Doctors are reporting a proliferation of dangerous blood clots in the lungs and other major organs of COVID-19 patients, raising the risk of stroke and other life-threatening complications. While anticoagulant medications can reduce that risk, patients need careful monitoring to ensure their blood is neither too thick nor too thin. To that end, Los Angeles-based startup Neural Analytics Inc. is deploying its robotically assisted transcranial doppler (TCD) system for real-time identification of blood clots and disruptions in blood flow to the brain.
Neural Analytics won U.S. FDA and CE mark approval for its Neuralbot robotic assistance technology in 2018, paving the way for the Lucid Doppler ultrasound system to be used in a wider range of settings. The autonomous system uses artificial intelligence (AI) and cloud computing, in addition to robotics, to noninvasively measure blood flow and clotting. The robots locates an opening in the skull between the ear and the eye where the ultrasound can be driven through and visualize the major arteries of the brain. The algorithms aid in identifying problems including blood clots, changes in velocity, occlusions, the size of clots and whether emboli are traveling through the arteries.
Patients can be positioned in less than five minutes at bedside – a plus in the current pandemic as patients in isolation units can be monitored with minimal exposure to clinical teams.
A clear use case
Recent correspondence in the New England Journal of Medicine by doctors at Mount Sinai Health System in New York City reported five cases of large-vessel stroke in COVID-19 patients under age 50 during a two-week period this spring. That compared with an average of 0.73 patients younger than 50 with large-vessel stroke over two-week intervals in the prior 12 months. Widespread clotting has been seen COVID-19 patient in other age groups as well.
For patients with blood clotting disorders and an elevated risk of stroke, anticoagulants are the most common treatment. However, while they can be life-saving, the therapy is risky as well. Anticoagulants increase blood flow, adding pressure on the arteries. Too much pressure can cause arteries to rupture, leading to brain bleeds and death.
“With the Neural Analytics system, you can monitor that and you know when the blood flow has increased to a velocity and pressure that becomes a risk for the patient, and then you can back off of the treatment,” Diane Bryant, Neural Analytics’ CEO, told BioWorld.
The company was contacted in mid-April by three large, East Coast hospitals asking to use the robotic TCD to measure blood flow in COVID-19 patients. The first robotic AI ultrasound system was deployed to Mount Sinai on May 4 for use with intensive care unit patients. The device did not require FDA emergency use authorization for COVID-19 because it is approved to perform ultrasound on the brain.
“We started scanning every single patient that was in the neurological department the next day, and we’ve been doing those 24 hours a day ever since,” Bryant said. The system is now being used in both the neurology and pulmonary ICUs.
The goal is to collect data on at least 100 patients, so that physicians have a good sample set for drawing conclusions about the device’s benefit in COVID-19 cases, Bryant said. “The data has been surprising, and the clinical team has submitted new findings to a major journal and is developing expanded studies of what they believe to be new learnings about the pathophysiology of COVID-19.”
Founded in 2013, Neural Analytics has raised more than $73 million, according to Crunchbase, the most recent a series C round that brought in $22 million in May of 2019. Of the total, about $22 million stems from U.S. government grants – Department of Defense (DoD) and National Institutes of Health – focused on traumatic brain injury. The DoD’s interest is in identifying soldiers in the field who have suffered a TBI.
Currently, Neural Analytics’ TCD is in 64 U.S. hospitals, some of which are starting to use it on COVID-19 patients. The company has a sales rep and clinical team in Europe as well, with customers in the U.K., Netherlands and Sweden.
Bryant, who joined Neural Analytics in January, said her aim is to get the company to the point where it can efficiently scale by beefing up internal operations and growing the salesforce. To fuel those goals, the company is planning to raise a series D sometime in the future. “We are in strategic mode on that and really trying to figure out, just based on the economic conditions, what is the right time,” she said.
With the coronavirus negatively impacting sales, the company qualified for about $2 million in funds under the Paycheck Protection Program for small businesses, part of the CARES Act.
The company has divided into four teams and is operating on a 25% model to ensure ongoing production with social distancing.
“Today, the full focus is on stroke in COVID-19 patients, given the crisis,” Bryant said, adding the company has a roadmap for future indications. “We’ll move from stroke to TBI to dementia, Alzheimer’s disease and then Parkinson’s disease. …We’ll move through all the other brain illnesses over time.”