UMB-born medical device startup wins FDA clearance
Published 4/30/19 in the Baltimore Business Journal
UMB-born startup CoapTech has developed a technology that allows for more efficient, less-invasive feeding tube placement for hospital patients.
Baltimore medical device startup CoapTech LLC has gained clearance from the U.S. Food and Drug Administration for its first product, moving it closer to commercialization.
The company’s point-of-care ultrasound magnet aligned (PUMA) technology has gained 501(k) clearance from the FDA, indicating the device is satisfyingly safe and effective to be brought to market. The clearance is specific to the PUMA’s use in placing gastronomy, or feeding tubes.
The tech allows clinicians to position and place a patient’s feeding tube using magnets, with clear visualization of paths inside the body. It provides an alternative to a typical feeding tube placement procedure, which may typically require specialists, greater levels of sedation and use of an operating room. CoapTech hopes its tech will enable placement procedures that are less expensive, and potentially less harmful than traditional methods.
CoapTech was born out of the University of Maryland, Baltimore and is based around technology developed by emergency medicine physician Dr. Steven Tropello of the UM School of Medicine, who serves as the company’s chief medical officer. The technology was successfully tested on dogs and humans before gaining its FDA clearance. The European Patent Office granted a patent in June 2018. A U.S. patent is pending.
“The inspiration for this product came after seeing countless patients needing a simple 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,” Tropello said in a statement. He said trained clinicians will be able to utilize the PUMA system to safely place the tubes at a patient’s bedside now, “which should keep patients progressing on their journey towards recovery and home.”
CoapTech raised $2.35 million in seed funding last summer, to support clinical testing and the push for FDA clearance. Major funders involved in the round included the National Institutes of Health, UM Ventures, Maryland Technology Development Corp. and the Maryland Industrial Partnerships program, as well as local angel investors.
The new FDA clearance clears the way for CoapTech to move its first product to market. The company is also planning alternate uses for its technology.
“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,” CEO Howard Carolan said in a statement.
