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® 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® 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 http://www.intrinsic-therapeutics.com/.