A flowable microporous biomaterial as a low cost, high efficacy diabetic chronic ulcer treatment

DESCRIPTION provided by applicant Chronic diabetic foot ulcers are a significant worldwide healthcare burden reaching a cost of $ billion in the US alone during These wounds are notoriously difficult to manage because of slow healing weak tissue after healing and high infection rates Low cost bandaging and wound dressings are used to treat diabetic wounds in the early stages but have poor efficacy and often allow progression to the chronic phase where expensive bioengineered skin substitutes are used These bioengineered treatments have not shown sufficient efficacy to warrant reimbursement early at their high cost and thus see low practical efficacy in wound care clinics today In there were amputations performed due to diabetic foot ulcers and the average cost of an outpatient visit was $ with ulcer healing rates of only and recurrence rates above It is clear that a significant market opportunity exists to create 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 and a regenerative therapy will increase healed tissue mechanical and vascular properties mitigating 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 sutures or implantation We at Tempo Therapeutics have developed a fundamentally new synthetic low cost poly ethylene glycol biomaterial MAP gel that is flowable ease of application and bonds to the wound bed upon application to produce a material that enables functional tissue regeneration Our technology is the first of its kind allowing filling of any shape size wound bed with a synthetic low cost product that actually promotes accelerated wound healing and functional tissue regeneration Upon application within the wound bed the material is set and bonded to the tissue bed with seconds of white light exposure This unique approach provides a microporous network of void space in the material where tissue can freely grow into the material before it is degraded In vivo the MAP gel enables immediate wound sealing accelerated healing and increased regeneration with a single application to the wound taking only minutes Here we aim to continue the development of the MAP gel for the treatment of slow healing diabetic wounds Specifically we will engineer a slowly degrading material to address slow healing wounds and harness the modular nature of our material to create degradation profiles that will support large tissue structure formation in vivo a characteristic unique to the MAP gel and previously unobtainable with current technologies We will assess both the rate of tissue healing and the amount of tissue regeneration in a diabetic murine wound healing model as well as the mechanical strength of the reformed tissue after healing compared to current treatments Completion of our proposed Aims will result lay the groundwork for successful phase II large animal porcine studies of safety and efficacy ultimately towards a strong FDA portfolio for k approval PUBLIC HEALTH RELEVANCE In the proposed work we will continue development of the Microporous Annealed Particle MAP gel system as a transformative high efficacy low cost treatment for diabetic foot ulcers The MAP gel the flagship biomaterial technology of Tempo Therapeutics Inc has unique characteristics that enable it to completely fill a wound site allowing strong integration with surrounding tissue while also enabling fast tissue healing and tissue regeneration The MAP gel is the first of its kind enabling tissue healing and regeneration without any further medical intervention Completion of the proposed Aims will enable Tempo to translate our previous high efficacy wound treatment in healthy mice to the impaired wound healing in diabetic mice both in terms of acceleration of healing and increased tissue mechanical properties after wounds are healed This data will lay the groundwork for phase II studies to support FDA approval via the k pathway