SCIENCE

Fos Biomedical Trial Underway with Yale-Griffin Prevention Research Center

Effects of the Fos Biomedical devices on Cardio-metabolic Risk Factors and Sleep Quality in Adults at Risk for Type 2 Diabetes: A Randomized, Placebo-controlled, Crossover Trial

PURPOSE:

Proposed is a randomized crossover placebo-controlled trial to assess the impact of the Fos Biomedical devices use on cardio-metabolic risk factors and sleep quality, among adults at risk for type 2 diabetes.

SPECIFIC AIMS:

  • To determine the effects of the use of the Fos Biomedical devices daily for 8 weeks, as compared to placebo patch, on glycemic control in adults at risk for type 2 diabetes. Specifically, to show that the use of the Fos Biomedical devices for 8 weeks, as compared to placebo patch, will improve glycemic control in adults at risk for type 2 diabetes.
  • To assess the effects of the use of the Fos Biomedical devices, versus placebo patch, for an 8-week period on serum lipids, C-reactive protein, anthropometric measures, sleep quality, and endothelial function in adults at risk for type 2 diabetes. Specifically, to show clinically meaningful improvement or neutral effects in serum lipids, C-reactive protein, anthropometric measures, sleep quality, and endothelial function in adults at risk for type 2 diabetes.
  • To assess the impact of Fos Biomedical devices on liver function and kidney function in adults at risk for type 2 diabetes.

HYPOTHESES: 

  • Daily use of the Fos Biomedical devices for 8 weeks will improve glycemic control in adults at risk for type 2 diabetes.
  • Daily use of the Fos Biomedical devices for 8 weeks will improve or have neutral effects on serum lipids, C-reactive protein, anthropometric measures, sleep quality and endothelial function in adults at risk for type 2 diabetes.
  • The use of the Fos Biomedical devices will have no clinically meaningful adverse effects on liver function and kidney function in adults at risk for type 2 diabetes.

Viral Response Pilot Study 

OVERVIEW: Open label trial with no control group with a sample of convenience of 8 subjects, both men and women aged 20-70 who are first responders. This study was 28 days per subject to complete and measures were collected on Day 1, 2, 7, 14, 21 and 28.

PURPOSE: To determine the efficacy and effectiveness of the Fos Biomedical Technology in conjunction with Chelated Copper supplement in inhibiting reception on COVID 19 virus in a first responder population.

MATERIALS: Fos Biomedical VR1 and VR2 patches, NASA Task Load Index (TXS), System Usability Scale, Stress Symptoms Questionnaire (SQ), Pittsburg Sleep Quality Index, Arizona Integrative Outcome Scale, Visual Analogue Scale for Vitality, PharmaTech COVID 19 Rapid Test, Temperature, Pulse Oximeter, Blood pressure, CBC with differentials, Sedimentation rate (ESED), C Reactive Protein (CRP), CD4/T Cell levels, Homocystine , The Liver Function Test 7 (LFT 7), Glycyl-L-histidyl-L-lysine
peptide (GHK), Copper tripeptide, glycyl-L-histidyl-L-lysine-Cu peptide (GHK Cu).

CONCLUSION: Efficacy was demonstrated through the NASA Task Load Index (TXS) at a 1 rating, the greatest ease of use. While there was clear immune system cycle present which might indicate some transference of infection, there was also clear recovery by next measure and no participant developed COVID-19 antibodies during the study despite daily continuous contact with COVID positive individuals. No liver toxicity was detected with the application of the daily 2mg oral chelated Copper. GHK increased production within 24 hours and GHK-Cu production was significant at p< 0.03 by day 28. No adverse reactions were reported.

 Full report available upon request

There are thousands of Photobiomodulation (PBM) studies published showing the medical health benefits of this method of treatment. We use these third party studies and trials to support the efficacy of our products.

The Effects of Photobiomodulation Therapy on Post-Surgical Pain

Objectives: To evaluate the effects of low level laser therapy (LLLT) on pain and side effects after surgery.

Methods: In this research, databases such as: PubMed, Science Direct, Google Scholar, Springer and Cochrane were used and the words of laser therapy, photobiomodulation, therapeutic laser, low level laser therapy, surgery and pain were searched. Articles, including systematic reviews, original articles, case series, and clinical intervention studies related to these words, were studied. The language of all articles was English and consists of papers from 2009 until 2017.

