ALBUQUERQUE, N.M. — An Albuquerque doctor who was part of an FDA trial for a recently approved aesthetic medical device would like to see the product eventually manufactured in New Mexico.
When the FDA approved Vivace micro-needling with radio-frequency (electrical) energy in January, New Mexico Facial Plastics had two years of experience testing the device on 125 local volunteers, said Dr. Farhan Taghizadeh. One of a couple of sites in the U.S. doing the clinical trials, Taghizadeh staffed up by two employees to help get FDA clearance of Vivace on behalf of South Korean manufacturer ShenB.
Taghizadeh, a board-certified ear, nose and throat doctor and facial plastic and reconstructive surgeon, said Vivace treatments help stimulate and tighten skin in the deepest layer. He said the treatments, which can be used on any area of the face or body and on any skin type, is especially helpful in reducing acne scarring. Doctors apply a numbing cream to the area to be treated before the procedure. The device has tiny needles that produce small skin punctures that stimulate collagen formation in the skin.
The machine, which sells for $45,000 to $50,000, is targeted to dermatologists and plastic surgeons, said Taghizadeh.
Taghizadeh said he is a minority shareholder and chief medical officer of the company’s North American distribution arm, Aesthetics Biomedical Inc. Not only is he eager to see Vivace sales and distribution grow, but he also would like to promote Albuquerque as a future manufacturing site.
“We have a lot of cohesion (with ShenB) because of the trials,” said the physician-entrepreneur, who envisions the manufacturer shipping components to New Mexico for assembly, packaging and shipping. Sales must reach a critical mass of unit sales, perhaps in the thousands, before the Korean company would consider a U.S. presence, he said.
“It’s called end-stage manufacturing,” Taghizadeh said of such an initiative, which would require backing from a separate investment group. “I think the aesthetic space could be a good driver for future economic development and jobs” he said.
When he isn’t busy doing surgeries, Taghizadeh works with other firms to test skin-oriented treatments in New Mexico. He said the diverse skin types of state residents and high-altitude sun make businesses like his a good place to test products. Taghizadeh said the medical aesthetic marketplace is the fastest-growing segment of the biotech industry in the U.S., with year-over-year growth of 14 percent.
Most procedures are funded out-of-pocket by consumers.
In terms of the competitive landscape, Taghizadeh said several companies already are marketing radio-frequency devices for skin tightening in the U.S.