A Cleveland company developing catheter infection prevention technology has reached a big milestone in the commercialization process — but to do so, it’s had to make a big shift in strategy.
Great Lakes Pharmaceuticalshas just begun the first clinical study of safety and efficacy of its antimicrobial solution to prevent infections associated with indwelling catheters in about 400 renal dialysis patients in Europe.
MedCity News reported back in 2010 that the Cleveland-based company planned to file an Investigational Drug Exemption for its liquid catheter lock solution with the U.S. Food and Drug Administration that year, but President and CEO Krzysztof Appelt said today that the company had shifted its focus to Europe after discovering it would take two years to get through the paperwork process with U.S. regulators. He hopes doing a trial in Europe will not only help the company get CE marking but also make the process smoother with the FDA.
In preclinical studies, B-Lock demonstrated quick killing of several bacterial and fungal strain infections, including antibiotic resistant strains of S. aureus, S. epidermidis and Enterococcus as well as Pseudomonas, Klebsiella, Acinetobacter and Candida, the company says. Complicated bloodstream infections can arise when these microbes form biofilms on central venous catheters, which are commonly used in administering chemotherapy and renal dialysis.
“Now we are going to be engaging the FDA and trying to impress them with the study in Europe,” Appelt said. “We believe nothing works better than data, so if we show them clinical data, perhaps it will be easier to discuss registration with the FDA.”
Safety concerns have kept liquid catheter locks from being adopted in the U.S., although they are widely used in Europe, according to the CEO of Pursuit Vascular, another company working in this space. But the demand for antimicrobial catheter technology in the U.S. has grown over the past several years, according to iData Research, driven partly by changes to reimbursement around hospital-acquired infections.
Great Lakes Pharmaceuticals was formed in 2005 by Case Western Reserve University, University Hospitals Case Medical Center and Ricerca Biosciences LLC. The company completed a $3.1 million series B round from Charter Life Sciences, Early Stage Partners, Everett Partners Ltd., Ohio TechAngel Fund and North Coast Angel Fund in 2010.