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SRS Medical Receives CE Mark for the In-Flow™ Device

Billerica, Massachusetts – November 5, 2002

SRS Medical Systems, Inc. today announced that it had received certification of CE marking for the In-Flow device, a urethral stent with a remote-controlled valve-pump mechanism that provides bladder drainage for women who cannot void on their own. (The CE Mark is the symbol used to indicate that a particular product complies with the relevant European regulatory requirements and has achieved a satisfactory level of safety, and thus may be freely marketed throughout the European Community.)

An estimated 400,000 U.S. women and their counterparts worldwide suffer from atonic bladder, usually as a consequence of spina bifida, multiple sclerosis, stroke, spinal cord injury, etc. In order to void, these individuals must use intermittent or indwelling (Foley) urinary catheters, although their use restricts activity and causes numerous medical problems. There is no cure for atonic bladder, however, the In-Flow device is designed to allow its users to use a toilet again. Unlike catheters, which rely on gravity to passively drain the bladder, the In-Flow device has an advanced turbine pump that spins at 10,000 RPM and actively empties urine.

The In-Flow device was originally developed by Influence Medical Technologies, an Israeli manufacturer, with funding from Medtronic, Johnson & Johnson and others. Key design aspects, including its magnetic activation, are patented worldwide. The In-Flow device has been used by women in Europe and the Pacific Rim since 1997. In the U.S., it is classified as an investigational device and is not currently available for sale, however, clinical trials have been completed and SRS Medical expects to submit a PMA application to the Food and Drug Administration (FDA) shortly.

Now that it has received a CE mark, SRS Medical will reintroduce the In-Flow device in France, Germany, Australia and Canada. In mid-2003, SRS Medical plans to expand its distribution to include Italy, Spain, Korea, Japan and certain other countries in the Pacific Rim. In order to better support prescribing physicians and their patients, SRS Medical is working with MedResources, a Brookline MA consulting firm, to develop a disease management program based on information from successful users worldwide.

SRS Medical Systems, Inc. is a privately held Delaware corporation with facilities in Billerica MA and Redmond WA. To learn more about SRS Medical and its products, please visit http://www.srsmedical.com.

Contact: Jane Stansbury, Product Manager
Mail to: jstansbury@srsmedical.com
Telephone: 800-345-5642, 425-882-1101
Fax: 425-882-1935

Urodynamics and Urodynamic Medical Solutions are provided by SRS Medical to provide better care for your medical patients. Best Practice for the care of patients with lower urinary tract symptoms (LUTS) includes urodynamics for prescriptive diagnosis. Urodynamics is good medicine and, due to increases in reimbursement, urodynamics, and urodynamic in general,now makes financial sense. SRS Medical offers such Urodynamic treatments and solutions such as the Eris Clarity System. The Clarity System features advanced technology from Eris, the group that first introduced computer-assisted urodynamics. In particular, the Eris Clarity System features two unique technologies that have significant real-world clinical benefits when dealing with Urodynamics: Effective Treatment of Urodynamic related illness begins with Accurate Diagnosis such as Pharmaceuticals, Conservative Treatments, Surgical Prodcedures Along with patient treatment of Urodynamic related illness and manufacturer of Urodynamic medical equpment, SRS Medical, Inc also deals with Incontinence, Supplier of the In-Flow product, Uro, Bladder, Biofeedback, Urinary, Pelvic, Catheter, Women's health, Urodynamics, Retention, Disability, Rehabilitation, Conservative treatment, Spina Bifida, Electromyography, Neurostimulation, Platinum, American Medical, Voiding, Orion, Influence, Urology, Kegel, Sensor, Colorectal, Levator ani, Atonic bladder, Gynecology, Uroflow, Overflow, Prosthetic, Physical therapy, Behavioral therapy, MS, Neuromuscular, Stimulation, Gemini, Medtronic, Overactive bladder, Perry, Urethra, EMG, Constipation, PVR, Urogynecology, Leak point, Rehab, Bulking agents, E-stim, SenseRx, Pathway, Pediatric Urology, Bedwetting and ControlWorks. In the world of urology and gynecology, SRS Medical deals with women's health such as bladder, pelvic, urethra, intraurethral, urine and neuromuscular disorders. Urodynamics of the urodynamic system can use catheter and urodynamic biofeedback to treat incontinence, atonic, retention, acontactile, neurogenic, LUTS. SRS Medical are medical manufacturers of the EasyPro, Orion, In-Flow, EasyFlo and C3 Penile Clamps. Browne, Eris, Perry, Influence, Timm, Endocare, AMS, EMG, leak-point, post-void residual, urogynecology, OB/GYN, female urology, rehabilitation, rehab, physical therapy, PT, colorectal, pediatric urology, voiding, bladder neck, penis, prostate, void, levator ani, prosthetic, urethral insert, Kegel exercises, Foley, e-stim, neurostimulation, electrical stimulation, intermittent catheter, intermittent catheterization, CIC, vaginal cones, penile clamp, catheterization, stimulation, bulking agents, injector, diagnosis, conservative therapy, conservative treatment, office-based, overflow, UTI, stress incontinence, urge incontinence, mixed incontinence, overactive bladder, neurogenic bladder, spina bifida, MS, multiple sclerosis, SCI, spinal cord injury, post-stroke, stroke, ui, diabetes, disability, Clarity, Regain, Gemini, sUrge, ControlWorks, MuscleWorks, GameWorks, MEP, SenseRx, American Medical, Pathway, Prometheus, Hollister, Platinum, Personalmed, Personal Medical, Kevin Connolly, David Mahoney, pressure, CMG, air-charged, electrodes, sensors, transducers, tubing, PVR, water perfusion, microtip. This web site designed by Bower Web Solutions, Inc.