Tough Adhesive Sealants for Vascular Surgery

Project Summary Delay or inability to achieve hemostasis can lead to excessive bleeding, which can complicate recovery, elevate the risk of morbidity and mortality, and increase the need for blood transfusions or other scarce and expensive products. In a study examining 1.6 million surgical procedures, over 30% of patients were found to have bleeding- related complications, resulting in prolonged hospital length of stay and $10k-15k in incremental costs per hospitalization. Despite use of industry-leading products, up to 68% of patients still have major bleeding events, resulting in up to $61k spent per patient, a 7% risk of mortality, and a 70% chance of requiring blood transfusions. Limax Biosciences, Inc. has developed HemoMax, a biodegradable hydrogel adhesive with 100-1000x adhesion energies on wet surfaces compared to those of existing sealants. Adhesion occurs within minutes, independent of blood exposure, and results in a seal that is compatible with in vivo dynamics. Published in vitro and in vivo studies demonstrate the tough adhesive’s efficacy in accelerating and supporting tissue healing. However, additional work is necessary to achieve FDA approval and commercial viability as a vascular sealant. The overall objective of this Phase I study is to perform the sterilization validation, bench performance, and pilot animal trials to support work towards an investigational device exemption (IDE) for HemoMax as a class III PMA. This project will: (1) conduct comprehensive bench performance testing on HemoMax, including sterilization validation and endotoxin assessment, and (2) Evaluate safety and efficacy (up to 2 weeks post implantation) in a large animal non-GLP trial examining injuries to aorta. The demonstration of safety and efficacy of HemoMax will bring about a paradigm shift in the management of severe hemorrhage during surgical procedures. By providing a cost effective and rapidly deployable solution, it could guarantee quick and dependable hemostasis, ultimately leading to a significant improvement in the overall effectiveness of medical operations. Clinical champions of HemoMax not only recognize its capacity to revolutionize systemic bleeding management but also believe that its integration into medical practices could mark a pivotal advancement in patient care and surgical outcomes. Together, this funding will enable Limax Biosciences to support its data package towards an IDE for HemoMax and follow-on Phase II funding.