A polymer spray which expands to exact wound dimensions, saving critical time in the operating room and replacing ineffective manually cut foam blocks to provide an optimal wound healing environment.
Complex acute and chronic soft tissue wounds affect 15% of all Medicare patients costing the health care system approximately 32 billion dollars annually. This issue is one of the most widespread problems in health care today, involving essentially all subspecialties of medicine.
Currently, the gold standard for management of complex wounds that are either contaminated and/or have significant soft tissue loss is through the use of negative pressure wound therapy (NPWT). NPWT utilizes a technique involving directly applying a sealed polyurethane foam that is manually contoured by the surgeon to a wound bed and then connecting it to continuous vacuum suction.
While NPWT has been shown to be more effective compared to previous treatments, there are still areas that need to be significantly improved. Currently, negative pressure wound therapy requires manual contouring of a pre-made porous polyurethane foam to the dimensions of a wound, making it technically cumbersome and difficult to use.
Unfortunately, the current system’s inability to perfectly contour the foam manually leads to a loss of the seal required to maintain negative pressure. This requires the need for reapplication of the foam either at the bedside or in the operating room, leading to increased patient morbidity and cost.
Our novel solution entails a porous, hydrophobic, and biologically inactive polyurethane foam polymer that expands, contours, and solidifies to the exact dimensions of the wound bed.
Our solution would significantly improve the current market products in three major ways:
The competitive landscape analysis below summarizes key features of this solution, and current competitors working to solve similar healthcare problems.
Our path to dissemination and implementation begins with the development of the expandable foam and the completion of animal studies. We believe this will be realistically attainable within the 12-month time frame based on our team’s experience with TissuGlu, which is an FDA- approved adhesive used for surgical wounds that Dr. Beckman developed and commercialized as a co-founder of Cohera Medical, Inc.®.
After development of the prototype, safety and efficacy testing in Dr. Urish’s established animal model will provide data regarding the outcomes and proof of concept for use of the expandable foam. These animal studies will serve as a foundation to aid in the transition to testing of the foam in currently ongoing phase III human clinical trials for which Dr. Kenneth Urish is a co-investigator. The regulatory pathway would be easy to navigate given that this is a modification of the currently approved NPWT and would be classified as a low risk product. Ultimately, the path to clinical adoption could be fast- tracked using resources from currently ongoing partnerships with an established vacuum assisted closure (VAC) company that has shown interest in the product.
What types of injuries or diseases lead to chronic and traumatic complex wounds?
Many common diseases, such as diabetes and peripheral vascular disease, can lead to chronic non-healing wounds for which NPWT is used. Additionally, high-energy traumatic injuries as seen in automobile or motorcycle accidents can lead to complex open wounds that require NPWT.
How do you create the negative pressure?
Similar to current NPWT, once our foam has expanded to the dimensions of the wound bed, a biocclusive dressing is placed over top and the construct is connected to a negative pressure device (vacuum suction). The porosity of the foam allows the negative pressure to reach the wound bed.
How do you remove the foam?
The foam is removed similar to other vacuum foams, i.e. via manual removal. The foam is a nonadherent biologically inactive hydrophobic foam that keeps it from sticking and interacting with the surrounding tissues.