This story first appeared in the August 2012 issue of DOTmed Business News

Back in the early 1980s, Dr. Raymond Lanzafame and his colleagues at Rochester General Hospital acquired the very first lasers for clinical use and surgical research. Since those days, significant strides have been made in laser medicine. Lanzafame, now a general surgeon in private practice in Rochester, N.Y. and director of continuing medical education for the American Society for Lasers in Medicine and Surgery, keeps a close eye on how his field continues to advance. Photoacoustic tomography, a novel technology that’s a blend of optics, ultrasound imaging and short-pulsed laser that can operate deep within tissue, is a new technology. Capable of producing images on par with MRI and CT, with the convenience of a hand-held scanner to boot, Lanzafame says the technology holds promise for image-guided procedures found most often in the angiography suite. But that’s not matching up to the market push he’s witnessed recently.

“There are a couple of folks who have such technologies but are trying to package it for cellulite. That’s probably because, while cardiovascular is still the sweet spot that companies look for [based on] numbers, the cosmetic marketplace seems to be a place where people are willing to invest,” he says.

Cosmetic lasers dominate more than half of all lasers sold in the U.S. And despite the sour economy in the past few years, the sector is growing, with new technologies coming down the pipeline and older ones being fine-tuned.

“If you look at the array of technology, it’s really been skewed toward the aesthetic market. It’s what people are buying,” says Lanzafame.


Enter the age of diversity
Employees at Palo Alto, Calif.-based Sciton Inc. sift through ideas for new cosmetic devices on a regular basis. After assessing how large the market might be for a particular application, the company looks at a variety of different energy sources it might use, ranging from laser to flash lamp to ultrasound and radiofrequency. “Then we work on developing the product from there,” says Robert Ruck, vice president of worldwide marketing for Sciton.

While lasers continue to evolve, alternatives to mainstays like YAG (yttrium aluminum garnet) and CO2 lasers are being used increasingly for cosmetic procedures.

“I call it the laser and energy field because, in fact, right now the most exciting stuff is not through lasers, but ultrasound,” says Dr. George Hruza, president of the American Society for Laser Medicine and Surgery, and director of the Laser & Dermatologic Surgery Center in St. Louis, Mo. High-intensity focused ultrasound [HIFU] can tighten skin on the face.

Ulthera, a device that consists of a hand piece that focuses heat energy to stimulate collagen onto a 2-5 mm area under the surface of the skin— deeper than a laser can go — utilizes that technology. It initially received Food and Drug Administration clearance for eyebrows lifts in 2009, and received approval last year for additional areas of the face. Various technologies are also being fused together. For example, intense pulsed light [IPL] combines with radiofrequency for photorejuvenation skin treatments “to give a little boost,” says Hruza.

“What the engineers are doing is beginning to provide technologies that marry some of the pros of various technologies so that one can more selectively target the problem tissue and spare the surroundings,” says Lanzafame.

But he cautions that no technology will be a panacea.

“Unfortunately, some folks use these technologies as hammer and nail: If I got a hammer, everything becomes a nail. I think each of these things has their role. A lot of people bought these devices with the promise that they would do everything. But the patients didn’t come. On the other side of that, folks who are doing this well do find they need an arsenal of techniques and technologies that can be expensive to acquire.”


Body contouring shapes the aesthetic market
Reports indicate as procedures become safer and more
effective for patients, the market will continue to expand,
with technologies finally catching up to consumer demands.

“There has been a great evolution of products in the last 12 months with results finally matching up,” says Thomas Merolla, sales director at Phase 2 Laser in Golden, Colo.

Merolla thinks non-invasive procedures using various tissue-modifying technologies to reduce fat and cellulite are being embraced on a large scale by patient and practitioner alike, especially as they become more clinically validated. In recent years, the FDA has tightened its regulations, asking for more clinical data for device approval, and states have pushed for
more stringent regulation against non-physician operation of devices.

