COMMUNICATED: FDA approves Celliant® Reactive Textile Products as medical devices and well -being products (1)

-Hologenix, LLC technology is first of its kind to achieve FDA joint designations

- Celliant designed products have been clinically shown to increase blood flow locally

- The FDA decision opens the door to a new era of active fabrics, reactive textiles

LOS ANGELES, July 25, 2017 /PRNewswire/ -- Hologenix, LLC, maker of Celliant [http://celliant.com/], the world's most advanced clinically proven reactive textile technology, today announced that The U.S. Food and Drug Administration (FDA) has determined that Celliant products are medical devices and general wellness products, as defined by Section 201(h) of the federal drug law. food, medicines and cosmetics. According to the FDA, Celliant's products were found to be medical devices that temporarily promote increased local blood flow at the application site in healthy people.

http://mma.prnewswire.com/media/538683/PureCare_Sheets.jpg [http://mma.prnewswire.com/media/538683/PureCare_Sheets.jpg]

The products designed by Celliant are the first of their kind to be designated as medical devices by the FDA, said Seth Casden, CEO of Hologenix. Our technology can be used in everyday products - t-shirts, clothing, bedding, and even airplane seats - to increase blood flow for increased energy, boosting performance and accelerating muscle recovery.

We believe Celliant is a truly disruptive technology that has transformative applications for textiles, Casden said. We are currently evaluating other Celliant applications in healthcare, where, for example, people with diabetes could benefit from increased blood flow in body tissues.

Celliant designed products harness and reuse the heat naturally emitted by the human body to improve performance and regenerate and recharge the body after physical activity and while sleeping. Celliant is made with a proprietary blend of thermoreactive minerals that are embedded in the core of the fiber used in any type of fabric so they won't wear down or wash out. Products made from Celliant fabric absorb body heat and convert it into infrared energy that is recycled and returned to the skin and tissues safely and naturally. Infrared energy has a vasodilatory action and increases blood flow to tissues and muscles throughout the body, bringing vital nutrients and oxygen to cells. The effect has been clinically shown to help the body to:

--increase energy, stamina, strength and performance; --recover faster from physical activity; --Induce restful sleep and greater comfort.

Celliant is used in a wide variety of textiles and applications: garments, bedding, wetsuits and veterinary products, such as:

--The Xcel Infinity Comp TDC Full Suit with Celliant, SIMA award winner, which uses Celliant to make a warmer wetsuit liner so you can surf longer and recover faster; --The Salewa Puez TirolWool Celliant Half Zip Jacket that blends TirolWool, Imbotex's naturally warm, hydrophobic and breathable insulation, with Celliant to keep outdoor enthusiasts warm and energized all day. Release Date: Fall 2017; --The ISPO award-winning women's ski boot, Tecnica Mach 1 Pro Women Ski Boot, which is built for women and uses Imbotex's Celliant and Lambswool Heat in its lining to address women's specific needs for warmth, comfort and performance on and off the track. Release Date: Fall 2017; --PureCare Elements: The Lumen Premium Celliant Sheet Set, the first Celliant-infused bedding collection that increases comfort and promotes faster recovery while you sleep.

Science has shown that infrared energy increases blood flow, improves muscle recovery and reduces chronic pain, says Michael R Hamblin, MD, principal investigator at Massachusetts General Hospital's Wellman Center for Photomedicine. The FDA's conclusion on the use of Celliant's products as medical devices and general wellness products will likely spark interest in infrared technology and prompt further development of garments and covers that can have a positive effect on people's well-being.

Celliant has been extensively researched, developed and clinically tested to ensure durability and effectiveness. Nine clinical trials have been conducted to evaluate the performance of Celliant at leading institutions 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's technology has been shown to increase tissue oxygen levels by 8% at the site of application(i). Click here [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3699878/] to view an independent NIH study on the benefits of infrared energy for recovery.

About Celliant Celliant is a revolutionary patented technology that harnesses and reuses the body's natural energy through the fibers. Celliant's applied science uses a blend of proprietary minerals and ingredients that are embedded in the core of the fiber. The use of products with this technology has been shown to increase oxygen levels in tissues, improve athletic performance, quality of sleep, health and well-being. Some of the most recognized brands in the world have fibers, wools and fabrics with Celliant technology. For more information, visit www.celliant.com [http://www.celliant.com/].

About Hologenix, LLC Founded in 2002, Hologenix, LLC, manufactures Celliant technology and is committed to creating, developing and bringing to market products that improve people's lives through the use of new materials. They work to deliver the future of healthcare innovation across a variety of consumer categories. In addition to the United States, Celliant has been classified as a Class I medical device in Canada, the European Union, Australia, and New Zealand. The company continues to explore new avenues and is currently conducting FDA-focused clinical trials to jump into the medical product space.

(i) Dr. Ian Gordon - University of California, Irvine, Effect of Garment with 42% Celliant Fiber on TCP02 Levels and Grip Strength in Healthy Subjects. TCP02 transcutaneous oxygen and grip strength in healthy people) 2010

Contact: Julia Moore, +1-212-445-8160, Julia.Moore@webershandwick.com [mailto:Julia.Moore@webershandwick.com]

http://mma.prnewswire.com/media/538684/Xcel_Infinity_Comp_Fu... [http://mma.prnewswire.com/media/538684/Xcel_Infinity_Comp_Fu...]

(CONTINUED)