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April 27, 2005
SpinalMotion Receives FDA Approval to
Launch Clinical Studies Evaluating Lumbar and Cervical
Artificial Disc Implants; Secures $20 million in Series
B Funding
We co-founded SpinalMotion with Malan de Villiers
to develop an artificial spinal disc which would overcome
the major shortcomings of current offerings. Below, SpinalMotion
reports receiving FDA approval to launch clinical studies
in the US evaluating its lumbar and cervical products.
In conjunction with this regulatory event, the company
also announces raising a $20 million round led by Three
Arch Partners. The proceeds from this financing will allow
the company to enroll patients into its pivotal trials
for its lumbar and cervical disc products.
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SpinalMotion, a developer of
advanced total artificial disc technology for treating
patients with degenerative disc disease, today announced
that it has received conditional approvals from the U.S.
Food & Drug Administration (FDA) of two Investigational
Device Exemption (IDE) applications. Under the IDEs, SpinalMotion
will commence two separate clinical trials, one for its
lumbar implant and one for its cervical disc implant.
In addition, the company announced that it has secured
$20 million of Series B financing.
IDE Studies
The lumbar trial will involve 25 U.S. sites in the first
randomized study comparing two artificial discs. The investigational
SpinalMotion Kineflex(TM) lumbar disc will be compared
to another FDA-approved lumbar artificial disc. The cervical
trial will involve 20 U.S. sites and feature a randomized
study comparing the investigational SpinalMotion Kineflex-C(TM)
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.
Series B Funding
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.
"The $20 million will enable us to substantially
complete enrollment in the cervical and lumbar studies,"
said David Hovda, President and CEO of SpinalMotion. "The
significant commitment from our venture partners validates
our team, our initial clinical performance data, and our
technology's significant market potential."
"There aren't many companies with both cervical and
lumbar IDEs," explained Bill Harrington, M.D., a
partner at Three Arch Partners. "These approvals
really separate SpinalMotion from the concept and early
stage efforts to more of a leading stage company."
He added, "SpinalMotion'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. We were also impressed
with the clinical experience with these implants in South
Africa."
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