New Thinking in Wound Healing: Reestablishing Microbiome Homeostasis with a Unique, 3D Nanofabricated Polymer Scaffold to Achieve Definitive Wound Closure

Abstract Body: Injured skin elicits an immediate reparative response, involving four phases: hemostasis, inflammation, proliferation and remodeling. However, normal cellular functions and interactions are dependent on a homeostatic, “healthy-state” microbiome. Loss of microbiome homeostasis, often results in healing dysfunction manifested by a sustained/stalled inflammatory phase.[1-5] The commercialization of a novel 3D nanofabricated polymer scaffold (3DNSP*) was designed to support the body’s natural wound healing process. This study is to evaluate the safety and efficacy of 3DNSP* for definitive wound closure. Composed of two, naturally biodegradable synthetic polymers, the 3D morphology of 3DNSP* mimics native hemodynamic ECM which allows for cellular adhesion, infiltration and proliferation. 3DNSP* supports a low wound pH and through hydrolysis, naturally encourages _-hydroxy acids and fatty acids to facilitate angiogenesis and oxygenation to help reestablish a healthy microbiome. In this case series, four patients were evaluated utilizing 3DNSP*. Average wound size was 77.3cm2 (range 1.63cm2 - 256.9cm2).   All wounds were treated with 3DNSP as a weekly application, compression and/or off-loading as necessary.  3DNSP is a USFDA regulated 361 Human Cellular Tissue (HCT/Ps) product under 21 CFR part 1271 part 361.    Case 1, demonstrated by Day 11 a 55% reduction in wound size with a 96% reduction in wound size by Day 67 following treatment with 3DNSP* and SOC. Wound closure was achieved in 18 weeks with 3 applications. Case 2, a noticeable change in the appearance of the wound tissue was noted by Day 7. By Day 42 a 70% reduction in wound size was achieved with definitive wound closure by Day 77. Case 3, a significant traumatic injury to the left anteromedial leg achieved wound closure in 11 weeks with 1 PHOENIX application, combined with HBOT, NPWT, and SOC. In case 4, a type 1 diabetic complicated by multiple sclerosis and Raynaud’s disease presented with a traumatic injury to the right ankle. Wound closure was achieved in 7 weeks with 2 PHOENIX applications. In each case, after application of 3DNSP, a noticable change in the wound environment was apparent followed by remarkable wound progression achieving an total average reduction in wound size of 63% in 31 days.