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CLINICALLY PROVEN

The Science Advisory Board works with primary investigators
to rigorously test and validate the science of infrared and
its benefits. This includes experts in photobiology, nanotechnology,
sleep medicine, human physiology, diabetes and wound care.
To date, Hologenix has 9 peer-reviewed published studies.

Recognized worldwide by government regulatory agencies

The FDA determined products containing CELLIANT® are medical devices because they are intended to temporarily increase blood flow and local circulation at the site of application in healthy individuals.

The FDA has determined that CELLIANT® products are medical devices as defined in section 201(h) of the Federal Food, Drug and Cosmetic Act and are general wellness products.

The FDA has not approved or designated CELLIANT® products for any purpose and has not made any determination about, or endorsement of, its stated use or benefits.
As part of the 513(g) submission process, the FDA reviewed and commented on appropriate health and wellness claims for CELLIANT products.

CELLIANT® is designated as a Class 1 Medical Device in Australia, Canada, the European Union, Japan, New Zealand, the United Arab Emirates and the United Kingdom. CELLIANT® is cleared to market in China, India, Indonesia, Korea, Mexico, Peru, Philippines, Russia, Singapore, Taiwan, Thailand and Vietnam, with more countries and regions to follow.

Clinical, Preclinical, Technical and Physical Trials

Effect of Shirts with 42% CELLIANT® Fiber on tcPO2 Levels and Grip Strength in Healthy Subjects: A Placebo-Controlled Clinical Trial
Randomized Controlled Trial Comparing the Effects of Far-Infrared Emitting Ceramic Fabric Shirts and Control Polyester Shirts on Transcutaneous PO2
Effect of CELLIANT® Armbands on Grip Strength in Grip Strength in Subjects with Chronic Wrist and Elbow Pain
The Test Report on the Impacts of Subject Socks with the Application of CELLIANT® Technical Fibers on Transcutaneous Oxygen Pressure on a Man’s Foot
Transcutaneous Partial Pressure of Oxygen (tcPO2) as a Primary Endpoint to Assess the Efficacy of CELLIANT® as a Vasoactive Material
Apparel with Far Infrared Radiation for Decreasing an Athlete’s Oxygen Consumption During Submaximal Exercise
Double Blind, Placebo Controlled, Crossover Trial on the Effect of Optically Modified Polyethylene Terephthalate Fiber Mattress Covers on Sleep Disturbances in Patients with Chronic Back Pain
Effect of Optically Modified Polyethylene Terephthalate Fiber Socks on Chronic Foot Pain
Holofiber Study of Thirteen (13) Healthy Subjects
Improving Blood Flow with Holofiber in the Hands and Feet of High-Risk Diabetics
Infrared Radiative Properties and Thermal Modeling of Ceramic-Embedded Textile Fabrics
Engineered Emissivity of Textile Fabrics by the Inclusion of Ceramic Particles
Far Infrared Radiation (FIR): Its Biological Effects and Medical Applications
CELLIANT Bedding Moderates Autoimmune and Inflammatory Responses
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SUMMARY OF CLINICAL TRIALS

