AdipoLABs, high-frequency hyperthermia cancer treatment device with a REMISSION 1℃, receives European certification and Malaysian MDA approval

 We expect that cancer treatment device developed with our own technology will make a significant contribution to exports from now on.

On December 17th, despite of the difficulty to travel abroad due to COVID-19, the company, AdipoLABs was successful in obtaining the approval from the Ministry of Health Malaysia regarding hyperthermia cancer treatment device, REMISSION 1℃. Procedure was rigorous over the course of two years but the company stayed persistent finally receiving MDA approval in the Hyperthermia category. Malaysian MDA, which stands for Medical Device Authority, is a domestic approval issued by the Malaysian Ministry of Health for medical devices.

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 by the Ministry to ensure verification and safety. Moreover, since MDA approval itself is mutually recognized among ASEAN countries, the ripple effect of MDA certification itself can be said to be grave.

AdipoLABs' high-frequency hyperthermia cancer treatment device REMISSION 1℃ has been targeting the Malaysian market since October 2018. To this end, the company has been preparing for CE certification which is a European certification, since the second half of 2018. As a result, AdipoLABs has obtained European CE certification in August of this year. Accordingly, in Malaysian market, the process of preparing for existing approval and clinical trials, was naturally accelerated in its certification process and consequently resulted into a good news of MDA certification.

In the future, it is very much expected that the demand for REMISSION 1℃ and its hyperthermia treatment will increase not only in hospitals and clinics in Malaysia but also in various cancer centers. The University of Malaya Medical Centre, a local quasi-governmental institution, has been conducting clinical trials on cancer patients since 2020, and Beacon Hospital Sdn Bhd, one of the largest hospitals in Malaysia, has also been conducting clinical trials on terminal cancer patients. REMISSION 1°C is being used for patients.

Additionally, AdipoLABs is working hard to deliver hope to cancer patients in Malaysia. In partnership with a company that sells oxygenated water in Malaysia (BubblesO2), AdipoLABs is planning to jointly use REMISSION 1℃ and oxygenated water within medical centers (Medical SPA & Wellness Centre's) for the purpose of cancer treatment for general cancer patients starting in March. A contract had been signed.

REMISSION 1°C, a high-frequency hyperthermia device, 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 RoHS certification in 2018. REMISSION 1°C is a medical device.

REMISSION 1°C, which is used in about 80 medical institutions across the country, was introduced to the Catholic University of Korea's Seoul St. Mary's Hospital in January 2019 and has been used on patients, showing many clinical effects. It is a proven medical device that is receiving tremendous attention from the medical community.

REMISSION 1℃ is a medical device that treats cancer and relieves pain by increasing our body temperature above 40℃, improving blood circulation and immunity through deep heat. The device stole the limelight from the domestic and foreign medical officials at the 'Middle East & Asia Business Expo' held in October 2018 and '35th International Medical Equipment and Hospital Equipment Exhibition (KIMES 2019)' held in March 2019.

Despite the economic difficulties at home and abroad due to the COVID-19 pandemic in 2020, REMISSION 1℃ is drawing more attention globally and receiving more favorable reviews overseas. In the upcoming new year of 2021, it is easily expected that the cancer treatment device developed with our own technology will make a clear contribution to exports with the end of COVID-19. Sung-ho Han, CEO of AdipoLABs, said, “The progress made so far to export REMISSION 1℃ is becoming visible one by one, and we are preparing for the new year with our executives and employees with the mission of taking responsibility for the health of all global citizens.”

Source: AdipoLABs, high-frequency hyperthermia cancer treatment device REMISSION 1℃, European certification and Malaysian MDA approval < NEWS & EVENT < Text of article - Monthly CEO& (ceopartners.co.kr)