Medical Device Daily Associate
SpinalMotion (Mountain View, California), a privately held developer of total artificial disc technology for treating patients with degenerative disc disease, reported receiving conditional approvals from the FDA of two investigational device exemption (IDE) applications, plus a second round of funding.
Under the IDEs, SpinalMotion, founded in 2003, will commence two separate clinical trials, one for its lumbar implant and one for its cervical disc implant.
In addition, the company said it has secured $20 million of Series B financing.
“The $20 million will enable us to substantially complete enrollment in the cervical and lumbar studies,” said David Hovda, president and CEO, in a company statement. “The significant commitment from our venture partners validates our team, our initial clinical performance data and our technology’s significant market potential.”
Hovda told Medical Device Daily that the Series B round funding was not contingent upon receiving the IDE approvals. The concurrent announcement of approvals and the funding was a planned event on the part of the company, he said.
“I just wanted to wait until I had some real substantive news to release,” he added. “We actually had our conditional approvals in the first quarter and closed in March, and prior to the Spine Arthroplasty Society meeting [May 4-7 in New York] we just really wanted to use this as an opportunity to update everyone on our progress to date.”
The lumbar trial will involve 25 U.S. sites in the first randomized study comparing two artificial discs.
In the first trial, the company’s SpinalMotion Kineflex lumbar disc will be compared to another FDA-approved lumbar artificial disc.
The cervical trial will involve 20 U.S. sites and will feature a randomized study comparing the SpinalMotion Kineflex-C to fusion.
Both trials are designed to demonstrate equivalent clinical success rates to their respective controls. A two-year follow-up period is required for both trials. Enrollment is expected to begin this quarter.
Three Arch Partners led the Series B funding of $20 million as a new investor. Thomas Weisel Healthcare Venture Partners, a SpinalMotion founder and the lead investor in the company’s Series A funding, also participated.
Bill Harrington, MD, a partner at Three Arch Partners, explained the significance of the two IDEs for the company. “There aren’t many companies with both cervical and lumbar IDEs,” he said. “These approvals really separate SpinalMotion from the concept and early stage efforts to more of a leading-stage company.”
He added that the company’s concept embodies all of the essential elements of disc design learned from experience with the various first-generation products, and “significantly simplifies the implantation process.”
The SpinalMotion Kineflex lumbar disc and the Kineflex-C cervical disc are designed to offer advantages over first-generation artificial disc implants, the company noted.
The technology preserves motion with low wear, and features an implant technique that includes specialized instruments for accurate placement.
This round of financing should take the company “substantially through enrollment,” said Hovda, “but not through PMA submission,” which will require another financing round, he said.
The Kineflex discs are currently sold in South Africa, where they were first developed by Southern Medical, a spinal implant company in that country.
Since October 2002, more than 375 Kineflex discs have been implanted in about 300 patients, with roughly 100 Kineflex-C discs implanted in 75 patients.
According to analyst reports, the artificial disc market potential is valued at almost $4 billion in 2005 and expected to grow to more than $5 billion in 2010.
According to Hovda, the company’s goal is to achieve a U.S. release for both products by 2008.