The company finished recruiting its direct sales forces for the United States and France early in the second half of 2012. Consequently, sequential growth in operating expenses began to slow in comparison to sequential sales growth in the second half of the year.
The company ended the year with a net loss of EUR 13.056 million. As of December 31, 2012, the company reported cash and cash equivalents of EUR 37.6 million. Mauna Kea Technologies had 121 employees as of December 31st, 2012 compared to 88 employees at the end of 2011.
"Optical biopsy is becoming established as a standard of care in gastroenterology and in other disciplines, paving the way for better care for patients," Sacha Loiseau, Chief Executive Officer of Mauna Kea Technologies, stated. "The healthy growth in Cellvizio system and miniprobe sales -- in spite of the very bleak global business environment -- reflects the medical community's adoption of the technology as a vital tool to improve the diagnosis and treatment of patients with many of the world's most common diseases. The investments we made in our commercial organization at the beginning of 2012, coupled with the growing body of clinical data and positive reimbursement milestones in the U.S. have helped us lay a strong foundation for success in our key markets. We continue to manage our substantial cash resources while delivering on our goals to increase the utilization of optical biopsies across clinical applications and regions around the globe."
Recent Developments and Highlights
Record Number of Cellvizio Studies Published in 2012
•Over 66 papers on the benefits of optical biopsies across indications were published. •Publications during 2012 supported the use of Cellvizio in new applications including needle-based procedures in the pancreas and stomach cancer. •Additionally, gastroenterologists in Japan and Germany used Cellvizio to view the enteric nervous system of the digestive tract during an endoscopy procedure for the first time. Study findings were published in the November 2012 issue of Gastroenterology, the leading medical journal in the digestive field. •There was also an increase in publications validating the use of Cellvizio optical biopsies for irritable bowel disease (IBD) and syndrome (IBS), Barrett's Esophagus (BE), colorectal diseases, and cancers of the bile and pancreatic ducts.
U.S. Reimbursement Highlights
•On January 1st, 2013, new Category I CPT codes for the use of Cellvizio in the digestive tract were implemented. Payment from Medicare/Medicaid for these codes had been established at $927 per procedure. The company recently launched an information and support initiative to help its customers obtain coverage from private insurers.
Cellvizio Optical Biopsy Probe CE Marked For Urological Applications
•In December 2012, the company's Cellvizio optical biopsy probe for urological applications received CE mark approval for use during cystoscopy procedures in Europe. First indication will be bladder cancer surveillance.
Regulatory Clearance in Brazil, Canada, Turkey, Russia, and China
•In December 2012, Mauna Kea Technologies received regulatory approval for Cellvizio from the State Food and Drug Administration (SFDA) in China. The company has a strategic partnership with FUJIFILM (China), for the expansion of Cellvizio optical biopsy distribution throughout China. •The company received regulatory clearance in Brazil in June 2012 to sell its Cellvizio 100 Series optical biopsy system throughout the country, which is the largest medical device market in South America. •In 2012, the company also received regulatory clearance from Health Canada, the Canadian Federal department responsible for medical device approval, the Turkish Ministry of Health, and the Russian Ministry of Health to sell both the Cellvizio 100 optical biopsy system and the AQ Flex 19 miniprobe throughout Canada, Turkey, and Russia. These countries are among the most dynamic medical device markets in the world.
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