AKRON, OH–(Marketwired – Jul 26, 2016) – 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 including the Queen City Angel First Fund V and JumpStart. Funds will be used to reach key milestones toward the commercialization of the company’s sensor technologies and related lumbar fusion implants.
In addition, Intellirod Spine is pursuing a de novo 510(k) at the FDA and is simultaneously seeking a CE Mark for LOADPRO™, the company’s intra-operative sensor for use in monitoring rod strain during kyphotic correction surgery. According to Ric Navarro, Intellirod CEO, “The LOADPRO gives a surgeon new and important information for improving surgical technique. The device becomes an adjunct to the surgeon’s tactile feel for avoiding excessive implant loading.”
Dr. Rolando M. Puno of Louisville, Kentucky, states, “With LOADPRO, for the first time, spine surgeons will have an accurate tool to measure and determine the amount of force being applied to the rod implant as spinal deformity is being corrected. Knowing the amount of applied strain will allow spine surgeons to adjust their surgical techniques to achieve the best possible correction of deformity. Furthermore, spine surgeons will be able to avoid the risk of inadvertently applying excessive strain causing fixation failure and/or loss of correction.”
Spine surgeon Dr. Michael Steinmetz further explains, “The information gained from LOADPRO may allow the surgeon, for the first time, to understand the forces applied to spinal constructs when performing deformity surgery. This information can lead to improved surgical results and patient outcomes.”
Intellirod Spine is recruiting patients for LOADPRO clinical studies at sites in Louisville, Kentucky, Columbus, Ohio and soon will add a third site in 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. The ACCUVISTA sensor monitors post-operative strain in rods in degenerative disc disease fusion patients, and the company is bullish on its new application for ACCUVISTA in children with scoliosis. 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. ACCUVISTA enables downstream cost reductions and informs surgeon decision-making to improve patient outcomes.
Dr. Puno says, “The ACCUVISTA sensor can be a game-changer for patients undergoing posterior spinal fusion for a wide range of spine conditions including those from deformity, degenerative disease, and trauma. ACCUVISTA allows a spine surgeon to be able to accurately determine when fusion has occurred without the need of CAT scans. CAT scans are costly, expose the patient to significant radiation, and are only done periodically as a ‘snapshot in time’. ACCUVISTA is a real time monitor. ACCUVISTA provides the doctor with an accurate basis for advising post-spinal fusion patients on when it will be safe for them to return to normal physical activity and/or work.”
About Intellirod Spine
Intellirod Spine™ (formerly OrthoData Inc.) was founded by renowned spine surgeon Rolando M. Puno, M.D. and professors from the University of Louisville. The company is developing a wireless implantable microelectronic spinal rod strain sensor. This innovative strain monitoring system will allow spine surgeons to objectively assess the strain on implanted spinal fusion rods. www.intellirodspine.com
About Queen City Angels
The Queen City Angels (QCA) is a group of more than 50 experienced accredited investors who provide funding, support and guidance to early-stage growth companies in the Cincinnati area and surrounding region. QCA members, which include former C-level executives and entrepreneurs, draw from their personal operating and management experience to evaluate opportunities and provide on-going mentoring to young businesses with exceptional growth potential. Since 2000, QCA members have directly invested approximately $50 million in nearly 80 portfolio companies. The total capital invested in these companies, including QCA members’ capital, syndication partners’ capital, follow-on venture capital funds and venture debt is in excess of $410,000,000. CB Insight recently ranked QCA second out of 370 national angel organizations. For additional information, visit www.qca.com