Evanston, IL – Rhaeos, Inc., a medical device startup from Northwestern University, announced today the receipt of a $225,000 Phase I grant from the National Science Foundation (NSF) Small Business Innovation Research (SBIR) program. The company is developing a number of wearable sensors that use innovative flexible electronics to monitor patients with difficult-to-treat conditions. The company’s first sensor, FlowSense, is being designed to monitor ventricular shunt function in patients with hydrocephalus. Prototypes have been successful in IRB approved clinical trials, and now a commercial device is being developed.
Hydrocephalus is a chronic condition wherein cerebrospinal fluid (CSF) pressure builds up in the brain. The condition affects over 1 million Americans and costs the U.S healthcare system over $2 billion annually. Currently, hydrocephalus is treated with the surgical implantation of a ventricular ‘shunt’- a catheter that drains this excess fluid away from the brain. Unfortunately, shunts fail regularly (about 98% in 10 years) and diagnosing this failure is a major pain point due to the nonspecific nature of symptoms, which include headaches, nausea, and sleepiness. Shunt malfunction can result in developmental disorders, altered cognitive state, and death if left untreated. Currently, neurosurgeons often resort to indirect imaging, such as CT and MRI, for diagnosis, but these can expose patients to radiation and are inaccurate, costly, and time consuming. More often than not imaging is unnecessary as the shunt is actually functional. Additionally, on average, patients with shunts are forced to undergo 3 hospital visits every year for suspected shunt malfunction which, when combined with admissions, imaging costs, and indirect caregiver-related expenses, add $8,500 per patient each year, representing significant waste to the healthcare system and patients.
The Rhaeos FlowSense device is a wearable, wireless, noninvasive sensor that is attached temporarily on the patient’s neck at a location overlying the shunt to detect the presence and magnitude of CSF flow. With FlowSense, physicians can monitor shunt function in clinics, in-patient settings, and emergency departments, while patients can use them to monitor shunt function at home to avoid unnecessary imaging, hospital visits, and admissions. Additionally, long-term trends in patient flow patterns can be used to predict future failure events.
Anna Lisa Somera is the COO and co-founder of the company and is the Principal Investigator of the grant. “I am proud to partner with the NSF through this SBIR grant. This award validates our technology and will be a springboard for the development of FlowSense,” commented Somera. “This SBIR program puts us on a path to rapid FDA clearance and clinical studies.”
Rhaeos President and co-founder is John Rogers, Ph.D., founding Director of the Center on Bio-Integrated Electronics at Northwestern University, who has over 20 years of experience in fundamental and applied aspects of nano- and molecular-scale fabrication, with an emphasis on bio-integrated and bio-inspired systems. He has published more than 650 papers, and is an inventor on over 100 patents and patent applications, more than 70 of which are licensed or in active commercial use by both large companies and startups that he has co-founded.
About Rhaeos: Rhaeos is an early-stage medical device company founded in 2018. The company’s mission is to use wearable sensors to improve the care of patients with chronic and difficult-to-treat conditions. The company’s first sensor, FlowSense, is being designed to monitor shunt function in patients with hydrocephalus. FlowSense has the potential to improve patient care by quickly identifying shunt malfunction. The company plans to seek FDA 510(k) clearance for the device and pursue investigation and development of additional sensors for other conditions.
Press Contact: Anna Lisa Somera, MS, MPH, MBA, Chief Operating Officer, Rhaeos, Inc., email: email@example.com , and visit www.rhaeos.com
Investigational use only. Products have not been approved by the FDA.
Rhaeos, Inc. 2019