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Classified in: Health
Subject: FDA

CoapTech Receives FDA 510(k) Clearance for Its PUMA-G System

BALTIMORE, April 29, 2019 /PRNewswire/ -- CoapTech LLC, a medical device company focused on delivering transformative solutions for minimally-invasive surgery, announced today that the U.S. Food and Drug Administration (FDA) on April 10, 2019 granted the company 510(k) clearance for its PUMA-G System, which enables ultrasound-based placement of percutaneous gastrostomy feeding tubes.  

Millions of patients around the world who cannot eat or swallow rely on feeding tubes to provide enteral nutrition via a tube through the abdominal wall directly into their stomach. Conventional procedures to place feeding tubes typically require a surgical suite, additional specialty consultant providers, and expensive and invasive imaging. The PUMA-G System, which is the world's first and only ultrasound gastrostomy system, allows physicians to place gastrostomy tubes at the point of care, using solely ultrasound imaging.  

By eliminating the need for a surgical suite, the PUMA-G System has the potential to improve efficiency, safety, and cost-effectiveness as well as expand access globally to this important therapy for nutrition administration.       

"As a healthcare provider, I have seen the challenges with current gastrostomy methods, and the delays in care and potential harm to patients that can result. The inspiration for this product came after seeing countless patients needing a simple G-tube insertion or replacement who needlessly wound up staying multiple days in the hospital waiting for a specialist and an operating room to be available," says CoapTech Founder and Chief Medical Officer Steven Tropello, M.D., a critical care and emergency medicine physician who invented the PUMA-G System. "Clinicians trained in point-of-care ultrasound will be able to utilize the PUMA-G System to safely and swiftly place a G-tube at the bedside, which should keep patients progressing on their journey towards recovery and home."  

The PUMA-G System is the first approved application of CoapTech's Point-of-care Ultrasound Magnet Aligned (PUMA) System platform, which enables ultrasound to work in hollow organs of the body for novel diagnostic or interventional procedures.  

"Our hardworking team is honored to have received FDA clearance as we continue our mission for safer, simpler, and faster patient care," says CoapTech CEO Howard Carolan.  "Based upon the success of the PUMA-G System to date, this milestone further motivates us to accelerate the development of other applications, expanding the PUMA platform to provide new solutions for ultrasound-guided procedures in other hollow organs of the body, such as the airway and lung."   

"This is tremendous news for University of Maryland, Baltimore (UMB) startup CoapTech," said Phil Robilotto, UMB Associate Vice President, Office of Technology Transfer and Director of UM Ventures, Baltimore. "UM Ventures participated in CoapTech's initial financing seed round last year and is very excited by the Company's continued excellent progress as marked by this  510(k) clearance and the prospect of soon seeing the important PUMA-G technology used in patient care across the United States."

About CoapTech

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 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

About UM Ventures

UM Ventures is an initiative to channel the tremendous technical resources and research expertise of the University of Maryland, engaging partners in industry and social ventures to expand real world impact. By encouraging students and faculty, and by providing expert advice and business services, more discoveries will reach the market. By engaging directly with external partners, UM Ventures brings new investment, expanded markets, and more startup ventures. Visit http://umventures.org to learn more.

SOURCE CoapTech LLC; UM Ventures

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