TECHNOLOGICAL PROPERTIES OF NANOBUBBLES:
Nanobubbles are extremely small gas bubbles in water that have several unique physical and chemical properties that make them very different from the larger normal bubbles we are used to. The diameter of nanobubbles is between 250 nm and 50 nm with a typical
mean diameter of around 100 nm (1,000 times smaller than one strand of hair). The most important properties of nanobubbles are :
Due to their very small volume and their lightness, the buoyancy is almost null and as a result the gas nanobubbles will be suspended in water for months or years depending on the packaging of the gas nanobubbled water.
EXTREMELY LARGE SURFACE AREA:
When nanobubbles are generated properly, the water contains a very large number of nanobubbles per unit volume and as a result their surface area per unit volume is extremely high. The large surface area will result in increased gas mass transfer.
NANOBUBBLES ARE ELECTRICALLY CHARGED:
At the interface between the gas and water the molecules are organized in such a way that the surface of the nanobubble in water is negatively charged.
GAS PARTIAL PRESSURE INCREASE:
At atmospheric conditions the partial pressure of oxygen (dissolved oxygen, DO) in nanobubbled water is increased 5-7 fold as compared to its partial pressure in regular water.
OXYGEN GAS RESERVOIR:
As stated above the vanishing of buoyancy, the negative surface charge and control on the surface tension of the nanobubbles contribute to their very long-time stability in water (years in our sealed containers). As a result, the nanobubbles suspended in water play a role as a gas reservoir which maintain elevated dissolved oxygen levels.
EXISTENCE AND STABILITY OF GAS NANOBUBBLES:
Since 2010, oxygen nanobubbles have been extensively studied at Harvard University, Oxford University, Rush and NY Medical Schools with respect to their influence on a spectrum of neurological diseases. These results were presented at the Society for Neuroscience Annual Meeting in 2014. In December 2016, researchers from Oxford University published a study entitled “ Reducing Tumor Hypoxia via Oral Administration of Oxygen Nanobubbles ” demonstrating the potential medical applications of oxygen nanobubbles. In a study published in 2018 American Chemical Society, researchers from the University of Birmingham UK finally proved with no doubt that oxygen nanobubbles exist and are very stable in water at high concentrations, approaching one billion (1,000,000,000 nanobubbles per milliliter). The results were confirmed in many laboratories, including Periphex’s, utilizing analytical equipment based on DLS (dynamic light scattering).
Nanobubbles (magnified 10,000 times) in water.
CLINICAL EVIDENCE FOR THERAPEUTIC USE OF NANOBUBBLES:
APPLICATIONS OF NANOBUBBLES IN NEURODEGENERATIVE CONDITIONS:
In a study performed on cellular models in mice having ALS (Lou Gehrigs Disease), it was demonstrated that the Nanobubbles of Oxygen have anti-inflammatory and neuroprotective properties. The authors showed that the injection of Nanobubbled saline solution protected motor neurons and slowed the disease progression through a significant protection of spinal motor neurons and neuromuscular junctions.
NERVE PAIN PROSPECTIVE CLINICAL STUDIES:
Nanobubbles Of O2 And Co2 For The Treatment Of Peripheral Neuropathy – A series of 29 consecutive patients suffering from peripheral neuropathy from various etiologies were treated using a footbath with 1 gallon of water infused with Nanobubbles of Oxygen and CO2 for 20-30 minutes. The results of this study have been published by Dr. Jefferey LaMour at the TPMA Southwest Foot and Ankle Conference September 12-15, 2019, Frisco, TX. He demonstrated that foot bath infused with Nanobubbles of O2 and CO2 provide statistically significant improvement of pain in patients suffering from Peripheral Neuropathy from various causes. More than 60% of the patients treated had a pain relief of 50% or more; this is significantly superior to the published results on prescription drugs (Gabapentin, Lyrica) currently used to treat peripheral neuropathy. All these drugs have significant side effects and complications, while no complications or side effects have thus far been reported with the nanobubbles treatment.
Prospective Study Using Hydrogel Infused With Gas Nanobubbled Water – A small study performed on 8 patients using NoxyPure showed that the tingling pain, numbness as well as foot sensitivity (measured with Semmes-Weinstein monofilament and evaluated with Toronto Neuropathy Score) have improved after 4 to 8 treatments, suggesting a potential regression of the nerves’ pathological conditions.
Prospective Multicenter Study – A Multicenter prospective IRB-approved (Institutional Review Board) observational study is in process to provide additional evidence on the safety and efficacy of NoxyPure in patients suffering from Diabetic Peripheral Neuropathy. Preliminary interim analysis seems to show significant improvement of tingling pain, burning pain, numbness, foot sensitivity (measured with Semmes-Weinstein Monofilament Examination and evaluated with Toronto Neuropathy Score). Subjects are also reporting a significant improvement of their Quality of Life as measured by the impact of their condition on their general activity, mood, regular work, relationship with other people, sleep and enjoyment of life.
