QUEBEC CITY, Sept. 26, 2016 /CNW Telbec/ - Opsens Inc.
("Opsens" or the "Company") (TSXV: OPS) (OTCQX: OPSSF)
announces 510(k) clearance from the U.S. Food and Drug
Administration ("FDA") for the OptoMonitor II, a new
multimodality monitor combining the ability to measure Fractional
Flow Reserve ("FFR") along with measuring intravascular and
intracatheter pressure.
In the United States, Opsens
already sells its products to measure FFR for the diagnostic and
treatment guidance in patients with coronary heart disease. The
OptoMonitor II is now indicated to be used with FDA cleared
Occlusion Perfusion Catheter® (OPC) from Advanced Catheter
Therapies, Inc. ("ACT") and its partner Toray Industries, Inc.
("Toray"). The OPC is indicated for localized infusion or
irrigation diagnostic and therapeutic agent to the peripheral
vasculature.
"We are pleased to provide our products and technologies to
partners like ACT and Toray for opportunities with strong potential
such as OPC," said Louis Laflamme,
President and CEO of Opsens. "This product is designed for the
infusion of therapeutic agents in the peripheral vasculature.
Marketing of the OPC will create a synergy with our FFR activities
through the deployment of a larger number of now multimodal
OptoMonitor, helping Opsens build critical mass," said Mr.
Laflamme.
Opsens aims to become a key player in the guidewire FFR market
with the OptoWire, a nitinol-based optical guidewire. The OptoWire
provides intra-coronary blood pressure measurements with unique,
patented optical pressure guidewire technologies. It is immune to
adverse effects related to blood contact, and allows easy and
reliable connectivity that leads to reliable FFR measurements in
extended conditions of usage. The OptoWire is also designed to
provide cardiologists with a guidewire that provides optimal
performance to navigate coronary arteries and cross blockages with
ease and safety. Based on industry sources, the FFR market
represented more than US$300 million
in sales in 2014 and is expected to reach US$1 billion in the medium-term.
About Opsens Inc. (www.opsens.com or
www.opsensmedical.com)
Opsens focuses mainly on the measure of FFR 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. Opsens is also involved in
industrial activities. The Company 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.