-- CE Mark granted for CleanFuze™ Orthobiologic Polymer
GEORGETOWN, Texas, Feb. 25, 2014 /PRNewswire/ -- DiFusion Incorporated announced today that the company has received a CE Mark and European clearance to market and implant its new CleanFuze™ antimicrobial orthobiologic polymer. "We are extremely gratified to announce European clearance of our CleanFuze™ line of antimicrobial spinal implants. This material has been in development for over five years and attaining this milestone represents significant value for our shareholders," commented DiFusion Cofounder and CEO Derrick Johns.
Health and Human Services (HHS) has characterized surgical site infections (SSIs) as the number one "never event" under the new Affordable Care Act (ObamaCare). Since its passage, there has been a scramble for medical device companies to deliver antimicrobial device based solutions to combat drug resistant forms of bacteria which are the number one cause of failure for hip and knee replacements. SSIs are also the 4th largest cause of death in the US and have a higher mortality rate than auto accidents, breast cancer and HIV combined!
DiFusion is an ISO 13485 Certified Life Sciences Company located in Georgetown Texas. The company has the first Class II fully implantable antimicrobial polymer in the world and plans to begin using CleanFuze™ in spinal surgeries within the European Union in early June. The company will also submit for FDA clearance in the summer of 2014.
Founded in 2008 in Austin, Texas, DiFusion Technologies, Inc. is a life sciences company focused on reducing the rising incidence of surgical site infections in orthopedic surgery through the development of a suite of patented antimicrobial orthobiologic polymeric implants. DiFusion management is currently considering a move to labs in Cambridge Massachusetts which would facilitate greater research in other SMART Medical Polymers for bone growth and tissue regeneration www.difusiontech.com. Contact: US email@example.com EU firstname.lastname@example.org
SOURCE DiFusion, Inc.