Consumer health & wellness · Pelvic floor
Liv Labs
A Y Combinator company that spent $2.5 million in federal grants on a prescription-free treatment for urinary leakage, closed its pivotal trial after seven patients, and now sells a silicone spring its own FAQ says treats nothing.
Seven women
The registry entry for NCT05611970 is short, and the numbers inside it are small. Seven women with diagnosed stress urinary incontinence enrolled. Four finished. The study closed on April 9, 2024, and the sponsor gave two words for why: “Management decision.”
That was the pivotal trial for the Pippa Fitness Pessary, a soft, reusable silicone device Liv Labs had been building since 2017 and that the National Institutes of Health had paid about $2.2 million to develop. Sites were listed at two Northwestern Medicine urogynecology clinics near Chicago and at Ohio State University Medical Center. The principal investigator was the company chief executive, Melody Roberts.
Results were posted anyway, which many abandoned device studies never bother to do. Three of the four evaluable participants hit the primary endpoint, a reduction of more than half in leakage by pad weight or by daily episodes at home. No deaths, no serious adverse events, three minor ones. The record carries its own caveat in a single sentence: “Early termination led to a very small number of subjects analyzed.”
A condition nobody brings up
Stress urinary incontinence is leakage brought on by a laugh, a sneeze, a sprint. The NIH abstracts Liv Labs filed put the affected US population at 27 to 29 million women over 25. Kegels require months of correct, unsupervised repetition. Surgery carries surgical risk. Pessaries work, but a physician normally fits them, which means a referral, an exam and a conversation most women never start. Roberts says she tests that gap on herself: she sees a doctor every year and is never asked.
Liv Labs set out to skip the fitting. A symmetrical spring that compresses into a 10mm cylinder, loads into an applicator, expands inside the vagina and presses the urethra through soft tissue, bought over the counter and reused at will. A sensible product idea. Also, by definition, a regulated medical device, and that is where the timeline went.
A designer and an operator
Carly Price invented it. She is a product designer with 25 years behind work for OXO, Casper, Walmart, Ford and Chase, and she lost pelvic floor strength after her second child. She tried therapy and a range of pessaries, filed a provisional patent in January 2017, then called someone to run the company.
That was Melody Roberts, who had met Price at Smart Design in 1998 and had since spent twelve years inside McDonald’s building restaurant and digital service platforms, then Panera. She took the job, moved the company through the Polsky Center incubator at the University of Chicago, won South Side Pitch in 2018, and got into Y Combinator in 2021. “Fast forward to today, I lead Liv Labs, where we’re on mission to make continence self-care popular,” she told the 2024 graduating class at the Institute of Design, her own alma mater.
The grant years
Investors were hard to find. Roberts told the Polsky Center in 2021 that it had been difficult to interest anyone in a direct-to-consumer technology that still had to clear a medical device pathway. The company had raised “over $200,000 from friends and family” and was planning a pre-seed round.
So it raised from the government. NICHD awarded a Direct Phase II SBIR in April 2021, worth $951,491 in year one and $722,496 in year two. NSF added $255,078 in January 2022 for coaching software. In July 2024 NICHD added a Phase IIB continuation of $563,008, on an application the company said earned “the highest possible overall impact score: a perfect 10.” Federal awards on record total $2,492,073.
The turn
The July 2024 release announcing that continuation said the money would fund nonclinical testing “in support of 510(K) premarket submission to the Food and Drug Administration (FDA)” and that it built on clinical research demonstrating ease of use and effectiveness. The pivotal trial had been closed for three months. The release did not mention that.
What reached the market was not the pessary. In June 2025 Liv Labs ran a Kickstarter for the Pippa Resistance Spring, a fitness accessory, and raised $29,069 from 209 backers against a $7,268 goal. First orders shipped that October, the company says, and Fast Company named Pippa an Innovation by Design honoree in September. Today the store sells kits from $119 to $179, an applicator, a bandana and coaching.
The Kickstarter FAQ puts it without hedging. The spring “does not treat any medical condition or pelvic floor disorder.”
