Microcyn® Technology

The  Microcyn®Technology family of products consist of liquids and gels which contain highly stable small molecule oxychlorine compounds.  One of these compounds, hypochlorous acid, is also produced by the human body’s immune system upon demand to eradicate foreign pathogens in the body.

The unique chemistry imparted through the patented Microcyn® manufacturing system provides superior product stability. Standard electrochemical processes used in the manufacture of other hypochlorous acid-containing products, cannot come close to matching this stability.

There are no known drug interactions or contraindications with Microcyn®-based products. Testing has demonstrated the gel and liquid products to be non-irritating, non-sensitizing and non-toxic. Microcyn®-based liquid products have been found to have no oral toxicity, cause no ocular irritation and are non-genotoxic.

With Revolutionary Microcyn Technology
HOCl

Hypochlorous Acid

The science of hypochlorous acid is simultaneously deceptively simple and highly complex. When developed intelligently and with scientific rigor, hypochlorous acid can be rendered safe, stable and consistent in an advanced wound care formulation. This is the foundation for our patented Microcyn® technology.

Under development and continuous refinement for almost 20 years, Microcyn® Technology is the original and very first hypochlorous acid introduced into the U.S. advanced wound care market.

Microcyn® Technology is highly stable, up to two years or more, and proven safe (non-cytotoxic).

HOCl

Safety

Impact of Microcyn® Technology on Fibroblast Cells as Compared to Brand V in Negative-Pressure Instillation Simulation

Study

An in-vitro study was conducted in which confluent monolayers of L-929 mouse fibroblast cells (as recommended by ISO and USP guidelines) were prepared and challenged by both Microcyn® Negative-Pressure Wound Therapy Solution and Brand V solution. The study was conducted on these fibroblast cells to evaluate potential toxicity with repeated exposure in-vitro. Results were recorded at one-hour intervals after four 15-second exposures (instillation), and later at 24 hours.

Microcyn Solution samples were graded as non-toxic: Grade 1 to L-929 mouse fibroblast cells under the conditions of this study. The Brand V samples were graded as cytotoxic: Grade 3 to L-929 mouse fibroblast cells under the conditions of this study. After 24 hours, the results remained unchanged.

Results

The monolayers of fibroblast cells were graded using light microscopy. Cellular morphology was graded in accordance with the ISO acceptance criteria and USP guidelines.

Microcyn® Exposure: As shown in microscopic photos numbered one and two, the fibroblast cells exposed to the Microcyn® Technology maintained their viability and indicate a non-toxic level of exposure.

Microcyn Exposure

As shown in microscopic photos numbered one and two, the fibroblast cells exposed to the Microcyn® Technology maintained their viability and indicate a non-toxic level of exposure.

1

Representative Image of Microcyn Treatment at T=1. After First 15 sec Exposure to 1ml (5ml Microcyn:1ml MEM) of L-929 Cells. Photo taken an hour after exposure at 200X.

Microcyn Exposure

2

Representative Image of Microcyn Treatment at T=4. After Fourth 15 sec Exposure to 1ml (5ml Microcyn:1ml MEM) of L-929 Cells. Photo taken an hour after exposure at 200X.

1
Representative Image of Microcyn Treatment at T=1. After First 15 sec Exposure to 1ml (5ml Microcyn:1ml MEM) of L-929 Cells. Photo taken an hour after exposure at 200X
2
Representative Image of Microcyn Treatment at T=4. After Fourth 15 sec Exposure to 1ml (5ml Microcyn:1ml MEM) of L-929 Cells. Photo taken an hour after exposure at 200X.

Brand V Exposure

As shown in microscopic photos numbered 3 and 4, the fibroblast cells exposed to the Brand V solution after the fourth treatment did not maintain their viability and indicate a cytotoxic level of exposure. Notice the proliferation of round, non-viable cells in photo four.

3

Representative Image of Brand V Treatment at T=1. After First 15 sec Exposure to 1ml (5ml Brand V:1ml MEM) of L-929 Cells. Photo taken an hour after exposure at 200X.

Brand V Exposure

4

Representative Image of Brand V Treatment at T=4. After Fourth 15 sec Exposure to 1ml (5ml Brand V:1ml MEM) of L-929 Cells. Photo taken an hour after exposure at 200X.

