Medical Device Daily Associate

TranS1 (Wilmington, North Carolina), a privately held firm focused on developing minimally invasive product solutions for the treatment of lower back pain, reported the U.S. market release of its Axial Lumbar Interbody Fusion (AxiaLIF) system.

The AxiaLIF system, which received FDA 510(k) clearance around the end of December, is touted as the least-invasive approach to lumbar fusion and, according to a recent clinical study, dramatically reduces patient recovery time in comparison to traditional lumbar fusion procedures.

“The market release of AxiaLIF is the culmination of almost five years of product and clinical development and testing,“ said President and CEO Rick Randall. “We are very pleased to offer surgeons and their patients a two-stitch' lumbar fusion alternative to the more invasive fusion and disc replacement therapies currently employed. With this minimally invasive alternative, we believe more patients will accept a definitive surgical solution for their chronic back pain.“

TranS1, formerly known as Axiamed, was founded in 2000 by Andrew Cragg, MD, a Minneapolis-based interventional radiologist as well as an inventor and entrepreneur who developed and patented the trans-sacral approach to accessing the spine for lumbar spine surgical procedures as the result of a challenge by his brother, an orthopedic surgeon.

“[His brother] kind of challenged Andy to find a percutaneous route to the spine to treat lower back pain,“ Randall told Medical Device Daily.

After studying the anatomy, Randall said that Cragg “fairly quickly found that there seemed to be a direct route to the two discs [the L5S1 and L4L5] that cause about 90% of the lower back pain in the lumbar region of the spine.“

From this discovery, Cragg developed and patented a procedure, dubbed the Cragg Spinal Access Approach, to access the spine. The procedure is minimally invasive and spares injury to the disc annulus and the paraspinal muscles and ligaments supporting the spine. Unlike other surgical approaches, the Cragg approach accommodates the application of conventional surgical options without destabilizing the spine.

In addition, Randall noted that this approach would enable surgical procedures such as multi-level lumbar fusions and nucleus replacements to be performed on an outpatient basis.

The AxiaLIF system was developed to take advantage of the Cragg approach by accessing the lowest portion of the lumbar spine through a percutaneous opening via the sacral bone.

This minimally invasive access enables surgeons to perform lumbar fusion without the major dissections of the surrounding spinal soft tissue structures typically associated with conventional fusion surgery. This approach is designed to reduce recovery time and discomfort for chronic back pain patients.

With the AxiaLIF system, Randall said a surgeon essentially can “walk up the sacrum, just follow the tailbone and walk a very small blunt tissue dilator right up to the face of the [L5]S1 and in doing so, he never cuts or dissects or causes any trauma to any soft tissue structures in and around the spine.“ This, he said, contrasts with all conventional lumbar surgery, or even some of the more recent minimally invasive surgical approaches to the spine, which he said all go in “in some form laterally . . . and in doing so they enter into the spine through the muscles.“

In a recent clinical study, the company said that AxiaLIF patients were able to walk the same day of the surgery, most were released from the hospital within 24 hours and, on average, returned to work within 15 days. In comparison, conventional lumbar fusion patients are typically discharged three to five days after surgery and do not return to work for one to two months.

“The para coccygeal axial approach to the spine as developed by TranS1 allows for what is unquestionably the least-invasive access to the L5S1 level of the spine,“ said Isador Lieberman, MD, orthopedic and spinal surgeon and director of the Minimally Invasive Surgery Center at The Cleveland Clinic Foundation and Cleveland Clinic Spine Institute (both Cleveland). “I expect that this approach will foster multiple therapeutic modalities, including fusion, disc replacement and biologic reconstitution of the degenerate spine.“

TranS1 said that 40% to 60% of adults suffer from chronic back pain in the U.S. every year, and more than 1 million spine surgery procedures are performed annually in this country. Medical costs to treat back pain approach $24 billion a year. The lumbar fusion segment of the spine surgery market is estimated at well over $1 billion in annual revenue in the U.S.

The company has continued to add to its intellectual property by tying method claims via the surgical approach to apparatus claims. These apparatus claims include the AxiaLIF system and a percutaneous disc replacement system the company is developing, which is scheduled for initial clinical testing this year.

Hopefully, Randall said, this lays out “a very complex web of intellectual property that protects us — both our method and our devices to do this.“

TranS1 plans to initially introduce the AxiaLIF system to a select group of spine surgeons geographically dispersed in the U.S. Each surgeon must complete a comprehensive pre-clinical and clinical training as part of a certification program.

“We're more focused on spine surgeons who have some reputation,“ said Randall. “What we really need to do in 2005 . . . is work with a group of reputable spine surgeons and validate this procedure.“ He added that the company is also establishing a registry of patients that are treated using he AxiaLIF system and will eventually publish that information to help bolster its case for market adaptation.

Randall said that TranS1 is rapidly approaching a crossroads of sorts as far as its next financial move with the market release of the AxiaLIF. “There will either be a transaction or we'll raise more money.“

While he didn't say whether that potential “transaction“ would be as an acquisition target or an initial public offering, he did note that a decision on some course of action needs to be made by the middle of this year, as the company's current cash situation “takes us through December [2005].“

Whatever happens, Randall said he believes 2006 is lining up to be a marketing year for TranS1 and its products. “[That] is the time when I believe we should take this technology to the market in a big way.“

He did hint at one possible future direction of the company by noting the highly competitive nature of the orthopedic and spine sectors and the possible need to partner with someone with a larger sales organization to help distribute the AxiaLIF. He also pointed to the significant costs of developing the company's percuataneous disc replacement system, which would require an FDA premarket approval study, as another factor that would influence TranS1's near-term direction.

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