The Akron, Ohio-based firm has secured additional equity financing. The new funding—from new and existing investors—would, according to the company’s leadership, help to reach key milestones toward the commercialization of its sensor technologies and related lumbar fusion implants. The company also received ISO 13485 certification for its quality management system at its facility in Akron, where the company performs quality assurance activities and distribution. Most of the company’s manufacturing is outsourced, company leadership told Orthopedic Design & Technology.
Intellirod Spine (formerly OrthoData Inc.) was founded in 2008 by spine surgeon Rolando M. Puno, M.D., and professors from the University of Louisville in Kentucky. The company’s primary technologies are its wireless disposable sensor, called LoadPro, for intraoperative monitoring of pedicle screw rod strains, and an implantable wireless disposable sensor, dubbed AccuVista, for postoperative monitoring of pedicle screw rod strains.
“Intraop strain measurements are expected to lead to more consistent loading in long-rod corrective surgeries,” Intellirod's CEO, Ric Navarro, told ODT. “Correlations will be developed between rod strains intraop and postop implant complications such as screw loosening, breakage, and fusion outcomes. Postop rod strain measurements will assist in determining the progress of load sharing between new bone and rod loading. This can be useful in reducing postop CT (computed tomography imaging) scans and exploratory surgeries, and [is] a new means of determining integrity of spinal fusion leading to earlier return to activity and work.”
Navarro said the company has submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for LoadPro, which is designed to provide surgeons with new information for improving surgical technique and avoiding post-operative adverse hardware related events. FDA clearance is expected this year. The company is establishing alpha clinical sites for LoadPro in Louisville and in Cincinnati, Columbus and Cleveland, Ohio.
Navarro noted that “surgeon champions exist in the above mentioned cities, and proximity to Akron makes these efficient for multiple clinical efforts on LoadPro and AccuVista.”
CE mark approval for Europe also is expected by the end of the year, Navarro told ODT.
“Surgeons are interested to begin correlating strains with outcomes to provide objective evidence of fusion, reduce complications and second surgeries, and to ultimately lower costs in the postop continuum of care,” Navarro said.
According to figures cited by the company, with more than 450,000 lumbar spinal fusions performed in the United States in 2011, the number of patients with continuing postoperative complications is estimated as high as 30 percent of cases. In a significant number of these patients, determining the cause of ongoing pain involves assessing the quality and degree of fusion. This is the key to determining the next course of treatment. Current postoperative aggregate cost of this subset of patients is more than $1 billion per year in the United States, including lost worker productivity, according to data cited by Intellirod.
In addition to its regulatory strategy for LoadPro, the company has completed its preclinical testing in support of an FDA application for AccuVista, its implantable version of the product. The AccuVista sensor is targeted at monitoring postoperative strain in rods in degenerative disc disease fusion patients. New objective evidence of the change in strain over time can lead to better postoperative decisions for patients returning to physical activity and work. The system targets downstream cost reductions and surgeon decision making to improve patient outcomes.
“The LoadPro and subsequently AccuVista will be marketed with a pedicle screw system, currently through Intellirod Spine under license and distribution agreements with X-Spine,” Navarro said.
X-Spine Systems Inc. is a Miamisburg, Ohio-based spinal implant company.
To date, according to Navarro, the company has raised a total of $5.4 million in debt and equity. Investors in Intellirod include individual angel investors; the states of Kentucky and Ohio; institutional investors; Queen City Angels (an investor group based in Cincinnati); JumpStart Inc. (a nonprofit in Cleveland dedicated to strengthening the economic vitality of Northeast Ohio by helping communities realize their entrepreneurial potential); and the city of Akron.
Navarro said for the immediate future, primary commercialization plans are to obtain FDA clearance and CE mark for LoadPro, and to begin direct distribution and OEM agreements for the technology.
And what about expansion for the future?
“We have had inquiries from two spine companies that may lead to distribution agreements and expansion would be through their surgeon networks and targets,” Navarro said, adding that a C round of funding will be pursued in the coming year with a goal of raising $4 million.
This additional cash would lead to increased internal expansion, including international sales in Europe, Navarro said.
To check out the LoadPro Intraoperative Rod Strain Sensor in action, click on the video below.