Polymer-Strengthened AcellularBiologically-Derived Grafts for Pelvic Organ Prolapse

SUMMARYPOP is an area of significant unmet medical need where patients and doctors alike are desperate for a safe and effective solution. Worldwide, over 1 billion women are impacted by POP, as it affects 33% to 50% of all women. POP symptoms can have significant negative impacts on womenandapos;s physical, mental, and sexual health, family relationships, daily living, and quality of life. Surgical options are the only available treatment for severe POP. In the US, over 300,000 POP surgeries are performed annually for symptomatic POP repair and can include the use of native tissue, synthetic meshes, and acellular biologic grafts (ABGs). Unfortunately, these materials do not currently perform well. Over 40% of vaginal POP surgeries using native tissue fail within 2 years. Synthetic meshes carry significant safety risks including chronic infection, nerve and tissue damage, and genital tearing; these risks are so serious that the use of surgical mesh was recently banned in the US and several other countries. Currently available ABGs have high recurrence rates and complications can include graft mechanical failure, host-integration failure, and infection. Despite these issues, surgeons still support the use of current commercially available ABGs for POP because ABGs have higher cure rates than surgical methods that use native tissue.BioAesthetics is developing a transformative, polymer-strengthened ABG for use in POP surgeries for women with severe POP. Our customer discovery identified mechanical strength as the key feature needed for improving ABGs, thus, we developed patent-pending tissue engineering techniques for decellularization, to make ABGs, and for polymer impregnation, which enhances the ABGandapos;s mechanical properties. Our strengthened ABG simultaneously provides an allogeneic scaffold for patient-mediated tissue regeneration while countering the onset of complications due to graft mechanical failure, improving the safety and efficacy of POP surgery. In this Phase I project BioAesthetics is assessing the feasibility of this innovative product for use in POP corrective surgeries by first focusing on determining the mechanical strength of our polymer-strengthened ABG both pre- and post-implantation in a rodent model.Successful completion of this project will validate the feasibility of our product and generate proof-of-concept data to serve as a foundation for future efforts. A subsequent Phase II project will focus on further developing the product, expanding preclinical testing in additional large animal models of POP, and performing necessary biocompatibility work for an FDA submission. Our ultimate goal is to develop a novel ABG that changes the clinical paradigm for POP surgical repairs, resulting in improved outcomes and improved health and quality of life for women with severe POP.NARRATIVE BioAesthetics is creating an acellular biologic graft for use in pelvic organ prolapse (POP) repair surgeries with enhanced strength from the addition of a biocompatible, biodegradable, tunable hydrogel within the graft itself. Our novel approach simultaneously provides an allogeneic scaffold for patient-mediated tissue regeneration while countering potential complications resulting from graft mechanical failure during the course of wound healing.