Overview

The idea for a pre-sacral approach to the lumbar spine came from Dr. Andy Cragg, an interventional radiologist in Minneapolis. Before TranS1, Dr. Cragg had invented several products and founded companies that went on to great clinical and commercial success.

The concept of presacral access began when Andy's brother, an orthopaedic surgeon, saw an opportunity to improve patient outcomes from his own experience with lumbar spine surgery. He felt the damage he did to the soft tissue structures with traditional access to the lumbar spine made the patient hurt more than their original back pain. After surgery, patients went through long recovery periods and consequently, lumbar fusion surgery had a bad name. Andy's previous inventions demonstrated new, less invasive ways to enter kidneys, the heart, and various vascular systems allowing major surgery to be performed through small percutaneous punctures. Based on this history of success, Andy's brother challenged him to apply his trade to the lumbar spine.

Next 2001 >

Dr. Cragg's experience as an interventional radiologist influenced him to view the spinal column as a tubular structure. Based on this unique perspective, Dr. Cragg developed a novel approach to access the lumbar spine: one that approaches the spine along its axis, rather than perpendicularly from the side, front, or back.

Dr. Cragg was able to demonstrate the viability of the axial approach in cadaveric models. He then worked with a highly experienced engineer, Bob Assell, who had a background in orthopaedics, spine, and interventional cardiology. Bob took Andy's catheter thinking and turned it into proprietary instrumentation that accomplished the task while retaining a design familiar to orthopaedic and neuro surgeons.

Next 2002 >

In 2002, it was time to select a clinician who would assist with further development. TranS1 was introduced to Dr. Carlos Oliveira in Brazil, who immediately saw the potential of this new technology. Dr. Oliviera routinely performed lumbar biopsies and was looking for a less invasive surgical approach.

In May of 2002, the axial approach to the spine was employed for the first time. Dr. Oliviera performed lumbar biopsies in a series of patients. Those early patients woke up with little pain and almost no sense that anything had been done to their lumbar spine. Dr. Oliviera's experience demonstrated for the first time that if no soft tissue was damaged while accessing the lumbar spine, then patients' pain was greatly reduced.

The success in Brazil led to the first round of venture capital investment. First, Rick Randall was hired as CEO to build a team around the technology. Rick had previously served as CEO of several other highly successful medical device venture-backed companies, such as Target Therapeutics, Inc. and Innovasive.

Next, a more robust engineering team was assembled to develop the instrumentation and implants required to access the spine in an axial fashion and perform standard-of-care lumbar fusion. The objective was not to change the way fusion was accomplished, but to use tried and true methods of fusing the spine through this new, presacral access. An intense development effort ensued, and TranS1 soon secured an impressive portfolio of intellectual property around both the method of access and the unique instrumentation associated with the pre-sacral approach to the spine.

Next 2003 >

In May 2003, Dr. Carlos Oliveira conducted the first three AxiaLIF surgeries in humans in Brazil. Over the course of the year, the TranS1 engineering team continued to revise and refine the system. In particular, the team focused on optimizing the tools needed for discectomy and preparation of the endplates. Nitinol, a superelastic, shape-memory alloy, was utilized in special cutters designed to debulk the nucleus of the disc and rough up the vertebral endplates. Stainless steel tissue extractors were created to remove the disc material so that bone graft could be inserted into the disc space. These devices were impressive engineering accomplishments that allowed TranS1 surgeons to achieve a standard-of-care discectomy through the presacral approach.

Next 2004 >

After close to another year of testing and refinement, AxiaLIF received 510(k) clearance from FDA in the fourth quarter 2004. This was the company's greatest milestone to date. AxiaLIF was now positioned as the primary growth engine for the company going forward.

Next 2005 >

In January, 2005, the first AxiaLIF case was performed in the United States to fuse the L5-S1 disc space. TranS1 was conservative in its approach to market entry. The company wanted to gain a wide body of clinical experience before proceeding to full market launch of its promising new technology. In 2005, 86 AxiaLIF cases were performed, providing the team with valuable insight into the nuances of this new approach.

Next 2006 >

Satisfied with the clinical experience to date, TranS1 made the decision to proceed with a full launch of the AxiaLIF technology. 2006 was characterized by rapid expansion of the TranS1 distribution channel. After the limited release of AxiaLIF in 2005, the sales force tripled in size in order to establish a national presence. Still a small, start-up company, TranS1 was beginning to make inroads in numerous regional markets.

In the third quarter of 2006, TranS1 launched a facet screw system designed to be a minimally-invasive alternative to pedicle screws.

Next 2007 >

By 2007, it became apparent that TranS1 needed additional resources to fully capitalize on its success. In October 2007, TranS1 successfully completed an initial public offering (IPO) on the NASDAQ stock exchange. Becoming a public company was a great milestone, providing the capital to expand sales and marketing efforts, continue the development of minimally invasive spine products, broaden and deepen the management team, and expand the company's intellectual property position.

In the third quarter of 2007, the 2,000th AxiaLIF case was performed.

Next 2008 >

In May, 2008, the first AxiaLIF 2L surgery was performed in the U.S., marking a significant milestone in TranS1's product evolution. A limited market release was conducted, followed by full market release in September. The AxiaLIF 2L allowed surgeons to fuse the L4-L5 and L5-S1 disc spaces through the same 1.5 inch incision as the single-level AxiaLIF. The addition of AxiaLIF 2L dramatically expanded the available market for TranS1 products.

Next 2009 >

With a goal of continuous improvement, TranS1's development team released a next generation facet screw system, which featured enhancements to both implants and instrumentation. The Vectre implants received a modified head to improve the bone/implant interface, while the instruments benefited from notable improvements in targeting, ergonomics, and design.

Next 2010 >

Drawing on the experience gained in over 1,000 AxiaLIF 2L surgeries, TranS1 developed a highly evolved second generation L4-S1 fusion system. The AxiaLIF 2L+ system incorporated numerous instrumentation refinements such as dilator trials, torque-limiting handles, and ergonomic designs. More importantly, the AxiaLIF 2L+ implants incorporated a number of key design enhancements intended to increase resistance to subsidence, measure implants more accurately, and provide variable, direct distraction from optimally-placed static anchors.

TranS1 also expanded its product portfolio in 2010 with the addition of Avatar, a minimally invasive pedicle screw system and Bi-Ostetic, a product line of bone void fillers.

Next 2011 >

In March, 2011, TranS1 launched the AxiaLIF 1L+ product line. This next generation one-level anterior fusion system incorporated the instrument and implant design enhancements first seen in the AxiaLIF 2L+ system: combination dilator/trials, ergonomic design, and most importantly, the ability to achieve distraction from static bone anchors.

2011 was a pivotal year for AxiaLIF in medical literature, with 27 papers published in peer-reviewed journals. This brought AxiaLIF’s compendium of clinical experience to over 50 peer-reviewed publications, collectively demonstrating low complication rates, high fusion rates, strong biomechanical data, and favorable outcomes in spondylolisthesis, degenerative disc disease, and revision.

In November 2011, TranS1 announced the launch of its new VEO Lateral Access and Interbody Fusion System. This minimally invasive lateral system features a unique, two-stage retraction method that focuses on nerve visualization followed by controlled retraction. The VEO Lateral System is designed for direct visualization of the psoas muscles and adjacent nerves prior to muscle dissection, and features a full range of PEEK lateral interbody implants and a variety of ergonomic instruments. The intuitive VEO Lateral System demonstrates TranS1's continued commitment to developing less traumatic approaches to lumbar spinal fusion.