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Opsens Inc
Symbol OPS
Shares Issued 60,467,003
Close 2015-06-30 C$ 0.95
Market Cap C$ 57,443,653
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Opsens loses $1.35-million in Q3 2015

2015-07-02 09:44 ET - News Release

Mr. Thierry Dumas reports

OPSENS - RESULTS FOR THIRD QUARTER 2015

Opsens Inc. has released results for its third quarter ended May 31, 2015.

Highlights of the third quarter of 2015

  • Receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) for commercialization of the OptoWire and OptoMonitor, Opsens's products to measure fractional flow reserve (FFR) in the United States;
  • Opsens announces its plan to move FFR manufacturing to an expanded facility;
  • Dr. Nico Pijls, one of the founding fathers of FFR, uses Opsens's FFR products for the first time;
  • Opsens's FFR products used in a live broadcasted case during the Congress of the European Association of Percutaneous Cardiovascular Interventions (EuroPCR).

Opsens gets 510(k) approval for sale of its FFR products in the United States

Recently, Opsens received 510(k) clearance to market its FFR products in the United States, the world's largest market for this type of procedure.

Precommercialization phase for FFR products well under way in Europe and Japan

In the past few months, the company initiated a limited market release of the OptoWire and OptoMonitor, Opsens's FFR products for cardiologists treating patients with coronary artery disease. The measurement of FFR is used to optimize the assessment and to guide treatment in patients with coronary artery disease.

Dr. Nico Pijls, one of the founding fathers of FFR, uses Opsens's products for the first time

Opsens was proud to see world-renowned cardiologist Dr. Pijls from the Catharina Hospital in Eindhoven, the Netherlands, one of the investigators in the FAME clinical studies on FFR, use its FFR products in his practice. He commented on the reliability of the OptoWire's measurement, its drift-free performance, the constant reliability of its connection and its support during percutaneous coronary interventions. At the end of his trials, he said that the arrival into the market of an optical guide wire such as the OptoWire is positive for interventional cardiologists and could help promote the use of FFR.

During the third quarter of 2015, precommercialization of Opsens's FFR products continued. As a result, hundreds of OptoWire units were safely used in hospitals in Europe and Japan. During EuroPCR 2015, one of the world's largest cardiology congresses, Opsens's FFR products were showcased in a live case presentation.

New production facility

The positive feedback on the performance of Opsens's FFR products and the recent receipt of the FDA approval for the commercialization of its products in the United States have motivated the company to move forward with a significant expansion to increase the manufacturing capacity and accommodate its growing number of employees.

Anticipating to add significant people to its current work force over the next two years, Opsens is taking measures to accommodate the growth, leasing a 30,000-square-foot building in a Quebec City technology park. Opsens anticipates completion of this transformative move during the first quarter of calendar year 2016.

Third quarter results

Consolidated revenues reached $831,000 for the three-month period ended May 31, 2015, compared with revenues of $1,703,000 for the same period in 2014. The decrease in revenues in the quarter ended May 31, 2015, is explained by lower revenues in the oil and gas sector resulting from the difficult economic environment in Alberta (Canada), where major producers have cut down investments due to the significant decline in crude oil prices.

The decrease in revenues was partially offset by increasing revenues in medical activities in the third quarter. During this third quarter, medical revenues were limited by production capacity. Also, part of the units produced were dedicated to the verification and validation activities of OptoWire II.

Net loss for the three months ended May 31, 2015, was $1,355,000, compared with a net loss of $1,022,000 for the same period last year. The increase in net loss is explained by lower revenues as mentioned above and by higher research and development costs generated by the company's validation and verification work for OptoWire II.

    
                                                    FINANCIAL SUMMARY          
                               (in thousands of dollars, except for per-share information)

                                Three-month period    Three-month period    Nine-month period     Nine-month period
                                ended May 31, 2015    ended May 31, 2014   ended May 31, 2015    ended May 31, 2014
 
Sales                                     $    831              $  1,703            $   7,555            $    5,024
Cost of sales                                  599                 1,197                2,706                 3,343
Gross margin                                   232                   506                4,849                 1,681
Administrative expenses                        612                   667                1,985                 1,781
Sales and marketing expenses                   342                   323                1,183                   829
Research and development 
expenses                                       635                   528                1,624                 1,391
Financial expenses (revenues)                   (2)                   10                   (7)                  230
Impairment charge                                -                     -                  796                     -
                                             1,587                 1,528                5,581                 4,231
(Loss) before income taxes                  (1,355)               (1,022)                (732)               (2,550)
Current income tax expense                       -                     -                  340                     -
Net (loss) and 
comprehensive (loss)                        (1,355)               (1,022)              (1,072)               (2,550)
Net (loss) per share 
-- basic                                     (0.02)                (0.02)               (0.02)                (0.05)
Net (loss) per share 
-- diluted                                   (0.02)                (0.02)               (0.02)                (0.05)

We seek Safe Harbor.

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