Making a procedure more accessible to patients
We worked with Dr. Steven Tropello, an Emergency and Critical Care Physician at the University of Maryland School of Medicine, to develop a novel method of Coaptive Ultrasound Gastrostomy to insert a feeding tube under ultrasound guidance. This patent-pending method simplifies the procedure so non-surgical providers can perform it outside the hospital setting with inexpensive equipment while reducing the rate of complication. Most of the development was supported by TEDCO and funded through Maryland Innovation Initiative (MII) grants.
Root3 Labs supported the project from the earliest concept, some of which are shown in the images below. We fabricated custom, low-cost prototypes to demonstrate feasibility and perform initial testing on human cadavers. Having shown favorable results, we refined the design through several stages of prototyping and cadaver studies toward a sterilized, medical-grade product. The preliminary data and 4th-generation prototypes have been well-received by the FDA in a pre-submission presentation. For more information about the procedure, including a video of one of the medical cadaver procedures (for those so inclined), see www.coaptech.com/about2.
The project has spun out of the University of Maryland to form Coaptech, LLC under an exclusive licensing agreement. We’re continuing to work with the company to take the device into manufacturing and through the regulatory approval process.
This project in the news:
- Apr 29, 2019 Coaptech.com – CoapTech Receives FDA 510(k) Clearance for Its PUMA-G System
- Nov 30, 2016 PR Newswire – CoapTech, LLC, And University of Maryland, Baltimore Set Stage To Commercialize Novel Procedure For Placing Feeding Tubes
- Dec 8, 2016 Technically Baltimore – How CoapTech turned a feeding tube innovation into a company
- April 13, 2017 MD&M East – “Developing a Novel Method to Insert a Feeding Tube Under Ultrasound Guidance at the Bedside”, Presented by Chad Schneider
- Dip Molding Balloons
- Material Selection
- Benchtop Fixtures
- Large Animals
- Demonstrate feasibility
- Support trial studies
- Design for manufacturing
- University of MD, Baltimore
- CoapTech, LLC