FDA grants new classification for revolutionary technology, heralding a new era of pandemic protection and infection control
RURAL HALL, N.C.--(BUSINESS WIRE)-- Filligent Limited has received unprecedented FDA clearance for its range of BioFriend™ BioMask™ (Series A) surgical facemasks. Market clearance was granted under a new medical device classification for anti-microbial surgical facemasks, “OUK,” created by the FDA to accommodate Filligent’s innovations in infection control and respiratory protection.
Being awarded the “OUK” medical device classification marks a first for the USA and a first for Filligent. It is also a first for the global healthcare industry, marking a new era in infection control and medical and work-pattern innovations.
“Healthcare workers need protection that works with them, not against them,” says Melissa Mowbray-d’Arbela, CEO of Filligent. “These masks are designed for real-life hard work and the reality of today’s infection control needs, especially pandemics.”
According to the CDC, roughly one in 20 hospitalized patients will contract a Hospital-Acquired Infection (HAI), including influenza, resulting in more than $30 billion in avoidable healthcare costs and 90,000 inpatient deaths.1
Ordinary facemasks contribute to HAIs. Ordinary facemasks create “bio-burdens” – they accumulate germs, even when used properly. We breathe and cough germs onto them, then touch, adjust and discard them – potentially spreading disease as we use them, infecting ourselves and others.
By contrast, the BioFriend™ BioMask™ reduces the bio-burden of germs on the mask. This reduces the wearer’s exposure to germs, and combats key sources for HAIs. When multiplied by the thousands of masks used daily in a hospital, the overall bio-burden of the hospital as a whole can be significantly reduced by the BioFriend™ BioMask™ technology. In this way, affordable anti-microbial technologies like the BioFriend™ BioMask™ surgical facemask can transform infection control in the United States.
They can also transform our approach to pandemic preparedness. In independent laboratory tests, the BioFriend™ BioMask™ facemask inactivated 99.99% of tested pandemic and seasonal strains of influenza A & B viruses at 5 minutes, including swine flu and bird flu. Inactivation is the technical term for “killing” viruses.
Protection at Work and at Home
By reducing the bio-burden of ordinary devices without changing the reality of human work patterns (such as touching facemasks), Filligent’s anti-microbial technologies can also transform infection control at other major contamination points, such as the home, school, workplace and battlefield. The common cold alone costs the United States over $20 billion every year in work-place productivity losses.2
This ability to transform infection control in other industries was confirmed by a recent user study of Australian dentists. Around two-thirds of Australian dentists would replace their existing masks with the BioMask™ and would recommend it to others. Over 80% found it easy to breathe in and comfortable to wear.
This is great news for Henry Schein Incorporated [NQ: HSIC], who conducted the study. They are now Filligent’s exclusive dental distributor for Australia. But it is highly disruptive news for most other healthcare distributors. A lack of innovation makes it difficult for other distributors to meet the changing needs of healthcare and other workers who cannot afford to get sick.
The recent FDA clearance joins Filligent’s other first-of-kind medical devices for the BioFriend™ BioMask™ range. These include self-sanitizing, anti-microbial facemasks approved by the TGA in Australia, the MHRA in the UK (on behalf of the European Union) and the HSA in Singapore. Filligent was also the first to achieve the new FFP2:2009 standard for its European range of powerful anti-microbial respirators.
It is because of this innovation pipeline that major companies have been quick to partner with Filligent. Medline Industries, Inc., the largest privately-held manufacturer and distributor of healthcare supplies in the U.S., is a leading supplier of facemasks in America. It holds exclusive distribution rights to the BioMask™ for its sector of the healthcare channel in the United States (excluding government sales) and certain other countries.
“This is game-changing technology for the healthcare industry. We look forward to using this and our partnership with Filligent to drive other innovations in the healthcare industry,” says Frank Czajka, President, Proxima Division, Medline.
About BioFriend™ BioMask™
BioFriend™ BioMask™-branded facemasks will soon be available to healthcare workers in hospitals and long-term care facilities across the United States and Canada through Medline and for US Government sales through C&A. To provide equal access to all healthcare workers, BioFriend™ BioMask™ facemasks will also be available in major US retail chains nationwide in a co-branding deal with CURAD®.
The BioFriend™ BioMask™ facemasks will soon be followed worldwide by the SMARTline™ range, which uses the same powerful BioFriend™ anti-microbial technology platform to provide advanced personal hygiene protection products and health & beauty tools. Filligent’s anti-microbial technologies can be used in textiles, paper, cardboard, polymers, and liquids for an ever-expanding range of innovative applications. To learn more about these and other Filligent products, visit www.filligent.com; US residents please see usa.filligent.com.
Filligent is a global innovation powerhouse that develops disruptive technologies and products to address unmet health needs in medical, consumer, industrial and government / military markets around the world. It has developed a series of revolutionary protective health technologies that rapidly trap and inactivate a broad range of dangerous pathogens and chemicals before they can enter the human body. Filligent’s mission: Save Lives; Stay Strong. Follow our disaster response work in Haiti, Pakistan and Japan.
1. Eighty-seven percent of U.S. hospitals do not take recommended steps to prevent avoidable infections. News Release. September 10, 2007. Available here.
2. See The total economic impact of cold-related work loss exceeds $20 billion per year. Available here.
For all enquiries:
Marketing & Communications
Emmanuel Benami, +852 2542-2400
Ogilvy Public Relations
Mary Coyle, 212-880-5258
For US Healthcare & Select Retail Chains:
Medline Industries, Inc.
John Marks, 847-643-3309
Jerreau Beaudoin, 847-643-3011
For US Government Sales:
C&A Bio International
Government Sales, 1-800-551-4105
C&A Media Contact
Laurie Roberts, 816-931-8900
KEYWORDS: United States Asia Pacific North America North Carolina Hong Kong
INDUSTRY KEYWORDS: Surgery Health Biotechnology Hospitals Infectious Diseases Medical Devices FDA