Karlos Medical Begins Clinical Trials of Hypertension Treatment Device 'DineX' in Four European Countries

[Asia Economy Reporter Lee Gwan-joo] Carlos Medical, a venture company developing therapeutic medical devices with Handok as the largest shareholder, announced on the 27th that it will begin recruiting patients for exploratory clinical trials of Korea's first hypertension treatment medical device, 'DENEX™,' in four European countries.

The clinical trial will be conducted at 21 institutions in Greece, Germany, Italy, and Poland, recruiting a total of 100 patients by next year. The target patients are adults aged 18 to under 80 who are either not taking antihypertensive drugs or can discontinue their use during the study period. The plan is to compare the group undergoing renal nerve ablation using DENEX with a sham procedure group to collect safety and efficacy data.

DENEX is Korea's first hypertension treatment medical device applying renal nerve ablation. A thin catheter with electrodes is inserted into the renal artery, and radiofrequency energy is used to deactivate the sympathetic nerves of the renal artery to lower blood pressure. Renal sympathetic nerve ablation is safe, has excellent blood pressure-lowering effects, and allows patients to resume daily activities immediately after the procedure. Recently, it has been recognized as an innovative technology that could change the paradigm of hypertension treatment, which has been centered on drug therapy, in the United States and Europe.

Kim Cheol-jun, CEO of Carlos Medical, said, “As recent research papers published in European cardiology journals suggest that renal nerve ablation can be applied not only to essential hypertension but also to various diseases, DENEX could become a new treatment option to improve the quality of life for hypertension patients.”

Carlos Medical was established in 2015 with a 10 billion KRW investment from the ‘Korea Investment Global Pharmaceutical Industry Development Fund’ created by Handok and Korea Investment Partners, with Handok as the largest shareholder. Since 2019, it has raised an additional 18 billion KRW and is developing the DENEX product targeting the global market.