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BioPlus Co., Ltd. Graft/Prosthesis Biomaterial for Joints Approved by the Ministry of Food and Drug Safety (MFDS)

By 2021년 February 1일February 10th, 2021No Comments

On February 26th, BioPlus BPAC-101, a graft/prosthesis biomaterial for joints was officially approved by the Ministry of Food and Drug Safety (MFDS).

This product, which will be put on the market named as <SynoFil>, is a Class 4 medical device that is the highest class of medical devices. It is a product that reduces the discomfort and aftereffects of patients after arthroscopic surgery, and it can be used on both knee and shoulder joints. The purpose of this product is to remove external contaminants such as physiological saline used on the human body during arthroscopic surgery and temporarily replace lost synovial fluid, thereby reducing mechanical friction around joints.

Hyaluronic acid, a biomaterial with good viscoelasticity (viscosity + elasticity), is essential in joints for lubrication and cushioning because they have to carry out rotational movements such as shoulders and wrists, or refractive movements such as knees and ankles and hold weight. BioPlus Co., Ltd. has firmly established its position as a biomaterial company by releasing its anti-wrinkle filler and anti-adhesion agent with its own MDM technology in the world. BioPlus has developed <SinoFil> by applying the technology where we have specialized in biomaterials for nearly 18 years, and this product was finally approved by the Ministry of Food and Drug Safety (MFDS).

The demand for this product is increasing every year because of the rising sports activity population and the elderly population. Since <SynoFil> for export is already known in the global market, the exports are being expanded to Europe and other territories, starting from Latin America. In the domestic market, the sales and consignment negotiations with 6~7 pharmaceutical companies is underway as of the end of January, and the sale will begin in earnest when the insurance fee is determined.

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