Poraderm: A Fully Degradable Synthetic Cutaneous Wound Treatment

摘要

We are PEURegen Inc. and we are developing Poraderm, an implantable, degradable, synthetic skin substitute designed for application in full thickness wounds such as diabetic foot ulcers (DFUs) or pressure ulcers (PUs). As an implantable scaffold, Poraderm presents a compelling opportunity for wound repair and restoration to healthy skin functionality. Poraderm is a prefabricated skin substitute, made of a porous polymer (polyurethane), which can be designed to have structural properties similar to those of native skin. Polyurethane (PUR) is a synthetic polymer that has been utilized in medical devices and resorbable scaffolds for tissue regeneration, and has a history of U.S. Food and Drug Administration (FDA) clearance for a variety of indications. Poraderm can be manufactured as a three-dimensional foam and customized post-hoc. The customizable size of the material will allow clinicians to completely fill the entire defect in one easy application. The porous structure of Poraderm provides a scaffold for skin regenerating cells to infiltrate, remodel, and replace with healthy skin. Additionally, the fully degradable synthetic chemistry naturally dissolves into non-toxic small molecules that are easily cleared from the body. This has been proven in preclinical porcine excisional wound studies, shown in Figure 1, where Poraderm provides advanced wound healing compared to controls. Poraderm's synthetic nature makes it an attractive material in that it has no potential of transmitting infectious diseases, does not induce a prolonged immune response, and subsides regulatory constraints that accompany biologics-based therapies. Current treatment options have disadvantages that affect the clinicians applying the grafts, the patients, and the insurance providers. The key technical/economic hurdles that have limited the uptake and effectiveness of current wound care products are the ability to 1) be easily handled by clinicians, 2) fill full-thickness voids with material that has structural rigidity that will 3) stay in place and 4) be incorporated into the healing process, while being offered at a 5) reasonable price. Poraderm is currently being developed to address these issues.