Although artificial intelligence (AI) seems to be making only incremental headway in the world of medical technology, Brainscope Co. Inc., continues to advance its AI offerings with the launch of the Concussion Index (CI). This algorithm, used with the company’s disposable headset, has been demonstrated to reduce the need for cranial CT scans by 30%, making this a double win for patients and for health care spending in the U.S.

The company won an expanded indication for its Brainscope One device in 2019 to include evaluation of mild traumatic brain injury and concussion, wrapping up a process that began roughly a year earlier. The clearance for the One device at the time was limited to those between the ages of 18 and 85, but the company already had 100 pending and successfully prosecuted patents on hand at that point. The first FDA-cleared device for the company was the Zoom-100 DC, which was granted marketing clearance in 2009.

The CI algorithm is the third algorithm available on the current generation, eight-lead Brainscope device, and allows the clinician to evaluate the patient at injury baseline and to track the patient’s progress in recovery. Use of this system in emergency departments (EDs) can help 30% of these patients avoid a CT scan by providing 99% sensitivity, and gives the patients who are suffering from significant injury a better picture of the severity of the injury.

Minimal training needed

The Concussion Index is used with the company’s disposable headset. Credit: Brainscope Co. Inc.

Brainscope CEO Susan Hertzberg told BioWorld that the device requires only minimal training to use, thanks to the intuitive nature of the design. The training can be used by any health care professional who is under a physician’s guidance, and a quick refresher course is available by phone or an online meeting platform.

At present, all the processing and the results of the device’s computations are self-contained, but there may be a reason to move the results of the procedure to the cloud. This could apply to the algorithm as well, a move that would enable the use of the system as a telehealth service, but Hertzberg said this is not in the company’s immediate plans. The device and the CI algorithm might seem to lend themselves for direct-to-consumer sales, but she said this is at least three to five years off, assuming the company sees fit to go down that road.

Hertzberg pointed out that a significant volume of CT scans are negative, which suggests that many patients leave emergency departments with little or no more information than they had when they arrived. The problem for ED physicians is that they must rule out brain bleeds, which the Brainscope system can do in 20 minutes with an accuracy of 99% compared to CT scans. The cost of a full set of CT scans can run to four figures even though the Centers for Medicare & Medicaid Services has consistently pressured hospitals and outpatient imaging clinics over the past few years on questions such as the CT system’s assumed utilization rate.

Hertzberg said the Brainscope device and the CI algorithm can beat this handily, even though the company is still amortizing the cost of R&D for the algorithm. The objective is to get the per-use cost to less than $100, perhaps even as low as $50, but she noted, “we’re not there yet.”

The Bethesda, Md.-based company typically seeks a strong clinical champion to help make the case to hospital administrators, who are fully aware that patients who ultimately discover they do not need ED services typically don’t have a lot of nice things to say about their experience in the ED. The Brainscope system can also ease some of the workflow stress on ED staff, thanks to the fact that the system can eliminate as many as half the CT scans that are currently performed on patients who have experienced some sort of cranial trauma.

The company is open to sales to retail health clinics, but Hertzberg noted that while a hospital might see 3,000-5,000 head injuries a year, an urgent care clinic will see maybe 50 such cases annually. The long game for the company is to persuade payers that a lower-cost site of service is the way to go in the absence of any difference in outcomes. Ambulance operators might seem a good target market as well, but Hertzberg said most of these patients don’t arrive at the ED via ambulance.

In any event, ambulance services are not paid to provide this kind of diagnostic work-up, so there’s a disconnect in terms of incentives for ambulances as a site of service. Still, the pandemic is prompting hospital administrators to reconsider the practice of allowing patents who do not need ED services into the building, given the hazards still associated with the COVID-19 pandemic.

Up next: COVID brain

Looking forward, the pandemic presents the company with an opportunity driven by the syndrome known as COVID brain, which at least according to anecdotal reporting is accompanied by concussion-like symptoms, such as fogginess and lack of focus. The Brainscope device, enabled by the right algorithm, should be able to detect indicators of COVID brain, assuming there’s a corresponding shift in electrical activity, which Hertzberg said is nearly inevitably the case.

“All roads lead to the frontal lobe” when it comes to executive and cognitive function, she said, adding that the company is working with a partner that may soon land a grant to study the phenomenon. Brainscope will probably know more about whether this development will take flight within the next nine months, but Hertzberg said she believes that “SARS will be with us for quite some time,” thanks to vaccination hesitancy and the still-burgeoning series of mutations and variants that have emerged thus far in 2021.