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Healthy.io acquires fellow smartphone urinalysis startup Inui Health

By Dave Muoio

Israel-based smartphone urinalysis and wound-care startup Healthy.io is purchasing fellow home-diagnostics company Inui Health in a roughly $9 million cash deal, CNBC reports.

The agreement also involves milestones that Inui Health will need to meet, and sees CEO Dr. Jaime Tenedorio take on a new role within Healthy.io's team.

MobiHealthNews has reached out to both companies for confirmation of the news, and will update this story with any additional comments.

WHAT HAPPENED

Inui Health has a long history within the digital health space, although most of it was spent under its previous name, Scanadu.

While it had a urine analysis project on the books as far back as 2012, the Silicon Valley company was best known for its 2013 Indiegogo smash hit and Tricorder X-Prize competitor called the Scanadu Scout. This device was described by the company as a multifunction home health-scanner.

However, the crowdfunding campaign ran into controversy: Following significant delays, the product was delivered to backers ahead of FDA clearance as an investigative device, and was shut down for all users at the conclusion of the study.

In 2018 the company reemerged with a new name and an FDA clearance for a smartphone-enabled home urine-testing platform. The product kicked off with five different test types and support for more than a dozen different phones, but looked to distinguish itself with AI and data architecture that allowed users to instantly review their own test results.

To date, Inui has raised about $56 million in financing.

Healthy.io is a much younger company, having received its first FDA 510(k) clearance for urinary analysis about two years ago. Its Dip.io testing kit similarly uses a smartphone camera to photograph disposable urinary test strips and generate a reading. The company also announced launch plans for a new wound management and tracking product at the top of 2020.

Healthy.io closed a $60 million Series C funding round in September, which brought the company's fundraising total to $90 million.

WHY IT MATTERS

The acquisition is a consolidation of two of the better-known startups in the smartphone urine-testing markets (the other star player in the conversation being Scanwell Health).

Per CNBC, Healthy.io's investment will have a short-term benefit of helping the international company secure a greater foothold in the U.S. market. Further, the ongoing impact of COVID-19 is making a strong case for the companies' smartphone diagnostics platforms, as well as for other at-home testing services. 

Finally, as Tenodorio mentioned to MobiHealthNews a few years ago, Inui Health has a deep bench of intellectual property from its Scanadu days which could substantially increase the value of the company for Healthy.io.

THE LARGER TREND

Prior to the rise of COVID-19, Healthy.io had announced launch plans for a new wound management and tracking product. Unlike the urinary-testing product, this offering was designed for nurses and other professionals to use at the point of care.

Scanwell, meanwhile, announced a $3.5 million seed funding round, a partnership with Lemonaid Health to distribute its home UTI tests and participation in a nationwide study of chronic kidney disease. More recently, the company turned its focus to the development of a consumer COVID-19 serology test that, as of an update on June 11, is still seeking an Emergency Use Authorization from the FDA.

Circadia Health's contactless respiration rate monitor receives 510(k) clearance >>

By Dave Muoio

London-based startup Circadia Health announced Thursday that it has received an FDA 510(k) clearance for its C100 System, a bedside device to measure respiration rate via radar in adult patients up to four feet away.

Circadia said in its announcement that the C100 system will be launching "immediately" in light of the high demand for respiratory-related illness management. The startup is aiming to deploy the tool in care settings such as hospitals and skilled nursing facilities as well as for at-home health monitoring.

Alongside the respiratory sensor, the system includes a cloud-based software component for care teams to track their patients and receive mobile alerts. The company's announcement and website also details motion, presence and sleep-quality monitoring capabilities, as well as algorithms for the early detection of adverse events, disturbances or coughing.

“We are building a ubiquitous data-driven platform, utilizing long-term continuous physiological parameters that we capture using our technology to develop proprietary early warning risk scores for various medical conditions,” Dr. Guy Leschziner, chief medical officer for Circadia, said in a statement.

Circadia said that it will be employing subscription model with no upfront costs for its device, and notes reimbursement revenue of $123 per patient, per month, under billable CPT codes.

WHAT'S THE IMPACT?

In early April, Circadia noted in a release that it had already put together plans to begin launching its C100 system in "a large hospital in Los Angeles" and other areas. In particular, the company said that it was pursuing an "expedited review" of its technology from the FDA, and cited the heightened demand for a flexible respiration-rate monitor in the midst of an emerging respiratory infection pandemic.

“Our goal is to provide a frictionless solution to clinicians in order to help improve patient outcomes and reduce the cost of care," Fares Siddiqui, cofounder and CEO of Circadia, said in a statement. "During this COVID-19 crisis, the FDA has recognized the life-saving potential of our technology. We are now able to deliver the most convenient and powerful method to monitor fragile patients both in-facility and remotely at home.”

THE LARGER IMPACT

The FDA has rolled out the red carpet for remote vital-sign monitors such as respiration rate and breathing frequency.

Case in point: The agency announced a policy in late March that expanded the use of these products throughout the duration of the COVID-19 public health emergency. This decision allowed approved software- and hardware-monitoring tools to be used remotely – a particular advantage for hospitals facing a high volume of patients.

The value of remote monitoring technologies is being recognized by patients as well. A recent Sony study found that 61% of survey chronic-disease patients said they would feel safer during the COVID-19 pandemic if they had a remote-monitoring device provided by their doctor.

 

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