Digitizing the last remaining vital sign with a smart device to measure kidney health.
CEO: Joe Urban
Based: San Francisco, California
The scoop: Potrero Medical has been working to fully automate one of the last remaining vital signs collected in the hospital—urine output and the health of the kidney—by gathering data through a sensor-laden update to the 100-year-old indwelling foley catheter.
The company’s Accuryn system is aimed at helping intensive care units track the progression of acute kidney injuries, which can affect half of all ICU patients and play a role in more than 300,000 deaths in the U.S. each year. In addition, changes in the body’s kidney function can reflect cardiac output and the onset of heart failure, not to mention guide clinical decisions in managing a patient’s fluid intake.
Potrero’s smart catheter system, which also measures core body temperature and intra-abdominal pressure, first received 510(k) clearance from the FDA in 2016. Since then, the company has been working on algorithms that can help predict a patient’s risk of developing an acute kidney injury earlier, to alert staff hours ahead of danger.
What makes Potrero Medical fierce: Previously, one of the main obstacles to automating accurate measurements has been vapor lock, where urine can get trapped inside the catheter line and block the flow, requiring a nurse to manually clear the line by moving either the patient or the tube.
“Hospitals are relying on the nurse being able to go in there every one or two hours to check on urine output, and in this day and age that's like asking the nurse to go check on the patient's heart rate with a stethoscope every 15 minutes. It's just not feasible,” says Potrero CEO Joe Urban.
“Also, it's inaccurate,” Urban added. “They’re making patient management decisions based on what they’re seeing in the bag. They empty it and that starts the flow again. They could have made decisions that could be catastrophic for the patient.”
Potrero’s Accuryn system sends a gentle vacuum down the line every one to two minutes, breaking the vapor lock and allowing the bladder to empty freely and at its own pace—and, in turn, provide high-resolution data on kidney function.
That data will be fed into a guideline-based algorithm that Urban said can predict oncoming renal failure with 97% accuracy up to nine hours ahead of other methods. Currently, Potrero is working to validate that algorithm in a clinical trial, alongside four other studies set for the first half of this year.
That includes two trials funded by the National Institutes of Health to evaluate the device’s use in sepsis patients, measuring mean arterial pressure and abdominal perfusion pressure. The company has also received a grant from the Department of Defense to test its ability to predict occult gastrointestinal bleeding. Other studies will examine its measurements of respiration rate as well as any link between keeping lines clear and open and the number of catheter-associated infections.
And with plans to take its AKI predicting algorithm to the FDA for review by the end of 2019, alongside the development of a next-generation monitor, Potrero has a busy year ahead.
But 2018 was quite busy as well, with the completion of a $26.6 million series C round last July, which helped the company transfer its tech to a contract manufacturer to scale up production and meet the demand coming from its U.S. distribution partner, Medline. Potrero also moved into a new, larger Bay Area headquarters in Hayward, California—and also stopped by South by Southwest to take first prize in the SXSW Release It startup pitch competition.
In addition, the company passed its auditing process for Europe and expects to receive a CE mark for its device by the end of March. Potrero has more than doubled its employees since 2017, with many focused on developing the device’s software and algorithms as well as its ability to integrate directly with electronic medical records.
“A number of new employees have come from hardware and software companies, some from the medical device industry and some not,” Urban said. “It’s been kind of fun to work with them. They feel like they have a true mission, instead of how to get likes or get people to stay on their webpage—now they're actually helping doctors and patients.”
“It's been fun to see it in their eyes and see how charged they are,” he said. “They finally have a purpose beyond most of what's Silicon Valley has been focused on.”