WASHINGTON BUSINESS JOURNAL: DC INNO
D.C.’s iCE Neurosystems Inc. just got the green light to help doctors widely diagnose and stop brain injuries in hospitalized patients, following its emergency use in coronavirus cases during the pandemic and a recent funding round to support its expansion.
The company has scored a coveted clearance from the Food and Drug Administration to take to market its brain monitoring device for critically ill patients, from those in intensive care following stroke or trauma, to those suffering heart failure or sepsis, to those undergoing complex vascular or cardiac procedures, for instance. And iCE is now rolling out its technology to several major acute-care facilities in the D.C. area, including Inova Health System’s and MedStar Health’s flagship hospitals, said Dr. Allen Waziri, its co-founder and CEO.
The iCE-SG Subcutaneous Electrode device, as it’s called, aims to give health care providers an accurate, real-time snapshot of the brain — and do it faster and better than the EEG, the current method used across hospitals to measure brain waves, Waziri said. “Currently, EEGs require dedicated technical support, are used very rarely and many of the benefits cannot be realized by the vast majority of patients at risk for brain injury during critical illness.”
The company’s solution involves placing tiny electrodes at the top of the head under the skin in a quick, minimally invasive procedure. They then process the brain’s activity while cutting out the technical challenges associated with the standard EEG, said Waziri, who is also a neurological surgeon.
The device works with the company’s iCEWav platform, which processes that data and spits it out in colors and numbers “that are easily interpreted by doctors and nurses at the patient bedside,” Waziri said. The goal: arm clinicians with insight so they can administer the right treatment at the right time — and in doing so, both avoid brain injury and save hospitals money.
All of that information connects to the patient’s medical records and the company’s cloud capability, so doctors can quickly access the results from the same room or remotely — important, given telemedicine’s expected permanence in the industry.
That proved vital during the height of the pandemic, as doctors and nurses had to minimize contact with infected patients, making the standard EEG tougher than usual to execute. But patients with severe Covid-19 — that required advanced support or medically induced comas, for instance — experienced brain injury due to stroke, hemorrhage or loss of blood flow to the brain. And such injury was “one of the major determinants of clinical outcome and often undetectable with standard clinical monitoring,” Waziri said.
So under emergency use authorization by the FDA, hospitals used iCE’s system to monitor patients. In those cases, Waziri said, the device “helped guide critical decisions about medication administration, monitor for stroke or hemorrhage and identify seizures that were otherwise clinically undetectable.”
Going forward, the company estimates the market that would benefit from its technology is much larger, at about 1,500 U.S. hospitals — and up to 2.5 million people per year. The business, pre-revenue through 2020, provides hospitals the hardware and software for the bedside at no cost. Those facilities then buy the devices on a per-patient basis and subscribe to its software-as-a-service cloud telemedicine offering, Waziri said. The company also expects to bring on as customers a number of major academic medical centers in the Northeast by the end of 2021, he said.
The 10-person startup, which doubled its headcount over the last year, is now actively hiring for computer and data scientists, clinical support personnel and other operational roles, Waziri said. That’s after closing a $2.95 million seed round in mid-April, bringing its total lifetime funding since its 2017 founding to $4.5 million. That capital will carry the company through this early commercialization stage and its expansion to more customers over the next year or two.
Then iCE will aim to raise a Series A round of roughly $10 million to$20 million in the latter half of 2022, Waziri said. That’s for the next stage of its commercial growth, a rollout of more devices and expansion of an artificial intelligence piece of its cloud software.
“The massive need for an effective brain monitoring system simply cannot be overstated and remains a central challenge for modern medicine,” Waziri said, adding: “The ability to detect and prevent otherwise avoidable brain injury is of obvious medical and fiscal importance to the millions of affected patients and society as a whole.”