A Medical Device Daily

Genyx Medical (Aliso Viejo, California) reported closing the sale of the assets related to its Uryx product to C. R. Bard (Murray Hill, New Jersey) for $60 million.

The final closing followed last month's FDA approval of Genyx's premarket application for Uryx, the company's urethral bulking agent for the treatment of stress urinary incontinence. The mid-December approval followed completion of a North American multi-center randomized clinical trial in 253 women, comparing Uryx to Bard's Contigen implant, an injectable collagen material.

Uryx is a biocompatible copolymer that is injected in a liquid state into tissue surrounding the urethra and then transforming into a solid spongy mass which serves to provide added bulk to the urethra. Bard acquired the right to purchase the Uryx assets in December 2002 (Medical Device Daily, Jan. 27, 2003).

Bard said it anticipates launch of the product in the first half of this year, with marketing to be done by its Urological division (Covington, Kentucky).

Minimally invasive bulking agent therapy can be a first line treatment choice and is often used for patients who are not candidates for surgery, according to Uryx.

Timothy Ring, CEO of Bard, said the purchase offers “an important opportunity for Bard,“ adding: “We believe that the addition of the Uryx device will further strengthen our broad product line and enhance our position in the incontinence market.“ He specifically pointed to aging demographics “and the increasing demand for more effective, minimally invasive therapies for stress urinary incontinence.“

Thomas Berryman, founder and CEO of Genyx, said the sale culminates “years of devoted effort by the Genyx team and a dedicated group of physician clinical investigators. For years Bard has demonstrated its leadership in the area of female stress incontinence, and we wish them great success as we transfer Uryx and all the Genyx technology over to them.“

Since its founding in 1998, Genyx has been developing products for urological and gynecological tissue bulking and vessel occlusion, its primary focus being development of an injectable tissue bulking agent and delivery systems to treat stress urinary incontinence.

Bard is focused on technologies targeting the vascular, urology, oncology and surgical specialties markets.

In other dealmaking activity, Medical Makeover Corporation of America (MMAM; West Palm Beach, Florida) reported signing a letter of intent to purchase 100% of the assets of two aesthetic services companies, Aventura Electrolysis and Skin Care (Aventura, Florida) and EliteSpa (Coral Gables, Florida). Both transactions are expected to close on Feb. 15. Terms were not disclosed.

Randy Baker, MMAM president and CEO, said: “Our strategy includes expansion into targeted markets through the acquisition of successful companies with a reliable revenue base, a loyal client following and a diverse mix of services. Our projections include marketing to clients currently receiving non-medical aesthetic procedures and introducing them to physician-based treatment programs that we believe will be more effective for them.“

MMAM provides what it terms “medical-grade 'makeover' treatments utilizing non-invasive technologies,“ and specializing in a variety of cosmetic procedures. It reports establishing a chain of “new generation aesthetic care centers“ throughout the U.S. and Canada.

Circulatory devices panel meeting

The FDA's Circulatory System Devices panel is meeting today to discuss the premarket approval application for a thoracic endoprosthesis device for endovascular repair of the descending thoracic aorta.

The product to be considered is the TAG Thoracic Endoprosthesis made by W.L. Gore & Associates (Flagstaff, Arizona). The meeting will be held at the Hilton Washington DC North in Gaithersburg, Maryland.

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