Anulex Technologies Completes Patient Enrollment Phase of Post Market Study: over 6,000 Patients Treated with the Xclose Anular Repair System

[Justin]

Anulex Technologies, Inc. Completes Patient Enrollment Phase of Post Market Study and Announces the Treatment of over 6,000 Patients with the XcloseTM Tissue Repair System

November 10, 2009

MINNEAPOLIS--(BUSINESS WIRE)--Anulex Technologies, Inc., a privately held medical device manufacturer focusing on spinal disc Preservation & Anular RepairTM products, announced the completion of the patient enrollment phase of its XcloseTM Tissue Repair System Post Market Clinical Study. 750 patients from 34 facilities around the U.S. were enrolled in the study. These patients will be followed for a two year period.

This prospective, controlled, randomized study will compare discectomy patients that receive anular repair (utilizing XcloseTM) to those who have no repair. Primary study objective is to investigate the outcomes of surgical management of disc herniation in terms of rate of reherniation. Other outcomes measures such as pain relief, functional improvement, patient satisfaction, disc height and the economic benefits associated with return to work and healthcare utilization, will also be measured.

The Xclose system has been used in over 6,000 U.S. procedures to date. Xclose was cleared in September 2006 for use in soft tissue approximation for procedures such as general and orthopedic surgery. Xclose provides a simple, convenient method for treating the compromised soft tissue of the anulus fibrosus.

Commenting on these two milestones, Rich Lunsford, Anulex’s President and Chief Executive Officer, said, “The completion of the enrollment phase of this landmark study for anular repair is an important achievement. As the pioneer in anular repair, this study represents Anulex’s commitment to provide further evidence to support the benefits of preservation and repair of the anulus. In addition, we are proud that over 6,000 patients have been treated with the Xclose system and we look forward to continuing to address the unmet clinical need.”

About Anulex

Anulex Technologies, Inc. is a privately held company dedicated to the development and commercialization of unique and proprietary soft tissue repair products with primary interests in treatments for the soft tissues of the spine. Back pain afflicts four out of every five individuals at some point during their life, and it is a major cause of disability. To date, Anulex has raised approximately $48.4 million through four rounds of financing to support these efforts. More information on the Company can be found at Anulex: Preservation and Anular Repair.

Xclose, Anulex, and Preservation & Anular Repair are trademarks of Anulex Technologies, Inc.

Contacts
Anulex Technologies, Inc.
Julie Osterberg, 952-224-4043
josterberg (at) anulex (dot) com

[sportsnut3007]

If i had found out about this when i first had my herniation i may had gone ahead with surgery and got a microdicectomy done, but I didnt find out about this till a year or so later and decided to just let my body finish doing its thing and hope i dont reherniate. The inclose thing is really cool if u just have a little hole in the annulus bc you have that extra little patch thing.