TECHNOLOGY | RESPONSIVE TEXTILES
Perseverance Pays Off for Celliant with FDA Approval.
The Salewa Puez Half Zip alpine trekking jacket features an innovative blend TirolWool and Celliant insulation material designed to reflect the radiant heat that a body emits, thus protecting the body from cooling.
When asked to rate on a scale of 1 to 10 the significance of the recent determination by the Federal Drug Administration (FDA), Seth Casden, CEO of Hologenix, the maker of Celliant, answered enthusiastically, “an 11!” And when asked to rate on a scale of 1 to 10 the challenges endured to obtain FDA approval, Casden responded, “111!”
It’s been a long slog for Hologenix to be able to post hash-tags like #pumped and #FDAapproval on the Celliant twitter feed. The company completed nine clinical studies and four physical studies over the course of 15 years. Not to mention dealing with the skeptics. Consider this email Casden received from a NASA scientist: “I’m not interested in your voodoo science. What you’re saying is like me saying I can grow broccoli on the top of my hand.”
“That’s a favorite quote of mine,” said Casden, enjoying a laugh.
According to Casden the FDA approval represents a huge, seismic shift in how Celliant is perceived. “Now brands can basically ‘check the box,’ when reviewing our technology. It takes the burden of proof off, and as such allows us to focus on getting the tech adopted,” said Casden, adding, “We want to be the ‘Kleenex’ of IR tech; the best of the best of responsive textiles.”
The FDA Stamp of Approval
This July the U.S. FDA 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 blow 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. The technology can be used in everyday products to create an increase in local blood flow thereby increasing energy, boosting performance and speeding muscle recovery, according to Casden. 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.
“We had a high bar to hurdle, but this is science based,” said Casden, who refers to Celliant technology as an “elegant use of science, that we are just on the precipice of.” “With Celliant you can achieve results in loose-fit, comfortable clothes,” said Casden. “You can wrap yourself in Celliant with no side effects.”
Believing in the Science Celliant is currently used in a diverse range of textiles and applications – apparel, bedding, wetsuits and veterinary products – with brand partners and products including Xcel wetsuits, sportswear by Salewa and Montura, Titika yoga wear, PureCare Elements bed sheets and Bear Mattresses. Casden is excited to expand adoptions in these established markets as well as pursue opportunities in new markets.
Draper Knitting has been keen on Celliant for years and company execs are pleased by the FDA approval. After eleven years of producing and working with Celliant fabrics, Kristin Draper, president of Draper Knitting isn’t surprised. “When I was first introduced to Celliant I was a skeptic too,” said Draper in a prepared statement, “but after seeing the remarkable way it reduced inflammation on myself and my family, we knew this was a winner. We have been working with Seth since the beginning and made fabrics, then equestrian products, which lead to dog and human products.”
“These firms have believed in our science,” explained Casden. “One company sent a bottle of champagne when the FDA news broke.”
Going forward Casden envisions Celliant gaining traction in a host of other markets such as workwear, textiles for furniture and transportation end use, as well as recovery wraps, braces and scrubs.
“There’s been an overwhelming positive response to the FDA approval,” said Casden, “We’ve stuck with this so long, and it’s just great.”