Uroplasty Announces Product Development and New Clinical Trial Initiatives

Uroplasty, Inc.

today announced two new research and development initiatives to expand its commitment to using the Company's neuromodulation technology to treat voiding dysfunctions. "We will begin development of an implantable tibial nerve stimulator for the treatment of overactive bladder (OAB), and conduct a pilot study in the U.S. for the treatment of fecal incontinence using our Urgent PC Neuromodulation System," said David Kaysen, Chief Executive Officer and President of Uroplasty, Inc. "These two new programs are an integral part of our vision to provide innovative solutions for the treatment of voiding dysfunctions. These initiatives utilize our intellectual property portfolio to address unmet treatment needs of many patients and are consistent with our mission to work with specialty physicians focusing on the treatment of voiding dysfunctions of all types." The development project, based on a patent the Company holds, of an implantable tibial nerve stimulator for the treatment of OAB is focused on securing a CE Mark for the European market. The Company expects the success of its Urgent PC Neuromodulation System, which delivers percutaneous tibial nerve stimulation (PTNS) by the temporary insertion of a needle electrode, will provide insight into the design and clinical elements of an implantable device. The implantable device will allow patients who initially respond to Urgent PC therapy administered in the doctor's office, to continue self-administering the therapy in the comfort of their homes. "Physicians have been asking us for a small, easy to insert, implantable tibial nerve stimulation system as a way to effectively continue treating patients who have positively responded to Urgent PC therapy. Because this is a chronic condition with no cure, we anticipate this new product idea will allow for a unique continuum of care for these patients. This multi-year effort will begin initially in Europe where we have past experience with potential partners and sets the stage for further clinical studies for regulatory and reimbursement work for the U.S. market," said Mr. Kaysen.