Medical Device Daily National Editor
NEW YORK - Two of the myriad small, private companies that presented at last week's Piper Jaffray Health Care Conference are competitors in the evolving spinal market who also followed one another on the conference program.
The first of the twosome to appear was SpinalMotion (Mountain View, California), with president/CEO David Hovda using the short-form, 20-minute presentation allotted such companies to discuss the firm's efforts to date in the cervical and lumbar segments.
Its Kineflex product comes in different versions for both markets, both designed to mimic the motion of a normal spinal disc. Kineflex has been used in clinical trials internationally since October 2002.
Hovda cited the Kineflex procedure, in which the disc is inserted halfway into the disc space so it can then be moved as needed. "That's an advantage for us," he said.
He said the firm's investigational device exemption study for the Kineflex Lumbar Disc for the treatment of degenerative disc disease has completed enrollment of some 450 patients at 25 U.S. sites. As of last month, the investigators had data out to two years on 100 of those patients in the randomized Kineflex vs. Charit study, Charit being the first-generation, early-market-leader artificial disc from DePuy Spine (Raynham, Massachusetts).
"We'll submit our PMA [pre-market approval application] in December 2008," Hovda said, with FDA approval anticipated the following year.
The lumbar disc uses a mobile bearing design, allowing translational movement within limits defined by a retention ring. Kineflex features a metal-on-metal, cobalt chrome design aimed at minimizing wear and improving longevity.
The endplates, SpinalMotion said, come in three sizes to "maximize coverage of the vertebral bodies, and incorporate endplate serrations and a locating fin for initial stability."
In the cervical space, Hovda said enrollment in its U.S. fusion trial has been completed, with 30 patients thus far out to two years follow-up.
The Kineflex|C cervical disk features a mobile-bearing design. It too is a metal-on-metal design with endplates coming in two sizes.
Hovda said approval of the cervical disc is anticipated in 2010.
He added that the company's future growth will be pegged to additional products that will grow out of the Kineflex modular design. "We'll add new capabilities" as we go along, he said, citing, for example, a spinal "shock absorption" indication.
"We have 16 patents pending," Hovda said, "which will lead to a series of product introductions."
Besides the U.S. trials that will eventually lead to approvals in the world's largest medical-products market, he said the company's present focus is "targeted international commercial activity."
SpinalMotion was founded in 2004 by Southern Medical, a spinal implant company in South Africa, and Thomas Weisel Healthcare Partners. Three Arch Partners became an investor in 2005, and in 2006 Skyline Ventures and MedVenture Associates joined the company's investor group.
Following Hovda to the podium was Patrick McBrayer, president and CEO of AxioMed (Garfield Heights, Ohio), another artificial disc developer that was established in 2001.
Like most CEOs given the opportunity to tout their companies' cases in such settings, he showed the utmost confidence in the company and its developing products: "We believe AxioMed will become the clinical and economic standard in spine."
He cited the "significant market opportunity" that exists in the space, underlined by first-generation disc replacements that will be outstripped by newer, more effective products.
In replacing a damaged disc with the Freedom disc, McBrayer said, "We provide natural restoration of function, not just motion."
He said the company has ongoing pilot studies in Europe for lumbar applications, with pivotal trials soon to follow. "We're also leveraging it into cervical applications."
McBrayer said his company sees the replacement-disc market growing to more than $1 billion, "driven by efficacy and outcomes."
He said AxioMed believes its technology "has the legs to expand in both the lumbar and cervical spaces," including, for instance, multi-level implants in lumbar.
Saying the first-generation products (think Charit ) are "focused solely on motion," he said that motion "is unnatural" at best.
"[Patients and surgeons] are looking for something beyond motion," McBrayer said. "They want to address the issue of pain ... payers are looking for that kind of outcome."
He said the company has had "early dialogue" with both physicians and third-party payers. "European surgeons are seeking other answers beyond the first-generation device."
He cited the Freedom Lumbar Disc's "shock absorption" feature, with an elastomeric core "that is proprietary to us."
That core, he said, is "viscoelastic, compressible and provides stability."
The device was co-developed with physicians at the nearby Cleveland Clinic, and AxioMed's multi-center studies are ongoing in Germany and the UK, with the initial patients now being tracked out beyond 16 months.
McBrayer said that through its trials, AxioMed will prove that the Freedom "reduces pain, reduces disability and restores the natural function in the spine."
He added that the company plans to file for the European CE mark "before year-end."
Asked by a listener if the company had considered starting in the cervical rather than the lumbar space, McBrayer acknowledged that cervical is "a much larger space," but added that it's also "a much more crowded space. [We think] it's an easier transition to move from lumbar into cervical rather than the other way around."