What was once a device solely used to protect astronauts against harmful particulates and microbes aboard the International Space Station, the PlasmairT2006 is quickly finding its way into a large number of hospitals to maintain patient air quality, courtesy of AirInSpace (Paris).

The company reported receiving FDA clearance for the PlasmairT2006 Mobile unit, a HEPA filter unit that is geared toward reducing the number of airborne bacteria and patient infections.

An $8.5 million Series B round of financing completed in October paved the way for the company’s expansion into the U.S. market and pursuing FDA approval for the device (Medical Device Daily, Oct. 9, 2007 ).

The approval comes nearly five years after the first generation of the device received CE Mark designation, said Wade Tetsuka, president of AirInSpace’s U.S. operations.

“It’s in over 100 hospitals in Europe,” Tetsuka told Medical Device Daily. “What we’re finding is that the medical community is enthusiastic about Plasmair. What we’re also finding is that a hospital will start with just one [Plasmair unit] and evaluate it – and then order more.”

According to the company more than 75% of the hematology wards in the home market of France use the AirInSpace devices.

“During our evaluation of the technology, we were very impressed by the added value delivered,” said Dr. Thierry Chignon, partner in Matignon Technologies, an investor in the company. “One hospital we interviewed had previously closed down one operating room that did not meet the air quality standards. In just a few days, a Plasmair unit was installed, and the operating room could be used again. The alternative for the hospital was to do massive reconstruction of its ventilation system that would have taken many months and cost much more.”

The technology has been used and tested in labs such as the Harvard School of Public Health (Boston) and research/teaching hospitals around the world for its ability to effectively and safely filter and inactivate even the most resistant airborne microorganisms.

Tetsuka said that the mobile unit stands at five feet and is about two feet wide – close to the size of a “mini” refrigerator.

The device works somewhat like other HEPA filter units, but is different because of a negative and positive ionization that occurs within it that captures and deactivates the harmful airborne substances. The ionization removes and takes the threat level away from these substances. Most HEPA filter units just capture the substances and have no safe removal of the particles.

“This sets us apart from the masses of other mobile ‘air cleaner’ products in the hospital market that lack this ‘medical device’ designation, said Laurent Fullana CEO of AirInSpace in a news release. “We have something that hospitals all over the world need and want — a mobile unit that catches and inactivates harmful microbes and is substantially more cost-effective than retrofitting hospital-building HVAC systems or even deploying less-efficient mobile HEPA filter units that are not able to provide any level of germicidal efficacy.”

“AirInSpace technology is one of the most important advances in indoor air treatment for medical purposes in the last 10 years due to its powerful combination of HEPA filtration and germicidal efficacy. Reliance upon conventional HEPA filters that lack germicidal attributes will soon become antiquated,” Eckhard Polzer, a medical technology consultant to AirInSpace said in the release.

The company also wanted to make a quieter HEPA system – highly distinguishable from the earlier noisy incarnations.

“All too often HEPA units would make a lot of noise,” Tetsuka said. “If you’re a patient lying there, you definitely don’t want to hear a loud humming noise. So for us, when we designed this generation of [Plasmair] determining an appropriate noise level was definitely a factor.”

AirInSpace said the device would launch at the upcoming Association for Professionals in Infection Control (APIC; Washington) annual meeting to be held in Denver in June. There also will be a rebranding for the device, which is said to help U.S. hospital sites improve patient and staff awareness concerning infection control.

AirInSpace has adapted its technology for air treatment in healthcare facilities, introducing a new line of products that lowers the levels of airborne pathogens in order to reduce incidences of nosocomial infections. The company said its solutions are “more cost-effective and flexible than traditional air-treatment technologies.”