Net Health’s Tissue Analytics just got FDA breakthrough designation

As of June 2022, the US Food and Drug Administration had authorized over 600 breakthrough designations for in-development medical devices. The designation is a sign that a device shows promise of improving patients’ lives in the near future, and is meant for products that treat or diagnose life-threatening diseases.

One of the latest firms to earn this green light? Net Health, the 30-year-old Strip District-based company specializing in electronic health record (EHR) systems. Net Health announced in early July that the FDA had deemed its AI-powered wound imaging and analysis solution, Tissue Analytics, worthy of breakthrough designation.

The Tissue Analytics platform is named for the Baltimore-based startup that Net Health acquired in 2020. Tissue Analytics’ cofounders, Kevin Keenahan and Josh Budman, developed the technology and now work as Net Health’s interim CTO and VP of analytics, respectively.

The platform’s Pressure Injury Deterioration Risk Indicator is one of two predictive analytics resources the company unveiled this summer. The risk indicator seeks to assist hospitals in better managing wounds and assess if they could potentially progress to more serious conditions. For Jason Baim, Net Health’s chief strategy and corporate development officer, the FDA designation signifies a vote of confidence that the software will make a splash in the healthcare world.

Jason Baim. (Photo via LinkedIn)

“We’ve made a lot of investments in analytics and data over the past few years and it was really great to be able to get that acknowledgement from the FDA that what we’re doing is history,” Baim told Technical.ly.

Currently, Baim said, there aren’t many alternatives when it comes to wound care rooted in artificial intelligence technology. In offering something that allows AI to automatically look at a skin condition or a wound and diagnose them, Net Health hopes to allow professionals to provide more accurate assessments and recommend treatments, which will lead to better outcomes in the industry.

Baim added that Net Health prides itself on making it easier for caregivers to meet their patients’ needs. The second predictive analytics resource the company’s rolling out is focused on helping doctors to better monitor which patients are at risk for missing doctor’s visits. As its title suggests, the Missed Visit Prediction Indicator — part of the company’s Net Health Wound Care EHR platform — will use data to determine which patients are most inclined to be no-shows or make last minute cancellations. From both a healing perspective and a financial perspective, Net Health hopes the indicator will leave less to chance and help healthcare professionals and caregivers intervene before an appointment is missed.

“Previously, all they could do was send them a reminder ahead of time and hope it would show up and didn’t really have any way of saying, ‘OK, this patient is really high risk of not showing up, or are they low risk,’” Baim said.

The company — which is a portfolio company of The Carlyle Group, Level Equity and Silversmith Capital Partners — is proud of not only the technology it’s developing, but in its overall growth. Although many tech-forward companies are making layoffs amid an economic downturn, Net Health boasts that it’s planning to continue hiring. (See open roles here.)

Of 630 total employees, 120 are based in Pittsburgh. Baim explained that bringing on more talent in and outside of Pittsburgh was a solid investment in ensuring that technology was something that made healthcare professionals’ lives easier.

“When you see what’s happening with the economy overall, you hear about the loss of tech companies, including healthcare companies, freezing hiring or laying off staff … we’re actually doing the opposite,” Baim said. Pittsburgh “is a great place to start building a company and a great place to keep expanding one.”