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Clinical Data and Reports

NEWEST CLINICAL STUDY                           

2020 Final Report: Hand Sanitizer vs COVID-19

Study Conclusions: “Under the conditions of this evaluation Test Product #1 ESC Brands My-shield/Glan Health Advanced Hand Sanitizer (Lot#05122020-HS-A), Reduced the infectivity of Coronavirus strain 229E by >.3.00 log10 (99.90%) following a 30-second and a 60-second exposure.” (FfNAL REPORT 112004279-402 Page 7 of 10 BIOSCIENCE LABORATORJES, fNC.)

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Additional clinical trial results for products distributed by Pathogen Shield Technologies:

NOROVIRUS HAND SANITIZER REPORT

Outline: The protocol TP016 was executed to evaluate the effectiveness of the client’s product, My-Shield® Hand Sanitizer, on Murine Norovirus 1 (MNV-1), on fresh, washed, shaved, and sterilized porcine skin to simulate human skin contact. The virus stock is prepared using the following materials, MNV-1 animal CW1, ATCC PTA-5935 hosted in RAW 264.7 Murine cells, ATCC T1B71. Once murine cell culture reached confluence, they were infected with MNV-1. These infected cells were incubated until full lysis of the cell monolayer occurs with virus stocks being tested on a set of porcine skin, M121015D, pads (3” x 6” pads) without the hand sanitizer (control) to ensure this can be used as a suitable substrate for challenging the clients’ product. On all three sets of pig skin pads, the MNV-1 is applied, dried, and treated with My-Shield® Hand Sanitizer. The pads are sampled and evaluated for viability of MNV-1. The second and third sets of pads are repeatedly washed with a mild non-antimicrobial soap to simulate hand washing. The second set of pads are washed 5x and the third set of pads are washed 9x. Each set of pads are sampled to evaluate viability of MNV-1. Following the 5x and 9x washings, each set of pads are contaminated again with MNV-1, dried, and sampled to determine long-term protection of the initial application of the product. To assay virus viability and potential effectiveness of My-Shield® hand sanitizer, samples from skin pads were inoculated with murine cell (ATCC T1B71) monolayers and after 72 hours of incubation, were examined for cytopathogenic effects (CPE) and graded using a 10 point scale (0= no CPE and 10 = 100% murine cell destruction).

Results: The results are reported in Table A, titled “Data for the Evaluation of My-Shield® Hand Sanitizer and its effects on Murine Norovirus (MNV-1) using porcine skin to simulate human skin”.

TP016.1 Noro Hand Sanitizer Report

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MY-SHIELD® HOSPITAL STUDY

My-Shield® Sanitizer/disinfectant participated in an extensive third-party sponsored 39-room, 27 day study at a prominent US-based hospital. The objective was to test the potential effectiveness and persistence of the product(s) and record any reduction of bacteria loadings over extended periods as compared to current cleaning & disinfection protocols currently incorporated by the medical facility.

Objectives of the study: To quantify the effectiveness of the My-Shield® nano silicone sanitizer & disinfectant technologies in reducing microbial loadings in a working hospital environment over current cleaning & disinfection protocols.

Study data summary and conclusions: The study included an extensive microbial study with some 370 platelet lab tests conducted – all acquired from 39 different patient rooms in a major working hospital over the course of a 3-week period, under 5 varied cleaning & sanitation protocols.

Category A (Baseline – Only using conventional disinfectant): current hospital cleaning & disinfection by hospital cleaning staff with continued routine cleaning & disinfection for 26 days.
Conclusion: Study A started with the lowest initial bacterial loading and only managed a marginal reduction of just 4% in overall microbial loading for the term of the study.

Category B: one single application of My-Shield® Sanitizing/Disinfection treatment applied by Electrostatic applicator & wipes. (no routine cleaning for 26 days).
Conclusion: Study B started with a modest initial bacterial loading and achieved a 92% reduction in week one, an 83% reduction in week two and a 70% reduction in week three with one single application of My-Shield® and no follow up cleaning.

Category C: one single application of My-Shield® Sanitizer/Disinfectant with combination steam & electrostatic applicator followed up with 26 days of routine cleaning.
Conclusion: Study C started with the third highest initial bacterial loading & achieved a 96% reduction in week one, an 94% reduction in week two and a 93% reduction in week three, with one single application of My-Shield® and continued daily routine cleaning.

Category D: one single application of My-Shield® Sanitizer/Disinfectant treatment applied with a combination of electrostatic applicator and wipes followed up with 26 days of routine cleaning.
Conclusion: Study D started the second highest initial bacterial loading and achieved a 97% reduction in week one, an 95% reduction in week two and a 91% reduction in week three, with one single application of My-Shield® and no continued routine cleaning.

Category E: continued application of My-Shield® Sanitizer/Disinfectant treatment applied with a combination of electrostatic applicator & wipes forming part of the routine cleaning & disinfection with My-Shield® for 26 days.
Conclusion: Study E started with a highest initial bacterial loading & achieved a 98% to 97% reduction in total bacterial loading with continued daily routine cleaning & disinfection with My-Shield®.

Hospital Grade Disinfectant Clinical Study

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HAND SANITIZING LIQUID – CLINICAL REPORT

ASTM E1115-11 Standard Test Method for Evaluation of Surgical Hand Scrub Formulations. Items of analysis:
1. Immediate Activity
2. Persistent Activity
3. Cumulative Activity (with validated neutralization).

Conclusion: When tested in accordance with ASTM E1115-11, My-Shield® Hand Sanitizer Foam with Aloe Vera possesses Immediate Activity and Persistent Activity but Cumulative Activity could not be determined based on the test data available. Immediate Activity results demonstrated that bacterial reduction of hand flora after using the product was greater than a 5.8 Log10 reduction factor. Persistent Activity suppressing regrowth of skin bacteria was seen to be in the same order of magnitude at 3 hours and 6 hours post treatment. Even at 12 hours after product application with hands kept occluded within surgical gloves, only a minimal lowering of antibacterial activity (suppression of growth) was seen. Cumulative Activity could not be determined from the data available because of the high kill rates with obvious near sterilization effect throughout the testing.

My-Shield®/Germfree24® Hand Sanitizer Liquid: Clinical Study

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FELINE INFECTIOUS PERITONITIS (A MERS-CORONAVIRUS SURROGATE)

Objective: Determine the efficacy of My-Shield® Hand Sanitizer Foam against feline infectious peritonitis virus on hands.

Results: My-Shield® Hand Sanitizer was able to achieve a >99.9% (>3.19 log10) reduction. All replicates in the presence My-Shield® Hand Sanitizer Foam were below the limit of detection for the assay suggesting that greater reductions are achievable. Results are shown in Table 1. My-Shield® Hand Sanitizer Foam is effective at reducing feline infectious peritonitis virus (a MERS-coronavirus) on hands by at least 99.9% following manufacturer’s instruction.

ESC My-Shield® Hand MERS Report

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