Product development and commercialization readiness for a class of ether-based bioresorbable polyurethanes for biomedical applications

NuShores Biosciences LLC's Sequential Phase II proposal focuses on the development and commercialization of a new class of bioresorbable polyurethanes for biomedical applications. NuShores’ initial product, NuCress™ Bone Void Filler (BVF), demonstrates potential in addressing large bone defects, a capability unmatched by current products. However, challenges with sourcing consistent biomedical-grade polymers, NuShores was required to develop a precise polymerization process to produce polymers with minimal batch-to-batch variation. The proposal highlights the outcomes from Phase I/II work, including the successful synthesis and optimization of NuPhilic™ polymers, which exhibit excellent biocompatibility, controlled degradability, and superior mechanical properties. This involved innovative mixing methodologies and the optimization of reaction conditions, resulting in polymers with controlled degradation rates and consistent properties. The proposal outlines three key aims for the Sequential Phase II effort. Aim 1 involves finalizing the polymer recipe optimization and documentation, ensuring reproducibility and quality. This includes studying the effects of stabilizers and environmental conditions using advanced monitoring technologies like IntelliLid™. Aim 2 focuses on scaling up the manufacturing process, automating the addition of reactants, and increasing batch sizes while maintaining quality. This includes designing automated dispensing systems and testing different mixer sizes to achieve efficient large-scale production. Aim 3 aims to mature the product and submit a comprehensive Polymer Device Master File (DMF) to the FDA, ensuring compliance with ISO 13485 and regulatory standards. This involves conducting biocompatibility studies and risk assessments, crucial for market acceptance and regulatory approval. NuShores plans to transition from development to commercialization by scaling up production to meet market demands, securing FDA registration for NuPhilic™ polymers, and expanding their use in various biomedical applications. Through this effort, NuShores aims to address a significant gap in the market for high-quality, precision polymers, benefiting not only their products but also other companies in the biomedical field. The successful implementation of this proposal will advance the technology readiness level of NuPhilic™ polymers, ultimately improving patient outcomes and solidifying NuShores' position as a leader in biomedical polymer manufacturing.