FDA approves Lansing firm’s product to disinfect N95 respirators

LANSING, N.Y. — NovaSterilis, a nearly two-decade old Ithaca–area company, says health-care workers can use one of its products to decontaminate “select” N95 respirators used as personal protective equipment (PPE) during the COVID-19 pandemic. 

The firm on Sept. 1 announced the emergency-use authorization by the U.S. Food & Drug Administration to use its Nova2200 system to disinfect the PPE.

The Nova2200 platform runs the NovaClean process, which decontaminates N95 respirators for single-user reuse based on the “proven science of supercritical carbon dioxide (scCO2),” as described in a NovaSterilis news release. 

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.”

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.

Working with several partners, 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 “rapid research” to demonstrate the effectiveness of the Nova2200 in the fight against SARS-CoV-2 was made possible by several collaborators, the firm said.

The partners included Cayuga Health Systems, which supplied respirators after NovaSterilis completed proof-of-concept testing, in addition to guidance and access to equipment that was used to determine the performance of N95 respirators in the workplace and shorten central sterile processing turnaround time.

In addition, Buffalo–based ZeptoMetrix Corporation tested the efficacy of the Nova2200 on viral samples, including SARS-CoV-2, in an “urgent manner” within its biosafety level 3 laboratory. The work helped prove that NovaSterilis’ technology “was effective” against the novel coronavirus.

The firm also worked with Cornell University, which supplied respirators and completed a preliminary coronavirus model study. It also collaborated with iFyber, LLC of Ithaca, a contract research organization. It led the regulatory-submission process, designed the necessary microbiology and material-compatibility testing, and performed sample preparation and decontamination testing.

NovaSterilis operates at 3109 N. Triphammer Road in Lansing. The firm employs six people, Eisenhut tells CNYBJ.

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.