CoapTech seeks to bring a series of breakthrough medical devices to worldwide markets, leveraging a patent-pending, disruptive technology called Coaptive Ultrasound which is owned by the company. CoapTech devices will reduce health care costs, and improve safety, quality, patient experience, and access to services around the globe.
Invented by Dr. Tropello, a critical care physician who was frustrated by the inefficiency of the current system, 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.
Our lead use case, selected because of its low risk, clear FDA pathway, and strong commercial viability, is for the insertion of gastrostomy tubes. We have 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.
The current gastrostomy tube market is ~$525M+ annually and projected to grow to over $650M by 2020. Given the aging population both in the United States and Asia (China, India), and the growing prevalence of chronic diseases, the number of gastrostomy tube insertions will continue to rise. Our disruptive approach using a simpler procedure requiring less costly clinical inputs is directly comparable to the model by which several other common medical procedures have successfully won and enlarged markets. We estimate that our simpler PUG procedure will drive an increase in the total number of procedures and that pricing above current levels will be feasible given the net added value of the PUG approach compared to current procedures.
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.
As CoapTech's first product is established in the marketplace for use in the PUG procedure, additional applications of the device to other procedure markets will be pursued by CoapTech to leverage the core technology, expand the company, and improve care quality, cost, safety, and access to patients around the world.