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YearEnd PointTitleInstitutionPrimary InvestigatorsNJournal /PublicationOutcome
2021Elbow and Wrist PainEffect of CELLIANT® Armbands on Grip Strength in Grip Strength in Subjects with Chronic Wrist and Elbow PainLong Beach VA Memorial Hospital Dr. Ian Gordon and Dr. Michael R Hamblin70Research Journal of Textile and ApparelImproved grip strength
2019Grip StrengthEffect of Shirts with 42% CELLIANT® Fiber on tcPO2 Levels and Grip Strength in Healthy Subjects: A Placebo-Controlled Clinical TrialLong Beach VA Memorial Hospital Dr. Ian Gordon, Dr. Mark Vangel and Dr. Michael R Hamblin24Journal of Textile Science and EngineeringImproved grip strength of over 12% in the dominant hand after 90 minutes
2018Tissue Oxygen (TCPO2)Randomized Controlled Trial Comparing the Effects of Far-Infrared Emitting Ceramic Fabric Shirts and Control Polyester Shirts on Transcutaneous PO2Long Beach VA Memorial Hospital Dr. Ian Gordon, James Wason, Dr. Lawrence Lavery, Dr. Michael R Hamblin and MS Thein153Journal of Textile Science and EngineeringAverage increase in TCPO2 of 8.4% after 90 minutes for 71% of the subjects
2012Tissue Oxygen (TCPO2)The Test Report on the Impacts of Subject Socks with the Application of CELLIANT® Technical Fibers on Transcutaneous Oxygen Pressure on a Man’s FootAcademy of Chinese SciencesDr. Li Shaojing, Wu Chuanhong, Gao Jian, Zhu Li and Wen Liwei100N/AIncrease in TCPO2 across all healthy subjects
2012Tissue Oxygen (TCPO2)Transcutaneous Partial Pressure of Oxygen (tcPO2) as a Primary Endpoint to Assess the Efficacy of CELLIANT® as a Vasoactive MaterialLong Beach VA Memorial HospitalDr. Ian Gordon and Dr. Michael Coyle51N/AAn average increase of 7% in TCPO2
2011Performance & RecoveryApparel with Far Infrared Radiation for Decreasing an Athlete’s Oxygen Consumption During Submaximal ExerciseUniversity of CalgaryDr. Jay Worobets, Dr. Darren Stefanyshyn and Emma Skolnik12Research Journal of Textile and ApparelElite/club cyclists VO2 reduced by 1.1%, increasing anaerobic threshold
2010Sleep (pilot)Double Blind, Placebo Controlled, Crossover Trial on the Effect of Optically Modified Polyethylene Terephthalate Fiber Mattress Covers on Sleep Disturbances in Patients with Chronic Back PainUniversity of CA IrvineDr. Marcel Hungs and Dr. Annabel Wang6N/ANighttime awakenings, sleep quality and sleep efficiency improved
2009Foot PainEffect of Optically Modified Polyethylene Terephthalate Fiber Socks on Chronic Foot PainUniversity of CA IrvineDr. Ian Gordon and Dr. Robyn York55BioMed Central Complementary & Alternative MedicineStatistically significant reduction of pain and improved comfort for subjects (diabetic/foot neuropathy)
2005Tissue Oxygen (TCPO2)Holofiber Study of Thirteen (13) Healthy SubjectsUniversity of Texas A&MDr. Graham McClue13N/AAn average increase in TCPO2 levels from 10% to 24%
2003Tissue Oxygen (TCPO2)Improving Blood Flow with Holofiber in the Hands and Feet of High-Risk DiabeticsLoyola University ChicagoDr. Lawrence Lavery20N/AAn average increase in TCPO2 levels from 12% in the hands and 8% in the feet of diabetic subjects

Summary of Preclinical Trial

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YearEnd PointTitleInstitutionPrimary InvestigatorsJournal/ PublicationOutcome
2021 Anti-inflammatory Markers and Improved MotionCELLIANT Bedding Moderates Autoimmune and Inflammatory ResponsesUniversity of BelgradeDr. Jasmina Djuretic, Dr. Mirjana Dimitrijevic, Dr. Marija Stojanovic, Dr. Jelena Kotur Stevuljevic, Dr. Michael R Hamblin, Dr. Ana Micov, Dr. Radica Stepanovic-Petrovic and Dr. Gordana LeposavicScientific ReportsThe appearance of the symptoms of collagen type II induced arthritis was postponed, while the disease was milder in infrared radiation exposed rats compared to nonexposed rats. Objective biochemical measurements of cytokines and autoimmunity were improved.

Summary of Technical & Physical Trials

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YearEnd PointTitleInstitutionPrimary InvestigatorsJournal /PublicationOutcome
2017Solar IR EmissivityInfrared Radiative Properties and Thermal Modeling of Ceramic-Embedded Textile FabricsExponentDr. David Anderson, John Fessler, Matthew Pooley, Scott Seidel, Dr. Michael R Hamblin, Haskell Beckham and Dr. James F BrennanBiomedical Optics ExpressEmissivity increased by approximately 10x when sunlight is also used to power CELLIANT technology
2016IR EmissivityEngineered Emissivity of Textile Fabrics by the Inclusion of Ceramic ParticlesExponentDr. David M. Anderson, Matthew Pooley, Haskell W. Beckham and Dr. James F BrennanOptics ExpressEmissivity increased by .14 MW per CM2 at fabric temperature of 32 Celsius with a 42% CELLIANT fabric vs. control
2012Principals of IRFar Infrared Radiation (FIR): Its Biological Effects and Medical ApplicationsHarvard/Wellman Center for PhotomedicineDr. Michael R Hamblin and Dr. Fatma VatanseverPhotonics and Lasers in MedicineFar Infrared Radiation (FIR) its biological effects and medical applications