July 30, 2013,Legal News Reporter–According to statistics from the American Chiropractic Association, 31 million Americans experience low-back pain at some point or another. When the pain becomes severe and chronic many people look to surgery to solve their problems. The trouble is, it does not always work.In fact during the 2011 P&M Corporate Finance Spine Technology Summit in Napa, California, data was unveiled showing that out of over 400,000 spinal fusions performed in the United States in 2010, up to 30 percent of those lumbar fusion patients continued to experience postoperative pain.As things stand now, doctors use X-rays or CT scans to determine whether the patient is healing properly but oftentimes the results are inconclusive, forcing the person to undergo a second surgery. But what if there was a device that would allow surgeons to measure the success noninvasively, enabling them to diagnose the progress even earlier than scans permit?
Since 2003, researchers at OrthoData, Inc. have been developing an implantable microelectronic spine fusion sensor that would do just that.Founded by spine surgeon Rolando M. Puno and professors from the University of Louisville, OrthoData’s IntelliRod™ system is designed to provide objective postoperative data to complement what is collected from X-rays and CT scans.
“If we are able to demonstrate that fusion is occurring before it shows up on an X-ray or CT Scan, and thus avoid reoperation we are ahead of the game,” said Dr. Scot Miller, a spine surgeon at Crystal Clinic Orthopaedic Center. “The costs involved in doing so now are astronomical.”
At the end of March, Akron officials announced that the company was relocating to the city’s White Pond Crossing Development after receiving $250,000 in Akron BioInvestment Funds, along with money from additional private backers for a total of $1.1 million.
“This is exactly why the city created the Akron BioInvestment Funds, LLC – to attract companies like OrthoData that help build out our biomedical infrastructure and draw research and talented graduates from our area universities,” said Akron Mayor Don Plusquellic. “The net result is more jobs for our citizens.”
Northeast Ohio native, Ric Navarro, took the reigns as chief executive officer and president of the company in 2011, after serving as vice president and site manager of the spine division at Integra LifeSciences in Medina, Ohio.
“We have interest and support from leading spine surgeons at the Crystal Clinic and MetroHealth System and look forward to working with the Austen BioInnovation Institute in Akron,” said Navarro who has been working with companies that develop medical devices since 1984 and helped spearhead OrthoData’s move to Akron.
As Miller and Navarro explain, patients who suffer from back pain are usually candidates for either a discectomy or a more complex fusion procedure. In a discectomy a portion of the disc pressing on the nerve or spinal cord is removed, whereas in the more complicated process of spinal fusion bone grafts are placed between vertebra and along the spine and stabilized with titanium screws and rods so that motion no longer occurs between the vertebrae.
“Successful fusion usually alleviates the pain however, some patients have pain relief without achieving a solid fusion,” said Navarro. “The converse can also be true; patients can have ongoing pain though they may have a complete and solid fusion. The IntelliRod™ sensor will be helpful in the latter situation in showing that the source of the ongoing pain is not attributable to the lack of fusion.
“The way our device would work is that the sensor would clamp onto the rod and then during the first postoperative visit, the physician could take a reading of the load on the spinal rod,” said Navarro. “The load represents the progress of the fusion. As the bones grow together there would be less of a load carried by the rod. If the rod load does not go down, then that would tell the surgeon that fusion is not occurring.”
Navarro said the detector would work wirelessly and would allow patients who are progressing to get back to work quicker, helping to prevent “at-risk populations like the elderly from developing complications and possibly having to undergo a second surgery.”
OrthoData currently employs four full-time and one part-time person. Navarro said the company must raise another $5 to $6 million by the end of next year to complete technical development of the device along with conducting human trials.If all goes well, he said the device could be on the market in the next three to four years.
“If we can get FDA approval for the device it will revolutionize the fusion procedure,” said Miller.
Company develops device to help surgeons determine spine surgery success
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