BIRMINGHAM, Ala.—Control Flo Medical L.L.C. has established a supply and design agreement regarding its ResQ Urological Catheter System with Degania Silicone Ltd.
Birmingham-based Control Flo said the partnership is the next step in the process of getting its ResQ system approved by the Food and Drug Administration. To do that, the firm needs to have a manufacturer to produce an alpha and beta prototype for utilization trials.
Control Flo began the vetting process in 2016, and Chief Operating Officer Philip White said the firm talked to more than 20 companies, narrowing it down to 11 proposals before settling on Degania.
"Degania was just the best fit for Control Flo," White said. "They're very well received in the silicone and medical device space. They have vast experience in balloon catheters through their French companies. It was just a great paring."
Control Flo was founded by Henry Allison Barnett when he obtained two patents surrounding his ResQ catheter system. White said the catheter consists of a volume-controlled balloon that expands in the urethra. The balloon changes locations on the next catheter insertion to minimize problems caused from inserting it in the same spot.
White said an intermittent catheter user goes through about 200 catheters a month, claiming this product can cut that number down to about 12.
"It's a vast improvement in the lifestyle and just in your psyche," White said. "I think this is going to be a game changer in that arena."
A five-employee operation, Control Flo has four additional patent applications that it plans to file within the next month.
Degania employs 1,700 through its four sites in Israel, France, India and Slovakia, with research and development capabilities in Israel and France. The firm specializes in silicone manufacturing with a focus on catheters, and posting about $85 million in sales. In December 2016, Q Holding Co. acquired Degania in a transaction that Q said will double its medical sales.