For investors
A first-in-class femtech device with NIH validation.
Smart Pessary addresses a $1B+ underserved category in women's health with a defensible IP position, planned non-dilutive funding strategy, and a credentialed founding team.
Of women globally experience pelvic organ prolapse at some point in their lifetime.
Estimated US addressable market for pessary therapy and related conservative care.
No biofeedback-enabled pessary currently on the market — clean white-space entry.
Why this category, why now
Women's health has been chronically under-invested in medical devices, AI training data, and conservative-care innovation. Pelvic organ prolapse — despite affecting roughly 40% of women — has not seen meaningful device innovation in a century. The conservative-care category (pessaries) is dominated by passive silicone devices unchanged since the 1950s. The surgical alternative carries 30%+ recurrence rates and meaningful morbidity.
Smart Pessary occupies clean white space: a first-in-class biofeedback-enabled device that fits into the established pessary clinical workflow, adds real-world data and active therapy, and has the potential to dramatically improve the 50% one-year dropout rate that drives most of the category's friction.
IP position
Issued and pending patents cover the device architecture, sensor integration, and biofeedback control system. Continued prosecution is actively maintaining the IP estate, with additional applications planned around AI-driven monitoring methods and form-factor variants. Smart Pessary LLC holds an exclusive license to the underlying University of Arizona technology.
Non-dilutive support
A non-dilutive funding strategy is central to our roadmap. We are preparing an NIH STTR Phase I application targeting NICHD, with parallel paths through DoD CDMRP, NSF SBIR, and state-level Arizona Commerce Authority programs.
Regulatory path
510(k) with established pessary predicate for mechanical support function, layered with De Novo classification request for sensing and stimulation features. We are aligning regulatory strategy with first-in-human study design and have engaged FDA presubmission processes.
Team
Founded by Ravi Goyal, MD, PhD, MBA, FAHA — Vice Chair of Research, OB/GYN at the University of Arizona, NIH-funded physician-scientist with $14M+ in PI awards and 55+ peer-reviewed publications. Smart Pessary LLC operates as a subsidiary of Epigenuity® LLC — Dr. Goyal's parent women's-health innovation company.
Talk to us
For diligence materials, financial models, IP documentation, or to schedule a call — reach out at info@smartpessary.com or use the contact form. Please mention investor interest.