This is the forth in a series of 6-Question interviews with the Orthopedic leaders who are challenging conventional thinking. (you can read other interviews here)
Ric Navarro has been a force in Orthopedics since he started his career as a Research Engineer in artificial organs at Cleveland Clinic back in the 1980’s. Through the years, we have watched him push the envelope of what is possible with implant technology. At Theken Disc as he developed the world’s first lumbar artificial disc with integral microelectronics. He also developed a superior implant grade polyurethane with unique properties suited for a long term load-bearing spine implant. Today, in a CEO role, he is once again pushing the envelope by developing microelectronic fusion sensors for the spine.
We sat down with Ric and asked him a few questions about his most recent venture – Intellirod Spine. Ric is always a great interview because he is so sharing and transparent with his work.
1. What was the origin of the idea behind Intellirod Spine? Take us back to the moment when the idea struck lightning.
Ric Navarro: The idea originated with Dr. Randy Puno of the Norton Leatherman spine center in Louisville and electrical and biomedical engineering professors at the University of Louisville back in 2001. Surgeons have observed for years anecdotal evidence of non-unions or pseudarthrosis leading to increased incidences of implant failures. The implication is that lack of anterior column support from fusion leads to sustained high loads on the implants causing loosening or fracture. So the idea was to wirelessly be able to detect the strain on the implants, in our case the rod, to deduce the mechanical integrity of the fusion through the off-loading of the rod. That led to an NSF grant that was funded and early proof of concept prototypes and testing.
2. What is the story behind the relo to Akron and name change and funding timing?
In 2010 the company had a pre-IDE meeting with the FDA which led to a conclusion that the company’s A round funding of $1.5M was not adequate to get the product commercialized. So in 2011 a search began for a new CEO from the spine industry to raise the next round of capital. In 2011, I was the general manager of the spine division of Integra in Ohio as a result of the acquisition of Theken Spine and Theken Disc in 2008. BioEnterprise
in Cleveland made the connection and I became the CEO of OrthoData in late 2011. The agreement was that if I raised a B round of at least $1M that the company would be moved to Northeast Ohio. One of the B round investors in 2013 was the Akron BioInvestment Fund which led to our motivation to locate the company in Akron, Ohio.
The company name change came about as a result of the confusion OrthoData seemed to create about the company. It conveyed a connotation of a database company when the company was clearly product focused. We also felt that the company needed to focus on the predominant opportunity in spine though other orthopedic uses are possible. This led to the name Intellirod Spine which more clearly conveys our market and technology.
3. OK, walk us through this cool new technology.
Ric Navarro: Early in the development, RFID technology was preferred over a battery powered implant due to the higher bar “active” implants must clear at the FDA. So our sensor clamps onto any 5.5mm rod and (both disposable and implantable versions) and operates through inductively coupled power from a primary coil in an external reader. Once power is received by the sensor it then converts a rod strain to a signal transmitted back through the inductive couple to the external reader. The disposable version, the LOADPRO, is intended to monitor strains intraoperatively during corrective surgeries while the implantable version, the ACCUVISTA, is intended to be used to monitor the trends in postoperative rod strain over time in lumbar fusions.
4. What is the clinical benefit of a surgeon’s ability of being able to measure strain in a spine rod?
Ric Navarro: LOADPRO and ACCUVISTA have similar yet different value propositions for the surgeon, patient and payers. LOADPRO is 510K pending and once approved can be used to monitor and adjust left and right rod strains intraoperatively. The objective is to balance loading with the intention of reducing screw loosening, pullout and hardware failures which can lead to poor fusions and readmissions. We will conduct post-market studies with our alpha site surgeons to help establish the correlation between intraoperative strain balancing and outcomes.
ACCUVISTA is a long term implantable device attached to 5.5mm (and other diameters) rods in lumbar fusions. We expect to apply for a 510K on ACCUVISTA with the intention of conducting a modest clinical trial to support the safety and performance of the system. This study will be the first human data to show a correlation between postoperative strain course and clinical outcomes. Our device will give the surgeon quantitative biomechanical information about the load carried by the rod and by implication the load sharing or lack thereof in the posterolateral and/or anterior column fusion. This data will complement the x-rays taken and aid in decisions regarding readiness for physical therapy, activities of daily living and return to physical work or sports.
5. We have watched the FDA struggle to get their hands around Smart Implant technologies. What is regulatory path in this area?
Ric Navarro: We are attempting to make it easy for them, LOADPRO is a low-risk intraoperative measuring instrument that sets the stage for our more complex ACCUVISTA implant that is technically identical to LOADPRO with merely the intent of longer term use. We don’t expect either device to fall into a high risk classification and therefore it comes down to the quality of the submission, the predicate strategy and the need for clinical studies to support the ACCUVISTA approval. We are hedging our US strategy with our application for the CE mark on LOADPRO later this year.
6. What new applications or new products are in the pipeline?
Ric Navarro: We have very exciting and intriguing plans for the expansion of data collection and analysis from ACCUVISTA by creating a cloud-based registry to establish demographic trends for strain versus outcomes. We even have intellectual property to expand into home-based data collection and monitoring. And perhaps our most interesting new application is the use of ACCUVISTA in the detection of strain as a function of growth in children with scoliosis. This has been the most exciting year in our history as we look forward to commercialization in the very near future.
For more information about Intellirod Spine click here