Medical devices & diagnostics · Neurogenic bladder
UroDev Medical
A Minnesota company built around a fully internal, remote controlled urinary catheter for men with chronic urinary retention. It won more than $5 million in federal awards and ran five registered studies. It never reached the market.
The device that is not there
On June 14, 2012, a sniper’s bullet entered Derek Herrera’s shoulder and stopped in his spine. He was a Marine Special Operations Team commander in Helmand Province. He kept giving orders while the medevac came in. He has used a wheelchair ever since.
Seven years later he told a TODAY reporter what actually bothered him most, and it was not the wheelchair.
“The reality is I can get around pretty much anywhere I want in a wheelchair, but I’m still using this archaic, medieval device to empty my bladder.”
The archaic device is a disposable intermittent catheter. Herrera went to business school at UCLA, founded a company in 2015, and set out to replace it with something that stays inside the body for a week and opens on command from a handheld wireless controller. Eleven years, five clinical studies and two name changes later, that device has never been cleared by the FDA.
A problem the industry had left alone
Neurogenic bladder is a failure of the nerve signalling that controls emptying. Spinal cord injury causes it, and so do multiple sclerosis, diabetes and other conditions. The company’s second chief executive told Medgadget in 2021 that about 30 million urinary catheters are used every year in the United States by more than 5 million adults, and that each one costs between $2 and $8.
The one published paper on this device, a 2019 case report in Urology Case Reports, opens with the same figures and cites a CDC estimate of roughly 560,000 hospital acquired urinary tract infections a year.
Herrera was blunt about why he picked the problem. “There were no other competitors in the space aiming to address this issue so I started working to fund a company to build this product for people like me,” he told Medsider.
From crowdfunding to the clinic
Spinal Singularity started the way underfunded device companies do. An Indiegogo campaign hit $50,000 in October 2015. MedTech Innovator reported that December that the company had won $150,000 at the first PrimeUC competition. Then the grants came: an NIH SBIR Phase I in 2016, a Phase II that ran to $1,488,616, and in July 2019 a Department of Defense award worth $3,553,457.21, described in the award record as the “CONNECTED CATHETER CLINICAL VALIDATION STUDY (CVS)”.
The clinic came in 2018. The first patient was treated in a feasibility study led by Dr Ernest Agatstein, a co-founder of West Coast Urology and a scientific adviser since 2015. A second study that year enrolled 27.
Minnesota, and then silence
In February 2021 the company renamed itself UroDev Medical, appointed Matt Monarski as chief executive, and moved from San Clemente to Edina in the Twin Cities. Herrera stepped back to chief technology officer. The logic was industry gravity: Minnesota is where urology device people are. He also conceded the scale of the thing. The company had three employees.
Monarski told Twin Cities Business that about $13 million had been raised, $8 million in equity plus $5 million in federal grants, and that a Series B of $10 million to $15 million was planned that year. He said UroDev had applied to the FDA’s Breakthrough Devices Program.
The submission never came. In April 2023 the company named a third chief executive, Dean Briesemeister, and the release still called the product an Investigational Device. That release is the last public statement the company has made.
What is proven, and what is still claimed
| Evidence | What the record shows | Source type |
|---|---|---|
| FDA authorisation | No 510(k) and no PMA under either company name. openFDA searches of the 510(k), PMA, registration and listing, and device event databases on Sep 24, 2026 returned no matches. Company releases from 2018 to 2023 carry the line “Limited by Federal (United States) law to investigational use.” | Public record |
| Breakthrough designation | The company said in February 2021 it had applied. No record of a grant was found. The FDA does not routinely publish individual designation decisions, so absence is not proof either way. | Not found |
| Registered studies | Five on ClinicalTrials.gov, sponsor Spinal Singularity, 2018 to 2024. Two completed, at 5 and 27 participants. Three terminated, at 9, 8 and 26. | Public record |
| Posted results | Only NCT04059159 posted. Eight enrolled, five had insertion attempted, three completed. Among those five: zero device related serious adverse events, zero urinary tract infections, zero lower urinary tract injuries. The sponsor’s posted caveat reads “single arm, small sample size”. | Public record |
| The pivotal study | NCT05330598 started Jan 27, 2022 and enrolled 26 across five sites. Terminated, completion date Feb 1, 2024, reason given as “Sponsor decision”. No results posted. | Public record |
| Peer reviewed evidence | One paper: a 2019 case study of a single 34 year old man with a T6 spinal cord injury, funded by Spinal Singularity. Post void residual volumes were 12 mL at baseline and 26, 15 and 11 mL at months one to three. | Public record |
| Money raised | $5,267,071 in federal awards on record. Three Form D filings disclose $4,924,839 of equity sold. The February 2021 figure of about $8 million in equity is roughly $3.1 million above what the filings account for. | Claim exceeds filings |
| Operating status | Archived captures of urodevmedical.com return 200 through Mar 7, 2024 and 404 from Mar 19, 2024. The March 2026 capture is an advertising redirect page. No announcement, filing or trade press item since April 2023. | Public record |
Read plainly: the technology cleared its early hurdles. No serious device related adverse events were posted in the one study that reported results, and a case report described acceptable post void residual volumes in one man over three months. What never arrived was the thing all of that was pointing at. There is no clearance, no marketed product and no published pivotal data. The pivotal study stopped five months before its Department of Defense funding period ended, and the registry gives the reason in two words.
