Comprehensive Safety & Efficacy Research

Oral ingestion of a novel oxygenating compound, Ox66™, is non-toxic and has the potential to increase oxygenation.  "The purpose of this study was to examine any potential toxicities  associated with the oral ingestion of Ox66™, its ability to withstand  the environment of the digestive tract...No toxicity was found associated with acute or chronic oral administration, ...the compound was able to withstand the environment of the digestive tract in vitro."  Reference: ScienceDirect, Food and Chemical Toxicology, Vol 125, March 2019: https://doi.org/10.1016/j.fct.2018.12.034

Oxygenation through oral Ox66 in a two-hit rodent model of respiratory distress. 

"The results here indicate that orally administered Ox66™  delivers therapeutically relevant oxygenation to capillary beds  improving tissue oxygenation and, by extension, reducing inflammatory  signalling. Ox66™’s oxygen appeared to be released  selectively at sites of tissue hypoxia, which magnified efficacy without  risk of hyperoxic injury...Since a more  significant effect was associated with the higher oxygen content of the  40% FiO2 group, Ox66™ appears suited to a  complementary role in severe situations of pulmonary dysfunction  requiring ventilatory support.”  Reference: Artificial Cells, Nanomedicine, and Biotechnology, Vol 52, 2024 - Issue 1:  https://www.tandfonline.com/doi/full/10.1080/21691401.2024.2307462

Gavage approach to oxygen supplementation with oxygen therapeutic Ox66™ in a hypoventilation rodent model of respiratory distress.  “When ingested, a solid-state,  oxygen-containing compound (Ox66™) increased oxygen delivery to the  peripheral tissues compared to volume control under the conditions of  hypoventilation.”  Reference: Artificial Cells, Nanomedicine, and Biotechnology, December 2021: https://www.tandfonline.com/doi/full/10.1080/21691401.2021.2013251 

Oxygenation via the Circulatory System. “This proof-of-concept study further demonstrates the potential of Ox66™ to  function as an oxygenating supplement that might be useful for treating  either pathological hypoxic-related* conditions or to improve oxygenation levels during or after exercise under healthy conditions.”  Reference: Food and Chemical Toxicology, Vol 125, March 2019: https://www.sciencedirect.com/science/article/abs/pii/S0278691518309074

Evaluating a novel oxygenating therapeutic for its potential use in the advancement of wound healing.  "It was determined that in both cell lines, there was no significant cytotoxicity found after independent treatment with Ox66™. Similarly, after induced chemical injury, the health parameters of cells treated  with Ox66™ were improved when compared to their untreated counterparts.”  Reference: Toxicology in Vitro, Vol 43, September 2017.    

https://pubmed.ncbi.nlm.nih.gov/28599845/ 

Evaluation of an Injectable, Solid-State, Oxygen-Delivering Compound (Ox66) in a  Rodent Model of Pulmonary Dysfunction-Induced Hypoxia.  “Treatment  with intravenous Ox66 improved interstitial oxygenation …Ox66 offers a  novel approach to supplemental oxygenation that bypasses lung injury and  dysfunction.”  Reference: Military Medicine, Vol 188, March 2022: https://pubmed.ncbi.nlm.nih.gov/35284916/ 

Effect of Novel Therapeutic on Systemic and  Microcirculatory Variables in Sprague-Dawley Rat Isovolemic Hemodilution Model. "Ox66™ animals  demonstrated an improvement in tissue oxygenation compared to control animals. This finding demonstrates that Ox66™ both transports and releases oxygen to the peripheral microcirculation.”  Reference: The FASEB Journal, Vol 30, April 2016.
https://faseb.onlinelibrary.wiley.com/doi/abs/10.1096/fasebj.30.1_supplement.946.11 

Safety and efficacy Clinical testing conducted over 30 days:  Placebo-controlled and Double Blind protocol measured blood, urine, and vital signs. Results showed no negative impact on any organ or general system; no negative interactions, sensitivities, or side effects; no negative impact in blood work, urine analysis, or vitals. Four key areas showed statistical significance*:   

SO2 (Oxygen Saturation increased) – indicates tissue oxygenation and arterial blood oxygen saturation levels; the body begins to fail at levels below 95%.

ATP (Adenosine Triphosphate increased) - principal molecule for storing and transferring energy in cells; serves as a source of energy for physiological reactions, especially muscle contraction.

CRP (C-Reactive Protein decreased) – inflammation marker, increases with inflammation.

B/P (Blood Pressure decreased) - all areas showed statistical significance (Systolic, Diastolic, Mean Arterial Pressure, Partial Pressure); high B/P leads to damage to arteries, the heart, brain, kidneys, and eyes.

* Statistical significance means less than 5% probability the results are random. 

Hypoxia-related: Any condition that reduces the amount of oxygen in your blood or restricts blood flow can cause hypoxia.  "People living with heart or lung diseases such as COPD, emphysema or asthma, are at an increased risk for hypoxia. Some infections, like  pneumonia, influenza and COVID-19 can also increase your risk of hypoxia." - Cleveland Clinic

Ox66®: A composition of poly-oxygenated aluminum hydroxide that comprises a clathrate containing oxygen gas molecules. The Ox66® composition is slightly soluble at 1g/100 mL, provided in powdered form, with a non-homogenous size particle population typically ranging from 50-800 micrometers (μm). Particles can be nano-engineered to 3 μm for IV usage or inhalation as a nebulizer. Ox66® exists under STP (standard temperature and pressure) as a poly-oxygenated aluminum hydroxide comprising a clathrate. A clathrate is a chemical substance consisting of a lattice that traps or contains molecules. The molecules trapped or contained within the clathrate are oxygen gas (O2(g)). The free oxygen gas molecules are separate from the oxygen molecules covalently bound in the hydroxide complex. Ox66® is non-flammable, non-corrosive, non-vapor producing, neutral pH of ~7; it’s reactive in acidic solutions, does not produce free radicals when decomposing. Its appearance is white, very light-weight, with 66-78% molecular weight from oxygen. Ox66® is configured to be therapeutically effective for hypoxic conditions by releasing the oxygen carried in the clathrate.