FDA determines Celliant products meet criteria as medical devices
Hologenix, maker of the Celliant clinically tested responsive textile technology, said that the US Food and Drug Administration (FDA) has determined Celliant products are medical devices and general wellness products, as defined in Section 201(h) of the Federal Food, Drug and, Cosmetic Act.
According to the FDA, Celliant products were determined to be medical devices because they temporarily promote increased local blood flow at the site of application in healthy individuals.
“Celliant-engineered products are the first of their kind that the FDA has designated as medical devices,” said Seth Casden, Hologenix CEO.
“Our technology can be used in everyday products – t-shirts, clothing, bedding, even airplane seats – to create an increase in local blood flow thereby increasing energy, boosting performance and speeding muscle recovery.”
“We believe that Celliant is a truly disruptive technology that has transformational applications for textiles,” Casden said. “We’re currently evaluating additional applications of Celliant in the healthcare space, where, for example, people who suffer from diabetes might benefit from increased blood flow to body tissue.”
Celliant-engineered products harness and recycle the natural heat emitted by human beings to boost performance and rebuild and recharge the human body after physical activity and while you sleep. Celliant is made of a patented blend of thermo-reactive minerals infused into the core of fiber used to create all types of textiles and fabrics so it does not wash or wear out.
Products made with Celliant fabric absorb and convert body heat into infrared energy (IR) that is recycled back into skin and tissue in a safe, natural way. IR is a vasodilator, increasing blood flow to tissue and muscles throughout the body, which delivers vital nutrients and oxygen to the cells.
The effect is clinically proven to help the body:
- increase energy, endurance, stamina and performance,
- recover faster from physical activity,
- promote restful sleep and increased comfort.
Celliant is used in a diverse range of textiles and applications – apparel, bedding, wetsuits and veterinary products, including:
SIMA award winner, Xcel Infinity Comp TDC Full Suit with Celliant which uses Celliant to create the warmest wetsuit lining so you can surf longer and recover faster;
Salewa Puez TirolWool Celliant Half Zip Jacket that blends TirolWool, naturally warm, breathable and hydrophobic insulation from Imbotex, with Celliant to keep outdoor enthusiasts energized and warm all day long. Release date: Fall 2017;
ISPO award winner, Tecnica Mach 1 Pro Women Ski Boot, a ski boot made for women by women that uses Celliant and Lambswool Heat from Imbotex in its lining to address women’s specific needs for warmth, comfort and performance on and off the slope. Release date: Fall 2017;
PureCare Elements: Lumen® Premium Celliant® Sheet Set, the first linen collection that uses Celliant to increase comfort and promote faster recovery while you sleep.
“Science has shown that infrared energy increases blood flow, improves muscle recovery and reduces long-term pain,” said Dr. Michael R Hamblin, principal investigator at the Wellman Center for Photomedicine at Massachusetts General Hospital. “The FDA’s determination of Celliant products as medical devices and general wellness products will likely spur interest in infrared technologies and further development of garments and wraps that can positively impact people’s well-being.”
Celliant has been extensively researched, developed and clinically tested for both durability and effectiveness. Prominent institutions have conducted nine clinical trials to evaluate Celliant’s performance including University of California Irvine, University of Calgary, UCI Long Beach Veterans Affairs Medical Center, Texas A&M University, Loyola University Chicago and Exponent. Celliant technology has been shown to increase tissue oxygen levels by eight percent at the site of applicationi. Click here for NIH independent study on the benefits of IR on recovery.
Source: Company Press Release