Tele: 561.316.3330
Breaking Medical Device News

Sunday, October 17, 2021
HomeFUNDINGRhaeos Awarded $4 Million NIH SBIR Grant

Rhaeos Awarded $4 Million NIH SBIR Grant

Rhaeos, Inc., a private medical device company focused on the care of patients with hydrocephalus, announced today it was awarded a $4 million, multi-year grant from the National Institutes of Health (NIH) Small Business Innovation Research (SBIR) program through the National Institute of Neurological Disorders and Stroke (NINDS). Grant funds will be used to expand the functionality of its FlowSense™ wireless noninvasive sensor to provide flow rate measurements and other quantitative data.

Designed to rapidly monitor ventricular shunt function in patients with hydrocephalus – a term for excesscerebrospinal fluid (CSF) that affects more than 1 million adults and children in the U.S. – FlowSense is a noninvasive wireless sensor that 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 their 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 multi-center clinical investigations that will ultimately lead to a marketing submission to the FDA.

“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, Jr., MD, PhD, T.S. Park Chair and Chief of Pediatric Neurosurgery at Washington University School of Medicine, and Neurosurgeon-in-Chief with St. Louis Children’s Hospital. “I am delighted to be part of the research team focused on developing this important new device. Rhaeos’s 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.”

Dr. Limbrick, who is active within the Hydrocephalus Clinical Research Network, and James McAllister, PhD, Professor of Neurosurgery at the Washington University School of Medicine, are investigators on the NIH SBIR grant.

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 enablingpoint-of-care diagnostics of 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, MD, a Cerebrovascular Neurosurgeon with Northwestern University Feinberg School of Medicine’s Division of Cerebrovascular/Neurointerventional Surgery in the Department of Neurological Surgery. “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 over $5 million. Earlier this year, theyalso received $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’scommitment to developing wearable sensors to improve the care of patients suffering from hydrocephalus and,eventually, other chronic, complex conditions,” said Anna Lisa Somera, MS, MBA, MPH, the CEO of Rhaeos. “We look forward to advancing the important work of identifying and developing safer, more reliable methods for detectingand managing failed shunts and providing patients with the peace of mind of knowing when their shunt is functioning as intended.”

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Stay Connected

spot_img

Don't Miss

Ganymed Robotics Awarded a €2.5M Grant from the EC through the EIC Accelerator Program

Ganymed Robotics is developing a radically new approach to surgical robotics by combining computer vision, a branch of artificial intelligence, and mechatronics.

Global Healthcare Exchange Announces Acquisition of Explorer Surgical

Explorer Surgical will operate as a wholly-owned subsidiary of GHX.

Arlington Scientific Broadens Product Portfolio and Further Expands its Product Offering Through the acquisition of Non-Mammalian Blocking Buffers

Arlington Scientific, Inc. (ASI) is pleased to announce that it has acquired the non-mammalian blocking buffer product line from Clark McDermith, former owner of...

Laborie Medical Technologies Acquires Pelvalon

Laborie was represented by Piper Sandler (financial advisor) and Simpson Thacher & Bartlett LLP (legal advisor). Pelvalon was represented by J.P. Morgan Securities LLC (financial advisor) and Dorsey & Whitney LLP (legal advisor).

Herculite Products, Inc. Promotes Two Employees to New Roles

Paul Flaherty Chief Strategy Officer and Marco Angelone is being promoted to the role of Chief Financial Officer.

Prof. Joseph Kvedar Added to the Sweetch Advisory Board Member

Prof. Josdeph Kvedar is the current chair of the board at the American Telemedicine Association (ATA), formerly VP of Connected Health at Mass-Gen Brigham, co-chair of the American Medical Association (AMA) Digital Medicine Payment Advisory Group, and author of The Internet of Healthy Things and The New Mobile Age.

Sid Bala Named President of HealthChampion

Sid Bala is the former president and chief executive officer of alligatortek, a custom software applications company that was acquired by HealthChampion in 2020 where he led them for 27 years after he founded the business

Cochlear Announces FDA Approval and Clearance of first-of-its-kind Remote Care Capabilities for Nucleus and Baha Systems

The FDA approval for the cochlear implant solution and FDA clearance for the Baha solution is the first step in commercializing the product offering, anticipated spring 2022, and complement Cochlear's existing Remote Care offerings.

By using this website you agree to accept Medical Device News Magazine Privacy Policy