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AdipoLABs enters the market with high-frequency hyperthermia cancer treatment device ‘REMISSION 1℃’
24-07-11 11:51 353회 0건

AdipoLABs enters the market with high-frequency hyperthermia cancer treatment device ‘REMISSION 1℃’

Obtained Level 3 MDA certificate from Malaysian Ministry of Health... CEO Han Sung-ho “Expanding the market and delivering hope to cancer patients around the world”


Health and Welfare News AdipoLABs Co., Ltd., which has developed the high-frequency hyperthermia cancer treatment device ‘REMISSION 1 and is delivering new hope to cancer patients around the world, has secured a bridgehead for expansion into the Asian market and is launching a full-fledged attack.

 

AdipoLABs Co., Ltd. (CEO Han Sung-ho) recently received a government-approved MDA (Medical Device Authority) certificate of Class C from the Ministry of Health Malaysia for its high-frequency hyperthermia cancer treatment device ' REMISSION 1'. Acquisition was announced.

 

▲ Malaysia MDA certificate.

AdipoLABs, which obtained Class B from the Malaysian Ministry of Health on December 17, 2020, has now obtained a medical device certificate of a higher medical grade.

With a level 3 approval, ‘REMISSION 1°C’ is used for pain relief, inflammation, tissue healing, wound healing, vasodilation, increased immunity, and adjuvant cancer treatment therapy.

 

In the meantime, AdipoLABs has supported domestic and international academic seminars in treating COVID-19 and cancer through IVRA (International Virus Research Association) and obtained numerous clinical results, proving the effectiveness of REMISSION 1℃ to medical professionals and government officials at home and abroad.


▲ 5th IVRA International Conference Malaysia 2023.

In particular, by presenting the cancer treatment results of excellent scholars at home and abroad at the ‘5th IVRA International Conference Malaysia 2023’, the company played a significant role in obtaining MDA approval by passing the rigorous procedures and verification from the Malaysian government.

 

MDA approval from the Malaysian Ministry of Food and Drug Safety is achieved through strict procedures and thorough verification, as in most countries.

 

In particular, equipment imported from overseas must have either international certification, European CE certification, or US FDA certification, and even if there is international certification, every effort is made to ensure verification and safety for imported products.

 

Moreover, since MDA approval itself is mutually recognized among ASEAN countries, the ripple effect of AdipoLABs' level 3 MDA certification will be very large.

 

Adipo LABs' high-frequency hyperthermia cancer treatment device 'REMISSION 1℃' obtained CE certification, a European certification, in August 2020 and received MDA level 2 certification in the same year to obtain MDA approval from Malaysia. In addition, from 2020, Clinical trials have been conducted on cancer patients at the University of Malaya Medical Centre, a government institution, and Beacon Hospital Sdn Bhd, one of the largest hospitals in Malaysia, has also conducted clinical trials on terminal cancer patients. After many years of effort, the device was certified as a cancer treatment device.

 

In addition, receiving recognition from the Malaysian government for a wide range of treatments, including pain relief and immunotherapy, is considered a significant achievement.

 

AdipoLABs predicts that the demand for ‘REMISSION 1℃’ through Hyperthermia (heat therapy device) will increase in the future not only in Malaysian hospitals and clinics but also in cancer centers.


 

▲ CEO Han Sung-ho

Currently, export consultations for 27 units of ‘REMISSION 1℃’ are being held with Malaysian government officials.

9 major hospitals in Malaysia (Kuala Lumpur Hospital, National Cancer Institute Malaysia, Penang Hospital, Sultan Ismail Hospital, Sarawak General Hospital, Sabah Women and Children's Hospital, University Malaya Medical Center (UMMC), Tuanku Muhiris UKM Hospital, Kubang Kerian, Malaysia Consultations for orders are in progress at Science University Hospital, and consultations are flooding in from Malaysia, Thailand, China, and Singapore.

 

CEO Han Sung-ho said, “The achievements so far for exporting REMISSION 1℃ are being visibly achieved one by one,” and added, “With the mission of taking responsibility for the health of all global citizens, we will secure an export bridgehead through Malaysia and enter the ASEAN market by 2024.” “It will be an opportunity to expand, and it will be a year that brings hope to cancer patients suffering from a difficult economy,” he said.

 

Meanwhile, AdipoLABs' high-frequency heater 'REMISSION 1°C' obtained manufacturing permission from the Ministry of Food and Drug Safety in 2015, and received halal certification, US FDA registration, ISO13485 certification, Shariah certification, and certification in 2018 along with RoHS certified professional medical device.

 

In particular, ‘REMISSION 1℃’ is a specialized medical device that treats cancer and relieves pain by increasing our body temperature above 40℃, improving blood circulation and immunity through deep heat.

 

 

link: 아디포랩스 고주파온열암치료기리미션 1 시장 본격 공략:후생신보 (whosaeng.com)