UW start-up Stasys: Helping emergency physicians save lives

Story by Eric Wagner

When a severely injured patient is rushed into a trauma ward, one of the first orders of business is to stop the bleeding. But in more than 25 percent of patients, it’s not that simple. This is because of a condition called coagulopathy, in which a patient’s blood doesn’t clot.

Confronted with a case of uncontrolled bleeding, medical personnel do not always have the time to wait for lab tests to identify the cause of coagulopathy. This leaves the physician in the difficult position of guessing at the cause of the clotting issue.

The prototype developed by the Stasys team

The prototype developed by the Stasys team

“Guessing wrong is not cost effective,” says Nathan Sniadecki, a professor of Mechanical Engineering at the University of Washington. “And throwing the kitchen sink at them by pouring platelets, plasma, and drugs is often not optimal for the patient.”

To target a treatment, then, doctors need to know why a patient’s blood won’t clot, and fast. Does the patient have hemophilia? Are they on an anticoagulant medication, like aspirin? Something else? Tests to answer these questions exist, but they may take up to one hour to complete.

In an emergency setting where finding the correct treatment can mean the difference between life and death, one hour is way too long. Five minutes is better. And five minutes is what Sniadecki and his team at Stasys Medical Corp. have whittled the time down to, with technology that they developed.

“Our idea,” Sniadecki says, “was to go smaller, faster, and be more sensitive.”

The Stasys handheld, point-of-care device works like this: whole human blood is injected at the inlet of a small tube. The blood flows towards the outlet, and as it does platelets pass over a block-and-micropost array laid out across the bottom of the tube. When platelets encounter the block, they start to aggregate between the block and the micropost, forming a clot.

Owing to the physics of a clot, as it forms, it starts to contract in on itself. When that happens, it bends the micropost towards the block. A camera and microscope above the device tracks the micropost’s movement.

The nature of the micropost’s bending is what gives the Stasys device its diagnostic power. “By analyzing the position of the post, we can pinpoint what the problem is,” Sniadecki says. If, for instance, there is delayed onset of clot formation at the block — i.e., the post doesn’t move much at all at first — the doctor knows something is wrong with the patient’s plasma. Or, if the post moves, but doesn’t bend very far, then the doctor knows something is wrong with their platelets.

How fast is your blot clotting? Three sample cards of the Syasys handheld, point-of-care device

How fast is your blot clotting? Three sample cards of the Syasys handheld, point-of-care device

“The more we can help ID what is wrong with a patient, the better the doctor will be able to tailor a treatment to their needs,” says Lucas Ting, a post-doctoral researcher in Sniadecki’s lab who helped develop the device. “And we can do it fast.”

For Sniadecki, solving the problem was one thing. Taking it to the market is the next challenge. “I always thought the science is the hardest part, but there are just as many problems and issues on the business side,” he says. “There’s a huge difference between manufacturing twelve of these things in a lab, and then making 12 million of them for hospitals around the world.”

This is where the UW Center for Commercialization (C4C) stepped in. The Stasys team went to Robert Barry, one of C4C’s Entrepreneurs-In-Residence. Barry has more than 20 years’ experience working with medical device companies. “Several things drew me to the project,” he says. “One, it will help save a lot of lives. And two, it will help save the healthcare system a lot of money.”

Another benefit is that test for coagulopathy has already been clinically approved. It means the path to FDA approval is potentially much shorter, and also that reimbursement is already in place. “From a business perspective, this means that we can start to generate revenue much more quickly,” Barry says.

Barry helped Sniadecki secure a National Science Foundation Small Business Innovation Research (SBIR) grant, aimed at helping small businesses develop technology. They are now hoping to be ready to go early next year, and prospects are bright.

“This is a real game-changer,” Sniadecki says. “It’s a great instance of a public university creating a technology, and helping to save peoples’ lives.”