FDA clears 2nd Generation CystoSure® Plus Urinary Access Catheter for Female Cystoscopy

Affordability for Routine Cystoscopy Using CystoSure^® Plus
Compatibility with current hsyteroscopes in inventory eliminate need for capital purchase

FOR IMMEDIATE RELEASE

FDA clears 2nd Generation CystoSure® Plus Urinary Access Catheter for Female Cystoscopy
System Represents the First New Approach for Diagnostic Cystoscopy in Decades

Boston, Ma. – October 5, 2018 – Emmy Medical, LLC announced today that the U.S. Food and Drug Administration (FDA) has cleared its 2nd generation CystoSure® Plus for female cystoscopy. CystoSure® Plus provides a simple, safe and efficient means for conducting diagnostic cystoscopy at the office, in the Operating Room, or at the bedside using any 300 mm x 2.9 mm OD or smaller cystoscope or hysteroscope. The 2nd generation Cystosure® Plus eliminates the need for additional capital purchases.

Cystoscopy is a commonly performed procedure used in hospitals and office to diagnosis lower urinary tract conditions. Traditional cystoscopy is complicated and cumbersome, preventing widespread use even when indicated. CystoSure® Plus’s patented design, specifically designed for the female patient and their care providers, reinvents the game – providing a technique which is safe, simple, and standardized.

“Over a million gynecologic and urogynecologic procedures are performed annually in this country which have a risk or urinary tract injury but few undergo routine cystoscopy despite recommendations from our professional societies,” according to Jim Greenberg, MD and inventor of CystoSure®. “Nothing has changed for female cystoscopy in the last 100 years so I created CystoSure® to be easier for doctors and safer for patients.”

The CystoSure® Plus is a 16 French 4-Way catheter whose proprietary design allows multiple passes of the scope to visualize the bladder while lowering risk of trauma or infection to the urethra/bladder and improving patient comfort. In addition, the catheter design allows full and consistent bladder evaluation with a simple 360 degree rotation of the scope, obviating the need for a learning curve or cystoscopy experience. According to Neeraj Kohli, MD, MBA, Chief Medical Officer, “CystoSure® is a game changer. It makes diagnostic cystoscopy more accessible to physicians and patients alike while making the procedure safer, faster, and easier while saving doctors and hospitals valuable time and money.”

“FDA clearance of CystoSure® Plus represents a new era of choice for clinicians who are uncomfortable with the traditional cystoscopy systems being employed today and need to evaluate the bladder in patients with hematuria, overactive bladder, and other urinary tract disorders in the office or the OR,” said Ron Adams, Emmy Medical president and CEO. “Emmy Medical is committed to improving the health and quality of life of women who are experiencing the challenges of managing urinary tract conditions. CystoSure® is a big step towards meeting that commitment.”

CystoSure® Plus is commercially available to medical professionals in the United States.