Research done prior to and including Phase I has led to publications and subsequent data that has proven the feasibility of utilizing a self-contained device as the standard of care in removing stagnated blood and generation of blood flow within congested skin flaps to promote survival. Completion of Phase I was the development of the AspiraideTM, a device that successfully mimicked the beneficial mechanisms of clinically used leeches. The skin flap therapy device was designed to minimize regulatory and manufacturing complexities. Phase II includes developing appropriately fabricated, labeled, and packaged devices for testing and preparing for commercial distribution. Due to the lack of a standard of care involving leeches, a clinical treatment schedule will be developed. Using a venous congested skin flap porcine model, research can lead to a standardized treatment regimen. The pig an optimal model for clinical relevance due to many similarities between human and porcine skin and wound healing properties between. The second portion will be using the AspiraideTM on human patients with venous congestion as part of a pilot clinical study to prove equivalency to leeches in the promotion of survival of venous congested tissues. Success of these tasks will lead to a commercially viable product.
