How Simini Products Work

Bacterial Cell Lysis

Bacterial Cell Lysis Bacterial Cell Lysis Bacterial Cell Lysis

Principle:

Science:

Safety:

“Like Solvents dissolve like polymers”

Identified three conditions that cause bacterial cell breakdown.

Employed safe ingredients to achieve all three conditions.

Destroys Biofilms

Destroys Biofilms 8 Destroys Biofilms 8 Destroys Biofilms 8

Principle:

Science:

Safety:

“Biofilm has similar structure to rubber”

Break down biofilm using same approach to break down rubber.

Employed safe ingredients to achieve biofilm disaggregation.

Safe Ingredients

Lavage Ingredients Lavage Ingredients Lavage Ingredients
Gel Ingredients Gel Ingredients Gel Ingredients

Safety Studies

ISO Intramuscular Implantation Test with Histopathology (14 Day Rabbit Study) – Simini Protect Lavage

  • No abnormal clinical signs
  • Lavage was considered a “Non-Irritant” as compared to predicate device

Porcine Dermal Testing (14 Day uninfected Study) – Simini Protect Lavage

  • Lavage resulted in normal wound healing and was comparable to a predicate device

ISO 10993 testing to establish safety

  • Passed evaluations

24 Hours Abraded Dermal Irritation – Simini Protect Gel

  • No irritation or sensitization

14 Day Abraded Dermal Irritation – Simini Protect Gel

  • No systemic toxicity, no irritation or sensitization

Maximal sensitization – Simini Protect Gel

  • Does not elicit sensitization response when compared to predicate device

Dilution Assay (cytotoxicity) – Simini Protect Gel

  • Equivalent to predicate device

Intracutaneous Irritation – Simini Protect Gel

  • Equivalent to predicate device

14 Day Full Thickness Wound in Rats – Simini Protect Gel

  • No irritation, complete wound healing in less than 14 days