The pieces are finally coming together for vascular device startup Catheter Connections.
CEO Vicki Farrar said the four-year-old company has secured new patents this summer, hired a new vice president of sales and has gotten back strong infection reduction data in a trial of its anti-infective cap for catheters. It’s also raising a $2 million round of financing.
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“Adoption was a little bit slow,” Farrar admitted of the company’s flagship device, DualCap, which has been on the market for several months. “We have several competitors that beat us to market.”
Conceptualized by two nurses and U.S. Food and Drug Administration-cleared in 2010, DualCap is a set of disposable caps that deliver 70 percent isopropyl alcohol to both ends at which the catheter and the IV tube connect: the luer access valve (also called needle-less injection site) on the catheter and the male luer connector on the IV tube. They’re intended to be used between infusion therapies.
Competing companies like Hospira, Excelsior Medical, Bard Medical and Ivera Medical also make antiseptic caps for the needle-less connector. But DualCap has the additional piece for the male luer, an area that can’t be swabbed with an antiseptic because that would introduce a toxin into the fluid path. That’s the company’s secret sauce: the ability to disinfect the male luer without letting a drop of alcohol into the fluid path, Farrar said.
A study sponsored by the company and led by a Loyola University Medical Center researcher last year found higher levels of contamination on male leurs than on the luer access valves. The researchers also found cross-contamination between the two parts. So why wouldn’t other companies be making a device to protect male luers?
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“The person who coined ‘biofilm’ did studies on the needle-less connector, so everybody knows that that’s an area of infection,” Farrar said. “We think it’s been an oversight; people just don’t think about it. The IV tubing will be near the bed pan, on the dresser, or just hanging loose.”
Loyola will be presenting the company’s most recent data about reduction in infections while using DualCap at an infectious disease conference this fall.
But things haven’t been all rosy at the company as it’s had some legal disputes in the past few months with Ivera Medical, maker of the Curos disinfection port for access valves. In April, Ivera sued Catheter Connections and claimed the Utah-based startup infringed upon Ivera-held patents with its disinfectant caps. Catheter Connections struck back in June with a lawsuit accusing Ivera of manufacturing a cap that disinfects the male luer and displaying it at trade shows without acknowledging in writing that it is not FDA 510(k) cleared. Ivera CEO Bob Rogers did not return a call.
For now, Catheter Connections will focus on the good things and continue attempting to establish itself in the infection-prevention market, a $16.7 billion market that’s becoming more fragmented as hospitals take novel approaches to fighting infections, hoping to avoid hospital readmissions and cuts to reimbursement. As many as one in 20 patients acquire an infection during a hospital stay, according to the Centers for Disease Control and Prevention.
“We now have infection reduction data, which took us awhile to get,” Farrar said. That gives the company more confidence in its approach moving forward. “One day this will be standard of practice — there’s no doubt about that.”
[Photo from Catheter Connections]
