Novasys Medical Receives CE Mark for Novasys Remodeling System.Business Editors/Health/Medical Writers NEWARK, Calif.--(BUSINESS WIRE)--April 22, 2003 Novasys Medical, Inc., a developer of new therapies and technologies for the treatment of female pelvic disorders, today announced that it has received approval to affix the CE Mark to its Remodeling(TM) System for female stress urinary incontinence stress urinary incontinence n. See stress incontinence. . The CE Mark allows Novasys Medical, Inc. to market the Remodeling System in European Union countries and signifies that the product complies with all applicable safety and quality standards. Per the CE mark approval, the Novasys Remodeling System is indicated for the treatment of female genuine stress urinary incontinence (SUI Sui (swā), dynasty of China that ruled from 581 to 618. This short-lived dynasty reunified China in 589 after 400 years of division and laid the foundation for further consolidation under the T'ang dynasty. ) associated with bladder outlet hypermobility (BOH BOH Bournemouth (UK) Airport Identifier BOH Bank of Hawaii BOH Board of Health BOH Back Of House BOH Board of Housing (Montana Dept of Commerce) BOH Badge of Honor BOH Bridge Of Hope BOH Bag of Holding ), with or without associated intrinsic sphincter deficiency (ISD). The Company estimates that there are more than 8 million women in the European Union who are potential candidates for the procedure. "Receipt of the CE Mark is an important milestone for our company and validation of our technology," said Debra Reisenthel, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Novasys Medical, Inc. "This is the first step toward the full launch of this highly anticipated non-surgical treatment." The Novasys Remodeling System is currently not commercially available, but is under investigation in the United States. Novasys Medical recently completed the treatment phase of its 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. , controlled clinical trial controlled clinical trial, n a research strategy that calls for two samples: an experimental sample of patients receiving a pharmaceutical, and a second sample of control patients receiving a placebo. and anticipates submitting its results to the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. in 2003. As many as 25 million Americans (of which at least 80% are women) suffer from bladder control problems. The most common incontinence problem for women is stress urinary incontinence, which is caused by weakening of the bladder outlet, resulting in the involuntary loss of urine during exercise, sneezing, coughing, laughing and other activities. While other treatments are available, most are either palliative or surgical. The Novasys treatment utilizes a transurethral device to remodel microscopic regions of tissue within the bladder outlet and proximal urethra using radiofrequency energy (RF), increasing resistance to leakage without the need for surgery. Unlike RF energy tissue ablation, which shrinks tissue, RF energy tissue remodeling reduces tissue compliance through the denaturation denaturation, term used to describe the loss of native, higher-order structure of protein molecules in solution. Most globular proteins exhibit complicated three-dimensional folding described as secondary, tertiary, and quarternary structures. of microscopic tissue targets without producing gross anatomical change. About Novasys Medical, Inc. Novasys Medical, Inc., a privately held, venture-backed company, develops novel solutions designed to better address significant health and lifestyle issues impacting women worldwide. The Company's initial focus is on the commercialization of a proprietary, non-surgical Radiofrequency device to treat female stress urinary incontinence. For more information, please visit www.novasysmedical.com or call 510/226-4060. |
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