What to watch
- Any FDA submission under either corporate name. Nothing has appeared in openFDA.
- Results posting for NCT05330598, still absent more than two years after termination.
- A new Form D or a patent assignment showing where the technology went.
- Bright Uro, which Herrera founded in 2021 around a bladder sensor licensed from Cleveland Clinic and still leads.
In their words
“The reality is I can get around pretty much anywhere I want in a wheelchair, but I’m still using this archaic, medieval device to empty my bladder.”
Derek Herrera, founder, TODAY, 2019 · Independent
“I am honored to have treated the first patient in the US with this device and look forward to collecting more data during this study.”
Ernest Agatstein, MD, study investigator, 2018 release · Company release
“If we do get that designation that would move some things up hopefully for us, move up our clearance timeframe.”
Matt Monarski, CEO, Twin Cities Business, 2021 · Independent
“We went through a lengthy search process to find someone with Dean’s background to navigate the current company and market complexities, while building on the near-term future for UroDev Medical.”
Tim Lenihan, board chair, April 2023 release · Company release
“We’re still not on the market today, but we’re optimistic we will be soon. But the product is real, and it works.”
Derek Herrera, founder and CTO, Medsider interview · Interview
“Additional studies are warranted to determine the long-term safety and effectiveness.”
Agatstein and Aynehchi, Urology Case Reports, 2019 · Peer reviewed
Related companies
Sources
- Public recordForm D and Form D/A, Spinal Singularity, Inc., CIK 0001717150
- Public recordFederal award W81XWH1910370, Defense Health Agency
- Public recordAwards R43DK109865 and R44DK109865
- Public recordNCT03405285, NCT03626324, NCT03843073, NCT04059159, NCT05330598
- Public recordPosted results and sponsor caveats, NCT04059159
- Public record510(k), PMA, registration and listing, and device event searches
- Public recordThe Connected Catheter for management of Chronic Urinary Retention in an adult male with Neurogenic Bladder
- Public recordCapture history for urodevmedical.com
- IndependentUroDev Medical Relocates to Minnesota From California
- IndependentMedical device company moves to Edina ahead of first product launch
- IndependentVeteran founded medical devices firm will bring its smart catheter to market in Edina
- IndependentSpinal Singularity launches feasibility study for smart urinary catheter
- IndependentA war hero, this former Marine and star MBA is leading an ambitious biomedical startup
- IndependentHow one U.S. Marine found a new purpose in life after paralysis
- IndependentSpinal Singularity Wins at First PrimeUC Competition
- InterviewWireless Smart Catheter for Bladder Control, with Matt Monarski
- InterviewGetting Past Rejection as a First Time Medical Device Entrepreneur
- InterviewDerek Herrera, CEO, Bright Uro: Changing the Standard of Care
- CompanyUroDev Medical, Formerly Spinal Singularity, Announces New CEO and Minneapolis Headquarters
- CompanyUroDev Medical Appoints Dean Briesemeister as CEO
- CompanySpinal Singularity Treats First Patient in Clinical Feasibility Study in US
- CompanyUroDev Medical website, home and Connected Catheter System pages
Profile researched and written by Healthcare Discovery. Last updated September 29, 2026.
