OrthoData Inc.

Article preview from Start-Up - July, 2013

 Surgeons would like to know, sooner, rather than later, whether there’s progress toward fusion following spinal fusions. That’s the mission of OrthoData Inc., which is developing an implantable, wireless, microelectronic spine fusion sensor that measures load on the implanted hardware to reveal the fusion status of patients sooner than plain X-rays.

OrthoData Inc.

Article preview from Start-Up - July, 2013

Lumbar spine fusion surgeries fail 10% to 40% of the time, according to the literature, which is a wide range that takes into account patients with different risk factors (smoking, diabetes, and obesity can interfere with healing) and different types of fusion surgery. In most cases, bone should begin forming a union with the implanted hardware within three months, but that’s often not the case. Surgeons would like to know, sooner, rather than later, whether there’s progress toward fusion, because they might be able to determine if a patient is engaging in activities that are hindering fusion, intervene to set a non-healing patient on a better course with targeted physical therapy, admonish the patient to quit smoking, or at least determine whether ongoing pain is due to a lack of fusion or something else. However, surgeons don’t know if fusion is taking place until evidence of calcification shows up on X-ray or CT scan, which doesn’t tend to happen until six months after the surgery.

Certain manufacturers would also like better measures to show that their bone growth products achieve and even speed up fusion, since payors are asking for increasingly higher levels of proof that the products they’re asked to pay for actually work. Medtronic Inc.’s recombinant bone morphogenetic protein (BMP) InFuse was approved by the FDA in 2002 for spinal fusions, and it has been associated with reduced operative time, shortened length of stay, and fewer reoperations due to non-unions. But recently BMP has come under scrutiny. In May 2013, data on more than 9,000 spinal fusion patients from the Kaiser Permanente Spine Registry indicated that reoperation rates for patients with non-unions were similar between patients with and without BMP. It’s not the first study to question the value of BMP, but it’s the largest. A controversial product area could benefit from objective data that shows when and if spine fusion is occurring.

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