A new spinal fusion device that is simpler and cheaper than existing technology and avoids the need for more invasive surgery and bone grafts will enter human trials next year, University of New South Wales (Australia) researchers say.

UNSW researchers and surgeons anticipate the innovative Thru-Fuze medical device will transform spinal fusion surgery, which is used when conservative therapies such as physical therapy, medication and injections have failed.

The human trials, which are expected to begin at the Prince of Wales Hospital in Sydney in late 2016, have been made possible through $1.59 million in funding from the New South Wales Government’s Medical Device Fund.

One of the goals of spinal fusion is to stabilise the spine to prevent the extraneous movement that causes back pain. Chronic back pain from spinal disorders or degenerative disc disease is a major public health issue around the world and is the most common reason for pain and disability in people aged under 50.

Professor Bill Walsh, surgical device inventor and director of Surgical and Orthopaedic Laboratories at UNSW, said the device will allow faster, simplier surgery with minimal radiation exposure compared to current methods.

“Existing methods of spinal fusion use rod or cage systems that require screws to be drilled into the spine and a painful bone graft harvested, which is the material used to form the bridge and obtain the fusion between the vertebrae in the spine,” Walsh said. “These systems are very costly, difficult and time consuming to implant and they also have relatively variable rates of fusion success. Existing methods rely on the bone to make its way right across the vertebrae and it can take up to a year to find out if the surgery has been a success."

Researchers believe the Thru-Fuze device is innovative because it stabilizes the spine without the need for a bone graft.

Pre-clinical and laboratory testing in animal models by Walsh’s team has shown fusion of bone on and through the device after it is placed between vertebrae, resulting in rapid "biomechanical" fixation.

“Over time, the device then acts as a bridge between the adjacent vertebrae for additional bone to grow across, fusing the adjacent vertebrae together, bone to bone,” Walsh said.

The new NSW Government funding comes on top of $2.3 million that has already been invested in the development of the device by private equity company, Intellectual Ventures of Bellevue, Wash. This funding allowed the UNSW team to engage global industrial experts, including Dr. Andy Carter and Orchid Design USA, in the research and development phase of the product.

Intellectual Ventures has exclusively licensed the device from UNSW as part of a five-year ongoing partnership with UNSW Innovations to source inventions to commercialize.

Device co-inventor Dr. Matthew Pelletier, from UNSW’s Prince of Wales Clinical School, said the team had so far successfully navigated the “valley of death” between the creation of the medical device and its commercialization. Patents for the technology have also been filed in Australia, Europe, China and the United States.

Dr. Ralph Mobbs, neurosurgeon and conjoint lecturer with UNSW’s Prince of Wales Clinical School, will lead the human trials. He claims the potential of the device is significant.

“New technologies such as the Thru-Fuze are of paramount importance, as surgeons strive to deliver better patient outcomes with less invasive and more effective implant and prostheses options,” he said.