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UROPLASTY'S HISTORY

Company History

Uroplasty, Inc., incorporated in the state of Minnesota in 1992, is a global company that develops, manufactures and markets innovative, proprietary products for the treatment of voiding dysfunctions. In 1996, Uroplasty became a reporting company pursuant to registration filed with the Securities and Exchange Commission.

Uroplasty, Inc. is the financial, operations and regulatory headquarters for the company and is located in Minnetonka, Minnesota, United States. Uroplasty, Inc. owns and operates a Dutch subsidiary located in Geleen, The Netherlands. The Geleen office serves as the international sales headquarters for the company, which relies on a network of local distributors to sell in markets outside the United States. Uroplasty, LTD. serves the United Kingdom with a direct sales force.

Product History

Macroplastique®, an injectable, soft, tissue bulking agent, has been marketed outside the United States since 1991. In international markets, Macroplastique is used to treat both female and male urinary incontinence and vesicoureteral reflux. Outside the United States Uroplasty also markets soft tissue bulking agents for other indications, including PTQ™ Implants for the treatment of fecal incontinence and VOX® Implants for vocal cord rehabilitation. Macroplastique was the first CE marked device for tissue bulking to be marketed in the European Union.

Since 2004, Uroplasty has expanded its portfolio of products offered to the urology, urogynecology and gynecology markets. Under an exclusive licensing agreement with CL Medical, Lyon, France, Uroplasty currently distributes the I-STOP® urethral sling and the I-STOP Toms device in the United Kingdom. In 2005, Uroplasty acquired the Urgent® PC Neuromodulation System from Cystomedix. This technology was first introduced to the medical community in February 2000 as the Stoller Afferent Nerve Stimulation (SANS) procedure. The name of the device was changed in late 2002 to Urgent PC.

In 2006, Uroplasty introduced a next generation Urgent PC device after receiving CE marking and FDA clearance on the new design. Uroplasty also received FDA PMA approval for Macroplastique as a treatment for adult female stress urinary incontinence due to intrinsic sphincter deficiency. In early 2007, Uroplasty began marketing Macroplastique in the U.S.

0540020D 06/08