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Opsens Inc T.OPS

OpSens Inc. is a medical device cardiology-focused company. The Company offers an advanced optical-based pressure guidewire that aims at improving the clinical outcome of patients with coronary artery disease. The Company’s segments include Medical and Industrial. The Medical segment focuses on physiological measurements, such as Fractional Flow Reserve (FFR) and Diastolic Pressure Ratio (dPR) in the coronary artery disease market and also supplies a range of miniature optical sensors to measure pressure and temperature to be used in a range of applications that can be integrated into other medical devices. The Industrial segment develops, manufactures and installs fiber optic sensing solutions for critical and demanding industrial applications. Its flagship product, the OptoWire, is a second-generation fiber optic pressure guidewire designed to provide the lowest drift in the industry and lesions access. It is approved for sale in the United States, European Union, Japan and Canada.


TSX:OPS - Post by User

Post by bossuon Jul 21, 2022 11:43am
228 Views
Post# 34840558

A game changer....FDA approval

A game changer....FDA approvalFrom the last CC:
''n regards to the FDA clearance, since the last call, we had a Q-Sub meeting with the FDA to discuss our proposed answers on last questions remaining. The Q-Sub meeting allows them to provide real-time feedback to the proposed answers. We are positive about our interactions with the FDA and expect to have final responses ready in the coming weeks. Upon our final submission of these responses, the FDA usually takes 60 days to respond, which would put a potential approval in the second half of calendar 2022 in line with our original expectations. While we await the FDA's clearance, we are advancing our commercial operations to ensure a successful commercial launch later this year.

This mean that just prior to the Q4 due november 23 in 4 months from now Opsen should have the FDA approval.
Thiis will make a ''Big SPLASH''on the share price and could be a 40 %
about what we has been  seen in April with the Healt Canada OK.
The actual share price is trading in a new range .
Action: 'We have to be patient and a great  reward for all share holders,
Later one OPSENS might be a take over target because of the potential it offer.


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