KNOXVILLE, Tenn., April 24, 2018 /PRNewswire/ -- Arkis BioSciences®, a leading innovator of next generation neurosurgical catheters and minimally invasive instrumentation, announced today that it is receiving promising clinical feedback for its new CerebroFlo™ External Ventricular Drainage (EVD) brain catheter. The company introduced the new catheter, incorporating the Endexo® molecule, into clinical use for neurocritical care during the fourth-quarter of 2017. The proprietary Endexo polymer macromolecule is intended to reduce the potential for catheter obstruction. Catheter obstructions are a costly complication frequently associated with conventional EVD catheters, and the CerebroFlo brain catheter is the only EVD catheter currently marketed in the U.S. to be indicated for intraventricular hemorrhage (IVH). IVH is a common comorbidity of hemorrhagic stroke, accounting for about 45% of intracerebral hemorrhagic occurrences, posing increased risks of mortality. The CerebroFlo EVD catheter is currently available in the U.S. and indicated for temporary use in patients with elevated intracranial pressure, intraventricular hemorrhage, or hydrocephalic shunt infections.
Hospital use of the CerebroFlo catheter is growing throughout the U.S. where annually, more than 200,000 neurointensive patients require EVD insertion. These patients are at high risk for catheter obstruction, which often leads to further complications, including infection and lengthier ICU stays. Studies have shown that approximately 1 in 5 EVD patients require catheter replacement due to obstruction, with some requiring multiple replacements. The Endexo molecule, an in-licensed technology by Interface Biologics, is intended to reduce the potential for protein adsorption, activation, and clot formation. Third party in-vitro testing* of the CerebroFlo catheter against a market leading EVD catheter has shown a remarkable improvement, demonstrating an average of 99% less biomatter accumulation onto its surface. Such reduction could lead to improved clinical outcomes by reducing the extent of catheter irrigations or replacements necessary during treatment, overall lowering the cost of care.
"Arkis' CerebroFlo EVD catheter is a major step forward in next generation clinical technology for neurology and neuro-intensive care. We are excited to have transitioned from the laboratory phase to clinical use for CerebroFlo and for patients and providers to realize the potential benefits Endexo has to offer." said Chad Seaver, President and CEO of Arkis BioSciences. "We look forward to further proliferating Endexo into other CNS catheters, such as subdural drains and, particularly, shunt catheters, with a vision toward reducing revision surgeries. We are concurrently investigating the Endexo molecules' ability to further inhibit biofilm formation toward reducing bacterial colonization, which can often lead to infection."
About Arkis BioSciences®
Arkis BioSciences® is a medical device company providing sophisticated surgical tools and advanced catheters for advancing the neurosurgical treatments of intracranial hypertension arising from hydrocephalus, traumatic brain injury, and hemorrhagic stroke. Located in Knoxville, Tennessee, Arkis began operations in 2013 to serve the neurosurgical market by improving intracranial hypertensive patient care while reducing healthcare costs.
Arkis will be exhibiting at the upcoming American Association of Neurological Surgeons (AANS) conference in New Orleans, April 29 - May 2 (booth 1644), the Neurotrauma Conference in Toronto, August 11 - 16 (booth 300), and also at this year's Congress of Neurological Surgeons (CNS) in Houston (booth 1241). Product demonstrations, case reports, and white papers will be available for review. For further information, please visit www.arkisbiosciences.com.
*In-vitro testing does not necessarily predict clinical results. Study protocols and data available at www.arkisbiosciences.com.