Neural Analytics Inc. raised $10 million to back the commercialization of its portable ultrasound Lucid System that's intended to better enable first responders and health care providers to measure, diagnose and track brain disorders including stroke and traumatic brain injury.

The system received FDA clearance last October and a CE mark this January. Part of this financing for the Los Angeles-based start up will also go to back the use of the Lucid system in early diagnostics of brain conditions.

In the future, Neural Analytics plans upgrades to its technology to include robotics that obviate the need for a skilled ultrasonographer, as well as to incorporate machine learning algorithms to more easily enable physicians to interpret the data.

BETTER BRAIN HEALTH

The idea is to bring a portable, easy-to-use system that could be used for rapid diagnostics and evaluation, to enable more effective treatment, as well as clinical trials. Major brain disorders such as brain injury, stroke and Alzheimer's disease have little diagnostic precision, which complicates efforts to develop and offer effective treatment.

"There's this massive lack of activity on the diagnostics," pointed out Neural Analytics CEO Leo Petrossian in an interview with Medical Device Daily. "What that means is that today on a macro scale, we only treat about 10 percent of the strokes that can be intervened on because of the lack of a diagnosis. In the other 90 percent of strokes, we don't even look at those because we don't get the patients early or we don't get them to the right center."

Lucid is a transcranial Doppler ultrasound system. The cleared version is a much smaller, connected and more sophisticated version of existing technology that's long been in use, upon which the company plans to layer further automation and machine learning algorithms.

Petrossian likens it to the early evolution of the electrocardiogram, which is now integrated into automated external defibrillators (AEDs) that are designed to be operated by non-expert users and placed widely in diverse environments.

"Starting off 30 years ago, where a person is looking at electrocardiograms on a piece of paper and making an interpretation, to today where we have automated distributors on the wall of offices, airports and malls. A number of discrete steps has to happen before the technology can migrate from the hands of a cardiologist in a hospital to being on the wall. And so for us, the first product is the first step of that transition," he said.

The cleared indication of the Lucid M1 Transcranial Doppler Ultrasound System is as an adjunct to the standard clinical practices for measuring and displaying cerebral blood flow velocity within the major conducting arteries and veins of the head and neck. In addition, it measures the occurrence of transient emboli signals within the blood stream.

"We developed our own ultrasound specifically so that it would be better for data mining, machine learning, reporting, algorithms, evolving cloud integration and all these things that are totally normal in 2017 that were not even in existence in 2005. Most Doppler ultrasounds that are used by the hospital today were of the type that were built before you had a smartphone," said Petrossian.

Brain health accounts for a significant portion of U.S. GDP, about 4 percent, he noted. That's a share that's likely to only increase, so it's a vital priority to develop more useful diagnostics and to use them to create and measure effective treatments.

CLINICAL, PARTNERING AIMS

Lucid is currently in the ongoing EXPEDITE trial aimed at demonstrating its usefulness as compared to standard computed tomography angiography in identifying patients who have suffered an acute ischemic stroke. The 150-patient trial is aimed at determining if Neural Analytics' technology can offer a more rapid assessment in an emergency room setting, thereby potentially improving the odds for these patients through faster treatment. The trial started last October, with results expected this year.

The company has launched the Lucid System in the U.S. and Europe. It's using a direct sales force in the U.S., building a team focused stroke centers and neurology ICUs. In Europe, it plans to rely heavily on distributors in specific geographies. For both regions, Neural Analytics is actively seeking partnerships.

Beyond distribution and manufacturing deals, in the long term the company is looking to partner with biopharmaceutical companies to aid in the development of central nervous system drug candidates.

"For example, we can build a mathematical argument for why we should be a part of any Alzheimer's drug trial going forward. And so, those are the partnerships that are more interesting for us. If you can increase the number of therapeutic options, that makes it much more valuable to develop and commercialize," observed Petrossian.

THERE FROM HERE

The latest infusion of $10 million in capital brings the total raised by Neural Analytics, which was founded in 2013, to $27 million. The round was led by early stage venture capital firm Reimagined Ventures. The firm's Ted Koutouzis will join the company's board.

With the new round, the company plans to complete the launch of the Lucid System, as well as the EXPEDITE clinical trial. The latter is slated to enable Neural Analytics to more easily demonstrate the system's value in enabling earlier, and potentially more successful, stroke treatment. In addition, it's slated to support regulatory clearance for a subsequent iteration that automates the role of the ultrasound technician, thereby better enabling the technology to stand on its own without an expert operator.

Neural Analytics started out specifically focused on traumatic brain injury, driven by the challenges of diagnoses since there's no standard definition of a concussion, no gold-standard for diagnosis and it's possible to have a concussion with no symptoms. The company in-licensed the technology to quantitatively analyze the ultrasound signals from the University of California at Los Angeles.

The company got a $3 million grant from the National Institutes of Health (NIH) for its TBI research. But it opted to expand beyond that initial focus on concussions.

"There's a long list of diseases that are known to affect the neurovasculature, and our job is to clinically validate the application of this type of technology in their assessments and then pursue regulatory clearance," summed up Petrossian.