Enhancing Dental and Craniomaxillofacial Surgery Outcomes with Cost-Effective and Scalable Animal-Free Amino Acid-Based Membranes for Guided Bone Regeneration

Abstract Regenerative strategies for oral and craniomaxillofacial (CMF) defects using autogenous bone grafts are often constrained by limited availability and donor site morbidity, necessitating a barrier membrane (BM) to facilitate bone growth. However, current BMs fail to provide the ideal properties required for guided bone regeneration (GBR) despite their critical role in dental and CMF surgeries. Many available BMs lack the mechanical strength and flexibility for proper adaptation to bone defect sites, leading to potential membrane rupture or displacement, which can compromise bone regeneration. Although GBR is a valuable tool for restoring lost bone tissue and improving function, these limitations can increase patient discomfort, costs, and morbidity. Matregenix has developed MatriNova, a bilayered BM produced using a proprietary, scalable, and reproducible electrospinning technology. MatriNova is an animal-free amino acid-based poly(ester urea) (PEU) membrane for oral and CMF bone regeneration. It features a unique microstructural design, including surface layers that prevent soft tissue invasion while promoting nutrient infiltration and bone healing. Using amino acid-based polyester derivatives, such as PEUs, is particularly advantageous because their degradation by-products are essential amino acids, reducing toxicity. In preliminary studies, we demonstrated that MatriNova supported bone formation similarly to Bio-Gide (gold standard collagen membrane) in critical-sized calvarial defects. In this Phase II proposal, Matregenix seeks to establish the efficacy and clinical significance of MatriNova, aiming to submit a 510(k) package to the FDA for regulatory clearance. First, we will assess the regenerative efficacy of the membrane using a large animal (Porcine) model under non-GLP conditions to determine the influence of the membrane's unique bilayered structure (large pore layer/LPL-bone side and small pore layer/SPL-epithelial side) in supporting alveolar bone and periodontal regeneration. Additionally, we will conduct pre-clinical investigations to support the FDA 510(k) application, including product stability, packaging and sterilization validation, biocompatibility assessment, and evaluating safety and effectiveness through a large animal GLP study. Our findings demonstrate that (1) MatriNova can be fabricated with tunable mechanical properties; (2) MatriNova can inhibit soft tissue ingrowth in a periodontal defect model while stimulating the regeneration of periodontal tissues; (3) PEUs elicit limited inflammatory response in vivo; (4) MatriNova delivers a sustained degradation profile; and (5) MatriNova can be manufactured at scale using our proprietary TURBO spinning technology, offering significant cost-effectiveness compared to competing technologies. The successful launch of our dental innovation will catalyze MatriNova to revolutionize the broader soft tissue repair field by introducing the first synthetic biomaterial that avoids inflammatory by-products. Bringing MatriNova to the market will lay the groundwork for developing additional products based on our platform technology, benefiting the broader soft tissue repair market with a biologically-free biomaterial that is scalable and cost-effective, ultimately helping to reduce healthcare costs.