Candidates for body shaping procedures want to reduce excess fat in areas such as the abdomen and flanks, but with less downtime than certain techniques, such as liposuction, which cuts into the body. All the big laser manufacturers, including Palomar, Syneron & Candela, Cynosure, Cutera, and Sciton are marketing products for the non-invasive body contouring market.

Solta Medical’s Liposonix took almost ten years to come to fruition. The company received FDA clearance for its second-generation system in Oct. 2011. Liposonix uses HIFU to destroy subcutaneous fat in areas of the stomach and sides non-invasively.


“In the past, some of this technology had problems where it became painful [to the patient] because of too much energy and caused damage to the skin. That was mainly in the European trials. Now they’ve really refined it so it’s a much safer method,” says Hruza.

He thinks cryolipolysis, a noninvasive technique that freezes excess fat, has more data to support it than HIFU and is a more attractive option because there are little to no side effects. HIFU can sometimes cause pain in patients afterwards because of the heat it generates.

Two FDA-approved devices, one from Erchonia and the other from Zeltiq, are currently on the market, using this technique to
freeze fat and kill it soon after exposure.

Winners and losers
Sellers and dealers of refurbished lasers and IPLs acknowledge that they might be one of the few to have benefited from a weak economy, with business growing steadily in the past few years.

“If the banks start lending money again the way they used to, I think my used business will slow down,” says Shawn Burkey, president of the Laser Warehouse in Deerfield, Fla. a servicer of most major brands of cosmetic lasers.

Banks used to let any private practice doctor borrow money to purchase expensive lasers, which can range upward of $150,000. But those days are gone.

Many medical spas throughout the country have had to shut their doors as a result of expensive upkeep and more frugal consumers, especially in the mid-west regions of the state, according to Hruza.


But Sciton’s Ruck has seen things improve this year. He attributes this to positive consumer sentiment and banks slowly starting to lend again.

“In 2009 and 2010 the desire was there to buy systems, the ability just didn’t exist, he says. “Now that ability is coming back.”

Blurring the lines
Experts agree that advances in laser technologies and applications can move beyond making people appear more youthful.

Old carbon dioxide lasers, which have transitioned into fractional CO2 lasers, have been most commonly used for wrinkles and skin rejuvenation. But, as Hruza points out, “In the last couple of years, these lasers [fractionated] have shown improvement for patients with burn scars.”



Fibrocell Science Inc. recently received FDA clearance for its LAVIV technology, which uses a person’s own fibroblast cells for the improvement of moderate to severe nasolabial fold wrinkles, or smile lines. But it’s also investigating LAVIV for the treatment of restrictive burn scars as well as vocal cord scarring.

“Fibrocell Science is continuing to investigate LAVIV for many secondary uses as well as using our proprietary technology to study the potential of dermal cells in the field of personalized, regenerative medicine,” says David Pernock, chairman and CEO of Fibrocell Science.

DOTmed Registered DMBN August 2012 - Surgical and Cosmetic Lasers Companies

Names in boldface are Premium Listings.
Domestic
Jim Mousseau, The Laser Network, CO
David Boegler, DC International LLC, FL
Sean O'Donnell, Laser Locators, FL
DOTmed Certified
Shawn Burkey, The Laser Warehouse, FL
DOTmed Certified
DOTmed 100
Tony Kokjohn, The Laser Agent, Inc, IN
DOTmed Certified
John Bailey, BMX Medical, Inc., MN
DOTmed 100
Alison Fortin, Global Inventory Management LLC, NH
DOTmed Certified
John Yorke, LaserMedix, NY

International
Richard Taylor, Med Rich, United Kingdom
Xiaoyi Zhu, ZHONGJI OPTOELETRONIC CO., China
Lachman Aswani, Aswani LaserCraft Pty Ltd, Australia
David White, Elegant Laser Inc., Canada
Jean Marc Poirier, Northern Optotronics Inc, Canada