CoapTech prepares for clinical trials of its ultrasound device

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Startup of medical device CoapTechthe pediatric version of PUMA-Gits already available and FDA-approved ultrasound device for adults, was recently cleared for clinical testing at Philadelphia Children’s HospitalDC National Children’s Medical Center and Columbia NewYork-Presbyterian Hospital At New York.

The study aims to prove that the device, which the company says enables safer placement of pediatric feeding tubes, significantly reduces children’s exposure to radiation. Essentially, when a child needs a feeding tube, a CT scan is needed to obtain X-ray images of the stomach that help verify the best placement of the tube after a procedure. Studies have shown show that such radiation exposure is significant enough to warrant concern. PUMA-G uses ultrasound and magnets to visualize tissues and organs in real time, avoiding the need for exposure to potentially carcinogenic radiation.

“It’s one of those things where this radiation exposure is not going to immediately lead to cancer, but 30 years later the risk factor in children is much higher,” Jack KentChief Marketing Officer of CoapTech, said Techncal.ly.

The team of 15 people working on LaunchPort at City Garage in Port Covington, along with several other Baltimore medical device companies, is excited to begin trials later this spring. The team expects clinical trials to be carried out in late 2022, or early 2023 at the latest.

The National Institute of Health rewarded the company $1.6 million in 2020 for this cycle of clinical trials and the pediatric development of PUMA-G.

Because children are considered a special patient population by the FDA, previous approval of PUMA-G does not expedite the process of getting a new device fully approved by the FDA. The only real benefit is that the device is still in the gastrointestinal branch of the FDA, so Coaptech can hope to get to grips with the new technology.

“We want our clinical data to demonstrate what we think is going to happen,” Kent said. “[PUMA-G Peds System] is safe and we will reduce radiation.


Donte Kirby is a 2020-2022 corps member of Report for America, an initiative of The Groundtruth Project that pairs young journalists with local newsrooms. This position is supported by the Robert W. Deutsch Foundation. -30-
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