Plasmapp

Market position

Plasmapp describes itself as a plasma MedTech company focused on medical device innovation. It was selected as a Unicorn Company Candidate by Korea's Ministry of SMEs and Startups in 2020 and has been designated a "Soon-to-be Unicorn" by the South Korean government. It has received multiple Korean government recognitions, including K-Global 300 selection, a New Excellent Product designation for STERPACK, and inclusion among the 100 Best National R&D Projects.

The company states that its STERLINK system was the first small-sized plasma sterilizer cleared by the US FDA, and that its Plasma Active implant surface activator was the world's first to obtain CE MDR certification. Its sterilizers are compact tabletop units suitable for point-of-care and smaller clinics, require no ventilation system because steam and oxygen are the only by-products, and operate at low temperature to avoid damaging heat-sensitive instruments. Plasmapp cites 174 patents, approvals across 26 FDAs, and QMS certifications including GMP, ISO 13485 and MDSAP.

Technology

Plasmapp's core technology is low-temperature plasma combined with vaporized hydrogen peroxide for sterilization, delivered in compact tabletop chambers (the STERLINK has a 14-liter chamber). Redundant temperature sensors regulate a roughly 130F chamber and a moisture detection system halts cycles if excessive moisture is present. The same plasma platform is applied to implant surface activation (ACTILINK / Plasma Active) to treat dental implant surfaces, to plasma surgery for root canal treatment, and to industrial plasma equipment used in secondary battery manufacturing lines.

Go-to-market

Plasmapp entered its home Korean market after KFDA approval in 2017 and expanded internationally through CE, Health Canada, JIS and cUL certifications. In the United States it first established itself in the animal health market, selling low-temperature plasma sterilizers since 2021, then used that experience to engineer human health versions that received FDA 510(k) clearances in 2023. It also reaches customers indirectly through ODM agreements with global dental products companies, and sells online and via quote requests through Plasmapp America, with a US distribution relationship with QMed.

Hospitals, dental clinics, ophthalmology and veterinary practices, and other point-of-care settings needing to sterilize heat- and moisture-sensitive instruments, plus dental and orthopedic device companies served through ODM and supply contracts.

Geography

Headquartered in Korea with its head office moved to Daejeon in 2016, Plasmapp operates manufacturing in Daegu, an R&D center in Osan, and a US entity established in January 2022 that trades as Plasmapp America. Its devices are sold in more than 50 countries, with certifications covering Europe (CE-MDD, CE MDR), Canada (Health Canada), Japan (JIS) and the United States (FDA 510(k), cUL). Partnerships and deployments have been reported in Japan and Singapore.

History

Plasmapp was established in 2015 in a KAIST laboratory. In 2016 it moved its head office to Daejeon, built a STERLINK production line, and obtained a medical device manufacturing license along with ISO 9001, ISO 14001, ISO 13485 and GMP certifications. Korean regulatory approval of STERLINK 15sp came in 2017, followed by CE-MDD certification and the start of overseas sales in 2018, a Daegu factory completion in 2018, and cUL certification enabling distribution to US veterinary clinics. In 2019 the company added STERLINK mini approvals, MDSAP and Health Canada certifications, an ODM agreement with Japanese dental company GC, and the 1-Million-Dollar Export Tower. Between 2020 and 2021 it expanded Daegu production toward implant products, was named a Unicorn Company Candidate by the Ministry of SMEs and Startups, and signed supply and ODM contracts for its ACTILINK regenerator/activator line. In January 2022 it set up a US entity, launched ACTILINK-motion at SIDEX in June 2022, and listed on the KOSDAQ market in October 2022 under stock code 405000. US FDA 510(k) clearances for STERLINK mini and STERLINK Plus followed in April and May 2023.