POP is an area of significant unmet medical need where patients and doctors alike are desperate fora 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 women's physical, mental, and sexualhealth, family relationships, daily living, and quality of life. Surgical options are the only available treatment forsevere POP. In the US, over 300,000 POP surgeries are performed annually for symptomatic POP repair and caninclude the use of native tissue, synthetic meshes, and acellular biologic grafts (ABGs). Unfortunately, thesematerials 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 genitaltearing; these risks are so serious that the use of surgical mesh was recently banned in the US and several othercountries. Currently available ABGs have high recurrence rates and complications can include graft mechanicalfailure, host-integration failure, and infection. Despite these issues, surgeons still support the use of currentcommercially available ABGs for POP because ABGs have higher cure rates than surgical methods that usenative tissue. BioAesthetics is developing a transformative, polymer-strengthened ABG for use in POP surgeriesfor women with severe POP. Our customer discovery identified mechanical strength as the key feature neededfor improving ABGs, thus, we developed patent-pending tissue engineering techniques for decellularization, tomake ABGs, and for polymer impregnation, which enhances the ABG's mechanical properties. Our strengthenedABG simultaneously provides an allogeneic scaffold for patient-mediated tissue regeneration while countering theonset of complications due to graft mechanical failure, improving the safety and efficacy of POP surgery. In thisPhase I project BioAesthetics is assessing the feasibility of this innovative product for use in POP correctivesurgeries 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-conceptdata to serve as a foundation for future efforts. A subsequent Phase II project will focus on further developing theproduct, expanding preclinical testing in additional large animal models of POP, and performing necessarybiocompatibility work for an FDA submission. Our ultimate goal is to develop a novel ABG that changes theclinical paradigm for POP surgical repairs, resulting in improved outcomes and improved health andquality of life for women with severe POP.
Public Health Relevance Statement: 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.
Project Terms: Adult ; 21+ years old ; Adult Human ; adulthood ; Affect ; Anatomy ; Anatomic ; Anatomic Sites ; Anatomic structures ; Anatomical Sciences ; Antigens ; immunogen ; Anus ; Anal ; Biological Assay ; Assay ; Bioassay ; Biologic Assays ; Cell Survival ; Cell Viability ; Cells ; Cell Body ; Collagen ; Elastin ; Family Relationship ; Family Relations ; Female ; Fibroblasts ; Fibroins ; Foundations ; Future ; Genitalia ; Genital Organs ; Goals ; Health ; Hemorrhage ; Bleeding ; blood loss ; Human ; Modern Man ; Incontinence ; Infection ; Mental Health ; Mental Hygiene ; Psychological Health ; Methods ; Nerve Tissue ; Nervous Tissue ; Pain ; Painful ; Legal patent ; Patents ; Patients ; Pelvis ; Pelvic ; Pelvic Region ; Polymers ; Quality of life ; QOL ; Sprague-Dawley Rats ; Rattus ; Common Rat Strains ; Rat ; Rats Mammals ; Reagent ; Recurrence ; Recurrent ; Risk ; Rodent ; Rodentia ; Rodents Mammals ; Safety ; Surgical Mesh ; Testing ; Tissues ; Body Tissues ; Urinary tract infection ; Urinary tract infectious disease ; urinary infection ; Uterus ; womb ; Vagina ; Vaginal ; Woman ; Work ; wound healing ; Wound Repair ; wound resolution ; Silk ; Measures ; Women's Health ; Female Health ; Anisotropy ; falls ; Mediating ; Organ ; improved ; Area ; Clinical ; repaired ; repair ; Phase ; Biological ; Histologic ; Histologically ; Physiological ; Physiologic ; Medical ; Pelvic floor structure ; Pelvic Floor ; Epithelial ; Dermal ; Failure ; nonhuman primate ; non-human primate ; Engraftment ; Deposit ; Deposition ; scaffolding ; scaffold ; mechanical ; Mechanics ; Complex ; Techniques ; System ; Country ; physical health ; physical conditioning ; reconstructive surgery ; Reconstructive Surgical Procedures ; Operative Procedures ; Surgical ; Surgical Interventions ; Surgical Procedure ; surgery ; Operative Surgical Procedures ; Surgeon ; bioengineered tissue ; engineered tissue ; Tissue Engineering ; biocompatibility ; biomaterial compatibility ; Cell Growth in Number ; Cell Multiplication ; Cellular Proliferation ; Cell Proliferation ; experience ; success ; Animal Models and Related Studies ; model of animal ; model organism ; Animal Model ; Hydrogels ; novel ; abdominal wall ; Modeling ; model development ; Involuntary Muscle ; Smooth Muscle ; Thickness ; Thick ; Address ; Sexual Health ; Symptoms ; Data ; pre-clinical testing ; Preclinical Testing ; in vivo ; Allogenic ; Apoptotic ; Patient-Focused Outcomes ; Patient outcome ; Patient-Centered Outcomes ; Rodent Model ; Small Business Innovation Research Grant ; SBIR ; Small Business Innovation Research ; Process ; Development ; developmental ; tissue regeneration ; regenerate new tissue ; regenerate tissue ; regenerating damaged tissue ; regenerating tissue ; tissue renewal ; tissue specific regeneration ; neovascularization ; reconstruction ; novel strategies ; new approaches ; novel approaches ; novel strategy ; Outcome ; wound ; tissue wound ; wounding ; wounds ; Population ; innovation ; innovate ; innovative ; Implant ; implantation ; preimplantation ; pre-implantation ; pelvic organ prolapse ; improved outcome ; mechanical properties ; Modulus ; chronic infection ; persistent infection ; Genital ;
