Hologenix LLC, maker of Celliant®, a clinically tested responsive textile technology, announced that the U.S. 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.
This determination was reached because the products temporarily promote increased local blood flow at the site of application in healthy individuals.
The company reports that products made with Celliant fabric absorb and convert body heat into infrared energy (IR) that is recycled into skin and tissue. IR is a vasodilator, increasing blood flow to tissue and muscles and, in turn, delivering vital nutrients and oxygen to cells.
The company reports that the effect is clinically proven to help the body increase energy, endurance, stamina and performance; recover faster from physical activity; and promote restful sleep and increased comfort. Hologenix is currently evaluating additional healthcare applications. For example, Celliant may prove useful to diabetics who could benefit from increased blood flow to tissue.
The product is made of a patented blend of thermo-reactive minerals infused in fiber, which is not affected by washing or wear. Celliant technology can be used in an array of products, including bedding, apparel, wetsuits and airplane seats.