CG Bio wins Korean approval for portable negative-pressure wound therapy device CuraSYS ME

[Financial News] CG Bio has expanded its wound care product lineup with the launch in South Korea of a portable, disposable negative-pressure wound therapy device. The strategy is to meet demand for wound care after discharge by offering a product that can be used at home as well as in hospitals.
CG Bio said on the 3rd that its portable, disposable negative-pressure wound therapy system, CuraSYS ME, received Korean product approval from the Ministry of Food and Drug Safety on September 22.
Negative-pressure wound therapy (NPWT) applies a controlled negative pressure to a wound to draw out exudate and help it heal. CuraSYS ME consists of a powered medical suction pump and a foam wound dressing. It can be used to manage closed surgical incisions, chronic, acute and traumatic wounds, partial-thickness burns, diabetic ulcers and pressure ulcers.
The product is a disposable model made by miniaturizing the existing stationary device. Small enough to fit in a pocket, it is designed for portability and applies the same negative pressure as the existing CuraSYS: -125 mmHg. It runs for up to 10 days after use begins and then shuts off automatically. The wound dressing has a four-layer hybrid structure that combines foam that contracts under negative pressure with exudate absorption and evaporation functions.
With this approval, CG Bio now has a lineup ranging from stationary products used in hospitals to portable, disposable products. Products can be selected according to a patient's wound condition, stage of treatment and living environment, and, based on a healthcare professional's judgment, negative-pressure therapy can continue at home after discharge.
CG Bio has supplied its CuraSYS negative-pressure wound therapy system in South Korea since 2010. Its existing stationary product, CuraSYS 2 Dual Channel, is also available in overseas markets including Thailand, the Philippines, Vietnam and China.
Yoo Hyun-seung, CEO of CG Bio, said, “We will expand our lineup from stationary models to portable, disposable products to offer options suited to patients' treatment environments.”

[email protected] Jung Sang-hee Reporter