Written by Barb Consiglio.
450,000 spinal fusion surgeries are performed in the United States each year, but nearly a quarter of the surgeries are unsuccessful. In order to monitor the fusion process, doctors have to know how much strain there is on the implanted spinal rod. However, they are limited by a lack of information, relying on x-rays and CT scans that do not provide a clear picture of recovery. Intellirod Spine in Akron, Ohio, created a wireless sensor, implanted directly on a spinal fusion rod, that measures strain in real time to eliminate recovery guesswork.
“After an operation, a surgeon uses a wireless reader to determine whether or not the patient’s vertebrae are fusing based on the changing tension on the rod,” said Ric Navarro, President and CEO of Intellirod Spine. “This helps the surgeon decide if a patient is ready to go back to work, start physical therapy or if there are complications that require rod adjustments.”
The Intellirod Spine sensor attaches to standard spinal fusion rods currently used in surgeries. The system’s scanner reads the unique identification code on the device implanted in a patient, providing continuous updates.
The technology was developed at the University of Louisville in 2008 at the request of spinal surgeons who needed a better way to detect the progress of fusions. Intellirod Spine was created to take the product to market. Navarro connected with the company in 2011 through BioEnterprise, a northeast Ohio partner of Ohio Third Frontier, after spending decades working in the medical device industry with companies like Theken Spine, which created spinal implants and a screw system to straighten the spine. He helped Intellirod Spine raise funds and move the product to clinical trials and through the FDA approval process.
Intellirod Spine received an early investment from JumpStart, another Ohio Third Frontier partner in northeast Ohio, as well as the city of Akron, which helped fund the company’s move from Kentucky to Ohio in 2013. They were awarded funding through Ohio Third Frontier’s Commercialization Acceleration Loan Fund (CALF) in 2014 to accelerate the design of the product and begin collecting clinical data.
Navarro says the presence of medical research facilities and world-class hospitals in northeast Ohio makes the region the best place in the country for a medical technology startup. In fact, Intellirod Spine has partnered with organizations across the state. A medical company in Dayton developed a screw system to attach the device to the spinal rod, and clinical trials at Columbus and Cleveland hospitals are helping the company move toward final FDA approval expected in early 2017.
“A lot of the hospitals and health networks I’ve worked with for years are here in northeast Ohio, including Cleveland Clinic and Summa Health,” said Navarro. “The initial data coming in has been very promising, and we’re confident that this will revolutionize the spinal fusion process, improving outcomes for millions of patients.”