Arizona Medtech Company's Technology Breakthrough The First To Achieve FDA Approval For See/Treat Ultrasound

Main Category: MRI / PET / Ultrasound
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 19 Nov 2009 - 21:00 PST

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Guided Therapy Systems, LLC (GTS), a leading medical technology company, is the first company in the world to develop and commercialize products that employ a unique form of ultrasound technology, Intense Therapeutic Ultrasound (ITU).

Addressing a $4 billion market, the company's patented products combine ultrasound imaging with ultrasound treatment in a single non-invasive "see and treat" device. The "see" capability allows physicians to see into the body without surgery. The "treat" capability allows the delivery of focused acoustic energy deep into tissue without affecting intervening tissue.

On September 11, 2009, following several years of product development and extensive clinical studies, the Federal Food & Drug Administration (FDA) granted approval for these products to be marketed in the United States, a first for any product in this technology category, and a definite first for its clinical use, aesthetic improvement.

Clinical studies have shown that the non-invasive face lift procedure has an excellent safety profile, is tolerated without the need for an anesthetic and the patient can return to his or her daily routine immediately. GTS's patented see/treat devices are being commercialized by spin-off company Ulthera, Inc. and promoted to physicians and surgeons throughout the world, including Europe, Asia and the United States. GTS continues to develop and commercialize its ITU technology platform to address large unmet needs in other specialties including women's health, aesthetic medicine and musculoskeletal applications including sports medicine, oncology and others.

GTS executives include founder Michael H. Slayton, PhD, chairman and chief executive officer; co-founder Brian D. O'Connor, president and chief operating officer; and co-founder Peter G. Barthe, PhD, vice president, research and development.

Source
Guided Therapy Systems, LLC