P-SEF

Patient-Specific Expandable Foam (P-SEF)

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. 

Highlights

• 8.2 million complex wounds are treated annually, often managed using negative pressure wound therapy (NPWT) – a therapy where the wound is sealed with a polyurethane foam and connected to a continuous vacuum suction device.
  
  
• NPWT vacuum seals are limited by manually cut foam blocks that do not fit wounds with irregular geometries or difficult anatomical locations.
  
  
• Our solution, Patient-Specific Expandable Foam (P-SEF), is an expandable porous polyurethane polymer spray, which expands to the exact dimensions of the wound bed and replace manually-cut blocks.
  
  
• Our product conforms precisely to each wound, is easier to apply, provides a better vacuum seal, and opens NPWT wound treatment application to previously inaccessible areas.
  
  
• In addition, P-SEF would be much more portable than current pre-contoured foams, which makes it an ideal solution for military medicine/battlefield injuries.

Problem

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.

Solution

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:

1. Ease of application: The expandable foam polymer would be patient and wound specific requiring no manual contouring making the technical application of the foam much less cumbersome. This would lead to a significant decrease in operative time and decreased cost to the patient and hospital system.
2. Improved bio-occlusive seal: Since the foam polymer will expand to fill the specific geometry of the wound bed perfectly, it will lead to an improved vacuum seal and a more uniform negative pressure across the entire wound bed. This would lead to a more effective debridement and reduced need for unexpected and unnecessary re-operation, which is a significant problem with the current product on the market.
3. Expansion to NPWT to new anatomic locations: This solution would allow for application of NPWT to an expanded set of anatomic locations that are currently inaccessible due to the inability to manually apply the foam in a safe and controlled manner.

Competition

The competitive landscape analysis below summarizes key features of this solution, and current competitors working to solve similar healthcare problems.

Team

• Eric Beckman, Ph.D., Bevier Professor of Engineering, co-director of the Mascaro Center for Sustainable Innovation, and co-founder of Cohera Medical. Expert in polymer science with a proven track record of bringing biomedical products, such as TissueGlu, to market.
  
  
• Kenneth Urish, MD, Ph.D., Assistant Professor, Department of Orthopaedic Surgery, Director of Magee Bone and Joint Center, and Medical Director of the Arthritis and Arthroplasty Design Laboratory. Expert in clinical wound care management with an established animal model for translational research.
  
  
• Malcolm Dombrowski, MD, and Neel Patel, MD, 4th-year Orthopaedic surgery residents in the clinician-scientist training program at the University of Pittsburgh Medical Center. Extensive experience in clinical and translational research in the Ferguson Laboratory for Orthopaedic Research, the Biodynamics Lab, and the Orthopaedic Robotics Lab.

Milestones

• Milestone 1: Development of initial expandable foam prototype. Design and Utility Patent Submission based on Developed Prototype.
  
  
• Milestone 2: Safety and efficacy testing of foam prototype in an animal model. Peer-reviewed publication of results to serve as a foundation for human clinical trials.

Path to Impact Plan

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.