Sources inform ''Globes'' that Ashkelon Technological Industries incubator company Sialo-Lite Ltd. has commenced the process of US Food and Drug Administration (FDA) registration of its disposable products for the treatment of Temporomandibular Joint (TMJ) syndrome and stones in salivary glands.
The FDA has awarded Sialo’s products a Class I 510k exemption, under which the FDA exempts various categories of low-risk devices, such as gas pressure gauges, oxygen masks, pacemaker chargers, dental floss, pneumatic tourniquets, patient scales, examination lights, and therapeutic massagers, from pre-market review. This means that approval for Sialo’s products is likely to be given within 30-60 days.
“Globes” has also learned that an additional five medical centers based on the “Nahlieli Method” (after company founder Prof. Oded Nahlieli) have been set up in the US. These centers treat salivary gland stones using Sialo products only. A similar center has been opened at the New York University Medical Center. Sialo CEO Itsik Hening said that the New York center is likely to generate $800,000 revenue a year for the company. The other centers are of a similar size, and are therefore likely to produce a similar volume of revenue with the passage of time. The center at NYU Medical Center received $4-5 million in investment from university funds.
In January, Sialo-Lite closed a financing round in which it raised $2.5 million from private US investors, following which it abandoned its plan for an IPO on the Tel Aviv Stock Exchange (TASE). Hening said that the company would use $850,000 of these funds by year-end, and therefore it had no need of an IPO at present, although he did not rule it out at a future date, “depending on the rate of company sales.”
Published by Globes [online], Israel business news - www.globes.co.il - on September 27, 2006
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