ENP Newswire - 07 July 2014
Release date- 04072014 - Quebec City, Quebec - Opsens Inc. (TSXV: OPS) today released results for its third quarter ended May 31, 2014.
First-in-human study well underway with 18 cases completed;
Preparing for FFR product regulatory clearance for US, European and Canadian markets;
Progressing towards gaining regulatory approval in Japan for the Fractional Flow Reserve ('FFR') products; on track to begin commercialization in first half of 2015;
Completes US$6-million licensing agreement with Abiomed, Inc.;
Strong balance sheet with over $10 million in cash and cash equivalents; additional milestone payments to be received for US$5.5 million from partners.
'We are successfully executing our plan to become a leading provider of FFR technology,' said Louis Laflamme, Opsens' President and CEO. 'We are pushing ahead with securing the regulatory clearances that will enable us to commercialize our unique FFR solutions. In Japan, the pre-market approval process is now underway and we expect to file for 510 (k) in the US in the fall and for CE Marking in Europe soon after. I'm also pleased to report that our robust balance sheet will enable us to further advance the Company's business strategy in the quarters to come.'
During this quarter, Opsens started a first in-human study. A cardiologist from the Quebec Heart and Lung Institute performed FFR measurement in 18 patients suffering from coronary blockages who were undergoing a coronary angiogram, in accordance with the specifications established in the report we filed with Health Canada. In every case, the goal of the study is to reach the lesion, measure FFR, disconnect and reconnect the OptoWire. Results of the study will be released when it is completed.
Opsens also entered into an amended and restated co-development agreement with Abiomed, Inc., pursuant to which Opsens will supply the sub-assembly of its miniature optical pressure sensor to be integrated in Abiomed's circulatory assist devices. Under the agreement, Abiomed is expected to pay Opsens an aggregate amount of US$6 million for the exclusive worldwide license to integrate its miniature pressure sensor in connection with Abiomed's circulatory assist devices.
Opsens is also engaged in implementing its global distribution strategy.
'We are on our way to begin commercializing our FFR products in the first half of calendar year 2015,' Mr. Laflamme said. 'It is our objective to continue increasing our global market penetration by pursuing additional distribution agreements with medical equipment companies around the world.'
THIRD QUARTER RESULTS
Consolidated revenues reached $1,703,000 in the three-month period ended May 31, 2014, compared with revenues of $1,706,000 for the same period in 2013. Lower revenues in the oil and gas segment were offset by the Company's solid performance in the industrial segment.
Net loss for the three-month period ended May 31, 2014 amounted to $1,022,000 compared with a net loss of $689,000 in the same period last year. The increase in the net loss is the result of higher administration fees related to the closing of the Abiomed agreement; by higher stock-based compensation costs and by higher marketing and research and development expenses incurred for the preparation of the commercialization of the Company's FFR products and for the finalization of its regulatory filings.
About Opsens Inc.
Focusing on two main growth markets, FFR in medical instrumentation and oil and gas, Opsens develops, manufactures and installs systems to measure pressure and temperature as well as other parameters using fiber optic sensing technologies. These systems are designed around patented technologies that are effective and durable in extreme conditions.
Forward-looking statements contained in this press release involve known and unknown risks, uncertainties and other factors that may cause actual results, performance and achievements of Opsens to be materially different from any future results, performance or achievements expressed or implied by the said forward-looking statements.
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