Navigation Links
New Data Presented on the Renessa(R) Treatment for Female Stress Urinary Incontinence
Date:11/9/2007

6 month results from long term durability study presented at Western

Section meeting of the American Urological Association

NEWARK, Calif., Nov. 9 /PRNewswire/ -- Novasys Medical, Inc., a developer of innovative therapies in women's health, announced today that six month data from its post-market, prospective open label study to evaluate the long term durability of the Renessa(R) treatment for stress urinary incontinence (SUI) in women was presented at the Western Section meeting of the American Urological Association (AUA). A total of 137 women in the trial have been treated at 13 different sites across the United States. The patients will be followed for three years post-treatment.

Denise Elser, M.D., a urogynecologist practicing in Oak Lawn, Illinois and the principal investigator in the trial, presented the data in Scottsdale, AZ. "The non-surgical Renessa procedure offers women suffering from the isolating effects of SUI a safe, effective alternative between conservative treatments such as Kegel exercises and biofeedback, and more invasive surgical therapies," Dr. Elser said. "Women are looking for an alternative to exercise and surgery. My patients and I have been very pleased with the safety and results of this noninvasive treatment," she continued. The trial results will also be presented during a poster session at the upcoming Global Congress of Minimally Invasive Gynecology in Washington, DC.

Highlights of the six month results include:

-- 74% of women showed an improvement in their symptoms with 63% of women

reducing their episodes to less than half

-- 74% of women reported improvement in their quality of life

"This multi-center three year prospective trial is expected to confirm the outcomes seen in our previous U.S. Pivotal Trial," said Charles S. Carignan, M.D., Chief Medical Officer of Novasys Medical. "The six month results so far not only validate our earlier studies, but outcomes have been better in a slightly more severely affected population of women. And as has been the case in all four previous studies and in our commercial experience, there have been no serious adverse events reported," he states.

The company previously reported long term clinical outcomes from its U.S. Pivotal Trial which confirmed an improvement in quality of life and a reduction in the frequency and severity of incontinence episodes in the majority of women almost 4 years after treatment.

SUI is the involuntary leakage of urine associated with laughing, coughing, sneezing and recreational activities. The condition is caused by a variety of factors, most commonly childbirth, and often restricts the social, professional, and personal lives of an estimated 15 million women in the U.S. alone. With currently available surgical and non-surgical SUI therapies, many patients and physicians have concerns about safety, recovery, compliance, and/or effectiveness. In fact, it is estimated that approximately 80% of women with SUI do not seek treatment of any kind due to concerns over recovery time, possible complications or lack of confidence in the effectiveness of available options. The Renessa procedure offers women a new non-surgical approach to the effective treatment of SUI.

The FDA-cleared Renessa System includes a small probe which a physician passes through the natural opening of the urethra (transurethral). The probe heats multiple small treatment sites in the submucosa of the bladder neck and upper urethra, denaturing collagen in the tissue. Upon healing, the treated tissue is firmer, resulting in increased resistance to involuntary leakage at times of increased abdominal pressure, such as laughing, coughing or during exercise, thereby reducing or eliminating leaks.

The Renessa treatment can be performed in the convenience of a physician's office using local anesthesia. There are no incisions, bandages or dressings required. Recovery is rapid and comfortable, with minimal post-procedure limitations.

About Novasys Medical

Novasys Medical, Inc. is a privately held, venture-backed company which develops innovative therapies in women's health. The company's initial focus is the development and commercialization of the Renessa System, a proprietary, non-surgical approach to the treatment of female stress urinary incontinence (SUI).

For more information, please visit http://www.novasysmedical.com or call (510) 226-4060.


'/>"/>
SOURCE Novasys Medical, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. Quark Pharmaceuticals, Inc. Presented Positive Preclinical Results of Systemic RNAi Compound for Acute Renal Failure (ARF)
2. Pre-clinical Data on Recent Advances with HIV VLP Vaccine Presented at AIDS Vaccine 07 Conference
3. New Study Presented at WorldSleep 2007 Demonstrates Ramelteon Has Sustained Efficacy Over Six Months in Adults With Chronic Insomnia
4. Genasense(R) Data in Melanoma to be Presented in Opening Session at First Worldwide Melanoma Center Meeting of the European Association of Dermato-Oncology
5. Ozarelix Phase 2 Data Presented at 29th Congress of the Societe Internationale dUrologie
6. GeoVax Successful HIV/AIDS Vaccine Trial Data Presented at AIDS Vaccine 2007 Conference
7. Study Results for Aclidinium Bromide, a Novel Anticholinergic, Presented at European Respiratory Society Annual Congress
8. Promising Data from Paratek Pharmaceuticals MAR Inhibitor Program Presented in Late Breaker Session at the 47th Interscience Conference on Antimicrobial Agents and Chemotherapy
9. New Phase III Data Presented for Once Monthly Dosing Regimen of Risedronate to Treat Postmenopausal Osteoporosis
10. Further Data on Safety and Efficacy of Cethromycin Presented at 47th Interscience Conference on Antimicrobial Agents and Chemotherapy
11. Further Data on Safety and Efficacy of Cethromycin Presented at 47th Interscience Conference on Antimicrobial Agents and Chemotherapy
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/21/2017)... , July 21, 2017 Did you know that PhRMA ... 2016? Or that combined spending on brand medicines, generics and the ... with brands accounting for just half of this (7 percent)? Or ... thirds of the world,s venture capital investments in high-growth biopharmaceutical startups? ... ...
(Date:7/19/2017)... , July 19, 2017  Mako Medical Laboratories partnered ... the Military Family Assistance Fund (MFA) to bring 140 ... to visit with their families one last time before ... coordinate the travel and logistics needed for these soldiers. ... soldiers and their families. We just wish we could ...
(Date:7/15/2017)... Enterin Inc., a Philadelphia -based biotechnology company ... the completion of a $12.7 million Series A financing round. ... as the participation of existing investors. ... of New Ventures III and our current investors, and view ... of our platform technology to transform the course of PD ...
Breaking Medicine Technology:
(Date:7/21/2017)... , ... July 21, 2017 , ... “Kids aren't born ... to tie their shoes,” says Suzanne Tucker, Founder of St. Louis-based positive education company ... which launches on Kickstarter on Monday, July 21st. , The kit uses colorful, ...
(Date:7/21/2017)... ... July 21, 2017 , ... ... (ACL) offer patients improved quality of life five years after injury, according to ... Annual Meeting in Toronto, Ontario, Canada. The study followed patients for five years ...
(Date:7/20/2017)... ... July 20, 2017 , ... Acute myeloid leukemia ... that progresses rapidly without treatment. Newly diagnosed patients face intense chemotherapy regimens and ... and relapse. With such a challenging diagnosis that requires immediate action, patients ...
(Date:7/20/2017)... (PRWEB) , ... July 20, 2017 , ... ... a telemedicine platform, in which their iMedSecure™ comes included with each system installation. ... encrypted live images to remote participants for real-time collaboration and immediate decision-making requirements. ...
(Date:7/20/2017)... ... , ... Girl Up Campaign Director, Melissa Kilby, released the ... of providing girls access to education in refugee settings. In May, Congressman Steve Chabot ... to Education in Vulnerable Settings Act.” Yesterday, companion legislation was introduced in the ...
Breaking Medicine News(10 mins):