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Built in Baltimore: CoapTech, Inc. Announces Market Launch of its Second Generation Magnetic Balloon Catheter for the PUMA-G System

Tuesday, March 19, 2024

BALTIMORE, MD, March 19, 2024 –, CoapTech, Inc., a medical device company delivering transformative solutions for minimally-invasive surgery, announced today the market launch and historic first bedside use case of its second generation magnetic balloon catheter. The magnetic balloon catheter is a key component of the PUMA-G System™ which enables ultrasound placement of gastrostomy tubes (i.e. permanent feeding tubes), necessary to nourish patients to recovery. The PUMA-G System is manufactured in Baltimore in collaboration with The LaunchPort™.

This first bedside use case was completed in the critical care unit (better known as ICU) at the University of Maryland Baltimore Washington Medical Center (UM BWMC) and was performed by Darwin Ashbaker, MD, and Stephen Griffin, PA, on February 27, 2024.

“We are honored to be the first ICU team to use the next-generation PUMA catheter, and it is historically fitting since we were the first ICU team in the United States to use the PUMA-G System four years ago,” said Dr. Ashbaker. The PUMA-G System is used across the U.S. in dozens of hospitals, with several sites, including UM BWMC, demonstrating significant decreases in length of stay and total hospital costs after PUMA-G implementation.

Over the last year, The LaunchPort, LLC (https://thelaunchport.com/) and CoapTech have collaborated to enable manufacturing of the PUMA-G System’s next-generation magnetic balloon catheter in Maryland. The LaunchPort is a medtech manufacturing accelerator located in Baltimore’s Port Covington. The first CoapTech assembly lines started operation in the fall of 2023. The first production-grade batch of catheters made at The LaunchPort was market-ready by mid-February 2024.

“We’re excited about the collaboration”, said Bob Storey, Managing Partner of The LaunchPort. “Coaptech is an example of the enormous potential arising from the Maryland
medtech ecosystem. The technology was a product of our region’s research institutions, and there was tremendous support during the translational stage from the City and State’s early-stage funds. As they launched their novel products, they established their manufacturing within Baltimore, coming full circle to support the region that nurtured them. The Coaptech team has many more milestones to come.”

This second generation catheter includes several new features. “Notably, the modular design facilitates simple exchanges of components to augment the intended clinical application(s),” said CoapTech Co-Founder and Chief Executive Officer, Howard Carolan. “We essentially now have one catheter design that can easily be modified to perform a variety of procedures in the body.”

Other near-term PUMA applications that will be possible due to the second generation design include PUMA-G Pediatrics, PUMA-G XL and PUMA-J. A smaller magnet size, for example, enables PUMA-G Pediatrics, where smaller magnets aid in navigating a catheter through a child’s relatively small gastrointestinal tract anatomy. The assembly process at The LaunchPort was developed to manage these minor modifications.

Similar to the PUMA-G System’s path to market, these other PUMA applications are undergoing rigorous verification and validation testing and/or clinical studies. The PUMA-G Pediatric System is currently utilized in a National Institutes of Health-funded study at the Children's Hospital of Philadelphia, Children’s National Hospital, and NewYork-Presbyterian/Columbia University Irving Medical Center, with several successful cases completed to date, eliminating the need for x-ray radiation. X-ray radiation, which can cause cancer in younger patients, is currently used in radiologic guided gastrostomy tube placement methods for children.

The PUMA-J System, designed to place feeding tubes into the jejunum, a deeper part of the gastrointestinal tract, has a U.S. Food and Drug Administration Investigational Device Exemption and is about to be utilized in a first-in-human study at the University of Maryland Medical System. This first-in-human PUMA-J study is funded by a Maryland Industrial Partnerships (MIPS) program grant. PUMA-XL, for very high BMI patients, is in validation and verification testing stages at CoapTech facilities.

CoapTech spun out of the University of Maryland, Baltimore (UMB) where the technology was developed by CoapTech’s Founder, Steven Tropello, MD, MS. UMB’s technology transfer arm, UM Ventures, Baltimore, also provided direct investment in the company.

“CoapTech’s recent progress and ability to expand product offerings to reach new patient populations is truly impressive,” said Phil Robilotto, DO, MBA, associate vice president for technology transfer at UMB and executive director of UM Ventures, Baltimore. “Their team is incredibly dedicated and it’s wonderful to see them succeed, especially right here in Baltimore where the technology was developed.”


About 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. 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 University of Maryland Baltimore Washington Medical Center
Located in Glen Burnie, Maryland, UM BWMC is an acute-care facility that is part of the University of Maryland Medical System. The medical center has 285 beds and more than 3,500 team members. It also has 1,000 medical providers on staff in over 50 specialties. For more information, visit www.umbwmc.org.

About the University of Maryland Medical System
The University of Maryland Medical System (UMMS) is a university-based regional health care system focused on serving the health care needs of Maryland, bringing innovation, discovery and research to the care we provide and educating the state's future physician and health care professionals through our partnership with the University of Maryland School of Medicine and the UM Schools of Nursing, Pharmacy, Social Work and Dentistry in Baltimore. As one of the largest private employers in the State, the health system's 28,000 employees and 4,000 affiliated physicians provide primary and specialty care in more than 150 locations and at 13 hospitals. UMMS' flagship academic campus, the University of Maryland Medical Center in Baltimore is partnered with the University of Maryland School of Medicine and is recognized regionally and nationally for excellence and innovation in specialized care. Our acute care and specialty rehabilitation hospitals serve urban, suburban and rural communities and are located in 13 counties across the State. For more information, visit www.umms.org.

 

Media Contacts
Howard Carolan
CEO, CoapTech
[email protected]
443.745.1120