Liv Labs Awarded Phase II Continuation SBIR Grant by the NIH

Liv Labs (@livlabsfitness) is a US-based consumer healthtech company making easy, at-home versions of proven-effective clinical treatments for the 29 million American women who worry daily about leaking pee in public.

Liv Labs has been awarded a third Small Business Innovation Research (SBIR) grant to support development of a novel continence pessary intended to treat stress urinary incontinence (SUI) without a prescription. This continuation funding, from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health (NIH), will be used to perform nonclinical safety and durability testing in support of 510(K) premarket submission to the Food and Drug Administration (FDA).

All proposals submitted to the federal SBIR/STTR program, also known as America’s Seed Fund, undergo a rigorous, merit-based scientific review. On this particular application, Liv Labs received the highest possible overall impact score: a perfect 10. Previous grant awards to Liv Labs (from all sources) now total over $2.5M and have included a $1.7M Direct Phase II award from the NICHD and a $255K Digital Health Phase I award from the National Science Foundation (NSF).

“This new grant accelerates development of the most comfortable and convenient continence pessary ever invented,” said Melody Roberts, Cofounder and CEO of Liv Labs. “The award funds standard nonclinical testing of our product’s materials and performance and builds upon clinical research demonstrating ease-of-use and effectiveness. Upon FDA clearance, our device will become an accessible and appealing alternative to incontinence pads and surgery.”

Some 78 million Americans with vaginal anatomy are affected by symptoms of urinary incontinence, with approximately 29 million managing moderate to severe leakage on a regular basis. This number will rise to 40 million or more by 2060, as the population ages. Too many have a current, unmet need for conservative, non-surgical treatment. In response to this growing need, Liv Labs is building an innovative continence self-care platform that includes not only their continence pessary but also semi-automated health coaching. They recently commercialized K+ Training Intensive, a 21-day continence coaching service with highly favorable customer reviews.

“The startup mantra is focus, focus, focus. And we do. We focus on solving a customer need that requires a platform approach. It’s not sufficient to merely address symptoms–however effectively–when a cure can often be achieved with targeted exercise and small habit changes. Our fundraising success shows the experts agree,” said Roberts.

Liv Labs’ ultimate mission is to make continence self-care popular, by building widespread self-efficacy and adoption of patient-controlled treatments that deliver the benefits of surgery, without the risks. For Liv Labs, continence care is just a first step toward a broader vision of consumer-friendly, evidence-based self-care solutions that improve quality of life while reducing chronic illness risks and demand for expensive clinical interventions.

This vision recognizes that fundamental patterns of healthcare seeking are in flux. In the US, the high cost and unequal distribution of care, combined with growing practitioner shortages, essentially requires a paradigm shift. As the Global Self-Care Federation in Switzerland states, “By promoting prevention, empowerment, health literacy, and cost-effective health management, self-care complements existing healthcare delivery systems.” This is particularly true for conditions like incontinence, which most people prefer not to disclose until symptoms become severe.

This continuation grant is supported by the National Institutes of Health under award number 2R44HD105574-03. The Small Business Innovation Research (SBIR) and the Small Business Technology Transfer (STTR) programs, also known as America's SEED Fund, are a key part of NIH's mission to turn discovery into health. These programs set aside $1.3 billion in non-dilutive funds every year—specifically to support early-stage small business research and development. The content of this press release is solely the responsibility of the author and does not necessarily represent the official views of the NIH.