A Philadelphia-based wearable medical device developer, spun out of the University of Pennsylvania, has received a key designation for its lead product from the Food and Drug Administration.
Neuralert Technologies is developing the Neuralert Monitor to improve how strokes are discovered in patients while they are in the hospital.
The FDA last month designated the Neuralert Monitor as a breakthrough device, which Neuralert CEO Eric Corkhill said will enable the company to have more frequent interactions with the FDA as it works to get its product improved. The designation should also help with payment issues should the monitor get marketing clearance, he said.
Corkhill, who joined Neuralert as chief executive officer in early 2020, said the company is currently seeking to raise $1.5 million in seed funding and has identified a potential lead investor who is conducting due diligence on the company.
Neuralert Technologies was founded in 2019 by Dr. Steven Messé, a member of Penn's department of neurology, and James Weimer, a research assistant professor in Penn's department of computer and information science.
"Dr. Messé has had a lifelong dream of doing a better job of detecting stoke in hospitalized patients," said Corkhill, a former Shared Medical Systems executive and serial entrepreneur who previously founded five life sciences companies that collectively sold for nearly $500 million.
Messé and Weimer developed a system to more quickly identify strokes suffered in hospitals. Those strokes can often go undetected for hours and result in long-term disability and death, Corkhill noted, while adding millions of dollars in annual costs to hospital systems.
Messé said starting a company was never a career goal, but the need to improve how strokes are detected in hospitalized patients was something that was apparent since he began his career.
"I am definitely not alone in my field in noting that as physicians, we do not detect stroke quickly enough in patients who are already in our care," Messé said. "This was leading to bad outcomes [because] all of our treatments are very time sensitive."
The company's Neuralert Monitor product is being developed as small, non-invasive bands worn on a patient's wrist that can detect 65% of strokes within 30 minutes and 94% within 80 minutes.
The bands, Corkhill explained, monitor for asymmetrical arm movements, a key indicator of a stroke. The bands incorporate the technology found in an accelerometer, a device that measures vibrations.
Most regular arm activities — such as eating, drinking, using a cell phone, and channel surfing — involve asymmetrical movements, so a monitor that only evaluates arm movements to detect stroke would generate a lot of false alarms.
"When you have an alarm firing off every 10 minutes, it gets ignored," Corkhill said.
To overcome that obstacle, Weimer and Messé developed an algorithm to isolate asymmetrical movements connected to stroke and take out the non-stroke asymmetry that causes false alarms.
"We can shave hours off the [stroke] detection time," Corkhill said.
Messé said developing the algorithm was the company's biggest challenge. "People who [aren't having a] stroke sometimes move one side more than the other. We had to be confident that we could achieve a high sensitivity, capturing strokes quickly, but also have high enough specificity that it wouldn’t be alarming frequently and interrupt the nurses caring for their patients," he said.
The company has raised about $150,000 from a variety of sources. That includes $50,000 from being selected in April to participate in the University City Science Center's Launch Lane Accelerator program, and $25,000 from the Bucks Built Accelerator Fund backed by Bucks County to support startups in the region.
Neuralert is working with an Eagleville firm, Inteprod, to develop a prototype it expects to be ready in October. The prototype will be tested at the University of Pennsylvania Health System.
Securing breakthrough designation from the FDA will make the company's dealings with the federal agency "more interactive" as it works to get marketing clearance for the Neuralert Monitor, according to Corkhill. The designation also has reimbursement ramifications, he said, because hospitals using it would qualify for "new technology add-on payments" from the Centers for Medicare and Medicaid Services.
Neuralert staff consists of Corkhill, the company's two co-founders, and Det Ansinn, who is serving as its chief technology officer on a contract basis. Ansinn, who has experience developing FDA-approved mobile and wearable health care technologies, is founder and president of Doylestown-based software developer BrickSimple.
Messé said his goal is to get a Neuralert Monitor in every hospital to monitor not just post-operative patients, but any patient that is admitted to a medical center with an elevated risk of stroke.
