Intellirod Spine Receives Funding, ISO Certification

Intellirod Spine has announced that it has received more equity financing, funding that will go a long way toward commercializing its disposable, implantable wireless RFID sensor technology for monitoring spinal rod strains.

Intellirod CEO Ric Navarro also announced the company has recently received ISO 13485 Certification for its Quality Management System. In the June 16, 2015 news release, he noted, “This sets the stage for us to be able to offer the LOADPRO through our sales channels and distribution partners as well as to pursue our CE Mark.” The company has submitted a 510(k) application for the LOADPRO intra-operative sensor for use in achieving rod strain balance during surgery. This gives the surgeon new information for improving surgical technique and avoiding post-operative adverse hardware related events. The company is establishing alpha clinical sites for LOADPRO in Louisville, Kentucky’ Cincinnati, Columbus; and Cleveland, Ohio.”

“In addition, the company has completed its pre-clinical testing in support of an FDA application for ACCUVISTA, its implantable version of the product. This ACCUVISTA sensor is targeted at monitoring post-operative strain in rods in degenerative disc disease fusion patients. New objective evidence of the change in strain over time can lead to better post-operative decisions for patients returning to physical activity and work. The system targets downstream cost reductions and surgeon decision making to improve patient outcomes.”

Navarro told OTW, “One year from now we hope to have: the LOADPRO CE Marked, FDA approval of LOADPRO, Alpha site launch of LOADPRO at four hospitals, and submission of the 510K for ACCUVISTA.”