What is proven, and what is still claimed
| Evidence | What the record shows | Source type |
|---|---|---|
| NIH SBIR R44HD105574 | Three NICHD awards, Roberts as PI: $951,491 (FY2021), $722,496 (FY2022), $563,008 (FY2024). Period Apr 2021 to Jul 2025. Total $2,236,995. | Public record |
| NSF SBIR 2126867 | $255,078, Jan 2022 to Jul 2023, for AI-assisted coaching. The outcomes report describes a feasibility test with two physical therapists and nine volunteers. No Phase II followed. | Public record |
| Trial as registered | NCT05611970, sponsor Liv Labs Inc. Started Feb 13, 2023. Status TERMINATED, reason “Management decision.” Enrollment 7, of whom 4 completed. Primary completion Apr 9, 2024. | Public record |
| Posted results | Endpoint reached by 0.75 of 4 evaluable participants. IIQ-7 change 7.483 points, standard deviation 27.320. Zero serious adverse events; 3 of 7 with other events. | Public record |
| FDA status | No 510(k), PMA, registration, listing or UDI record for Liv Labs or Pippa in openFDA as of Sep 22, 2026. Two hits on the string Liv belong to unrelated firms. | Not found |
| Grant claim versus registry | The Jul 2024 release said the grant supported a 510(k) submission and built on research showing effectiveness. The trial had ended three months earlier. No submission appears. | Differs from record |
| NIH SEED profile | In 2024 it called the pessary “currently the subject of a pivotal clinical trial at Ohio State University” and the company “on track to enter the market in 2025.” The trial had ended in April 2024. | Differs from record |
| Patents | US 11,337,788 B2, Stress urinary incontinence (SUI) device, priority Jan 2017, granted May 2022. Design patent US D1,071,181 S1 granted Apr 2025. A continuation is pending. | Public record |
| Claim for the product sold now | The company says Pippa increases “effective function by up to 35%” and is “clinically shown to boost natural neuromuscular activation.” No supporting study is published or registered. | Company-stated |
| Literature | No PubMed record for Liv Labs or Pippa as of Sep 22, 2026. | Not found |
| Commercial activity | Kickstarter $29,069 from 209 backers against a $7,268 goal, closed Jul 24, 2025. Store live and in stock Sep 22, 2026, no pessary listed. | Public record |
Read plainly: the medical claim and the product have come apart. What the record proves concerns a pessary that reduced leakage in a handful of women and never reached the FDA. What the company sells is a fitness accessory whose central number, a 35% lift in muscle function, rests on no published evidence and ships with a disclaimer that it treats nothing. A wellness product needs no clearance. But $2.5 million of public money went into the regulated version, and that version is not on sale.
What to watch
- Whether a 510(k) for the pessary is ever submitted. The grant funding that testing ended July 31, 2025.
- Any study behind the “up to 35%” activation figure. Today it is a marketing number.
- Whether the pessary returns to the catalog, or the company says plainly that the program is over.
- Headcount. The Y Combinator directory lists a team size of 1, against three people named on the site.
- Retail distribution. The wholesale and multipack bundles are both marked unavailable.
In their words
“We needed a substantial sum to get through the formal product development process, which has more overhead when there is regulatory compliance involved”
Melody Roberts, co-founder and CEO, Polsky Center, 2021 · Independent
“If this were a sex toy instead of a medical device we would have been on the market two years ago.”
Melody Roberts, Polsky Center, Aug 18, 2021 · Independent
“Fast forward to today, I lead Liv Labs, where we’re on mission to make continence self-care popular.”
Melody Roberts, Institute of Design address, May 2024 · Speech
“This new grant accelerates development of the most comfortable and convenient continence pessary ever invented”
Melody Roberts, company press release, Jul 20, 2024 · Company release
“Early termination led to a very small number of subjects analyzed.”
Posted results, NCT05611970 · Public record
“Other pelvic floor strength products and services require dedication to a months-long regimen performed in private. By contrast, our Pippa resistance spring provides an immediate boost to fitness with each use.”
Melody Roberts to Hypepotamus, Feb 2026 · Independent
“The Pippa resistance spring is a fitness and wellness product intended to promote physical conditioning and a healthy lifestyle. It does not treat any medical condition or pelvic floor disorder.”
Liv Labs, Kickstarter FAQ, Sep 2026 · Company-stated
“As you listen, it’s important to remember: these are device companies.”
Carrie Pagliano, PT, Active Mom Podcast, Apr 2026 · Independent
Related companies
Sources
- Public recordClinicalTrials.gov NCT05611970, with posted results
- Public recordNIH RePORTER R44HD105574, awards 01, 02 and 03
- Public recordNSF award 2126867 and outcomes report
- Public recordopenFDA device database queries
- Public recordUS Patents 11,337,788 B2 and D1,071,181 S1
- Public recordSEC EDGAR company and full text search
- IndependentLiv Labs Lands SBIR Grant and Spot in Y Combinator
- Independent78 Million American Women Experience Pelvic Floor Issues
- SpeechMelody Roberts alumni address
- IndependentInternal Resistance Training for Your Pelvic Floor
- CompanyFirst Study Participant Enrolled in Clinical Trial
- CompanyLiv Labs Awarded Phase II Continuation SBIR Grant
- CompanyPippa Recognized by Fast Company
- CompanyGet fit, inside and out, with Pippa: campaign and FAQ
- CompanyLiv Labs profile and launch post
- Companylivlabsfitness.com pages and store catalog
- CompanyLiv Labs company showcase entry
Profile researched and written by Healthcare Discovery. Last updated September 29, 2026.
