Endomimetics, LLC has been awarded a $2.8 million Phase II Small Business Innovation Research (SBIR) grant to further develop and evaluate its Bionanomatrix™ technology for improving the performance of flow diverters used in the treatment of brain aneurysms. The funding will support research into the application of Bionanomatrix™ to accelerate healing following medical device implantation.
The Phase II SBIR grant will facilitate the scale-up and optimization of the Bionanomatrix™ coating manufacturing process, including long-term stability testing and packaging validation. Additionally, the grant will fund the assessment of the coating's efficacy and safety over two and six months in a rabbit aneurysm model. Endomimetics is collaborating with Ramanathan Kadirvel, Ph.D., and David Kallmes, M.D., from the Mayo Clinic, to evaluate the Bionanomatrix™ coating for flow diverters in the brain.
Addressing the Risks of Brain Aneurysms
Brain aneurysms affect approximately 3% of the U.S. population, with about 30,000 ruptures occurring annually. These ruptures lead to death in approximately 40% of cases, and significant disabilities in four out of seven survivors. Flow diverters are increasingly used to prevent aneurysm rupture by covering the aneurysm neck and promoting durable occlusion. However, until endothelialization and aneurysm occlusion occur, patients face an elevated risk of thromboembolic complications and intracranial hemorrhage, often requiring dual antiplatelet therapy.
Bionanomatrix™ Mechanism of Action
The Bionanomatrix™ coating is designed to mimic the properties of native endothelium. By incorporating this coating onto flow diverters, Endomimetics aims to enhance endothelial coverage and accelerate aneurysm closure, ultimately reducing post-treatment adverse events. The coating facilitates the sustained release of nitric oxide, which recruits and retains endothelial cells while reducing inflammation. It also includes an endothelial cell adhesive ligand to promote endothelial cell retention and migration.
Future Plans
"Brain aneurysms carry the devastating risk of rupture, leading to death or permanent disability," said Joseph Garner, Ph.D., Chief Executive Officer of Endomimetics. "Application of the Bionanomatrix™ coating to flow diverters could accelerate endothelialization and reduce the risk of embolic stroke or brain hemorrhage and improve patient outcomes. If this research is successful, we plan to partner the technology with a flow diverter manufacturer and begin IND Enabling studies and clinical development."
