Published by UM Ventures, 10/21/19
BALTIMORE, Md., Oct. 21, 2019 (GLOBE NEWSWIRE) — CoapTech LLC announced today that the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) within the National Institutes of Health (NIH) awarded the company a two-year, $1.2M R44 Small Business Innovation Research (SBIR) Phase II grant on August 29, 2019. This builds on a $225,000 Phase I SBIR R43 grant and a $200,000 Maryland Industrial Partnerships (MIPS) grant awarded to the company last year.
The new $1.2M grant will support a 40-patient clinical trial at the University of Maryland Medical Center (UMMC) evaluating safety and cost-effectiveness characteristics of a novel medical procedure known as percutaneous ultrasound gastrostomy (PUG), which is enabled by CoapTech’s PUMA-G device.
The PUG procedure is the world’s first and only ultrasound-based procedure for placing semi-permanent feeding tubes into the stomach. These feeding tubes are vital for patients who cannot eat or swallow, and require liquid nutrition (known as enteral feeding). Common conditions that require enteral nutrition include cancer, diabetes, and recovery after stroke – all of which are on the rise.
R. Gentry Wilkerson, MD, assistant professor of emergency medicine at the University of Maryland School of Medicine, will serve as the principal investigator for the study. According to Dr. Wilkerson, “This study aims to demonstrate that a broad, multidisciplinary team of physicians, including critical care intensivists, interventional radiologists, and interventional pulmonologists, will be able to complete feeding tube placement using point-of-care ultrasound. The expansion of types of providers that will be able to place feeding tubes may benefit patients by decreasing delays in having the procedure performed. In addition, the medical system can benefit through improved resource utilization.”
The grant will also fund an evaluation of training and workflow approaches for the new PUG procedure. This evaluation will inform and optimize best practices, leading to a validated training methodology for new users, aiding in rapid dissemination of this novel option for feeding tube placement to physicians around the world. Experts in human factors and ultrasound-procedures from the Johns Hopkins Medicine Armstrong Institute for Patient Safety and Quality will inform the training and workflow evaluation.
“As an early investor in CoapTech, we are excited to see the company hit another significant milestone,” said Phil Robilotto, Associate Vice President for the Office of Technology Transfer at University of Maryland, Baltimore, and Director of UM Ventures, Baltimore. “The Company’s PUMA-G technology has now been validated through multiple sources of external funding and this important clinical trial will hopefully validate its efficacy in practical applications.”
CoapTech, founded by Steven Tropello, MD, MS and Howard Carolan, MPH, MBA, is a medical device company based in Baltimore, MD commercializing a new platform called the PUMA System which allows ultrasound to be utilized in hollow organ cavities. The PUMA (Point-of-care Ultrasound Magnet Aligned) System seeks to enable several new minimally-invasive, bedside medical procedures, substantially reducing costs while improving patient safety and experience. The platform’s first product application, PUMA-G for ultrasound gastrostomy, has been cleared for use in the USA by FDA via the 510(k) pathway. CoapTech was selected as a Medtech Innovator 2019 Best-in-Class Startup company and was named 2018 Maryland Incubator Company of the Year for Best Medical Device Company. Visit www.coaptech.com for more information. Or connect via Twitter @coaptech
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