Merrimack firm sets sights on cellulite

What would you think about a device that promises to reduce the appearance of cellulite in a completely non-invasive way, is affordable, has virtually no side effects, relaxes you like a spa massage — and the results can last for a year?It sounds too good to be true, but the Food and Drug Administration and three rounds of capital venture support – with a fourth on the way – have shown their confidence in SmoothShapes, a device created by Elemé Medical in Merrimack.SmoothShapes, a non-invasive body-shaping technology that combines lasers, mechanical massage and a vacuum, has been shown in clinical trials to smooth the appearance of skin dimpled and lumped by cellulite. Cellulite is a skin condition unique to women because of the composition of women’s underlying tissue layers. Fat cells under the skin increase in size, and collagen and its associated structures lose their elasticity and become more rigid. When this happens, the skin’s ability to adapt to irregularly shaped fat cells decreases and “cottage cheese thighs” or “orange-peel skin” appears.The treatment module of the SmoothShapes is a small hand-held medical device with rollers on the bottom, attached to a computer system that regulates and monitors the treatment. Each treatment lasts about 20 minutes per area.The device uses a specific wavelength of laser – 915 nanometers – to target and liquify the enlarged fat cells that cause cellulite. A second, 650-nanometer light source increases the cell’s permeability, allowing massage and a vacuum to move the fat out of the cell to the lymphatic system to be removed from the body.A typical regimen involves a series of two treatments per week for four weeks, with results lasting between six and 12 months.“Most of us women grow up believing that cellulite is related to our diet or exercise – we’re eating the wrong things or we’re not exercising enough,” said Nancy Briefs, the company’s chief executive and five-time entrepreneur. “That’s not really the case. It’s partly driven by genetics. If your mother had it, you’ll probably have it. It’s also driven by hormones — estrogen.”400 installationsIf there is any condition for which the market is riddled with snake oil, it is in the reduction of the appearance of cellulite.In fact, Briefs – who has three degrees and has earned seven patents — was so skeptical of SmoothShapes’ ability to treat cellulite, she requested the treatment before agreeing to become Elemé’s CEO in 2006.“I have built a 30-year career in medical technology leaning on three things – vision, passion and courage. If I was not passionate for the medical condition or the market or the technology, I knew I could never lead the team,” said Briefs. Briefs quickly became a convert – her initial results lasted 13 months before she returned for a maintenance procedure.After she joined the company, she took to running it like one of her cardiology enterprises, putting SmoothShapes through prospective randomized controlled studies “so we knew what worked and what didn’t work. There is no magic bullet.”On the market since 2008, the SmoothShapes device is considered a Class II, FDA-regulated medical device, meaning it can only be sold to physicians.The safety of the device is due in part to the specificity of laser wavelengths – they are simply not absorbed by other structures, such as blood vessels, nor do they penetrate the body very deeply.“We have never had a burn — ever,” said Briefs. “The technology is also so sophisticated that it has to be touching the skin and moving for the lasers to be on. If the clinician stopped moving it some reason during the treatment, it shuts off.”Currently, Elemé has over 400 installations in 20 different countries. The company employs 25 at its Merrimack office, who do everything except manufacture the device. Production is in Worcester, Mass.As a privately owned firm, sales and revenue figures were not disclosed, but Briefs did say she expected to close on a fourth round of funding by the end of the year of approximately $10 million to $12 million.‘Lean and mean’Bringing a product to market in the spring of 2008 – one focused on aesthetics no less – had been a challenge.As far as high-end aesthetic procedures go, SmoothShapes is fairly economical, quite a bit cheaper than surgical procedures like liposuction. However, a series of eight treatments costs about $2,000 – not an insignificant amount of pocket change in a struggling economy.“Our procedures are elective and self-paid,” Briefs said. “The average product cost to the doctor is $50,000. As the credit market was restraining and drying up, it became harder and harder for our doctors to buy products.”As the recession hit full force in November 2008, Briefs made the decision to lay off half of Eleme’s workforce.The move kept the company going, but Briefs admits it’s now running “lean and mean.”Briefs said she saw the market beginning to turn in 2009, and improving even more in 2010.“We’re seeing a couple of things. We’re seeing that physicians are looking for new technologies to drive their top-line revenue. And treating cellulite, for many of them, is a new opportunity,” she said. “Our market is very lightly penetrated. Less than 10 percent of clinicians have any type of technology for cellulite. So we have a big opportunity.”Much of that opportunity comes internationally.Briefs said that about half of Elemé’s revenue comes from outside the United States, translating into big sales for Elemé as the company is “cautiously optimistic that we see break-even on the horizon,” said Briefs.Also on the horizon is the expansion into Asia — one of Elemé’s most important goals for 2010.The company also recently introduced its latest model, SmoothShapes XV.“It’s more compact and easier to move between offices,” said Briefs.As sophisticated as the SmoothShapes device is, Briefs said she believes the company’s consumers are even savvier.“For some reason, people tend to underestimate us women as consumers. Women’s expectations of the SmoothShapes protocol are really in line,” said Briefs. “We’re not expecting to have the legs of an 18-year-old. We just want our legs to look as good as they can. I think women are very realistic about that.” Taking the team approach Running her fifth venture-backed medical firm, Elemé Medical chief executive Nancy Briefs pulls 60- to 70-hour weeks and serves on the board of another medical start-up company and the national board of the Medical Device Manufacturers Association – all while raising a blended family of six, aged 14 to 35.Her secret to making it all work?Briefs said she leads the company as a team, serving as a strong advocate for workplace flexibility.“I’ve spent my entire career developing and building teams,” she said. “I think science and technology are the engines that drive innovation, and it’s the entrepreneurial spirit that pulls it all together. For me, it’s the perfect match.”While the Nashua resident describes herself as a “gadget girl” and is passionate about medical technology, she said what she really “loves most” is leading and building successful teams.“We’ve tried to create an environment here that is very comfortable and flexible. Almost half of our staff are female. That’s not because we did that – we hire the best people. We don’t care whether they’re male or female, but that means so many of us are mothers or caretakers,” said Briefs. “We’re very flexible with our work hours.”“I’m able to attend events and things that I want to and need to with (her children) and still be able to work later at night,” said Briefs. “I also think that because I leave to go to functions at school, people think that they can do that as well.”She added: “We tend to have generally happy, engaged team members.” Cindy Kibbe can be reached