Conclusion: LLLT may be an appropriate modality for reducing pain after surgery, nevertheless the effect size of this modality is variable. Therefore, further research based on proper protocols for these patients and follow-up of therapeutic course should be designed and implemented.

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Effectiveness of High Intensity Laser Therapy for Reduction of Pain in Knee Osteoarthritis

Objectives: This is a pilot, randomized clinical study about the effect of high intensity laser therapy in patients with osteoarthritis of the knee (OA of the knee).

Methods: 72 patients (aged between 39 and 83 years) with (clinically and radiographically proved) OA of the knee were included in the study. They were randomized in two groups: therapeutic (test) one (𝑛 = 37, 65,11 ± 1,40 (mean ± SD) years old; patients were treated with HILT) and control group (𝑛 = 35, 64,71 ± 1,98; patients receive sham laser). Both groups had seven sessions of treatment. VAS and dolorimetry were used for assessment of pain before and after the therapy. Pedobarometric analysis (static and dynamic) was used to assess comparatively the contact surface area and maximum pressure under the heel.

Conclusion:  Pain levels measured by VAS and dolorimetry decreased significantly in the therapeutic group after seven days of treatment (𝑝 < 0,001). The results after seven days of treatment show more intensive and cumulative effect after the application of high intensity laser therapy in comparison to sham laser. This is the reason why HILT can be a method of choice in the treatment of gonarthrosis.

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Efficacy of pulsed Nd:YAG laser in the treatment of patients with knee osteoarthritis: a randomized controlled trial

Objectives: The purpose of this study was to investigate the effects of pulsed Nd:YAG laser plus glucosamine/chondroitin sulfate (GCS) in patients with knee osteoarthritis (KOA) by examining changes in pain and knee function, as well as synovial thickness (ST) and femoral cartilage thickness (FCT). 

Methods: Sixty-seven male patients participated, with a mean (SD) age of 53.85 (4.39) years, weight of 84.01 (4.70) kg, height of 171.51 (3.96) cm, and BMI of 28.56 (1.22). Group 1 was treated with high-intensity laser therapy (HILT), GCS, and exercises (HILT + GCS + EX). Group 2 was treated with GCS plus exercises (GCS + EX), and group 3 received placebo laser plus exercises (PL + EX).

Conclusion: The outcomes measured were pain level and functional disability using the visual analog scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), respectively. ST and FCT were measured by ultrasound examination. ST was significantly decreased in the HILT + GCS + EX group posttreatment, with nonsignificant decreases in the GCS + EX and PL + EX groups, as well as nonsignificant differences to FCT in all groups. Overall, pulsed Nd:YAG laser combined with GCS and exercises was more effective than GCS + EX and exercises alone in the treatment of KOA patients.

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Short-Term Efficacy of Low-Level Laser Therapy in Patients with Knee Osteoarthritis: A Randomized Placebo-Controlled, Double-Blind Clinical Trial 

Purpose/Objectives: This study was designed to evaluate the short-term efficacy of low-level laser therapy (LLLT) for improving pain and function in patients with knee osteoarthritis.

Design: Forty-seven patients with knee osteoarthritis (79 knees), of both genders, participated in this randomized controlled double-blind clinical trial. LLLT was performed three times a week, totaling nine sessions, using a AsGa 904 nm laser with mean power of 60 mW and beam area of 0.5 cm(2). Nine points were irradiated on the knee, with energy of 3.0 J/point. The placebo group was treated with the same laser device, but with a sealed probe. Evaluations using Lequesne, visual numerical scale (VNS), Timed Up and Go (TUG), goniometry and dynamometry were conducted before the treatment started and after the nine sessions of LLLT.

Results: A significant improvement in pain and function was found in all the assessments applied to the laser group. On comparing the laser group with the placebo group, significant differences were found in the VNS-resting and Lequesne evaluations.

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Effect of NASA Light-Emitting Diode Irradiation on Wound Healing

Purpose/Objectives: The purpose of this study was to assess the effects of hyperbaric oxygen (HBO) and near-infrared light therapy on wound healing.

Design: In vitro and in vivo (animal and human) studies utilized a variety of LED wavelength, power intensity, and energy density parameters to begin to identify conditions for each biological tissue that are optimal for biostimulation.

Results: Wound size decreased up to 36% in conjunction with HBO in ischemic rat models. LED produced improvement of greater than 40% in musculoskeletal training injuries in Navy SEAL team members, and decreased wound healing time in crew members aboard a U.S. Naval submarine. LED produced a 47% reduction in pain of children suffering from oral mucositis.

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