CoapTech, LLC — Department of Health and Human Services SBIR Phase I: 300

Description

The goal of this project is to test a safer more accessible method for placement of gastrostomy feeding tubes Millions of patients worldwide require enteral nutrition and hundreds of thousands of gastrostomy feeding tube placement procedures are performed annually Key patient populations receiving gastrostomy procedures include Medicare enrollees in the United States pre term infants in developing nations and individuals managing chronic diseases which are increasing in incidence such as cancer and strokes The current standard of practice for placement of nearly all feeding tubes worldwide is called the Percutaneous Endoscopic Gastrostomy PEG method PEG is costly complex and potentially risky to perform as it is performed in a surgical suite about of the time requiring specialty providers and sophisticated imaging instruments We have invented a new device and method using magnets and low cost ultrasound called Percutaneous Ultrasound Gastrostomy PUG which will improve and simplify the gastrostomy procedure on many dimensions The most important difference between our method and PEG is that the PUG device will allow of all gastrostomy procedures to be performed at the patient s bedside without specialist consultants expensive imaging and surgical suite time for the remaining of cases the PUG device will be contraindicated and a conventional PEG may be performed Migration of methods from the surgical theatre to the patient bedside has successfully occurred for many different specialty procedures over the previous two decades and in each instance has led to substantially reduced cost and improved patient satisfaction with comparable or better safety outcomes The PUG device has been successfully tested in human cadavers and live canines and has a clear regulatory pathway laid out through meetings held between CoapTech and the FDA In this Phase SBIR project we will complete FDA requested verification and validation testing and necessary quality controls of the device with an eye toward safety and commercial viability Successful completion of this project will position the device for submission to the FDA for Investigational Device Exemption approval in preparation for a small clinical study bringing this new method significantly closer to improving outcomes and experience for patients worldwide The goal of this project is to conduct verification and validation testing on a novel method for safer more accessible placement of gastrostomy feeding tubes The current standard of practice worldwide is costly difficult and requires specialty providers and imaging instruments We have invented a new device and method which will improve and simplify the gastrostomy procedure on many dimensions and has a clear regulatory pathway laid out with supporting guidance by the FDA