‘Handok Kalos Medical’ celebrates the development of ‘DENEX^TM’
, a medical device to treat refractory hypertension

-Recently received approval by Ministry of Food and Drug Safety to conduct
an early phase clinical trial on patients suffering from refractory
hypertension

-Selected as a Health technology research and development project as well,
receiving fund of a total of 900 million won for the development of DENEX

A medical appliance R&D subsidiary company of Handok,
Handok Kalos Medical’s DENEX^TM’ , a medical device to treat refractory
hypertension, is celebrating showing of green lights in its development. Handok Kalos
Medical recently received approval by Ministry of Food and Drug Safety on their
plan to conduct an early phase clinical trial. Also, the development of ‘DENEX^TM’ (hereafter ‘DENEX’) has been selected as a Health
technology research and development project by Ministry of Health and Welfare as
well, which entitles the company to the fund of a total of 900 million won from
Korea Health Industry Development Institute over the course of next three
years.

An early
phase clinical trial of ‘DENEX’ to be conducted in 3 major hospitals

‘DENEX’, which recently received approval by Ministry of
Food and Drug Safety to conduct an early phase human clinical trial, 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 despite treatment with more than
three antihypertensives. Out of the total hypertension patients, 12~15% of
patients are deem to be experiencing refractory hypertension. Early phase
clinical trials for ‘DENEX’ will take place from June at Severance hospital,
Seoul National University Hospital and Seoul St. Mary’s hospital on
hypertensive patients whose blood pressure is uncontrolled on standard drug
therapy.

Research
funding accelerates ‘DENEX’ development

On top of the approval for the early clinical trial,
research fund grant had also contributed to the commercialization of ‘DENEX’. Handok-Kalos
Medical announced on 1^st of April that development of ‘DENEX’ has
been selected as a Health technology research and development project, where a
research fund of 900 million won will be granted from Korea Health Industry
Development Institute over the course of the next three years. Currently,
demonstration version of ‘DENEX’ has been developed with support from the
Industrial technology institute. 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.
Expansion of indications, such as usage in other cardiovascular conditions will
also be worked on.

President Euljoon Park of Handok Kalos Medical had
mentioned that “good news of early clinical trial approval and research fund
grant really accelerated the development of ‘DENEX’. We will endeavor to
commercialize the product so patients who suffer from refractory hypertension
could receive better treatment and enjoy healthier lives”.