QUEBEC CITY, July 3, 2014 /CNW Telbec/ - Opsens Inc. ("Opsens" or the
"Company") (TSXV: OPS) today released results for its third quarter
ended May 31, 2014.
HIGHLIGHTS
-
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.
|
|
|
|
|
(In thousands of Canadian dollars, except for information per share)
|
Three-month
period ended
May 31, 2014
|
Three-month
period ended
May 31, 2013
|
Nine-month
period ended
May 31, 2014
|
Nine-month
period ended
May 31, 2013
|
$
|
$
|
$
|
$
|
|
|
|
|
|
Revenues
|
1,703
|
1,706
|
5,024
|
6,075
|
Cost of sales
|
1,197
|
1,142
|
3,343
|
3,650
|
Gross margin
|
506
|
564
|
1,681
|
2,425
|
|
|
|
|
|
Administrative expenses
|
667
|
546
|
1,781
|
1,695
|
Marketing expenses
|
323
|
254
|
829
|
729
|
R&D expenses
|
528
|
426
|
1,391
|
1,238
|
Financial expenses
|
10
|
27
|
230
|
53
|
|
1,528
|
1,253
|
4,231
|
3,715
|
|
|
|
|
|
Net loss and comprehensive loss
|
(1,022)
|
(689)
|
(2,550)
|
(1,290)
|
Net loss per share - Basic
|
(0.02)
|
(0.01)
|
(0.05)
|
(0.03)
|
Net loss per share - Diluted
|
(0.02)
|
(0.01)
|
(0.05)
|
(0.03)
|
About Opsens Inc. (www.opsens.com)
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.
Neither TSX Venture Exchange nor its Regulation Services Provider (as
that term is defined in the policies of the TSX Venture Exchange)
accepts responsibility for the adequacy or accuracy of this release.
SOURCE OPSENS INC.