CoapTech Announces IDE Approval from FDA to Initiate Clinical Trial for its PUMA-G Peds System for Pediatric Gastrostomy
Tuesday, March 8, 2022
BALTIMORE, March 8, 2022 /PRNewswire/ -- CoapTech, Inc, a medical device company focused on delivering transformative solutions for minimally-invasive surgery, announced today it has received an Investigational Device Exemption (IDE) approval from the Food and Drug Administration (FDA) to initiate a clinical trial for its PUMA-G Peds System, a device designed to provide a safer and more efficient way to place feeding tubes in children.
The PUMA System™ is a new category of minimally invasive devices, enabling ultrasound procedures in hollow organs of the body where previously it was impossible or unsafe to do so. The PUMA-G Peds System is being developed to allow ultrasound-based placement of gastrostomy tubes in pediatric patients as an alternative to traditional endoscopic, fluoroscopic and open surgical procedures. Endoscopic procedures cannot "see through" tissue which can result in organ damage and other complications exist related to the large sizes of endoscopes relative to small children. Fluoroscopic procedures require the use of ionizing radiation which presents a great risk of future cancer to young children. The PUMA-G Peds System uses ultrasound to visualize tissue and organs in real-time without ionizing radiation.
"We are delighted that the FDA has granted this IDE, allowing us to begin a study with our world-class partner sites. The approval is a testament to our robust preclinical work and the potential of the PUMA-G Peds System to greatly impact pediatric care," said Jack Kent, Chief Commercialization Officer at CoapTech. The multicenter non-inferiority trial with a matched retrospective control group is part of an NIH SBIR grant and will begin enrolling patients this spring at Children's Hospital of Philadelphia, Children's National Medical Center, and Columbia NewYork-Presbyterian Hospital.
CoapTech spun out of the University of Maryland, Baltimore (UMB) where the technology was developed. UMB's technology transfer arm, UM Ventures, Baltimore, also provided direct investment in the company.
"This is a significant milestone in CoapTech's efforts to bring to market a pediatric version of their groundbreaking PUMA-G platform technology," said Phil Robilotto, Associate Vice President for the Office of Technology Transfer at UMB, and Director of UM Ventures, Baltimore. "We look forward to the clinical trial getting underway and seeing what is next for CoapTech."
CoapTech is a Baltimore-based medical device company 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 enables 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 in adults, has been cleared for use in the U.S. by the FDA via the 510(k) pathway and has received a CE mark. 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 at @coaptech.
SOURCE CoapTech LLC