SBIR-STTR Award

Reia is working to address a prevalent gynecological condition, pelvic organ prolapse (POP), which affects more than 50% of women over the age of 50. POP occurs when the pelvic floor connective tissue and muscles weaken, allowing the uterus or vaginal walls to descend. In extreme cases, the uterus descends through the opening of the vagina and hangs outside of the body. POP can be treated non-surgically with a medical device called a pessary which is inserted into the vaginal canal and acts as a shelf to support the descending organs. Commonly used pessaries have a fixed and rigid design, making them difficult or impossible for patients to remove and insert independently. Reia has done preliminary work with affected women and their practitioners to design an innovative collapsible pessary that will enable autonomous use and address many unmet needs of current pessaries on the market. The purpose of this Phase I SBIR is to modify and optimize Reia’s vaginal pessary design to further meet user and regulatory requirements and evaluate the technical feasibility of the design. Reia will achieve these aims by optimizing the actuation mechanism that allows for collapsibility, changing the geometry to minimize irritation, and enhancing cleanability to improve hygienics. Reia will also examine safety and efficacy via simulations and benchtop testing. Defined evaluation criteria have been established in order to measure progress and success. Reia’s founding team is comprised of a urogynecologist with 25 years of experience fitting pessaries and treating POP and three female engineers with combined experience in R&D, product development and IP advisory. Additionally, an advisory board contributes expertise in urogynecology, bringing medical devices to market, and successful completion of numerous NIH grant funded projects. Reia has strategically aligned with facilities in New Hampshire and Massachusetts to gain access to necessary equipment and resources to successfully complete this project. Reia is committed to optimizing the pessary design to bring to market the first-ever pessary specifically designed to address women’s needs.

Public Health Relevance Statement:
Project Narrative The purpose of this proposal is to develop a novel, collapsible vaginal pessary for the non-surgical treatment of pelvic organ prolapse (POP), a condition which symptomatically affects 4.5 million women in the United States. Recent medical studies suggest that surgical treatments for POP are less effective than once believed, and current pessaries in common use are limited by a rigid and fixed design which can make them uncomfortable as well as difficult or impossible for patients to remove and insert independently. Consequently, there is an imperative to develop non-surgical treatment alternatives for women who suffer with POP which are easy to use, accepted, effective, comfortable, and cause minimal complications.

Project Terms:
3D Print; Address; Affect; Age; alternative treatment; Area; Bacteria; Blood; Caliber; care providers; Caring; Connective Tissue; design; Development; Devices; dexterity; Drainage procedure; Engineering; Equipment; Evaluation; Excision; expectation; experience; Failure; Female; Frequencies; Funding; Future; Geometry; Goals; Grant; Gynecology; Hand Osteoarthritis; Hand Strength; improved; innovation; Intuition; irritation; Legal patent; Massachusetts; Measures; Medical; Medical Device; meetings; Methods; Modification; Muscle; New Hampshire; novel; Operative Surgical Procedures; Organ; Patients; Pelvic floor structure; pelvic organ prolapse; Pessaries; Phase; Positioning Attribute; pressure; Probability; product development; prototype; Radial; Recommendation; research and development; Resources; Risk; risk minimization; Safety; Silicones; simulation; Small Business Innovation Research Grant; Soaps; Structure; success; Surface; Testing; United States; United States National Institutes of Health; Update; Uterus; Vagina; Vaginal Discharge; Water; Woman; Work

Reia is working to address a prevalent gynecological condition, pelvic organ prolapse (POP), which affects more than 50% of women over the age of 50. POP occurs when the pelvic floor connective tissue and muscles weaken, allowing the uterus or vaginal walls to descend. In extreme cases, the uterus descends through the opening of the vagina and hangs outside of the body. POP can be treated non-surgically with a medical device called a pessary which is inserted into the vaginal canal and acts as a shelf to support the descending organs. Commonly used pessaries have a fixed and rigid design, making them difficult or impossible for patients to remove and insert independently. Reia has done preliminary work with affected women and their practitioners to design an innovative collapsible pessary that will reduce pain and discomfort associated with insertion and removal, enable autonomous use, and address many unmet needs of current pessaries on the market. During Phase II, Reia will modify and optimize its pessary to meet mechanical and manufacturing requirements, perform critical path testing in preparation for approval by a local IRB for clinical use, and conduct early feasibility and feasibility clinical trials. Reia will achieve these aims by designing for and prototyping in realistic manufacturing techniques for production at scale, performing benchtop mechanical testing to quantify function and wear properties over a full lifecycle, and performing biocompatibility studies and microbiological testing. We will then conduct a single-visit early feasibility clinical trial with 15 patients to assess performance and function of Reia’s pessary, followed by a multi-visit feasibility clinical trial with 50 patients to evaluate the effectiveness, safety, comfort, and function of Reia’s pessary in day-to- day use. Defined evaluation criteria have been established in order to measure progress and success. Reia’s founding team is comprised of a urogynecologist with 25 years of experience fitting pessaries and treating POP and three female engineers with combined experience in product development, operational manufacturing and production practices, and IP advisory. Additionally, an advisory board contributes expertise in urogynecology, commercialization of medical devices, and successful completion of numerous NIH grant funded projects. Reia has strategically aligned with manufacturing facilities, testing laboratories, and regulatory consultants to gain access to necessary equipment, resources, and guidance to successfully complete this project. Reia is committed to optimizing its pessary design for clinical use and manufacture to bring to market the first-ever pessary specifically designed to address women’s needs.

Public Health Relevance Statement:
Project Narrative The purpose of this proposal is to optimize and prepare to commercialize a novel, collapsible vaginal pessary for the non-surgical treatment of pelvic organ prolapse (POP), a condition which symptomatically affects 3.6 million women in the United States. Recent medical studies suggest that surgical treatments for POP are less effective than once believed, and current pessaries in common use are limited by a rigid and fixed design which can make them uncomfortable as well as difficult or impossible for patients to remove and insert independently. Consequently, there is an imperative to develop non- surgical treatment alternatives for women who suffer with POP which are easy to use, accepted, effective, comfortable, and cause minimal complications.

Project Terms:
Address; Adverse event; Affect; Age; alternative treatment; Anatomic Models; biomaterial compatibility; Caliber; care providers; Caring; Clinical; clinical efficacy; Clinical Trials; commercialization; Connective Tissue; Controlled Environment; cost; Coughing; Critical Pathways; cytotoxicity; Data; design; Devices; Drainage procedure; effectiveness evaluation; efficacy clinical trial; Engineering; Environment; Equipment; Evaluation; Excision; experience; Failure; Feasibility Studies; feasibility trial; Female; Funding; genotoxicity; Goals; Grant; Growth; Guidelines; Hand Osteoarthritis; implantation; in vivo; innovation; Institutional Review Boards; Investigation; irritation; Laboratories; Left; manufacturability; manufacturing facility; Measures; Mechanics; Medical; Medical Device; meetings; microbial; Microbiology; Muscle; next generation; novel; Nylons; Operative Surgical Procedures; Organ; pain reduction; Patients; Pelvic floor structure; pelvic organ prolapse; Performance; Pessaries; Phase; premature; Preparation; Prevalence; Process; product development; Production; Property; prototype; Ptosis; Recommendation; research and development; Resources; Risk Assessment; Safety; Severities; Silicones; Site; Small Business Innovation Research Grant; Staphylococcus aureus; success; Symptoms; systemic toxicity; Techniques; Technology; Testing; Toxic Shock Syndrome Toxin-1; trial comparing; United States; United States National Institutes of Health; Uterus; Vagina; Vaginal Discharge; Validation; Visit; Woman; Work