CoapTech Receives CE Mark Approval and CPT Procedure Code for Its PUMA-G System
Wednesday, July 14, 2021
BALTIMORE, July 14, 2021 /PRNewswire/ -- CoapTech, Inc, a medical device company focused on delivering transformative solutions for minimally-invasive surgery, announced today it has received CE Mark certification, as well as an approved CPT Procedure Code for its PUMA-G System, the world's first and only ultrasound gastrostomy system that allows physicians to place gastrostomy tubes at the point of care, using solely ultrasound imaging.
The PUMA System™ is a new category of minimally invasive devices, enabling ultrasound to be used for procedures in hollow organs of the body where previously it was impossible or unsafe to do so. The first application of the PUMA platform technology, the PUMA-G System, is an FDA-cleared procedural kit allowing bedside clinicians, rather than consultant specialists, to place gastrostomy tubes using solely ultrasound and their existing skill sets and team. With CE Mark approval, the PUMA-G System now has the potential to improve efficiency, safety, and cost-effectiveness on an international level. CoapTech plans to begin a targeted launch in Europe later this year.
"CE Mark approval allows the PUMA-G System to be sold in Europe and is a major milestone enabling CoapTech's commercial success," said CoapTech Co-founder and Chief Executive Officer Howard Carolan. "Additionally, recent granting of a CPT code by the American Medical Association will facilitate coding and billing for users of PUMA-G for performing our new ultrasound gastrostomy procedure. This is a key enabler during our pilot commercialization phase, during which we continue to see significant interest in PUMA-G."
Furthermore, CoapTech has had new safety studies accepted for publication. A study published in the Journal of Intensive Care Medicine demonstrated CoapTech's ultrasound gastrostomy procedure could be readily performed in intensive care units (ICUs) (as data published previously have demonstrated) and was beneficial in use on COVID positive patients. Additionally, results published in Abdominal Radiology confirmed that the PUMA-G device has a safety profile on par with conventional gastrostomy methods.
"With these studies, CoapTech and our research partners have established that ultrasound gastrostomy (PUG) is safe, can be performed in the ICU, and is valuable in the post-COVID world. Future studies will identify additional benefits, including efficiency and cost advantages of our method and the PUMA-G device," said Dr. Steven Tropello, founder and chief medical officer.
Phil Robilotto, DO, director of UM Ventures, Baltimore, noted, "It's rewarding for the UM Ventures team to watch CoapTech, as a University of Maryland, Baltimore startup, reach significant milestones for its products and help grow the Baltimore medtech ecosystem."
CoapTech closed on a Series B financing last year led by Hunniwell Lake Ventures to further extend the PUMA technology to other minimally-invasive procedures.
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, 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.
About the University of Maryland, Baltimore and UM Ventures
The University of Maryland, Baltimore (UMB) is a fast-growing biomedical research center with nationally ranked professional schools of dentistry, law, medicine, nursing, pharmacy, social work, and an interdisciplinary graduate school. UM Ventures commercializes UMB's breakthrough therapies, diagnostics and devices, fuels the creation of innovative start-up companies, and attracts industry leaders and entrepreneurs to the University's thriving downtown campus. A wide portfolio of technologies is available for licensing at www.umventures.org.