Medical Device Daily Contributing Writer

ZICHRON YAAKOV, Israel — One could say that ultimately it is best to look for the key where the key is, especially when carrying one's own light. In this case, Israel's founding aesthetic laser and light device maker, Lumenis (Yokneam, Israel), set its sights to the east of the well-lit path that has become a bit crowded.

Now the Korean FDA has granted the Lumenis One laser device approval, opening up the aesthetic laser and light device market in South Korea and Taiwan, estimated at more than $38 million and expanding rapidly, with skin treatments driving the growth.

Along with the marketing approval has come an import license from the Taiwan Ministry of Health.

President and CEO Avner Raz said, “The launch of our popular Lumenis One into Korea and Taiwan will further strengthen Lumenis' position as the leading aesthetic system supplier in the Asia region.“

Raz added: “We are pleased that the clinical efficacy and product safety of our flagship Lumenis One aesthetic system has once again been stringently reviewed and publicly validated. Our Lumenis One provides practitioners leading-edge technology to address the vast majority of their aesthetic treatment needs in one sophisticated platform — better for their patients and their practice.“

Qiying Zhai, Lumenis' vice president for China and Asia Pacific, said, “We are confident that Lumenis One will be as well received in Korea and Taiwan as it has been elsewhere in the region, where physicians report very safe and effective treatments on Asian skin, and we find that the demand for Lumenis One is growing steadily.“

Lumenis One is a multi-technology, multi-application and upgradeable platform designed for comprehensive aesthetic treatments. The platform combines several proprietary technologies into a single modular and customizable system: IPL (Intense Pulse Light) for skin rejuvenation and treating vascular and pigmented lesions, LightSheer diode laser for hair removal, Multi-Spot Nd:YAG laser for deeper vascular lesions and leg veins, and the recently introduced Aluma for predictable and virtually pain-free skin renewal.

The system's key features include Optimal Pulse Technology, numerous preset settings that can easily be customized and an intuitive touch-screen software interface. These combine to provide not only greater patient comfort and faster treatments, but readily recorded, repeated and tracked patient treatment histories.

Raz said that global markets have high importance in the company's turnaround plan and reorganization, initiated last year to correct flaws that knocked Lumenis into Pink Sheet trading.

Raz indicated that the company is striving not only to boost financials and bring about greater efficiency, but also overwhelming customer satisfaction among both practitioners and patients.

“Improvements have been made in operational efficiencies, margins and expenses, which resulted in solid operating profits and continued positive cash flow, demonstrating the benefits of our new organization and operating model, while remaining firmly committed to new product development,“ he said.

Raz noted a growing backlog of orders for Lumenis One, which received regulatory approval in June 2005 from the State Food and Drug Administration of China. By that date, Lumenis had sold more than 500 IPL Quantum systems in the Asia Pacific region, which consists of all of Asia outside of Japan.

He added that in the broadly defined future goals, “by leveraging our global infrastructure, we also intend to drive growth and profitability in all of our markets.“

One market segment in particular is glaucoma. In October, Lumenis announced the sale of the one-thousandth Selecta SLT Laser for selective phototherapy of glaucoma, but Raz noted that “while adoption of SLT in the U.S. has been remarkably high, Lumenis also has identified and will pursue the untapped markets in Asia Pacific and Europe.“

He cited available estimates suggesting that there are 70 million glaucoma patients worldwide, and open-angle glaucoma is the most common form of this condition. Only 3 million of these glaucoma patients are in the U.S., and the incidence of glaucoma is expected to increase worldwide as the global population ages. “We are uniquely positioned to address this growing global need,“ Raz said.

Synova inks Israel supply accord

Synova Healthcare (Media, Pennsylvania), a subsidiary of Synova Healthcare Group, entered into an exclusive five-year distribution and supply agreement with Common Sense, an Israeli developer of diagnostic products for women's healthcare. Common Sense will supply Synova with products utilizing its technology, which will complement Synova's developing female healthcare lines.

Synova's current products, Menocheck and MenocheckPro, are over-the-counter and point-of-care/professional use non-invasive diagnostic tests used to detect the onset of menopause. In early 2006, Synova said it plans to utilize the Common Sense technology to introduce a non-invasive at-home test that will indicate whether users need to seek professional care for infections such as bacterial vaginosis or Trichomonas. Synova recently announced similar plans for the introduction of an infertility diagnostic, and also continues to develop a novel, non-invasive fetal monitor.

Synova CEO Stephen King said, “We look forward to continuing our commitment to our customers and shareholders, by delivering a portfolio of leading-edge products to both the retail and professional point-of-care marketplace, through collaboration with valued research and development partners like Common Sense.“

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