CoapTech Considers Colombia For its First-In-Man Clinical Trial to Prove The Efficacy of its Enteral Nutrition Feeding Tube Placement Technology
[ORLANDO, FL, January 28, 2018] - CoapTech is an early-stage medical device company with a patent-pending, platform technology to disrupt the market for enteral nutrition feeding tubes. The CoapTech system will de-skill the procedure for feeding tube placement, offering a simpler, safer, and more affordable method. CoapTech has chosen to explore Colombia to conduct its first-in-man clinical trial.
Invented by Dr. Tropello, the CoapTech delivers a novel platform technology combining magnetic attraction for device placement guidance, and low-cost, point-of-care ultrasound for visual feedback in diagnostic, interventional and therapeutic procedures. Strong rare-earth magnets are used to manually guide device placement inside the human body, while real-time, low-cost ultrasound provides visual feedback to the clinician to ensure safety. This platform technology, invented by the company founder, has the potential to disrupt multiple medical procedures, substantially reducing costs while improving safety and patient experience.
CoapTech's lead use case, selected because of its low risk, clear FDA pathway, and strong commercial viability, is for the insertion of gastrostomy tubes. CoapTech has defined the use of Coaptive Ultrasound to perform this novel gastrostomy procedure, as Percutaneous Ultrasound Gastrostomy (PUG). Briefly, PUG is a point-of-care (as opposed to operating room) procedure for inserting gastrostomy tubes which can be quickly and easily performed by non-surgical providers. It employs readily available medical devices such as ultrasound, feeding tubes, guide-wires, and dilators.
Current procedures to insert gastrostomy tubes require expensive, inpatient hospital equipment and have high complication rates between 4% and 20%. The need for highly trained surgeons, operating room time, and use of specialized equipment including endoscopes, fluoroscopes, and Computed Tomography (CT) scanners, translates into higher consultation costs, greater patient wait times and additional hospital admission costs.
Percutaneous Ultrasound Gastrostomy (PUG) has been validated in live canines, as well as human cadaver models and has a streamlined regulatory pathway based on FDA presubmission feedback. Preliminary tests in cadaver, animal, and gelatin models have been successful and the now 4th-generation prototype product has been reviewed in formal pre-submission proceedings with the FDA to highly favorable results. CoapTech expects the PUG device will receive FDA clearance via the standard 510(k) pathway without a human trial requirement, expediting market viability. CoapTech has filed patent applications broadly with solid intellectual property basis as indicated by legal counsel review of IP landscape.
CoapTech's first-in-human clinical trial is prepping to begin in the first quarter of 2018 and will take place at a reputable health institution in Colombia. The country’s clinical research regulation is friendly to medical device trials. The approval of a medical device trial at a research center in Colombia takes about 60-90 days (including ethics committee and Ministry of Health submission). This positions Colombia as the country with the fastest approval time in Latin America for medical device research.
BIOACCESS™ —a Florida-based clinical research company which mission is to help innovative life science companies conduct clinical research and commercialize their innovations in Colombia— will design the study and will provide trial support services such as regulatory submission, logistical support, project management, statistical analysis, and study monitoring; among others. More information at www.bioaccessla.com.