Arkis BioSciences said yesterday it won FDA clearance for its CerebroFlow external ventricular drainage catheter.
The CerebroFlo catheter is designed for insertion into a ventricular cavity of the brain for external drainage of cerebro spinal fluid, and features the comapny’s Endexo technology designed to reduce obstructions, infections and lower treatment costs, Arkis BioSciences said.
“Arkis’ CerebroFlo catheter is the 1st neuro catheter to incorporate Endexo, a permanent polymer additive whose properties have been shown to reduce protein adhesion and activation in laboratory in vitro studies. The catheter’s Endexo formulation has properties that may lead to reduced complications such as catheter occlusion and infection. The clearance of CerebroFlo marks an expansion of Arkis’ surgical line, extending our reach into neurocritical care. Arkis’ new CerebroFlo catheter is poised to disrupt the neuro catheter market with its Endexo technology. Arkis’ in vitro studies have shown 99% less biomatter accumulation onto CerebroFlo’s catheter surfaces, which may reduce fouling. Further in vitro studies are underway to characterize CerebroFlo’s ability to prevent infectious biofilm formations without the use of eluting antibiotic drugs,” CEO Chad Seaver said in a prepared statement.
The Knoxville, Tenn.-based company said it hopes to launch the device at the upcoming Congress of Neurological Surgeons in Boston next month, with plans for an international distribution beginning next year.
“Given the early success we have seen with our new tunneling guidewire line, I’m excited to now introduce this innovative neuro catheter to current and prospective customers. Existing ventricular catheters are particularly problematic due to obstructions and Endexo has the potential to make a remarkable difference to patients,” sales director Ryan Gray said in a press release.
Last June, Arkis said it raised a $3.4 million Series A round for its line of neurosurgical tools, led by Innova Memphis.