Sales & Earnings In Brief
This article was originally published in The Gray Sheet
Hansen Medical: Firm reported a 43% drop in second-quarter revenues Aug. 4 -- to $3.3 million from $5.8 million in the same quarter of 2008 -- with lower-than-expected sales of the Sensei robotic catheter system. Hansen shipped six Sensei systems in the quarter, but only recognized revenue on three. Firm anticipates FDA clearance of an enhanced Sensei platform and Artisan catheter in the third quarter, and hopes to launch a smaller, more flexible ablation catheter in Europe in early 2010. The firm is working on a new platform for complex vascular procedures, but CEO Fred Moll says a clinical trial is not likely to begin before 2010 (1"The Gray Sheet" Dec. 8, 2008)
You may also be interested in...
Despite a scarcity of capital available to hospitals to buy imaging equipment, Volcano placed 74% more intravascular ultrasound (IVUS) consoles in the first quarter of 2009 than it did in the same quarter a year ago, the company reported May 7
Hologic is now forecasting a late 2010 launch of its Selenia Dimensions tomosynthesis three-dimensional mammography system, after recent discussions with FDA led the firm to back out of a planned June advisory panel review
Qiagen: Firm will pursue full pre-market approval for Ensemble, "the first ever continuous loading molecular diagnostic instrument," Qiagen Senior VP of R&D Jim Godsey announced Dec. 2 at the Piper Jaffray Healthcare Conference in New York City. Ensemble is compatible with Hybrid Capture human papilloma virus screening technology. According to Qiagen, the Ensemble JC2000 instrument can run 2,000 specimens per one eight-hour cycle and 5,000 specimens in two back-to-back shifts. The company also is developing a model for low-to-medium throughputs. Clinical trials, which likely will include 30,000-40,000 specimens, will begin in the first half of 2009, Godsey says. Qiagen gained Hybrid Capture 2, the only FDA-approved molecular HPV screening test, when it acquired Digene in 2007. Qiagen dominates the U.S. HPV market now, but will soon face competition from Hologic/Third Wave's Cervista, which is pending PMA approval, and down the line, from Gen-Probe (Aptima) and diversified drug giant Roche (Amplicor)