The AxiaLIF technology isn't new to the field, but since gaining FDA clearance and a Category I CPT codes more surgeons are taking notice. TranS1 purchased the technology from Baxano in 2014 and since then has produced clinical trials to show the procedure's effectiveness and advocated for reimbursement.
"AxiaLIF is our primary technology and it's something we're proud of. It has advantages because the system avoids major nerves, requires less blood loss and has a shorter intraoperative time," says Jeffrey R. Schell, president and CEO of TranS1. "AxiaLIF has a 94 percent fusion rate, which is comparable to the gold standard, and can be done on an outpatient basis."
Beyond the clinical advantages, AxiaLIF also has economic benefits. There are currently 90 supportive peer-reviewed studies on AxiaLIF. A study published in The Journal of Managed Care showed estimated blood loss and hospital stay was significantly less than other spinal fusion procedures, which drove a $396,000 cost savings.
The procedure's economic analysis shows it could save $3,500 per procedure when compared with TLIF, according to Scott Parker, MD, director of the Spinal Column Surgical Quality and Outcomes Research Laboratory at Vanderbilt University in Nashville, Tenn., and Matt McGirt, MD, of Carolina Neurosurgery and Spine Associates in North Carolina. The procedure also had a lower complication rate than TLIF, saving around $178,000.
"That is a tremendous advantage for AxiaLIF and TranS1 as the healthcare industry is looking to improve quality as well as save money," says Mr. Schell. "Spinal fusion needs innovation like AxiaLIF, which is an effective alternative to other procedures."
But surgeons are often unfamiliar with the presacral space because it's not an area where they typically train in residencies. As a result, TranS1 is expanding training efforts, with new individual and group training options already started for the year.
"The procedure has grown substantially and will continue gaining steam," says Mr. Schell. "We think this is the best option to treat pathology L5-S1 for patients with the right indications."
More than 14,000 cases with the AxiaLIF technology were performed by surgeons in 35 states. The company has seen surgeons more open to considering AxiaLIF due to the cost-effectiveness and available data showing the technology can achieve favorable results.
TranS1 has filed 30 patents related to new technologies, with about one-third related to AxiaLIF; most are connected with new technologies the company hopes to bring to spine surgeons in the future. Some of the technologies look at new materials and methods to support fusion and minimize muscular disruption.
"We are committed as a company to push the boundaries of what spine surgeons can do while treating patients without causing trauma that's almost as bad as the pathology that lead them to surgery in the first place," says Mr. Schell. "We have filed a number of patent applications for novel approaches and methods of performing surgery. We look to reuse technologies in novel ways as well as create new technologies from the ground-up."
The research and development efforts focus on surgeons while leveraging engineers' expertise. Their model is built to involve surgeons in development, although there isn't any surgeon ownership in the company.
"We are always trying to innovate around the ways surgeons can be empowered to drive innovation while maintaining compliance with healthcare regulations around surgeon ownership," says Mr. Schell. "We are developing relationships in good and compliant ways to create new technologies in healthcare. I'm excited for 2016 because we're moving in the right direction."
TranS1 leadership includes both engineers and patent attorneys who work with the surgeons to support new development. TranS1 is a relatively small company in the spine space and nimble enough to respond quickly to changes in the market.
"I think the consolidation in healthcare has led to a number of challenges including major conflicts of interest by larger companies and we're solving that challenge by aggressively innovating and responding in nimble ways to the surgeon needs," he says. "We can ensure we're advancing the paradigm shifting technologies that surgeons demand."