NANOBUBBLES OF O2 AND CO2 FOR THE TREATMENT OF PERIPHERAL NEUROPATHY:
Jefferey LaMour, DPM, Family Foot Care, presented at TPMA Southwest Foot and Ankle Conference September 12-15, 2019, Frisco, TX
A series of 29 consecutive patients suffering from neuropathy from various etiologies were treated using a footbath with 1 gallon of water infused with Nanobubbles of Oxygen and CO2 for 20-30 minutes. The first 20 patients were treated in a water bath while the system was continuously infusing nanobubbles into the bath, while the remaining patients were treated using water that was infused with Nanobubbles a few hours before treatment. As the nanobubbles are very stable in solution, no difference was expected between the two populations and the experiments results are combined. The system used to produce nanobubbles was manufactured by Nanobubbling (Austin, TX). Efficacy of the treatment was evaluated by a patient reported response of their overall pain level at baseline and after each treatment to verify the hypothesis that the treatment significantly reduced the pain.
|N=29||Mean ± standard deviation|
|Age||Mean: 71.9 ±10 (48 – 88)|
|Gender||Female: 17 (59%)
Male: 12 (41%)
|Etiology||Diabetes: 19 (66%)
Unknown: 8 (28%)
Chemotherapy: 1 (3%)
Rheumatoid Arthritis: 1 (3%)
|Time since Neuropathy onset||Mean: 6.35 ±8.45 (0.5–35) years|
|Number of treatments||Mean: 7.8 ±3.74 (1 –11)|
|Time between treatments||3.75±3.86 (2-46) Days
Mode: 2 Days
Table 1: Demographics
Although two third of the patients suffered from Diabetic Peripheral Neuropathy, Peripheral Neuropathy from several other origins are represented.
|N=29||Mean ± standard deviation||Range|
|Complications / Side Effects||0|
|Initial Pain (± standard error)||Mean: 6.33 ±2.07||2.5—9|
|Final Pain||Mean: 3.19 ± 1.81||1—9|
|Relative Improvement||49.59% ± 23%||p<0.0001 (paired t-test)|
|Patients with pain reduction of 50% or more||18 (62.1%)|
|Table 2 – Results summary|
Pain improved significantly by the end of the treatments and only 2 patients, both diabetic, did not have any improvement. Pain level seems to decrease progressively with every treatment for the first 6 to 8 treatments. No correlation was found between the level of pain improvement and the etiology of the Neuropathy or the time since the onset of the Neuropathy.
Figure 1: pain improvement with treatments
Figure 2: Comparison with current drugs
The author concludes, that, “the number of patients (18, 62.1%) who had an improvement of 50% or more compares very favorably with the results reported in literature for Gabapentin (Neurontin) or Pregabalin (Lyrica).
Several patients have also reported improvement in their sensitivity, and a few reduced intake of narcotics or Gabapentin. Restoration of sensitivity may also explain that 3 patients reported temporary increase of pain while “numbness” improved. More studies are required to better understand the effects of topically applied nanobubbles on all the neuropathic symptoms. Although this data is based on a small sample size, it seems that topical application of nanobubbles of O2 and CO2 may be a safe and effective alternative for the treatment of peripheral Neuropathy for those patients who are dissatisfied with current pharmacological approaches.”
The author has also reported Many positive comments from patients:
- “I have stopped Neurontin and my narcotics.”
- “I can feel the gas pedal and feel much more safe driving.”
- “I’m no longer waking up at night with burning pain.”
- “I feel more stable on my feet.”
- “My toes do not curl up as much as they were and are in better contact with the ground.”
- “I am better able to move my toes and they are not so stiff.”
PROSPECTIVE STUDY USING HYDROGEL INFUSED WITH GAS NANOBUBBLED WATER (Completed September 2018)
Single site prospective non randomized feasibility clinical study. (Dr. J. Lamour, Austin, Texas)
Population: 8 patients suffering from Peripheral neuropathy from various etiologies.
4 to 10 treatments utilizing NoxyPure, a hydrogel infused with nanobubbled water of O2 and CO2 delivered for 20 minutes in a flexible disposable bootie.
- Tingling pain improved from 7.0 to 2.75 (60%)
- Numbness improved from 7.50 to 5.25 (30%)
- Toronto Neuropathic Score (scale 0-30, 0 is normal, 12 is considered severe neuropathy) improved from 21.5 to 14 (35%)
- Semmes-Weinstein Monofilament 5.07 test, a measurement of feet sensitivity to touch (scale 0-20, 20 is normal), improved from 3.57 to 13 (264%).
Improvements on these 2 objective tests after 4 to 8 treatments show that the treatment does not only affect the pain, but it may also have some effects on the neuropathic disease, potentially affecting or reversing the evolution of the disease.
Semmes-Weinstein 5.07 Monofilament Examination
Toronto Neuropathy Score