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| Continuous blood pressure monitor--Courtesy of Blumio |
Hardware tech accelerator Highway1 is debuting its sixth class of startups, and it's got a handful of medical device startups in the mix. A couple of the stars include Blumio, with its cuffless continuous blood pressure monitor, and Sensassure, with its incontinence patch that alerts caregivers when seniors need pads changed.
Highway1 is part of PCH, which last summer partnered with Johnson & Johnson ($JNJ) to launch a consumer-health focused hardware incubator. It's been around for about two and a half years and has accepted 67 companies that have gone on to raise more than $100 million. Twice yearly Highway1 accepts a dozen startups into its program.
Continuous blood pressure monitoring promises to reveal all sorts of undiagnosed and overlooked medical conditions. In fact, a study published by the American Heart Association earlier this week found that ambulatory monitoring over 24 hours in African Americans with masked or undetected high blood pressure can help detect undiagnosed hypertension.
Startup Blumio wants to do better than an ambulatory application of standard blood pressure cuff technology. It has an armband that continuously monitors blood pressure by measuring the pulse at two points along an artery and calculating the pulse wave velocity.
It's in the midst of a small pilot test that Blumio is refining and is slated to go into a larger trial starting this summer. That study is expected to give the company the data it needs to submit for a 510(k) clearance from the FDA.
The company opted not to make a wrist-worn wearable, since there's a lot of distrust from the medical community because of problems with inaccuracy with inexpensive drug-store models.
Blumio sees its potential target population as patients who have had a serious cardiac event, pregnant women at risk for hypertension and people who are occasionally hypertensive. It expects to sell the device for $200 to $400 online after clearance.
In addition, blood pressure for healthy people dips at night during sleep. Monitoring this could offer a good indicator of cardiovascular risk. Since it's tough to reliably track blood pressure continuously, it's actually an open question what sort of data might result.
"This opens a new door into our cardiovascular health," Blumio co-founder and CEO Catherine Laio told FierceMedicalDevices. "You know that within a minute of you doing intensive exercise that if your heart rate doesn't drop by 12 points, that's not very healthy. What is the equivalent for blood pressure? We could do so much data collection."
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| Senassure incontinence sensor and app--Courtesy of Sensassure |
For their part, the 20-something Sensassure team has been living in nursing homes in an effort to better understand and serve the needs of nursing home patients and their caregivers. The official policy of most nursing homes is that patients are supposed to be checked and changed every two hours whether they are asleep or not.
But that often doesn't happen, which can potentially result in skin breakdown and ulcers. And, if it does happen, patients are often being woken unnecessarily.
Sensassure has done two proof-of-concept trials showing that its sensor reduces the time spent in a wet brief by 73% with an 81% reduction in unnecessary checks.
The company has raised $500,000 in financing and is raising at least another $2 million to $3 million more, in part to fulfill a prepurchase from Canadian long-term care provider Revera, who is also working with Sensassure as a development partner.
But Sensassure doesn't want to bury caregivers in more alarms either. "On the app side, we want to make the tool less of a big brother and more to use as a tool to do your job more effectively," said Sensassure CEO Sameer Dahr. "No one likes to wake a dementia resident in the middle of the night."
The startup is looking to get to market next year and is aiming for a 20- to 30-resident study that could cover the entire incontinence population at a given home.