線上銷售平台(www.mysnoreclinic.co.uk),並結合了英國皇家耳鼻喉科醫院的指標性專業醫師Dr.Vik Veer(Vik)進行推廣。他在他自己YOUTUBE頻道以淺顯易懂的方式對iNAP鉅細靡遺的說明(https://youtu.be/2VF6o1nfaIU)及推薦,引起全球對iNAP這項產品的關注以及訂購需求。

除了在線上銷售,TMX更攜手Vik計畫將產品推進至英國國民醫療服務體系(NHS–National Health Service)。目前已由Vik主導評估進入NHS體系,進入NHS體系後萊鎂醫出貨量可望大幅提升,並創造一個多贏的局面。

萊鎂醫表示,英國市場原本就是公司的戰略要地,非常感謝全體同仁們的努力以及寶捷公司的牽成讓萊鎂醫在2021年底奠定未來強大動能的基礎。

寶捷新材料公司委請在英國合作的經銷商TMX Electronics Ltd(TMX)建立了iNAP專屬的線上銷售平台(www.mysnoreclinic.co.uk)。

報導原文網址:Yahoo!新聞 萊鎂醫無畏疫情嚴峻 再添英國經銷