ZuraGard™: Being second with a better product.

Area of Science:

• Pharmaceutical Development
• Antiseptic Formulations
• Medical Device Solutions

Background:

• Development of an anticoagulant and antibacterial catheter lock solution revealed an effective skin antiseptic formulation.
• A sister company, Ash Access, was established to advance the skin preparation through clinical trials.
• Intellectual property was exchanged for partial ownership in the new venture.

Purpose of the Study:

• To report the development and regulatory approval of a novel pre-operative skin antiseptic.
• To outline the successful progression toward production and marketing of the approved product.
• To leverage insights from a previous product for a streamlined second product launch.

Main Methods:

• Formulation of a skin antiseptic from components of a catheter lock solution and alcohol.
• Establishment of a dedicated company for development and clinical trials.
• Pursuit of regulatory approval from the Food and Drug Administration (FDA).

Main Results:

• Demonstration of the components and alcohol as an effective skin antiseptic.
• Securing Food and Drug Administration (FDA) approval for the pre-operative skin preparation, ZuraGard™.
• Successful initiation of production and marketing strategies for the new product.

Conclusions:

• The developed skin antiseptic has achieved FDA approval, marking a significant milestone.
• The company is actively moving towards commercialization of the pre-operative skin preparation.
• Experience gained from prior development facilitated a clearer path for this second product's regulatory and market entry.