mauna kea technologies (MKEA) Snapshot

Mauna Kea Technologies SAS announced that the U.S. Food and Drug Administration (FDA) has cleared 510(K) to Market AQ-Flex(TM) 19 miniprobe to provide real-time optical biopsies during endoscopic ultrasound-guided fine needle aspiration (EUSFNA) procedures in the digestive tract. This represents the sixth U.S. regulatory clearance for Mauna Kea Technologies' Cellvizio or one of its dedicated miniprobes, which already obtained the CE mark in Europe. A growing number of pancreatic cysts are being diagnosed as a result of the estimated 70 million scans being performed in the U.S. every year. Data from a large retrospective analysis showed that pancreatic cysts were present in 2.4% of asymptomatic patients who underwent CT scans of the abdomen for non-pancreatic issues. However, the relatively low sensitivity of standard procedures to characterize pancreatic cysts as benign or cancerous means there is a significant need for effective, low-cost, non-invasive diagnostic techniques that can significantly improve patient outcomes and lower overall treatment cost. The AQ-Flex miniprobe is compatible with all Cellvizio 100 series systems currently marketed by Mauna Kea Technologies and will be immediately made available in the U.S. through direct sales force. Mauna Kea Technologies is also exploring other commercial partnerships in order to accelerate its market reach.

Mauna Kea Technologies SAS announced sales results for the first quarter ended March 31, 2013. For the quarter, sales were EUR 1.784 million against EUR 1.611 million a year ago. Sales grew by 11% year-over-year in the first quarter of 2013.

Mauna Kea Technologies SAS announced earnings results for the full year ended December 31, 2012. For the year, the company reported sales of EUR 8,810,000 against EUR 5,016,000 a year ago. Total revenue was EUR 10,282,000 against EUR 5,976,000 a year ago. Operating loss was EUR 12,969,000 against EUR 8,103,000 a year ago. Net loss was EUR 13,056,000 against EUR 7,909,000 a year ago.