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.MINNEAPOLIS -- Anulex Technologies, Inc., a privately held medical device manufacturer focusing on spinal spinal /spi·nal/ (spi´n'l) 1. pertaining to a spine or to the vertebral column. 2. pertaining to the spinal cord's functioning independently from the brain. spi·nal adj. disc Preservation & Anular Repair(TM) products, announced the completion of the patient enrollment phase of its Xclose(TM)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 ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. study will compare discectomy disc·ec·to·my n. The partial or complete excision of an intervertebral disk. Also called discotomy. patients that receive anular repair (utilizing Xclose(TM)) to those who have no repair. Primary study objective is to investigate the outcomes of surgical management of disc herniation herniation /her·ni·a·tion/ (her?ne-a´shun) abnormal protrusion of an organ or other body structure through a defect or natural opening in a covering, membrane, muscle, or bone. 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 approximation /ap·prox·i·ma·tion/ (ah-prok?si-ma´shun) 1. the act or process of bringing into proximity or apposition. 2. a numerical value of limited accuracy. for procedures such as general and orthopedic surgery Orthopedic Surgery Definition Orthopedic (sometimes spelled orthopaedic) surgery is surgery performed by a medical specialist, such as an orthopedist or orthopedic surgeon, trained to deal with problems that develop in the bones, joints, and ligaments . 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 un·met adj. Not satisfied or fulfilled: unmet demands. clinical need." About Anulex Anulex Technologies, Inc. is a privately held company privately held company A firm whose shares are held within a relatively small circle of owners and are not traded publicly. 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 www.anulex.com. Xclose, Anulex, and Preservation & Anular Repair are trademarks of Anulex Technologies, Inc. |
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