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Ithaca-area firm gets FDA approval to decontaminate N95 respirators used in COVID-19 care

NovaSterilis of Lansing says the U.S. Food & Drug Administration authorized the use of its Nova2200 product to decontaminate “select” N95 respirators that health-care workers use during the COVID-19 pandemic. (Photo credit: NovaSterilis)

The firm also says the technology is “non-toxic,” has a low environmental impact, and has “broad material compatibility.” The process “penetrates deep” within materials, is minimally reactive, and “completely inactivates multiple types” of bacteria, fungi, and viruses, NovaSterilis contends.

“With the onset of the COVID-19 global pandemic, NovaSterilis recognized the potential for the Nova2200 to help address the extreme shortage of PPE for medical personnel by using our process to decontaminate N95 masks,” Tony Eisenhut, president and CEO of NovaSterilis, said. “The NovaClean process effectively kills the coronavirus, and provides added comfort for health-care personnel who receive their own N95 respirators back after decontamination, rather than someone else’s.”

Working with several collaborators, NovaSterilis demonstrated that the NovaClean process “rapidly and completely” inactivates human-coronavirus strains from N95 respirators, including SARS-CoV-2, the virus that causes COVID-19.


The Nova2200 is deployed and operated at the point of use in the hospital setting, resulting in decreased turnaround time, and “increased” respirator availability to health-care personnel, the company contends.

Collaborators included Cornell University, Cayuga Health System, and ZeptoMetrix Corporation of Buffalo. Also, iFyber LLC of Ithaca led the regulatory submission process, designed the necessary microbiology and material compatibility testing, and performed sample preparation and decontamination testing.

NovaSterilis, which employs six people, operates at 3109 N. Triphammer Road in Lansing.


About NovaSterilis

Founded in 2001, NovaSterilis has developed and commercialized medical products based on the application of supercritical carbon dioxide (scCO2) with proprietary additives designed for specific use scenarios. The company’s scCO2 equipment platforms are currently being utilized for a variety of functions, ranging from sterilization of multiple biomaterials products, including allograft tissues used in orthopedic surgeries, to impregnation of bioactives into drug-delivery devices, and to industrial fiber cleaning.



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