‘DENEX’, a renal-denervating device for the treatment of difficult cases of hypertension by ‘Handok-Kalos Medical’, acquires CE qualification

– DENEX is a renal-denervating device for the treatment of difficult cases of hypertension, uncontrolled by medication
– This qualification not only confirms the international level quality of DENEX but also provides platform for future exports

Handok (Chairman Youngjin Kim)’s R&D subsidiary, Handok-Kalos Medical (CEO Euljoon Park) specializing in medical devices receives ‘CE qualification’ for their medical device. ‘DENEX™’ allows treatment of refractory hypertension uncontrolled by medication.

After receiving ‘ISO 13485’ certification in March last year which is an is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry, the current acquisition of ‘CE mark’ granted by MDD (Medical Devices Directive) of EU testifies the international level standard of DENEX and furthermore, will be an important stepping stone for Handok-Kalos Medical’s entrance into the worldwide market.

DENEX, currently under development by Handok-Kalos Medical, is an innovative medical device which enables treatment of refractory hypertension uncontrolled by medication. Refractory hypertension is characterized by systolic blood pressure of more than 140mmHg/ 90mmHg despite treatment with more than three anti-hypertensives of different class, including a diuretic. Out of the total hypertension patients, 5~10% of patients are deem to be experiencing refractory hypertension. ‘DENEX’ is a new generation medical device which offers convenience, efficacy and safety to its users. DENEX’s catheter design yielded 3 patent cases and it is also ready to be exported to overseas markets.

The demonstration version of ‘DENEX’ has been developed with support from the Industrial technology institute and Handok-Kalos Medical is conducting the early phase clinical trials in a number of sites in Korea. Also, the upgraded version (DENEX II) is being developed in partnership with A*STAR, a Singaporean national research and development institutes through a joint international research support scheme by Korea Health Industry Development Institute and Ministry of Health and Welfare. In near future, Handok-Kalos Medical will launch ‘DENEX’ in Korea and Europe, following the completion of clinical trials required for both countries. ‘DENEX’ will hopefully land smoothly in Korean market, with help of the mother company Handok which has abundant experience in the cardiovascular field, and subsequently pursued to be licensed out to overseas markets such as Europe and China.

Since 2012, Handok has been developing ‘DENEX’. In 2015, Handok-Kalos Medical, the R&D subsidiary company specializing in medical devices was launched to accelerate global development of DENEX. Handok-Kalos Medical has been established with help of 10 billion won investment by ‘Korea Investment Global Pharmaceutical Company Development Fund’, founded by Korea Investment Partners. Currently, Handok holds 51% of its stock share and 41% is held by Korea Investment Partners.

‘CE mark’ is a safety related certification which was introduced at the unification of EU market in 1993. The intention for its development was to remove technical boundaries within the union. It is applied in 27 countries in Europe and is a compulsory requirement for distribution and sales of medical devices within the EU. On the other hand, ‘ISO13485’ is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry and services relevant to medical devices.