Medical Device Daily

Just in time for swimsuit season, SmoothShapes (Merrimack, New Hampshire), an emerging aesthetics company, says it will use the $15 million it raised in a recent Series B financing to commercialize its SmoothShapes 100 cellulite reduction system.

Three Arch Partners (Portola Valley, California), a venture capital firm that manages more than $1 billion in capital, led the financing. Mark Wan, founding partner of Three Arch, and Michael El lwein, former executive VP of Medtronic (Minneapolis) who has joined Three Arch as a venture partner, will join the board of SmoothShapes.

The company's first product, the SmoothShapes 100 is an FDA-cleared combination therapy that uses lasers at predetermined wavelengths in the visible and infrared spectrums with vacuum massage to treat cellulite. It is indicated for the temporary reduction in the appearance of cellulite, as well as for the relief of minor muscle aches and pain, relief of muscle spasms, and temporary improvement of local blood circulation.

Nancy Briefs, president/CEO of SmoothShapes, told Medical Device Daily that the scientific documentation of efficacy of its SmoothShapes 100 system makes it stand out in the already-overcrowded market of cellulite treatment.

"We think we have something that we have demonstrated works well, is extremely safe, and the patients love it because it's like getting a massage," Briefs said.

A multi-center clinical study of the system concluded that 81% of patients experienced "significant volumetric reduction in subcutaneous fat," according to the company. Targeted markets for the system will include not only traditional practitioners of aesthetic procedures — plastic surgeons and dermatologists — but also non-traditional practitioners, such as OB/GYN and primary care specialists, as well as medi-spas, aesthetic clinics and health clubs.

Briefs said the procedure can be done in less than an hour and patients are able to go back to their daily routine afterwards.

"It's really a lunch-hour procedure," she said.

The company plans to introduce SmoothShapes 100 at the annual meeting of the American Society for Laser Medicine & Surgery (Wausau, Wisconsin) in April, Briefs noted.

Other therapeutic options available to treat cellulite include liposuction surgery, which, according to SmoothShapes, can be painful and produce inconsistent results, or massage therapy improvement, which the company says, is temporary.

According to the company, more than 85% of women will develop cellulite at some point in their life, and that includes naturally thin women, ultra-slender super models, women devoted to a healthy lifestyle and diet, and toned athletes.

"Cellulite is not a disease, it's a skin disorder. Beautiful skin really depends on healthy cells," Briefs said.

Wan of Three Arch Partners said the firm is interested in the non-invasive aesthetic procedures market for several reasons, including the emergence of non-traditional practitioners, along with the growth of medical spas and specialty skin care centers, fortified by a market shift toward less-invasive procedures. Total expenditures for cosmetic procedures exceeded $12 billion in 2005, he said.

"The SmoothShapes system is a combination laser plus mechanical vacuum massage that can smooth out bumps and decrease the circumference of women's thighs, making them feel firmer and smoother. With tens of millions of American women being bothered by the problems of cellulite, we firmly believe that the market opportunity for the SmoothShapes 100 system is significant," Wan said.

In other financing news:

• Cardium Therapeutics (San Diego) reported the closing of a $21.5 million private placement financing with institutional and other accredited investors.

The investment included the sale and issuance of roughly 8.6 million shares of Cardium's common stock and warrants to buy up to about 3 million shares of common stock. Oppenheimer & Co. served as placement agent for the offering.

Cardium and its subsidiaries, InnerCool Therapies, and the Tissue Repair Company (both San Diego) are medtech companies primarily focused on the development of therapeutic products and devices for cardiovascular, ischemic and related indications.

The company said it will use the net proceeds from the financing to initiate its Phase III AWARE clinical study for Generx, initiate the Phase IIb clinical study for Excellarate in the second half of 2007, accelerate the commercialization of InnerCool's Celsius Control system and broaden and expand its temperature modulation technology into other medical indications and applications, and for general working capital.

In the fall of 2005, the company brought in its first funding of nearly $30 million and bought a cardiac angiogenesis drug portfolio from Schering AG (Berlin). At that time, the firm also merged with a subsidiary of Aires Ventures to gain a public listing (Medical Device Daily, Aug. 22, 2006).

In March 2006, Cardium acquired the technologies and products of InnerCool Therapies, a medtech company in the temperature modulation sector, which is designed to rapidly and controllably cool the body in order to reduce cell death and damage following acute ischemic events such as cardiac arrest or stroke, and to potentially lessen or prevent associated injuries such as adverse neurological outcomes.

In August 2006, Cardium acquired the technologies and products of the Tissue Repair Company, a biopharmaceutical company focused on the development of growth factor therapeutics for the treatment of severe chronic diabetic wounds. Its lead product candidate, Excellarate, is a DNA-activated collagen gel for topical treatment formulated with an adenovector delivery carrier encoding human platelet-derived growth factor-B .

• Zonare Medical Systems (Mountain View, California), a developer of ultrasound technology, said the company is closing additional equity funding, representing about $15 million.

The Series G financing was led by existing investors Frazier Healthcare, 3i, Mosaix Ventures and CB Health Ventures. Other investors in this round included Draper Fisher Jurvetson, Ascension Health Ventures, Kaiser Permanente Ventures and several other existing investors.

Zonare makes compact sonography devices.

• IntelliDOT (San Diego) reported the closing of $10 million in Series D financing led by Psilos Group. Other investors in the company include Menlo Ventures, American River Ventures, Integral Capital Partners, Shoreline Ventures, Dick Allen, and Shea Ventures.

The company said it intends to use the new capital to support the expansion of its CAREt bedside barcoding system into acute care hospitals throughout the country.

IntelliDOT provides a wireless workflow optimization and medication error prevention solution for hospitals and other healthcare providers.

• Quidel (San Diego), a provider of point-of-care rapid diagnostic tests, said its board of directors has authorized the company to repurchase up to an additional $25 million in shares of its common stock. This is in addition to the remaining amounts authorized under the company's May 2005 $25 million repurchase program.

This increased authorization also extends Quidel's share repurchase program to March 9, 2009. Shares of the company's common stock may be repurchased from time to time in both privately negotiated and open market transactions, subject to management's evaluation of market conditions, applicable legal requirements and other factors.

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