News: Intellirod Spine Raises Capital and Obtains ISO Certification
AKRON, Ohio, June 16, 2015 /PRNewswire/ -- Intellirod Spine, the spinal implant company developing disposable and implantable wireless RFID sensor technology for monitoring spinal rod strains, secured additional equity financing from new and existing investors to reach key milestones toward the commercialization of its sensor technologies and related lumbar fusion implants.
Intellirod's CEO, Ric Navarro, also announced the company has recently received ISO 13485 Certification for their Quality Management System. "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," says Mr. Navarro. 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.
About Intellirod Spine (formerly known as OrthoData) The company was formed in 2008 by University of Louisville professors and Dr. Rolando Puno. It is developing new sensor technology for intra-operative and post-operative monitoring of rod strain to benefit surgeons and patients while lowering post-operative continuum of care costs. www.intellirodspine.com