QUEBEC CITY, July 2, 2015 /CNW Telbec/ - Opsens Inc.
("Opsens" or the "Company") (TSXV: OPS) (OTCQX: OPSSF) today
released results for its third quarter ended May 31, 2015.
HIGHLIGHTS OF THE THIRD QUARTER 2015
- Receipt of 510 (k) clearance from the U.S. Food and Drug
Administration ("FDA") for commercialisation of the OptoWire and
OptoMonitor, Opsens' 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' FFR products for the first
time;
- Opsens' 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 U.S.
Recently, Opsens received 510 (k) clearance to market its FFR
products in the U.S., the world's largest market for this type of
procedure.
PRE-COMMERCIALIZATION PHASE FOR FFR PRODUCTS WELL UNDERWAY IN
EUROPE AND JAPAN
In the past few months, the Company initiated a limited market
release of the OptoWire and OptoMonitor, Opsens' 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' 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 guidewire like the OptoWire is
positive for interventional cardiologists and could help promote
the use of FFR.
During the third quarter of 2015, pre-commercialization of
Opsens' 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' FFR products were showcased
in a live case presentation.
NEW PRODUCTION FACILITY
The positive feedback on the performance of Opsens' FFR products
and the recent receipt of the FDA approval for the
commercialization of its products in the U.S. 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.
|
|
|
|
|
(In thousands of
Canadian dollars, except for information per share)
|
Three-month
period
ended
May 31,
2015
|
Three-month
period
ended
May 31,
2014
|
Nine-month
period
ended
May 31,
2015
|
Nine-month
period 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
|
R&D
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)
|
About Opsens Inc. (www.opsens.com or
www.opsensmedical.com)
Opsens focuses mainly on two large and growing markets:
interventional cardiology with a focus on Fractional Flow Reserve
("FFR") and the industrial, oil and gas segment. In interventional
cardiology, Opsens offers an advanced optical-based pressure
guidewire (OptoWire) that aims at improving the clinical outcome of
patients with coronary artery disease. In the industrial, oil &
gas segment, Opsens develops, manufactures and installs innovative
fibre optic sensing solutions for critical applications such as the
monitoring of oil wells and other demanding industrial
applications.
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.