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Tria Preps 510(k) For OTC Skin Rejuvenating Laser, Files For IPO

This article was originally published in The Gray Sheet

Executive Summary

Aesthetic device maker plans to file a 510(k) this year for its over-the-counter, non-ablative laser to treat facial wrinkles, supported in part by proceeds from an initial public stock offering worth up to $86.3 million.

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Financings In Brief

Tria Beauty postpones IPO. Agendia raises $65 million for cancer tests. Kona Medical gets $30 million for hypertension device development. More financings.

Financings In Brief

Zonare Medical IPO would bolster portable ultrasound system sales effort: Maker of compact ultrasound systems plans initial public stock offering worth up to $86.3 million, according to a July 2 preliminary prospectus filed with the Securities & Exchange Commission. A portion of the proceeds are tabbed for R&D, sales and marketing, as well as "general corporate purposes," the firm says. The Mountain View, Calif., company currently fields a 26-rep U.S. sales force and uses a combination of direct reps and distributors overseas. Revenue for the quarter ended March 31 was down 23% from last year to $8.9 million and the firm is not yet profitable, with an accumulated deficit of $148.5 million. Founded in 1999 as NovaSonics, the company received 510(k) clearance for its system in 2002. The firm's primary competitors in the $4.4 billion worldwide ultrasound market include large players GE, Philips and Siemens, as well as smaller firms specializing in the handheld ultrasound market, including SonoSite, with which Zonare is in patent litigation (1"The Gray Sheet" March 3, 2008, p. 16). Underwriters for the IPO include Citi, Piper Jaffray, Cowen and Co., and Canaccord Adams

Cell/Gene Therapy Is Ripe For Real-World Data Given Length Of Follow-Up Required, Abernethy Says

The former principal deputy commissioner outlined what she sees as the future data requirements for real world evidence and why cell and gene therapy will lead the way.


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