Electrospun Amino Acid-based Poly(ester urea) Biodegradable Barrier Membrane for Guided Bone Regeneration

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Abstract In the US, it is projected that by 2027 more than 200 million Americans will experience partial tooth loss. In addition, 41% of American adults need one or more treatments and at least 23% of adults over 65 years of age are edentulous (lacking teeth). With an unprecedented surge in the proportion of individuals at risk for tooth loss, dental extraction, and implantation, is becoming an increasingly prevalent treatment. However, to achieve a long-term and consistent recovery, patients must have adequate bone volume to anchor an implant at the extraction site. Post-extraction resorption of bone commonly occurs which leads to alveolar ridge bone loss. As a result, many patients lack sufficient horizontal or vertical bone, necessitating the use of GBR techniques which regenerate adequate amounts of bone for securing implantations. The prevalence of tooth loss and tooth decay in adults remains a problem to be solved, despite advancing technologies. Matregenix has developed MatriNova which is a bi-layered BM composed of a small pore size layer (SPL) and a large pore size layer (LPL) that are fully integrated into one BM. MatriNova possesses unique microstructural design (surface layers) aimed at preventing soft tissue invasion, while promoting nutrient infiltration and bone healing. Matregenix will utilize a proprietary electrospinning processes to produce fibrous and highly porous membranes with tunable properties. Amino acid-based polyester derivatives, which includes PEUs, are appealing as their degradation by-products are essential amino acids which limits toxicity. PEUs have been shown to have a limited inflammatory response in vivo. To combine the tunable mechanical properties and limited inflammatory response with sustained degradation profile, we propose a series of resorbable copolymers consisting of L-valine and L-phenylalanine monomers. These precursors will be used to produce a GBR membrane via simple electrospinning process with unprecedented properties that meet the clinician’s requirements in treating oral and craniomaxillofacial bone deficiencies. MatriNova will address the gaps inherent in both resorbable and nonresorbable BMs by eliminating the need for animal-based materials while introducing a new biomaterial to benefit the areas of wound healing, adhesion barriers, and other tissue reconstruction applications. Unlike collagen membranes, MatriNova is free from animal derivates, avoiding risk of vector transmission of animal pathogens. MatriNova will be the only synthetic resorbable membrane that does not produce acidic by-products, avoiding tissue inflammation risks. Our Phase I goal is to validate the clinical significance of the proposed electrospun amino acid based PEU degradable membrane for GBR applications in dentistry. Phase I completion will lead to a working prototype of MatriNova. In Phase II we will assess the effectiveness of the bilayered membrane on bone regeneration in an alveolar defect using a canine model, and focus on the clinical performance evaluation for a 510(k) application.