Prytime Medical Devices, a Boerne-based, privately-held medical technology company that develops minimally invasive solutions for treating trauma, announced Tuesday that it has received CE Mark approval for the company’s ER-REBOA Catheter and has begun preparation for a targeted market release in Europe.
“Simply put, no one should bleed to death, and the sooner you stop bleeding the better,” CEO of Prytime Medical Devices David Spencer stated. “CE Mark approval enables us to accelerate our expansion outside the U.S. while providing European clinicians an exciting new tool to temporarily stop bleeding and save lives.”
CE Marking is an unfamiliar term to most in the U.S. market, but in the European Economic Area (EEA) it signifies a product’s approval for sale across the 28-nation market.
The letters ‘CE’ appearing on a product indicates that it meets high safety, health, and environmental protection standards. CE marking extends to everything from over-the-counter consumer products such as toys, to smart phones and medical equipment. Their rules are universal for all companies doing business in the EEA.
Prytime’s ER?REBOA Catheter is the first one “designed specifically for rapid, temporary occlusion of large vessels in the emergency and critical care environment. Key design benefits include a patented atraumatic P-Tip, guidewire free placement, external insertion length markers, small sub 7 Fr size, and built-in blood pressure monitoring.”
“Getting our CE Mark is another major milestone for our organization,” Senior Vice President of Global Sales and Marketing Roger Baker stated in a press release. “This certification allows us to broaden our support for clinicians globally and begin impacting patients’ lives in the European market.”
The company expects it will take up to 90 days to finalize its European distribution and reporting infrastructure, and plans a targeted roll of its new catheter to key European physicians by early 2017.
Spencer is a well-known entrepreneur, venture capitalist, and civic leader in San Antonio, with his business offices in Boerne. He founded OnBoard Software in 1996, which grew to more than 90 employees and $17 million in annual revenue. Spencer sold his 100% stake in the company to MTC Technologies for $34 million, and has since become both an investor in other startups and a key player in developing new technologies for use on the battlefield and in treating wounded military personnel.
He also is an avid UTSA supporter and donor widely known for his tailgating parties at Roadrunner football games.
“Prytime Medical is an innovative medical device company that designs, develops, and commercializes minimally invasive solutions for trauma,” a Prytime news release stated. “The company’s flagship product is the ER-REBOA Catheter, a patented 7 Fr compatible balloon catheter for temporary occlusion of large vessels and pressure monitoring. In addition, the company is developing multiple next generation REBOA catheters and other minimally invasive solutions of interest.”
REBOA (Resuscitative Endovascular Occlusion of the Aorta) is a minimally invasive technique to temporarily plug large vessels by using a balloon catheter. Leading trauma centers across the U.S. are adopting REBOA as a vital temporizing adjunct to control hemorrhage, which has been identified as the number one cause of potentially survivable death in the surgical, emergency, and critical care environment.