Plasma sterilizer 'STERLINK' gets US FDA certification

Startup Plasmapp (CEO Lim You-bong) developed a small plasma sterilization system and obtained FDA certification.

Plasmapp announced on the 1st that the plasma sterilizer system "STERLINK" has obtained FDA Class II Medical Device certification. The U.S. FDA divides medical device certification into three grades and classifies the higher the number, the higher the technical difficulty.

This is the first time that a non-American company has been certified by the U.S. FDA with its "plasma sterilizer" technology. In particular, small plasma sterilizers that can be used in small and medium-sized hospitals in the U.S. are expected to become the standard for Korean medical devices as there are no FDA-certified cases.

Until now, the sterilizer market has traditionally chosen a high temperature or chemical sterilization method. Each of these methods has limitations that can damage medical devices at high temperatures and cause toxicity due to the nature of chemical sterilizers. For this reason, the medical community paid attention to the method of "low-temperature plasma sterilization" technology.

Plasmapp is called the "fourth substance state" along with solids, liquids, and gases, and can implement sterilization effects. However, as the existing large plasma sterilizer was sterilized for more than an hour, large-capacity manufacturing was inevitable. This is because if it takes a long time, you have to deal with a large amount at once.

▲ It is expected that the plasma sterilizer STERLINK, which has obtained FDA certification, will become the standard for small and medium-sized medical facilities in the United States. Photo = Plasmapp
◇ Securing miniaturization, economic feasibility, and reliability

Plasmapp has overcome the limitations of existing large equipment and can utilize and manage low-temperature sterilization solutions at the level of large hospitals even in small and medium-sized medical facilities through "fast small sterilizers."

If the existing large equipment is 100L, the plasma equipment is 7L and 14L. It was miniaturized, but it even obtained certification while maintaining and increasing reliability.

In particular, it is known that it has the advantage of reducing the amount of sterilizers injected through its own technology, direct injection of sterilizers by more than 10 times. This has the effect of minimizing damage to medical equipment by minimizing the amount of residual sterilizers.

Previously, Plasma STERLINK obtained European certification (CE) in 2018. So far, it has been certified by 15 countries including the United States, Europe, Canada, Australia, Brazil, Japan, Saudi Arabia, and Malaysia.

"The existing large plasma sterilizer takes a long time to sterilize and has a limitation of expensive equipment," CEO Lim You-bong said. "The STERLINK system is the only FDA-approved product that can enter small and medium-sized medical facilities in the United States." "This FDA approval means that it has been recognized not only for its technology but also for the growth potential of Plasmapp that pioneered untapped markets," he said.

Plasmapp, which was born in 2015 at KAIST's physics and plasma laboratory, is a "Deep Tech" startup company based on long scientific research and has applied for 130 patents.

Last year, it was evaluated by the Ministry of SMEs and Startups as a preliminary unicorn (a venture worth 1 trillion won within 10 years of its start-up), and earlier this year, it received an A grade in a special technology evaluation for listing on the Korea Exchange. So far, the cumulative investment has reached about 45 billion won. Recently, it also attracted investment through Pre-IPO.

Meanwhile, Plasmapp announced that it will also target the dental implant market. It is planning to establish plasma technology as a key technology in the implant business.