FDA Approves Pivotal Clinical Trial for Technology to Treat Overactive Bladder

Yesterday, the FDA approved the conduct of a pivotal clinical trial using a new technology to treat overactive bladder. The technology, developed and manufactured by Valencia Technologies, is called eCoinTM. It works by sending out electrical impulses to the tibial nerve which takes these signals to the part of the brain that controls bladder response.

The device is about the size of a US nickel and is implanted in a ten minute in-office procedure. The physician who cares for incontinence patients, a urologist or urogynecologist, does the procedure under local anesthetic. The protocol approved by the FDA shows Valencia will attempt to prove that its device produces superior effectiveness to the published results of a leading drug. If proven, patients will have an effective alternative to drugs currently on the market--without side-effects.

Jeff Greiner, founder and well known entrepreneur in the field of neuromodulation, believes that "eCoinTM will change the way overactive bladder is treated because it is minimally invasive, has no side effects, and may prove to be superior in effectiveness to drugs and alternative therapies."

The pivotal clinical trial will be conducted at 20 different medical centers throughout the United States. According to Roger Dmochowski, one of the leading urologists in America, "There is great excitement for a therapy that delivers more than modest improvement in overactive bladder symptoms while avoiding the side-effects of drugs."

About Valencia

Valencia Technologies is a medical technology company that has developed a fully-implantable coin-sized bioelectronic device for the treatment of various chronic conditions.

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