TORONTO, ONTARIO--(Marketwired - Sept. 26, 2017) - Interface Biologics Inc. ("IBI"), a privately held, commercial stage company developing innovative material science technologies that save lives and improve patient outcomes, is pleased to announce that Arkis BioSciences® has received 510(k) clearance from U.S. Food and Drug Administration (FDA) for its exclusive CerebroFlo™ EVD Catheter with IBI's Endexo® technology.
Arkis BioSciences signed an agreement to license Endexo technology for Cerebral Spinal Fluid (CSF) shunting, including External Ventricular Drain (EVD) catheters, in March 2015. IBI's Endexo technology has been proven to be highly effective for reducing catheter occlusions and thrombosis. A recently published study1 of 656 patients from The Ottawa Hospital reported a low rate of Deep Vein Thrombosis (DVT) of only 1.5% for patients using the BioFlo PICC catheter (AngioDynamics Inc). This represents a 56% lower rate of DVTs compared to the average rate of 3.4% reported across 8 studies of 9462 analogous patients using PICCs without Endexo2. In addition, The Ottawa Hospital study reported a low incidence of catheter related blood stream infections (CRBSI) of 0.6% for patients using BioFlo PICCs - an 88.5% lower rate of CRBSI compared to a pooled analysis of 20 studies using other PICCs3. Endexo has significant manufacturing advantages over other anti-thrombogenic coating or impregnation alternatives and does not change the mechanical or functional properties of the underlying medical device.
The CerebroFlo catheter has demonstrated a 99% reduction in thrombus accumulation in-vitro, and is indicated for temporary use in patients with elevated intracranial pressure, intraventricular hemorrhage, or hydrocephalic shunt infections.
"I am pleased that Arkis has received 510(k) clearance for the EVD Catheter as it represents a beachhead for Endexo technology applications in the brain," commented Mark Steedman, V.P. Business Development, Interface Biologics, Inc. "With Endexo's proven effectiveness at reducing DVT and infections, and this recent 510(k) clearance, we are extremely excited about the prospects for Endexo in Neurology and other categories."
"At Arkis, we're all about enhancing treatment outcomes, reducing risks and lowering the overall cost of care to improve the lives of people suffering from intracranial hypertension, and licensing Endexo technology helps us to deliver on this promise", stated Chad Seaver, CEO and Board Member, Arkis BioSciences. "We are grateful to Interface Biologics for all of the support they provided us through the regulatory process and look forward to the debut of CerebroFlo EVD Catheter at the upcoming Congress of Neurological Surgeons (booth 747), in Boston MA, October 7-11, 2017".
1 CMAJ Open 2017; 5(3): E35-E39
2 Lancet 2013; 382: 311-25
3 Infection Control and Hospital Epidemiology 2013; 34(9): 908-918
Interface Biologics (IBI) is an early commercial stage privately held company developing innovative material science technologies for products that save lives and improve patient outcomes. IBI's primary technology focus areas are anti-thrombogenic additives that reduce thrombosis in blood contacting medical devices and polymer enabled drug delivery platforms. www.interfacebiologics.com.
Arkis BioSciences® is a medical device company providing minimally invasive surgical instrumentation for enhancing a variety of surgical procedures. The company further provides advanced implantables for improving the treatments of intracranial hypertension commonly arising from hydrocephalus, traumatic brain injury, and hemorrhagic stroke. In 2016, Arkis introduced its Single Pass Tunneling Guidewire™ as well as its Subcutaneous Guidewire™. In 2017, Arkis introduced the next generation CerebroFlo™ EVD Catheter, which incorporates Endexo® polymer technology. Located in Knoxville, Tennessee, Arkis began operations in 2013 to serve the minimally invasive surgical markets and to improve intracranial hypertensive patient care while reducing healthcare costs. www.arkisbiosciences.com