Noveratech L.L.C. — Department of Health and Human Services SBIR Phase II: 200

Description

ABSTRACT Diabetes is the leading cause of nontraumatic lower extremity amputations in the United States Diabetic foot ulcers DFUs are responsible for more hospitalizations than any other diabetic complications Currently even the best available treatments achieve only a healing rate for these wounds and this healing is often only temporary with a chance of recurring Our company has developed an intracellular ATP delivery technique ATP vesicles or VitaSolTM for tissue ischemia When used in wound treatment it heals wounds faster than many control dressings During the Phase I period VitaSolTM healed wounds faster than Regranex and showed no toxic effects in the local lymph nodes or reproductive systems in both male and female rabbits One special feature of VitaSolTM is its ability to trigger extremely rapid tissue regeneration granulation growth appears within hours after application This growth continues and covers the wound cavity within a few days a phenomenon never seen or reported before with any other treatment strategy The Phase II study will bring this new technique closer from the bench to bedside We will first undertake a larger scale manufacturing of VitaSolTM in a cGMP facility to meet FDA requirements and to produce VitaSolTM in a practical package for easy application We will then test the new VitaSolTM preparation in an animal model close to DFU month diabetes plus ischemia and to compare the healing effects with Regranex Our approach is a potential game changer for DFU treatment The wound healing process involves hemostasis inflammation proliferation and remodeling resulting in a day lag before granulation tissue starts to appear This process seems to be carved in stone and no one has ever been able to change it The elimination of the lag time and the ability to support cell survival and proliferation in a wound cavity without blood supply are two features never been achieved with any other treatment These characteristics could have tremendous potential in the treatment of DFUs The potential impact is high NARRATIVE Our company has developed a new technique for intracellular ATP delivery to provide the diabetic wounds with much needed energy The Phase I study has shown its superior healing capability than Regranex and no toxicity was found in local lymph nodes and the reproductive systems in both male and female rabbits The Phase II will produce the dressing in cGMP facility to make the package for easy application and to test its healing effects in month diabetic plus ischemic wounds This new approach is a potential game changer for diabetic foot ulcers