Rhaeos has been awarded a US$4 million, multi-year grant from the National Institutes of Health (NIH) Small Business Innovation Research (SBIR) programme through the National Institute of Neurological Disorders and Stroke (NINDS). This funding will be used to expand the functionality of FlowSense—its wireless, non-invasive sensor technology—to provide flow rate measurements and other quantitative data.
Designed to rapidly monitor ventricular shunt function in patients with hydrocephalus, which, according to a Rhaeos press release, affects more than 1 million adults and children in the USA, FlowSense adheres to a patient’s skin above the implanted shunt tubing. Critical data on shunt functionality is measured in a matter of minutes and wirelessly transmitted to a mobile app to improve clinical decision-making.
Under the NIH SBIR grant, Rhaeos will leverage its existing wireless sensor hardware to provide additional quantitative flow data to the clinician, giving insight into this currently inaccessible and highly relevant shunt performance metric. The grant will support substantial animal model validation, advanced algorithm development, and multicentre clinical investigations, that will ultimately lead to a marketing submission to the US Food and Drug Administration (FDA), the release adds.
“Shunts are life-saving devices for patients with hydrocephalus, but the reality is that the tools we have today to assess their functionality are very limited,” said David D Limbrick, chair and chief of Pediatric Neurosurgery at Washington University School of Medicine, and neurosurgeon-in-chief with St. Louis Children’s Hospital (St. Louis, USA). “I am delighted to be part of the research team focused on developing this important new device. Rhaeos’ FlowSense is poised to dramatically impact care of these patients by reducing the number of evaluation assessments and, potentially, surgeries required to manage a highly complex, lifelong disease.”
Limbrick, who is active within the Hydrocephalus Clinical Research Network, and James McAllister, professor of Neurosurgery at the Washington University School of Medicine, are investigators on the NIH SBIR grant.
According to the release, about half of all implanted shunts—the standard approach to managing hydrocephalus—fail within the first two years of placement and require repeated surgical intervention. Failure is typically diagnosed by computed tomography (CT) and magnetic resonance imaging (MRI), which can be inconclusive and expensive. The ability to directly measure flow dynamics addresses this crucial care gap by enabling point-of-care diagnostics for shunt function.
“One of the most frustrating and worrisome aspects of managing hydrocephalus for both patients and physicians is not knowing with certainty if an implanted shunt is working,” said co-investigator Matthew B Potts, a cerebrovascular neurosurgeon with Northwestern University Feinberg School of Medicine’s Division of Cerebrovascular/Neurointerventional Surgery in the Department of Neurological Surgery (Chicago, USA). “This device has the potential to give us an immediate, direct way of confirming if a shunt is functioning properly. With the backing of the NIH SBIR grant, we can compress the development timeframe and move to clinical trials more rapidly than would otherwise be possible.”
The current grant brings the total SBIR funds awarded to Rhaeos in 2021 to more than US$5 million. Earlier this year, it also received US$1.19 million from the National Science Foundation for development of a remote monitoring version of FlowSense that will allow the company to offer a full suite of shunt monitoring solutions that can follow hydrocephalus patients from hospital to home.
“This NIH SBIR grant is an important milestone in Rhaeos’ commitment to developing wearable sensors to improve the care of patients suffering from hydrocephalus and, eventually, other chronic, complex conditions,” said Anna Lisa Somera, CEO of Rhaeos. “We look forward to advancing the important work of identifying and developing safer, more reliable methods for detecting and managing failed shunts and providing patients with the peace of mind of knowing when their shunt is functioning as intended.”