Development of an Innovative Biomaterial for the Minimally Invasive Embolization of Vascular Malformations
Abstract
Arteriovenous malformation (AVM) is an abnormal connection between an artery and a vein marked by a complex tangle of blood vessels. AVMs occur in both Service Member and civilian populations and can lead to serious complications, including uncontrolled bleeding or hemorrhage. Current methods, including endovascular coils, which are inserted inside the blood vessel are used to treat AVM. However, these methods have major drawbacks, including incomplete stoppage of blood flow, high cost, reliance on natural blood clotting within the patient, the difficulty of proper administration, and challenges with patient imaging after the procedure. Obsidio, Inc. is developing an innovative universal biomaterial designed for the treatment of vascular malformation. Specifically, Obsidio is developing a patent-protected shear-thinning biomaterial (STB) technology that is biocompatible, non-toxic, stable, durable, promotes blood clotting, adhesive, inexpensive, requires less specialized skills to handle and does not rely on the body’s natural ability to coagulate blood. We are advancing STB development to serve as an effective and versatile treatment for AVM in a broad range of settings, including hospitals and health care centers with fewer resources and limited equipment. For this Peer Reviewed Medical Research Program (PRMRP) Technology/Therapeutic Development Award, our proposal relates to the Fiscal Year 2022 (FY22) cardiovascular health portfolio in the Topic Area of Vascular Malformations. This project addresses the PRMRP Strategic Goal to develop less-invasive treatment technologies for associated cardiovascular conditions. Obsidio’s scientists, Dr. Ali Khademhosseini and Dr. Rahmi Oklu, designed and developed STB. This material has unique physical properties that make it unique as compared to other available treatments, including its ability to completely block an AVM, its ready-to-use formula, and its versatility in various parts of the body. The rationale behind our research lies in abundant research showing that STB appears to be biocompatible and safe to use, while also enabling very rapid obstruction of blood flow at the affected site. Using animal studies, it was demonstrated that STB can effectively stop blood flow without the downsides observed with other treatment options. Together, these studies showed that STB may be a safer and more effective treatment for AVM. Based on these achievements, we propose to further develop STB as a treatment for AVM. Our first objective is to optimize the formulation of STB for use in hospitals by ensuring that the formula works with readily available microcatheters, which hospitals use to treat AVM. Our second objective will confirm that STB is biocompatible and safe for use using a panel of tests recommended by the Food and Drug Administration (FDA). These include ensuring that STB does not cause cell damage or mutations, is safe for the bloodstream and whole body, does not cause fever or allergic responses, and is safe to have in the body for an extended period of time. Our third and final objective is to confirm STB is effective in animals using Good Laboratory Practice (GLP) animal studies in preparation for Investigational Device Exemption (IDE) submission to the FDA, which will enable us to translate our preclinical findings into clinical applications. Ultimately, this proposed work will advance STB closer to clinical trials and to the market.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Jan 04, 2024
- Source ID
- HT94252310485
Entities
People
- Bhanu Prasanth Koppolu
Organizations
- United States Army