BALTIMORE, July 14, 2021 / PRNewswire / – CoapTech, Inc, a medical device company focused on providing transformative solutions for minimally invasive surgery, today announced that it has received CE Mark certification, along with an approved CPT procedure code for its PUMA-G System, the first and only ultrasound gastrostomy system that allows physicians to place gastrostomy tubes at the point of care, using only ultrasound imaging.
The PUMA System ™ is a new class of minimally invasive devices, allowing ultrasound to be used for procedures in hollow body organs where it was previously impossible or unsafe to do so. The first application of PUMA platform technology, the PUMA-G System, is an FDA-approved procedure kit that allows bedside clinicians, rather than specialist consultants, to place gastrostomy tubes using only ultrasound and their existing skills and teams. With the approval of the CE mark, the PUMA-G system now has the potential to improve efficiency, safety and cost efficiency internationally. CoapTech plans to start a targeted launch by Europe Later this year.
“The CE mark approval allows the PUMA-G system to be sold in Europe and is a major milestone for the commercial success of CoapTech, ”said CoapTech co-founder and CEO Howard carolan. In addition, the recent granting of a CPT code by the American Medical Association will facilitate coding and billing of PUMA-G users for the performance of our new ultrasound gastrostomy procedure. This is a key part of our pilot commercialization phase, during which we continue to see significant interest in PUMA-G. ”
In addition, CoapTech has had new safety studies accepted for publication. A study published in the Journal of Critical Care Medicine demonstrated that CoapTech’s ultrasound gastrostomy procedure could be easily performed in intensive care units (ICUs) (as previously published data demonstrated) and was beneficial for COVID-positive patients. In addition, the published results in Abdominal radiology confirmed that the PUMA-G device has a safety profile comparable to that of conventional gastrostomy methods.
“With these studies, CoapTech and our research partners have established that ultrasound gastrostomy (PUG) is safe, can be performed in the intensive care unit, and is valuable in the post-COVID world. Future studies will identify additional benefits, especially in terms of efficiency and costs. of our method and of the PUMA-G device, ”said Dr. Steven tropello, founder and chief physician.
Phil robilotto, DO, director of UM Ventures, Baltimore, noted: “It is gratifying for the team at UM Ventures to watch CoapTech, as University of Maryland, Baltimore start-up, take important steps for its products and contribute to growth Baltimore medtech ecosystem. ”
CoapTech closed a Series B funding last year led by Hunniwell Lake Ventures to further extend PUMA technology to other minimally invasive procedures.
CoapTech is a Baltimoremedical device company marketing a new platform called the PUMA system, which enables ultrasound to be used in cavities of hollow organs. The PUMA (Point-of-care Ultrasound Magnet Aligned) system enables several new minimally invasive medical procedures at the bedside, dramatically reducing costs while improving safety and the patient experience. The platform’s first product application, PUMA-G for ultrasonic gastrostomy, has been cleared in the United States by the FDA via the 510 (k) route and received CE mark. CoapTech was selected as Best Medtech Innovator 2019 Startup 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 University of Maryland, Baltimore and UM Ventures
the University of Maryland, Baltimore (UMB) is a rapidly 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 revolutionary therapies, diagnostics and devices, fuels the creation of innovative start-ups, and attracts industry leaders and entrepreneurs to the University’s thriving downtown campus. A large portfolio of technologies is available for licensing at www.umventures.org.