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Align Technology

This article was originally published in The Gray Sheet

Executive Summary

Maker of Invisalign clear, removable appliances for treatment of dental misalignment files preliminary prospectus with the Securities and Exchange Commission Nov. 14 for a proposed initial public offering of up to $200 mil. in common stock. The number of shares and price per share have not yet been determined. Proceeds would be used to expand manufacturing capacity, fund a national advertising campaign and other marketing activities, and continue product development. Invisalign is designed to compete with conventional metal or ceramic braces made by such firms as 3M Company, Sybron International and Dentsply International, and yet to be less burdensome to the wearer. The device gained 510(k) clearance from FDA in November 1998 and commenced commercial sales in July 1999. Each Invisalign appliance is worn over the teeth for two weeks before disposal of and replacement by the next appliance in a series. As of October, Align has trained over 5,300 orthodontists in Invisalign use, representing over 60% of U.S. and Canadian orthodontists. The Santa Clara, California firm generated sales of $3.2 mil. for the nine months ended Sept. 30 and a net loss of $53.3 mil. Underwriters include Deutsche Banc Alex Brown, Bear Stearns, J.P. Morgan and Robertson Stephens

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Align Technology

Developer of Invisalign clear, removable appliances for dental misalignment raises $130 mil. from a Jan. 25 initial public offering. Proceeds will go toward scaling up manufacturing at the firm's Santa Clara, California facility, as well as funding sales and marketing activities, including a national direct-to-consumer ad campaign and a physician training program highlighting the benefit of the Invisalign system over conventional metal or ceramic braces. Align claims to have trained more than 5,300 orthodontists and has enrolled an additional 1,000 for a training program that was slated to begin in January. The offering included 10 mil. shares priced at $13 each, with an underwriter over-allotment option for up to an additional 1.5 mil. shares. The issue will trade on the Nasdaq exchange under the symbol "ALGN." The offering was led by Deutsche Banc Alex. Brown and co-managed by Bear Stearns, Robertson Stephens, and JP Morgan. Align received 510(k) clearance for Invisalign in November 1998 and commenced commercial sales in July 1999 (1"The Gray Sheet" Nov. 20, 2000, p. 17)

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FDA officials have said hiring could be slowed if an inflationary pay increase is not included in the agency budget, but CDER and CBER continue to add staff at a steady pace.

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