OPSENS APPLAUDS JAPANESE GOVERNMENT NEW REGULATION SUPPORTING DIAGNOSIS, SUCH AS FFR, BEFORE TREATMENT OF CORONARY STENOSIS
Quebec City, Quebec, April 24, 2018 – Opsens Inc. (“Opsens” or the “Company”) (TSX:OPS) (OTCQX:OPSSF) applauds Japan’s Ministry of Health, Labor and Welfare (“MHLW”) on its new regulation requiring the evaluation of any coronary stenosis prior to its treatment, specifically mentioning Fractional Flow Reserve (“FFR”) as a preferred assessment method.
The MHLW recently revised medical fees and established a requirement that functional ischemia (blockage of arteries) be evaluated before treatment for stable coronary artery disease.
This new review regulation is consistent with the results of multiple studies, such as the FAME study, which demonstrate that, when a patient’s lesion is assessed with FFR prior to treatment selection, clinical outcome is improved significantly.
The MHLW regulation is expected to have a positive impact on FFR penetration in the Japanese market, which currently represents the largest user of Opsens’ FFR products. Opsens’ revenues may be positively impacted as soon as the fourth quarter of fiscal year 2018.
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 in developing, manufacturing and installing innovative fibre optic sensing solutions for critical 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.
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For further information, please contact:
Louis Laflamme, CPA, CA, Chief Executive Officer, 418.781.0333
Robin Villeneuve, CPA, CA, Chief Financial Officer, 418.781.0333