About
Dr. Andy Cragg
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 and still allowing patients to go home the same day. Based on this history of success, Andy's brother challenged him to apply his trade to the lumbar spine.
Access Point for AxiaLIF Surgery
Dr. Cragg's experience as a interventional radiologist influenced him to view the spinal column as a tube. 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 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.
Sao Paulo, Brazil and Rick Randall, CEO
In 2002, it was time to find a clinician who could do further testing. Through a series of introductions, the team met Dr. Carlos Oliveira in Brazil, who believed in the 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 no sense that anything had been done in the lumbar spine. The series demonstrated not only that the procedure was safe, but that it was efficacious as well. More importantly, Dr. Oliviera's experience demonstrated for the first time that if no soft tissue was damaged while accessing the lumbar spine, then patients' pain is greatly reduced.
The success in Brazil led to the first round of venture capital investment. Now it was time to build a team around the technology. Rick Randall was hired as the CEO. Rick had been the 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 hardware 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.
First AxiaLIF Cases
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 perfecting the tools needed for discectomy and preparation of the endplates. The nitinol cutters and tissue extractors were a great engineering accomplishment, showing that a thorough discectomy could be accomplished to existing standards with radically new radial cutting and extracting tools.
FDA Clearance
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.
First U.S. AxiaLIF Case
In January, 2005, the first AxiaLIF case was performed in the United States to fuse the L5-S1 disc space. In spite of its success to date, 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.
Sales Force Expansion and AxiaLIF 360° Construct
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 market release of AxiaLIF in 2005, the sales force tripled in size in order to have 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 variant of AxiaLIF, the AxiaLIF 360, in the U.S. The AxiaLIF 360 added new, percutaneous facet screws posteriorly to complement the anterior AxiaLIF Rod . Biomechanical testing demonstrated that an AxiaLIF Rod with facet screws was comparable to an AxiaLIF with pedicle screws in resisting motion at L5-S1. Pedicle screws were the industry standard, but were much more invasive than TranS1's new facet screws. The market recognized this fact, and through 2007, the AxiaLIF 360 would be used in over 40% of all AxiaLIF cases.
TranS1 IPO
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, demonstrating the rapid growth rate of AxiaLIF as the least invasive solution to L5-S1 fusion.
AxiaLIF 2L
In May, 2008, the first AxiaLIF 2L surgery was performed in the U.S., marking a significant milestone in 2-level lumbar fusion. A limited market release followed until September when the full product launch took place. 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.
Also in 2008, second generation of PNR (Percutaneous Nucleous Replacement) devices were implanted in 10 patients in The Netherlands. This "non-fusion" investigational device is designed to replace the degenerated disc and reduce or eliminate associated leg pain and back pain while preserving the full range of motion and function of the affected lumbar spine segment. The PNR implant is surgically deployed through the same lumbar access as is used for AxiaLIF lumbar fusion. The future of this technology remains bright and we look forward to learning more from expanded clinical studies in 2009 and beyond.
Future
Since the first AxiaLIF surgery, over 8,000 AxiaLIF and AxiaLIF 2L cases have been performed. With this clinical history, Dr. Cragg's original concept has been validated: patients routinely go home the same day or the next day as opposed to three days for traditional lumbar surgery. Patients recover from surgery faster, with less pain than traditional surgery and fusion rates comparable to classic fusion techniques in repeated clinical studies.
By accessing the spine though the unique, axial approach, native bone and soft tissue anatomy is avoided, as are nerves and great vessels. As a result, AxiaLIF has maintained an overall complication rate of approximately 1%, making it the most reproducible and least invasive access to lumbar fusion.
TranS1 continues to develop minimally invasive techniques and products for the spine to help patients and surgeons through exceptional clinical outcomes. In 2009 and beyond, TranS1 plans to expand its product offerings and further refine its current systems.
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