Spokane-based Gestalt Diagnostics LLC has secured eight patents in the United Kingdom for its PathFlow software, as well as clearance for clinical use of the software throughout Europe. 

Dan Roark, CEO of Gestalt, says the UK patents are a vital step in proving the viability of the technology.

“We’re a startup, so it’s great validation that what we’re doing is cutting-edge and we’re at the front of what’s happening in our space,” Roark says.

PathFlow is a digital workflow platform that replaces glass slides and microscopes with data-rich digital images. Roark compares PathFlow to the digitization that revolutionized the radiology field about 20 years ago.

“We’re dealing with much bigger images, so the data sets are huge compared to radiology,” he says.

The health care startup is working with Spokane-based intellectual property law firm Lee & Hayes PC to file more than 10 U.S. patent applications.

“It’s hard to know when patents will be issued in the U.S.,” Roark says. “The process is daunting, and then you wait.”

PathFlow also has received the CE designation, which is required for goods to be sold in Europe and indicates a product meets European standards of health, safety, and environmental protection standards.

“It’s easier to get approval outside the U.S. for your product to be used in a clinical environment, so we started in Europe,” he says.

Currently, PathFlow is approved in the U.S. exclusively for research purposes. Roark says Gestalt is working to secure Food and Drug Administration approval for clinical use of the software.

“It’ll probably be 2024 before we see FDA approval,” he says. “Because we don’t have that, the easiest way to work toward that is to start in another country that has a recognized process.”

It’s important to demonstrate the product has proven it’s appropriate for clinical use and can pass engineering and design quality tests, he says. 

PathFlow allows pathologists and surgeons to work together in real time via cloud technology. Currently, pathologists who wish to consult with specialists must send tissue samples on slides through the mail or courier services.

“If you have to ship materials back and forth, that slows the process,” he  says.

Roark established Gestalt here in 2017.

The startup most recently held a funding round in April 2021, when Gestalt received $2 million in seed funding from Inland Imaging, Morningstar Foundation, Cowles Ventures, Tacoma Venture Fund, and Kickstart Seed Fund. 

Also last year, Gestalt was named to the list of Top 10 Healthcare Workflow Solution Providers for 2021 by Healthcare Tech Outlook Magazine.