Development of an Innovative Material for Transcatheter Peripheral Embolization

点击翻译按钮获取中文摘要

PROJECT SUMMARY Hemorrhage and uncontrolled bleeding are a leading cause of death, and when not fatal can result in adverse health outcomes with long term negative consequences including organ damage or failure, and coma. Uncontrolled bleeding can arise from a variety of diseases, traumatic injuries, and health conditions, such as atrial fibrillation, which afflicts over 2.6M people in the United States. Most atrial fibrillation patients are required to take anticoagulants (ACAs). The standard of care (SOC) for internal hemorrhage is transcatheter embolization to occlude the bleeding artery or vein, however, there are major drawbacks of currently available methods, including high cost, lack of complete occlusion, reliance on patient coagulation, difficultly of proper administration, imaging artifacts, and the chance of migration or fragmentation of the material. There is a significant unment need for embolization materials that are compatible with ACAs, are easy to use, and are effective and safe for use. To address this need, in this Fast-track proposal Obsidio, Inc is developing an innovative embolic material called shear-thinning biomatieral (STB) that has the qualities required for a versatile and effective embolic material. STB is ready to use and does not require mixing or preparation, is easy to administer via standard microcatheters, can be delivered over a short or extended time period without fear of clogging the catheter, does not produce an image artifact after administration, and is comprised of materials that are safe and biocompatible. Moreover, STB is a more cost-effective option for both patients and hospitals and does not require the same level of expertise to administer as other methods.The objective of this Fast-track proposal is to develop a clinical-grade formulation of STB for peripheral hemorrhage control and initate a design freeze, demonstrate safety of both the biomaterial and the device through ex vivo and in vivo studies, and complete the testing required by the FDA including biocompatibility studies and GLP animal studies. In Phase I of the Fast-track we propose to finalize STB formulation, validate the safety and efficacy of clinical- grade STB, and evaluate its performance in a non-GLP rodent model. In Phase II of the Fast-track we propose to validate STB performance in a non-GLP bleeding porcine model of hemorrhage, followed by ISO-10993 biocompatbility studies to confirm safety of the biomateirals, including an in vitro in vivo correlation studies to determine the degradation of STB. Finally, we will conduct GLP studies in a porcine model to characterize the performance and safety of STB. Successful completion of this work with enable Obsidio to advance to 510k clearance for STB used in peripheral hemorrhage. Overall, development of this novel biomaterial will provide physcians a novel embolization option with superior performance and versatility that will ultimately help to save hundreds of thousands of lives annually.