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.
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