SBIR Phase I: Development of a Novel, Sprayable, Large Volume Hydrogel Delivery System Platform

Karios Technologies, Llc, Charlottesville VA

Investigators

Abstract

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is a simplified system for applying compound in situ to form biomaterials during surgical procedures. Controlled biomaterial applications pose significant potential surgical advantages including for anti-adhesion, tissue sealant, and drug delivery purposes. The proposed platform will enable procedural consistency to provide new and improved ways to manage bleeding and reduce scar tissue formation during surgical procedures. This product aims to gain a share of the $1.5 billion adhesion prevention market and $1.2 billion hemostat market, and enable eventual site-specific delivery cells and drugs, depending on the biomaterial delivered. This Small Business Innovation Research (SBIR) Phase I project will develop a ready-to-use, large volume delivery system for in situ forming biomaterials. The scope of activities includes transferring a novel, proprietary, in situ biomaterial with applicability as a tissue sealant, scar tissue reductant, and drug/cell delivery vehicle, into a novel single use applicator. The prepackaged delivery system will formulate the suspended biomaterial with the resuspension solution using an internal mechanical mechanism which delivers the biomaterial in a controlled aerosolized manner suitable for clinical use. This Phase 1 project aims to complete and validate prototypes with lyophilized biomaterials within good manufacturing practices, engineer the design of the syringe barrel and delivery tips/nozzles, and complete laboratory validation in a manner suitable for first in human use. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.