NEXERA MEDICAL, INC. ANNOUNCES THAT IT PLANS TO SUBMIT NEW DATA TO THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) TO AMEND ITS CURRENT 510K MEDICAL DEVICE CLEARANCE TO INCLUDE CERTAIN STRAINS OF VIRUSES
FORT LAUDERDALE, Florida (September 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).
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 Personal Protective Device ("PPD") 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.
Nexera Medical Inc. is headquartered in Fort Lauderdale, Florida. The company is engaged in the development, manufacturing, and distribution of antimicrobial respirator and surgical masks, as well as other planned antimicrobial textile based medical products such as medical slings, surgical site aprons and hospital linen products worldwide. All of Nexera's products are designed to provide maximum protection against microorganisms such as bacteria, virus and fungus using Fosshield® patented technology. Nexera partners with governments and leaders in the health care industry in the fight against viral pandemic and other health care crises. To learn more, visit www.nexeramed.com.
About Foss Manufacturing:
Fosshield® fabric is manufactured by Foss Manufacturing, LLC (Foss) based in Hampton, New Hampshire. Foss is a well-known leader and pioneer in the use of non-woven fabrics and specialty synthetic fibers in an ever-expanding number of environments and applications. Using new technologies and state-of-the-art computerized production, it is unrivaled in its ability to efficiently and effectively design, manufacture, convert, package, and distribute a vast array of specialty textile products worldwide. Foss is one of the world's largest needle-punch based manufacturers, and it has the expertise and experience to support customers' needs across virtually all applications and markets. To learn more, visit www.fossmfg.com. www.fossmfg.com.