Novasignal Corp. has a launched a cloud-based app to provide alerts to clinicians directly from its cerebral ultrasound device.

The new app allows physicians to get instant notifications from the company’s Novaguide device, a transcranial doppler ultrasound technology that allows for real-time assessment of blood flow in the brain by combining robotics and artificial intelligence (AI). The goal is to get information to physicians faster when patients are experiencing blood flow changes that could indicate an emergency, such as a stroke.

“Time to treatment with stroke is critical,” Novasignal chairman and CEO Diane Bryant told BioWorld.

The other half of the new technology launch from Novasignal is an AI component that allows the device to collect data from every scan. This data is then used to provide clinicians with predictive insights about how a patient is likely to progress over time.

The launch of the app technology is part of a larger push to increase uptake of the device beyond the 65 research institutions that are currently customers. Bryant said the company’s next target is the large hospital and clinic market, followed by the thousands of U.S. stroke centers. Their eventual goal is to integrate the technology into individual physician offices, with cerebral blood flow considered a “fifth vital sign” in assessing brain health.

Outside of the U.S., they are also marketing the Novaguide device in Europe, where it has received regulatory clearance.

Expanding FDA indications

The Los Angeles-based company has set an aggressive research and regulatory agenda for 2021, with the goal of expanding its current regulatory clearance for the Novaguide device to two new indications.

The Novaguide has already received two 510(k) clearances from the U.S. FDA covering broad applications for the collection of cerebral blood flow, including determining the attributes of the blood flow, such as velocity and the presence of blood clots.

Following the results of a clinical trial at the end of the year, the company plans to seek specific indications for identification of patent foramen ovale (PFO) and vasospasm.

PFO represents an especially large market since about 25% of people have the defect, which is more commonly known as a hole in the heart that did not close after birth. While most of the time, the condition does not create a medical problem, it can cause stroke in others. Cardiologists are excited about this technology, Bryant said, because the treatment for PFO is simple. “The closure of the hole in the heart is a very simple treatment,” she said. “Their problem is, they don’t know who has a hole in the heart.”

Bryant, who joined the company in early 2020 and brings experience at Google Cloud and Intel, said the company is looking at a variety of potential future applications for the Novaguide device, including Alzheimer’s disease and traumatic brain injury. The company received a $30 million research grant from the U.S. Department of Defense to study the use of the device in identification of traumatic brain injury on the battlefield.

COVID-19 applications

An additional application in pulmonology emerged in April 2020 during the first wave of the COVID-19 pandemic. Clinicians at Mount Sinai Health System in New York began to see patients who were experiencing strokes while on ventilation and invited the Novasignal team to use their device to monitor COVID patients. This led to a study of 18 mechanically-ventilated patients with COVID-19 using the Novaguide device. They found that 83% of patients had detectable microbubbles, which indicated vascular shunting.

The findings, which were published in the American Journal of Respiratory and Critical Care Medicine in October 2020, revealed key insights into the pathophysiology of the disease indicating that pulmonary vascular dilatation may be a cause of hypoxemia in patients with COVID-19 pneumonia.

“That was an enormous epiphany for the medical community,” Bryant said. “That study continues. We’re now supporting Harvard’s Brigham and Women’s hospital and they are continuing the study with more and more patients.”

Bryant said the Novaguide device also has potential applications in assessing the health of so-called COVID-19 long haulers, a group of roughly 22 million COVID-19 patients who continue to experience symptoms months after their acute illness. The device is being assessed to see if it can identify issues in clotting and de-oxygenation for these patients. “We continue to support that analysis,” she said.