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39684 Eureka Drive
Newark, CA 94560 USA
phone:(510) 226-4060
fax:(510) 353-0524
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Private |
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| www.novasysmedical.com
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| Research Sector |
Medical Devices & Tech |
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| Summary Description |
| Non-surgical treatment for female stress urinary incontinence. |
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| Management |
| Debra Reisenthel, President and Chief Executive Officer; Charles Carignan, M.D., Chief Medical Officer and Vice President, Michael Angel, Chief Financial Officer; Simon Thomas, Vice President of R&D, Quality and Operations; Perry Needham, Vice President of Sales; Lauri Campbell, Vice President of Marketing and Reimbursement |
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| Keywords |
| therapy, women health, stress urinary incontinence, non-surgical, Renessa System, urology, advamed |
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| Description |
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Novasys Medical, Inc. is a privately held, venture-backed company developing therapies to improve female health and wellbeing. The company is initially focused on the research, development, and commercialization of its Renessa (R) System, a proprietary, non-surgical approach to the treatment of female stress urinary incontinence (SUI). When the urethral sphincter muscles do not adequately support the bladder, the increased intra-abdominal pressure associated with basic physical activities (i.e. laughing, coughing, lifting, and exercising) leads to the involuntary leakage of urine. |
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| Products / Services |
The FDA-cleared Renessa (R) System is intended to treat female SUI arising from bladder outlet hypermobility. The procedure can be performed in a physician's office, or other outpatient setting, using local anesthesia. No incisions, bandages or dressings are required, which-coupled with minimal post-procedure limitations-facilitates rapid and comfortable recovery. The Renessa (R) System can potentially provide a less invasive alternative to surgery and a more potent alternative to conservative measures (i.e. Kegel exercises).
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| Technology / Differentiation |
| The Renessa (R) System uses radiofrequency (RF) energy to generate controlled low-temperature heat to approximately thirty-six tissue targets within the lower urinary tract. A physician inserts the Renessa (R) probe through the urethral opening to heat small treatment sites in the submucosa of the bladder neck and upper urethra, consequently denaturing the collagen after sixty seconds of RF delivery. After the probe is repositioned, RF is administered over nine additional sixty-second periods. Upon healing, the treated tissue is firmer and more resistant to involuntary leakage during occasions of heightened intra-abdominal pressure, therefore reducing or eliminating episodes of SUI. |
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| Market / Customers |
Female stress urinary incontinence (SUI) is the most common type of urinary incontinence, affecting fifteen million women in the United States alone. SUI affects women of all ages, including approximately 25% of women between thirty and fifty-nine. The condition is caused and/or exacerbated by various factors, such as vaginal childbirth, smoking, and obesity. An estimated 80% of women with SUI do not seek any treatment because of their concerns (or those of their physicians) about the safety, recovery, compliance, and/or effectiveness of current surgical and non-surgical procedures. Over 300 urologists, urogynecologists and gynecologists have been trained in the Renessa (R) procedure, which has been performed in over 2500 patients to date.
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| Status |
| Novasys Medical received FDA clearance to market Renessa (R) in 2005. It is currently conducting a three-year clinical trial of its product; the company reported that 74% of women experienced improved symptoms (63% reduced their SUI episodes by 50%) and that another 74% improved quality-of-life within the first six months. Novasys announced in May 2008 that it had secured $49.5 million in Series D preferred stock financing. |
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Biotech & Specialty Pharma
Healthcare Services
Medical Devices & Tech
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