Chronic diabetic foot ulcers (DFUs) are a significant worldwide healthcare burden, reaching a cost of $11 billion in the US alone during 2014. The current treatment capability is limited by (i) inability of standard wet-to- dry bandaging techniques to heal these wounds and (ii) the high costs of advanced treatments such as tissue- based or living-cell bioengineered skin substitutes. The high costs of these treatments have limited reimbursement until after a wound is chronic. Each year in the US, ~1.5 million new and continuing DFU cases are documented. Over their lifetime, a diabetic patient with a foot wound has a 20% chance of lower limb amputation in the US. Reported mortality rates for DFU patients range from 55 to 74% after 5 years, which are above cancers such as prostate, breast, and colon. This significant clinical need and lack of cost-effective products creates significant market opportunity that can be addressed with a biomaterial therapy with the efficacy of an advanced skin substitute at the cost of a wound dressing. Low product cost and ease-of-use will drive reimbursement and adoption in the early (acute) phase of wound care in these at-risk diabetic patients. The ability to control inflammation and promote tissue ingrowth could mitigate the chronic wound phase, improving outcomes for patients and reducing costs to payers. Until now, there have been no low-cost treatments that when applied can integrate into the wound bed and promote regeneration without cells or biologics. To answer this market need, Tempo Therapeutics is developing a suite of tissue regeneration biomaterials based on our proprietary Microporous Annealed Particle (MAP) technology. MAP allows us to empower synthetic chemical formulations with unique geometric scaffold structure. Our MAP materials are flowable (ease of application) and fill wounds of multiple shapes and sizes and convert to a hyper-porous sponge-like network in the wound site after exposure to LED white light. The hyper-porosity geometry promotes fast tissue ingrowth, early vascularization, and faster wound re-epithelialization when compared to leading decellularized tissue-based matrices, with minimal inflammatory response. Tempo has developed our first product, the MAP Wound Matrix, for treatment of acute healthy wounds and has recently submitted a regulatory application via direct De Novo to FDA with safety and performance data. Tempo has completed initial scale-up of product manufacturing and is preparing for post market clinical data efforts beginning in 2019. In the proposed direct-to-phase II work, we will develop our second product based on the MAP technology, targeting impaired healing in diabetic wounds. We will employ specialized models of impaired wound healing in diabetic pigs, performed under Good Laboratory Practices (GLP), to test a suite of three formulation variants already demonstrated in a preliminary healthy swine study. The optimal formulation of MAP that performs in slow healing environments and stimulates tissue regeneration will be selected for safety profiling and an Investigational Device Exemption (IDE) will be submitted at the end of the proposal.
In the proposed direct-to-phase II work, Tempo Therapeutics, Inc. will continue the development of our MAP biomaterial technology for the treatment of impaired diabetic foot ulcers (DFUs). This study was initiated in a healthy porcine wound healing model and will be translated here to a diabetic pig impaired wound healing model to show performance in a clinically relevant model and prepare for clinical study. The MAP biomaterial has unique characteristics that enable it to completely fill a wound site, integrate rapidly with surrounding tissue, and promote fast tissue healing and regeneration. Completion of the proposed work will enable Tempo to develop our MAP product as a targeted diabetic wound healing matrix for the treatment of a prevalent and costly complication of diabetes worldwide.
