Research Project
8337525
DESCRIPTION (provided by applicant): Pressure Wound Therapy (NPWT) is the application of sub atmospheric pressure to a wound through a specialized dressing system. The effects of NPWT promote wound healing through the following actions: drawing edema from the wound, promoting vascularization and increased blood flow, removing of exudate from the wound environment, and providing a closed, moist wound healing environment. NPWT has been widely accepted within the US medical community; however, the per-treatment cost of the currently marketed NPWT systems makes the treatment option cost prohibitive for low-resource settings. The proposed OsmoHeal System is a low cost NPWT system targeted for low-resource settings. The OsmoHeal System is a single use, disposable wound care system that functions to provide sub atmospheric pressure to the wound through a combination of mechanical air removal and osmotic fluid removal. The system consists of a mechanical air pump, an osmotic fluid pump and a specialized dressing system. The primary goals of the project are to adapt Ceramatec's proprietary technology for use in a NPWT setting, optimize the function and manufacturability of the OsmoHeal System, prove OsmoHeal functionality in an animal study, develop a manufacturing plan for large scale production, and develop a regulatory plan for gaining clearance to use the system in public commerce. In order to meet the low cost target, Ceramatec proposes to work collaboratively with Reliance Life Sciences of Maharashtra, India for the manufacturing scale-up and large scale production. This collaborative Indo-US project will be performed over a period of two years. The first year will consist of design development and optimization, in vitro testing, and transfer of the design to manufacturing. The second year will consist of pilot production, in vitro/in vivo testing, and the development of plans for manufacturing, regulatory approval, and low-cost distribution. PUBLIC HEALTH RELEVANCE: Negative Pressure Wound Therapy (NPWT) is used in the US for the healing of acute wounds, chronic wounds, and wounds that are expected to present difficulties while healing, including diabetes related wounds.1, 2, 3, 4, 5, 6 It has been shown that healing time can be as high as 61% faster and 38% less costly with combination treatment utilizing NPWT,6 even with the relatively high per-treatment cost of the currently marketed NPWT systems. The objective of this proposal is to develop and manufacture a low-cost NPWT system in order to provide individuals with low resources the opportunity to utilize the NPWT treatment modality, accelerate the wound healing process, and reduce their medical related expenses.
