AGE Reader mu receives market approval in South Korea.
Groningen, the Netherlands – February 27, 2018
The AGE Reader mu has received medical device approval from the Korean Ministry of Food and Drug Safety (MFDS). This allows the Korean AGE Reader distributor, DiosPharma, to market the AGE Reader mu as a medical device.
Korean healthcare professionals are now allowed to use the AGE Reader mu in clinical practice. Immediately upon receiving the official regulatory approval DiosPharma successfully started the market introduction. Tim Souk, CEO of DiosPharma: “Recently, the Korean market is interested in AGE parameter from the media and the doctors. I am very excited and pleased to have registered the AGE Reader mu device at the right time. We have successfully held the first seminar in September in 2017 with the goal of selling more than 300 units in 2018.”
After receiving regulatory approval in China and Japan earlier, this approval in Korea is another milestone in the business development in Asia for Diagnoptics. Bart van den Berg, CEO of Diagnoptics, is confident that DiosPharma will be successful in marketing the AGE Reader: “Already from the first contact DiosPharma showed to be a professional and dedicated partner. By creating awareness about AGEs and obtaining this regulatory approval DiosPharma created a strong basis to build a promising business. This has immediately been confirmed by a first substantial order and more expected to come”.
The AGE Reader yields a real time and non-invasive assessment of cardiovascular risk in 12 seconds. The method is convenient, easy to use and validated. The AGE Reader measures tissue accumulation of Advanced Glycation Endproducts (AGEs) by means of fluorescence techniques (skin autofluorescence). AGEs play a key role in the pathogenesis of many age-related diseases, such as diabetes, cardiovascular disease and renal failure.
Diagnoptics was the first company worldwide to introduce a technology to non-invasively measure the tissue accumulation of AGEs by means of fluorescence techniques (AGE Reader). The AGE Reader has been used in clinical practice and research since 2006. Since the introduction of the AGE Reader over 200 peer reviewed scientific papers have been published.
Established in 2003, Diagnoptics is the pioneer and inventor of cutting edge diagnostic devices that can non-invasively diagnose and assess the risk of diabetes and its complications. Its technological advance in detecting fluorescence of Advanced Glycation Endproducts (AGEs) has led to the invention of the AGE Reader – a state of art diagnostic device that can non-invasively determine the tissue accumulation of AGEs. Since the CE certification on the first AGE Reader in 2006, Diagnoptics has been marketing this medical device to thousands of clinics around the world. Currently the company is working on obtaining additional regulatory approvals in other regions and is engaged in new product development activities. The head office of Diagnoptics Technologies BV is in Groningen, the Netherlands.
About AGE Reader
The AGE Reader provides an immediate cardiovascular risk prediction for major chronic diseases, such as diabetes, cardiovascular disease and renal failure. The method is convenient, easy to use and validated. The AGE Reader measures tissue accumulation of Advanced Glycation Endproducts (AGEs) by means of fluorescence techniques (skin autofluorescence). AGEs play a key role in the pathogenesis of many age-related diseases, such as diabetes, cardiovascular disease and renal failure. Since the market introduction in 2006, the AGE Reader has been clinical validated extensively in over 200 peer reviewed scientific publications.
AGEs are essential biomarkers of metabolic and glycemic stress and have been implicated as causative factors in the progression of a host of age-related diseases, such as atherosclerosis, diabetes, renal failure and Alzheimer. The level of AGEs in tissue reflects the glycometabolic memory and is a valuable predictor of (pre)diabetes and cardiovascular complications.
Bart van den Berg
Diagnoptics Technologies B.V.
9723 JJ Groningen
tel: +31 (0)50 5890612