Expanding Global Reach Through Regulatory Determination
Part of our mission is to impact the most people possible with the benefits of infrared. From improved quality of life, to better performance, faster recovery, and more restful sleep, we believe there are endless communities around the world who can benefit from CELLIANT®.
That’s why we are so proud to announce that our regulatory status now reaches over 50 countries, making CELLIANT an ideal global partner.
As our co-founder and CEO, Seth Casden puts it, “We’ve laid the groundwork for our partner brands to capitalize on the benefits of our infrared technology and to enhance their ability to do business. We firmly believe that regulatory status matters and that is why we have grown the number of countries we have such relationships with by over a third in the last three years. It is definitely a competitive advantage of our company and CELLIANT.”
Regulatory Growth Demonstrates Commitment to Science
Our growth in regulatory status is also an indication of our commitment to science. We have a Science Advisory Board composed of experts in the fields of photobiology, nanotechnology, sleep medicine, diabetes and wound care that have overseen 9 peer-reviewed published studies and our rigorous testing methods, collectively demonstrating CELLIANT’s effectiveness and the benefits of infrared energy. These studies form the basis of our ability to partner with global regulatory bodies to allow our brand partners to make infrared (IR) benefit claims.
Strategic Global Growth
CELLIANT has recently celebrated our 20th anniversary and the growth in regulatory status has been steady and in step with the growth of our team globally. We now have offices on 4 continents with 9 global sales support employees and 10 different legal and regulatory firms. CELLIANT is determined or designated as a Class 1 medical device in 38 countries and cleared to market in a further 15 countries.
Our global growth has led to some great products with brand partners around the world, including:
- CentaStar’s Regeneration line of duvets in pillows
- Tecnica high performance ski boots
- Oxeego performance socks
- Kymira performance apparel
- Blackroll’s Recovery collection
- Avanti pet products
We also will be sharing exciting announcements later in 2023 about new products and partnerships with major sportswear retailers in Europe.
In What Countries is CELLIANT Determined or Designated as a Class 1 Medical Device?
CELLIANT is determined or designated as a Class 1 medical device in 38 countries:
- EU (27 countries) plus European Economic Area (3)
- New Zealand
- Northern Ireland
In What Countries is CELLIANT Cleared to Market?
CELLIANT is cleared to market in 15 countries:
- Saudi Arabia
- South Africa
What Does Cleared to Market Mean for CELLIANT?
For our purposes, cleared to market means that, based on research in a specific country or region, the evidence supports a conclusion that CELLIANT products and the proposed claims fall outside of the definition of a medical device and no medical device registration is required. In other words, independent assessments have been made that permit certain CELLIANT claims to be made as a non-medical device.
Differentiate Your Brand
If you’d like to learn more about incorporating CELLIANT into your textile products and how they can help differentiate your brand, please fill out the form below – we would love to hear from you.