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[Press release] Kalos Medical Receives Korean MFDS Innovative Medical Device Designation for DENEX Hypertension Treatment System
SEOUL, KOREA, June 27, 2023 (GLOBE NEWSWIRE) – Kalos Medical Inc. (“Kalos”), a developer of innovative medical devices treating hypertension and other chronic illnesses, announced on June 23rd that South Korea’s Ministry of Food and Drug Safety (“MFDS”) designated the company’s DENEX hypertension treatment system as an Innovative Medical Device, a designation that recognizes medical devices that have or are expected to significantly improve safety and efficacy compared to existing medical devices and treatments.
The DENEX system is an innovative medical device that treats hypertension using minimally invasive renal denervation technology. Electrodes are inserted into the renal artery through a thin catheter tube to sympathetic nerve locations in the kidneys. The device then uses radiofrequency energy applied to the arterial wall to inactivate portions of the sympathetic nerves, which has been demonstrated to lower blood pressure. Unlike laparoscopic surgery, the DENEX system procedure is short and safe, without the negative side effects associated with general anesthesia.
Similar to the U.S. Food and Drug Administration Breakthrough Device designation, the Innovative Medical Device designation is MFDS’s formal recognition of high-value medical devices that have the potential to provide more effective treatment of serious medical conditions than the current standard of care. The MFDS, in consultation with South Korea’s Ministry of Health and Welfare and other related ministries, selects medical devices for the designation, which grants special benefits such as priority MFDS review and expedited patient access.
Peter Chang, CEO of Kalos Medical, remarked, "We are delighted to have received the Innovative Medical Device designation and, with it, the recognition that the DENEX renal denervation systems is an innovative, high technology solution, with improved safety and efficacy compared to existing hypertension treatments."
About Kalos Medical
Kalos Medical is the developer of innovative and minimally invasive medical devices using proprietary catheter-based technology. Kalos Medical has developed DENEXTM, a medical device for the treatment of hypertension for renal denervation, the device includes three electrodes that are introduced into the rental artery through a catheter and deliver radio frequency energy to the arterial wall, thereby deactivating the renal nerves, the effect of which is the reduction of hypertension. Currently, Kalos Medical is conducting clinical trials in Korea and Europe.
For more information, visit www.kalosmedical.com.
CONTACT: Min, SeungKi, VP of Business Development, Kalos Medical (SeungKi.Min@kalosmedical.com)