Nexera to submit amended claims for FDA 510(k) clearance of SpectraShield 9500 Surgical N95 Respirator

Sep 8 2011

Nexera Medical, Inc. ("Nexera"), today announced plans to submit to the U.S. Food and Drug Administration (FDA) amended antimicrobial claims for its current 510(k) clearance for the SpectraShield™ 9500 Surgical N95 Respirator with embedded antimicrobial technology. The expanded antimicrobial claims will be supported by test data on the inactivation performance of certain strains of viruses. These tests will be performed at independent laboratories utilizing viral protocols recognized by the FDA on strains of viruses that cause various types of influenzas and colds. The strains of viruses that are planned to be tested are viruses considered public health issues, including the H1N1 (Swine Flu) Virus, H5N1 (Bird Flu) Virus, Rhino Virus (common cold), and SARS (Severe Acute Respiratory Syndrome).

“People have very little protection in the event of a healthcare crisis involving airborne pathogens, and our SpectraShield™ Mask can provide a person with the highest degree of protection.”

These tests are essentially similar to those tests that have already been conducted by Nexera in the European Union where the SpectraShield™ surgical respirator mask demonstrated its ability to kill these strains of viruses. The SpectraShield™ mask was certified in March 2009 in the European Union as an antimicrobial FFP3 respirator mask and has been issued a CE Mark by INSPEC, the applicable jurisdictional agency to certify Class II Medical Devices in the European Union. Nexera has already received 510(k) clearance from the FDA for the SpectraShield™ Mask as an N95 Antibacterial Surgical Respirator, which kills certain bacteria within one hour up to 99.99 percent, including MRSA (Staph infections, or Methicillin Resistant Staphylococcus Aureus), Streptococcus Pyogenes, and Haemophilus Influenzae.

The planned 510(k) amended filing is based on the positive findings from Nexera's viral testing performance in the European Union that indicated substantial inactivation of these mentioned viruses.

Nexera's president, Paul Sallarulo stated, "We are pleased to announce our plans to amend the claims for the SpectraShield™ Mask in our amended 510(k) filing, and that we are continuing down this regulatory pathway to clear the best antimicrobial technology and the best respiratory protection for people." He added, "People have very little protection in the event of a healthcare crisis involving airborne pathogens, and our SpectraShield™ Mask can provide a person with the highest degree of protection."

The SpectraShield Mask is designed to capture harmful germs and kill them when they are on the surface of the mask. The mask also traps and kills any additional germs in the middle filtration layers to prevent them from entering the body and causing an infection. The SpectraShield Mask utilizes a revolutionary antimicrobial technology called Fosshield^®, made in the USA by Foss Manufacturing. This antimicrobial technology is currently in use in many industries from hospitality, to healthcare, to apparel.

Nexera plans to roll out a portfolio of other textile-based healthcare products made from Fosshield^® technology, including other types of surgical and dental masks, mattress pads and covers, warming blankets, hospital uniforms, lab coats, wound care products, and hospital divider curtains to name a few. All of these solutions are designed to assist hospitals in controlling or reducing "hospital acquired infections." This revolutionary Fosshield^® fiber technology is ideally suited for infectious disease prevention, thereby assists in reducing the spread of infectious diseases in any environment.