Smart Pessary — from passive support to proactive pelvic health
Why Invest in Smart Pessary LLC
Pelvic organ prolapse (POP) affects nearly 40% of women worldwide and is projected to increase dramatically with aging demographics. Despite this, the technology used for non-surgical management has remained virtually unchanged for decades. Traditional pessaries are passive, low-cost silicone devices with high dropout rates. Women, clinicians, and payers are asking for better solutions.
Smart Pessary LLC is addressing this gap by developing the first biofeedback-enabled pessary — a device that combines proven pelvic support with real-time biosensing, pelvic floor stimulation, and digital health integration. This first-in-class product positions us to lead a new category in women’s health devices.
High prevalence: ~3.3 million U.S. women currently live with symptomatic POP.
Growing market: The global pessary market is valued at ~$450M (2024), expected to grow to ~$590M by 2030 (CAGR ~4.6%).
Unmet need: Current devices have 25–50% discontinuation rates; many patients eventually undergo costly surgery.
Premium positioning: Our smart device introduces technology and data value to a proven therapy, opening reimbursement and subscription revenue pathways.
Even modest adoption — capturing just 10% of new pessary fittings — translates to tens of millions in potential annual revenue.
Market Opportunity
Competitive Advantage
First-to-market: No commercial pessary today integrates sensors, wireless alerts, or AI-guided therapy.
Strong IP position: Exclusive license from the University of Arizona (UA25-206), with utility patent filings underway.
Clinical validation path: NIH-funded Fast-Track STTR grant supports prototype development, Phase I pilot, and Phase II multi-center trials.
User-centric design: Adaptive shape-memory fit, patient-friendly removal, and remote monitoring address real-world pain points.
Revenue Model
Device sales: Smart Pessary priced at a premium compared to $30–50 traditional pessaries.
Recurring revenue: Subscription app and data services (remote monitoring, compliance tracking).
Replacement cycle: Devices replaced annually or semi-annually, generating repeat sales.
Reimbursement-ready: Supported by CPT 57160 and HCPCS coding pathways; aligned with Remote Patient Monitoring reimbursement trends.
Traction & Validation
NIH STTR Fast-Track award.
Provisional patent filed and licensed exclusively to Smart Pessary LLC.
Functional prototypes developed and tested in bench and ovine models with successful performance.
Clinical partnership with University of Arizona for feasibility and validation studies.
Traction & Validation
NIH STTR Fast-Track award.
Provisional patent filed and licensed exclusively to Smart Pessary LLC.
Functional prototypes developed and tested in bench and ovine models with successful performance.
Clinical partnership with University of Arizona for feasibility and validation studies.
Exit Strategy
Strategic acquisition by a women’s health or medtech leader (CooperSurgical, Coloplast, Medtronic, or emerging femtech companies).
Alternative: Scale as an independent femtech brand with expansion into adjacent pelvic health markets (incontinence, postpartum recovery, menopause).
Our Ask
Smart Pessary LLC is seeking strategic investors and partners to accelerate product development, regulatory approval, and commercialization. Capital raised will be allocated to:
Scaling prototype to production-ready device.
Conducting pivotal Phase II clinical validation.
Expanding IP portfolio and regulatory submissions (FDA 510(k), CE Mark).
Building commercialization infrastructure (manufacturing, distribution, digital platform).
Join Us
We are creating a new category in pelvic health that combines device innovation with digital healthcare. With a large underserved market, clear reimbursement pathways, and strong early validation, Smart Pessary LLC offers investors a unique opportunity to generate both financial returns and meaningful impact in women’s health.
⚠️ Disclaimer: This content is for informational purposes only and does not constitute an offer to sell or a solicitation of an offer to buy securities. Investments involve risk and should be evaluated carefully.
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Smart Pessary LLC
Empowering women through advanced medical technology.
Investigational Device – Not FDA Approved
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