3
Representative Image of Brand V Treatment at T=1. After First 15 sec Exposure to 1ml (5ml Brand V:1ml MEM) of L-929 Cells. Photo taken an hour after exposure at 200X.
4
Representative Image of Brand V Treatment at T=4. After Fourth 15 sec Exposure to 1ml (5ml Brand V:1ml MEM) of L-929 Cells. Photo taken an hour after exposure at 200X.

Shelf Stability

The patented and proprietary manufacturing process of the original Microcyn® Technology guarantees that each and every lot of Microcyn® hypochlorous acid is consistently safe and stable, always within our strict manufacturing specifications. Not all HOCl solutions can make this claim. In fact, some HOCl irrigants can actually inhibit wound healing and harm mammalian cells due to their cytotoxicity and inability to maintain control over free available chlorine (FAC) levels.

Due to poor stability, competitive hypochlorous acid products are generated at very high concentrations of HOCl to assure product preservation over their shelf lives. The concentration of HOCl in these products, therefore, varies significantly depending on product age. The initial elevated level of HOCl in Brand V is necessary to assure that some free available chlorine is available at the end of that product’s shelf life. It is also indicative of a product that likely has cytotoxic tendencies towards human cells. Both Microcyn and Brand V HOCl formulations were scientifically tested to determine levels of FAC at time of manufacture and over the shelf life of the products.

This chart demonstrates the level of degradation of the Brand V 500 mL product over a 240-day period as compared to the Microcyn® 500 mL product. As is shown in the chart, Brand V degrades at seven times the rate of Microcyn®. As a result, Brand V is required to manufacture an HOCL product at a relatively high and cyto-toxic “free available chlorine” level of 300 parts per milions in order to secure a minimum level of shelf life.

With Revolutionary Microcyn Technology

Preservative Testing

Microcyn® Skin and Wound Care with Preservatives demonstrates in vitro activity against a broad spectrum of gram-negative, gram-positive and yeast species in just 30 seconds.

Preservative Testing – Successfully meets USP Category 1 Criteria.

Organisms Result Day 7 Result Day 14 Result Day 28
P. aeruginosa ATCC 9027 >1 log reductionfrom the initial

calculated count

> 3.0 log reductionfrom the initial

calculated count

No increase from Day 14
E. coli ATCC 8739
S. aureus ATCC 6538
C. albicans ATCC 10231 No increase from theinitial calculated count No increase from theinitial calculated count No increase from theinitial calculated count
A. niger ATCC 16404

Preservative Time Kill Testing

Name of Organism Log Reduction (30 sec.) Time to Kill Percent Reduction
Acinetobacter baumannii 6.3692 30 seconds 99.9999%
Bacteroides fragilis 7.6435 30 seconds 99.9999%
Candida albicans 6.3345 30 seconds 99.9999%
Enterobacter aerogenes 6.0881 30 seconds 99.9999%
Enterococcus faecalis-VRE 6.3646 30 seconds 99.9999%
Enterococcus faecium-VRE MDR 6.5119 30 seconds 99.9999%
Escherichia coli 5.6990 30 seconds 99.9998%
Haemophilus influenzae 5.1775 30 seconds 99.9993%
Klebsiella oxytoca-MDR 6.0492 30 seconds 99.9999%
Klebsiella pneumoniae 6.1430 30 seconds 99.9999%
Micrococcus luteus 5.8420 30 seconds 99.9999%
Proteus mirabilis 6.2028 30 seconds 99.9999%
Pseudomonas aeruginosa 5.8096 30 seconds 99.9998%
Serratia marcescens 5.9978 30 seconds 99.9999%
Staphylococcus aureus-MRSA 6.3454 30 seconds 99.9999%
Staphylococcus aureus 6.2266 30 seconds 99.9999%
Staphylococcus epidermidis 6.0233 30 seconds 99.9999%
Staphylococcus haemolyticus 5.9112 30 seconds 99.9999%
Staphylococcus homins 5.4456 30 seconds 99.9996%
Staphylococcus saprophyticus 5.9590 30 seconds 99.9999%
Streptococcus pyogenes 6.7160 30 seconds 99.9999%

Note: The solution contains sodium hypochlorite and hypochlorous acid as preservatives to reduce/ prevent the growth of microorganisms within the solution. The effect of this product in the wound bed has not been tested clinically.