Intrinsic Enrolls First Patient in Barricaid(R) Trial
By Intrinsic Therapeutics Inc., PRNEWednesday, February 16, 2011
WOBURN, Massachusetts, February 17, 2011 - Intrinsic Therapeutics, Inc., a developer of novel lumbar spine anulus
closure devices, announced today that it has enrolled the first patient,
December 17, 2010, in a Randomized Clinical Trial of its Barricaid(R) device.
Barricaid is designed to prevent reherniations following lumbar discectomy,
while allowing the surgeon to retain as much of the native nucleus as
possible preserving normal disc height and biomechanics. Barricaid
accomplishes this by providing the added security of a bone-anchored device
that can be used to close larger anular defects or in cases where anular
integrity is in question.
The procedure was performed by Guido Dua, M.D., Chief of Neurosurgery,
Middelheim Hospital in Antwerp, Belgium. Robert Hes, MD, Principal
Investigator at Middelheim, stated, "What I like about the Barricaid device
is that it provides an elegant solution to possible reherniation. Barricaid
allows for a limited discectomy while offering the potential for secure
closure of the anular defect and a reduction in both the risk of recurrent
disc herniation and disc height loss. I was very satisfied with the
simplicity and ease of the procedure. I anticipate that we will be able to
recreate the outstanding results seen in prior Barricaid studies."
"We are pleased to have begun our randomized study in Europe," said Noel
Rolon, Intrinsic Vice President, Regulatory and Clinical Affairs. "The fact
that we have started enrolling patients so quickly indicates the level of
enthusiasm among our investigators. It is clear that the positive clinical
and commercial results recently presented at the DWG meeting in Bremen and
published in the November 2010 issue of the European Spine Journal, provide a
strong foundation for this post-marketing study."
Intrinsic is enrolling up to 800 patients in a prospective, randomized,
superiority study comparing Barricaid to traditional limited discectomy. "We
are excited to start the trial and prove that Barricaid is a superior
alternative for patients suffering from symptomatic, herniated discs," said
Greg Lambrecht, President and CEO of Intrinsic. "Because so very many
patients undergo surgical treatment of herniated discs, we believe a large
number of patients stand to benefit from the technology."
About the Barricaid(R) Prosthesis
Intrinsic's Barricaid is an anular closure device that enables surgeons
to directly close the defect in the region of the herniation. Implanted
between the anulus and the nucleus, the Barricaid creates a mechanical
barrier, allowing the surgeon to leave more nucleus within the disc.
About Intrinsic Therapeutics, Inc.
Intrinsic Therapeutics, Inc., based in Woburn, MA, is a medical device
company focused on developing innovative therapies that address the spine
market's many unmet clinical needs. The company's first product, Barricaid,
is a revolutionary spinal implant that was developed to treat patients
undergoing surgery for herniated lumbar discs. For more information about
Intrinsic Therapeutics, Inc., please visit
www.intrinsic-therapeutics.com/.
Contacts: Noel Rolon, VP, Clinical and Regulatory Greg Lambrecht, President and CEO Intrinsic Therapeutics, Inc. www.in-thera.com/contact.shtml clinical@intrinsic-therapeutics.com +1-781-932-0222
Noel Rolon, VP, Clinical and Regulatory, or Greg Lambrecht, President and CEO, Intrinsic Therapeutics, Inc., clinical at intrinsic-therapeutics.com, +1-781-932-0222
Tags: February 17, Intrinsic Therapeutics Inc., Massachusetts, Woburn