Mesa company gets approval to market ultrasound treatment

A Mesa medical device maker has received approval from the U.S. Food and Drug Administration to begin marketing its ultrasound technology to perform eyebrow lifts without surgery. Next, it hopes the same technology will be OK’d for other applications ranging from the treatment of liver cancer to acne.

Using “intense therapeutic ultrasound,” dermatologists and cosmetic surgeons will be able to see deep tissue while delivering focused energy into the skin without affecting the surrounding tissue, said Michael Slayton, inventor of the technology and chairman and CEO of Guided Therapy Systems LLC.

GTS created a spin-out company called Ulthera Inc. to commercialize the technology, entering a $30 billion global aesthetics market. The company’s technology is different from other in-office devices because it allows doctors to see under the skin’s surface and deliver ultrasound energy to enable significant lifting of the skin, said Slayton, who also serves as chairman of Ulthera.

Jonah Shacknai, president and CEO of Medicis Pharmaceutical Corp., a Scottsdale company that sells prescription skin treatments to dermatologists, said he wishes the new company success.

“It’s a credible device for skin tightening with demonstrated value in raising the eyebrows,” Shacknai said. “I’ve heard nice things about the product and we, of course, hope it does well. We always like to see Arizona-based companies that are not competitors of ours do well.”

In addition to prescription skin treatments, Medicis treats pediatric asthma and podiatric fungal infections. The company also is nearing completion of U.S. clinical trials for an ultrasound fat-buster called Liposonix.

The GTS product is approved only for facial treatment, which means it will not compete with Liposonix, Shacknai said. Liposonix received approval this past summer to be sold in Canada, and Shacknai said he hopes to receive FDA approval to launch the product by 2011.

As Ulthera begins marketing the ultrasound technology as a facial treatment, GTS is focusing on using the same concept to develop a hand-held device to treat acne. GTS President and Chief Operating Officer Brian O’Connor said he would like to see the device sold on retail shelves.

“We’re now preparing commercialization of that as well,” he said.

GTS has created another spinoff called Xthetix Inc. to market that device. O’Connor said it initially will be sold through physician offices and later will be marketed to consumers over the counter.

He said it is too soon to determine a price tag for the hand-held device.

“Based on clinical studies conducted to date, we expect the use of Xthetix devices to prevent the occurrence of acne and blemishes will become as common as use of a toothbrush to prevent tooth decay,” he said.

Clinical trials for the device were conducted at Arizona State University.

GTS hasn’t put a management team in place for Xthetix, said O’Connor, who also is serving as CEO of Xthetix.

Slayton said GTS has more than 100 patents issued, published or pending for its intense therapeutic ultrasound.

The Mesa company also is developing treatments for injured ligaments and liver cancer, O’Connor said.

GTS originally developed the ultrasound device for Johnson & Johnson to treat unresectable liver cancer, in which surgeons cannot cut the tumors out without damaging crucial blood structures. At the time, in 2000, O’Connor was working for J&J in Cincinnati as worldwide director of business development.

“We wanted to develop the next-generation surgical device that could leap-frog everyone else,” he said. “We in-licensed this technology from GTS in Arizona.”

J&J and GTS co-developed the product, but after three years and $20 million in research and development, J&J decided not to pursue commercialization of the technologies, O’Connor said.

“All the technology and patents were returned to GTS,” he said. “If GTS continues to commercialize these products to physicians, J&J receives a very small trailing royalty on product sales.”